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Original Articles
Gastrointestinal cancer
A Single-Arm Phase II Study of Nab-Paclitaxel Plus Gemcitabine and Cisplatin for Locally Advanced or Metastatic Biliary Tract Cancer
Ting Liu, Qing Li, Zhen Lin, Chunhua Liu, Wei Pu, Shasha Zeng, Jun Lai, Xuebin Cai, Lisha Zhang, Shuyang Wang, Miao Chen, Wei Cao, Hongfeng Gou, Qing Zhu
Cancer Res Treat. 2024;56(2):602-615.   Published online October 12, 2023
DOI: https://doi.org/10.4143/crt.2023.726
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Patients with advanced biliary tract cancer (BTC) have a poor survival. We aim to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine and cisplatin regimen in Chinese advanced BTC patients.
Materials and Methods
Eligible patients with locally advanced or metastatic BTC administrated intravenous 100 mg/m2 nab-paclitaxel, 800 mg/m2 gemcitabine, and 25 mg/m2 cisplatin every 3 weeks. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS) and adverse events, while exploratory endpoint was the association of biomarkers with efficacy.
Results
After the median follow-up of 25.0 months, the median PFS and OS of 34 enrolled patients were 7.1 months (95% confidence interval [CI], 5.4 to 13.7) and 16.4 months (95% CI, 10.9 to 23.6), respectively. The most common treatment-related adverse events at ≥ 3 grade were neutropenia (26.5%) and leukopenia (26.5%). Survival analyses demonstrated that carcinoembryonic antigen (CEA) levels could monitor patients’ survival outcomes. A significant increase in the number of infiltrating CD4+ cells (p=0.008) and a decrease in programmed death-1–positive (PD-1+) cells (p=0.032) were observed in the response patients.
Conclusion
In advanced BTC patients, nab-paclitaxel plus gemcitabine and cisplatin regimen showed therapeutic potential. Potential prognostic factors of CEA levels, number of CD4+ cells and PD-1+ cells may help us maximize the efficacy benefit.

Citations

Citations to this article as recorded by  
  • Efficacy and biomarker analysis of second‐line nab‐paclitaxel plus sintilimab in patients with advanced biliary tract cancer
    Xiaofen Li, Nan Zhou, Yu Yang, Zijian Lu, Hongfeng Gou
    Cancer Science.2024; 115(7): 2371.     CrossRef
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  • 2 Web of Science
  • 1 Crossref
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Gemcitabine Inhibits the Progression of Pancreatic Cancer by Restraining the WTAP/MYC Chain in an m6A-Dependent Manner
Pei Cao, Weigang Zhang, Junyi Qiu, Zuxiong Tang, Xiaofeng Xue, Tingting Feng
Cancer Res Treat. 2024;56(1):259-271.   Published online August 16, 2023
DOI: https://doi.org/10.4143/crt.2022.1600
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Pancreatic cancer (PC) is a common malignant tumor of the digestive system, and its 5-year survival rate is only 4%. N6-methyladenosine (m6A) RNA methylation is the most common post-transcriptional modification and dynamically regulates cancer development, while its role in PC treatment remains unclear.
Materials and Methods
We treated PC cells with gemcitabine and quantified the overall m6A level with m6A methylation quantification. Real-time quantitative reverse transcription polymerase chain reaction and Western blot analyses were used to detect expression changes of m6A regulators. We verified the m6A modification on the target genes through m6A-immunoprecipitation (IP), and further in vivo experiments and immunofluorescence (IF) assays were applied to verify regulation of gemcitabine on Wilms’ tumor 1–associated protein (WTAP) and MYC.
Results
Gemcitabine inhibited the proliferation and migration of PC cells and reduced the overall level of m6A modification. Additionally, the expression of the “writer” WTAP was significantly downregulated after gemcitabine treatment. We knocked down WTAP in cells and found target gene MYC expression was significantly downregulated, m6A-IP also confirmed the m6A modification on MYC. Our experiments showed that m6A-MYC may be recognized by the “reader” IGF2BP1. In vivo experiments revealed gemcitabine inhibited the tumorigenic ability of PC cells. IF analysis also showed that gemcitabine inhibited the expression of WTAP and MYC, which displayed a significant trend of co-expression.
Conclusion
Our study confirmed that gemcitabine interferes with WTAP protein expression in PC, reduces m6A modification on MYC and RNA stability, thereby inhibiting the downstream pathway of MYC, and inhibits the progression of PC.

Citations

Citations to this article as recorded by  
  • The biological roles and molecular mechanisms of m6A reader IGF2BP1 in the hallmarks of cancer
    Li Qiu, Shourong Wu, Lei Zhang, Wenfang Li, Debing Xiang, Vivi Kasim
    Genes & Diseases.2025; : 101567.     CrossRef
  • WTAP-mediated N6-methyladenosine modification promotes the inflammation, mitochondrial damage and ferroptosis of kidney tubular epithelial cells in acute kidney injury by regulating LMNB1 expression and activating NF-κB and JAK2/STAT3 pathways
    Fan Huang, Yuchen Wang, XiaoLi Lv, Chenda Huang
    Journal of Bioenergetics and Biomembranes.2024; 56(3): 285.     CrossRef
  • 3,334 View
  • 171 Download
  • 2 Web of Science
  • 2 Crossref
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Gynecologic cancer
Effectiveness of Concomitant Chemoradiotherapy with Gemcitabine in Locally Advanced Cervical Cancer Patients with Comorbidities
Hasan Brau-Figueroa, Eder Arango-Bravo, Denisse Castro-Eguiluz, Tatiana Galicia-Carmona, Leopoldo Abraham Lugo-Alferez, Ivette Cruz-Bautista, Roberto Jiménez-Lima, Lucely Cetina-Pérez
Cancer Res Treat. 2022;54(2):554-562.   Published online August 10, 2021
DOI: https://doi.org/10.4143/crt.2021.375
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The standard treatment for locally advanced cervical cancer (LACC) is concomitant chemoradiotherapy with cisplatin (CDDP) followed by brachytherapy. The presence of comorbidities are risk factors for nephrotoxicity and are associated with lower survival. Gemcitabine is a radiosensitizing drug that has shown efficacy and safety in this context. The effectiveness of concomitant chemoradiotherapy with gemcitabine was evaluated versus cisplatin in LACC patients with comorbidities and preserved renal function.
Materials and Methods
An observational, longitudinal and paired study was carried out that included patients treated between February 2003 and December 2015. The primary objectives were to evaluate response rates, progression-free survival, and overall survival; the secondary objectives were to evaluate toxicity and renal function.
Results
Sixty-three patients treated with gemcitabine at 300 mg/m2 weekly and 126 patients treated with CDDP 40 mg/m2 weekly were included. There were no significant differences in response rates and survival rates. Treatment with cisplatin presented a higher frequency of hematological toxicities, while gemcitabine presented a higher frequency of gastrointestinal toxicities. A decrease in glomerular filtration rate (GFR; baseline vs. 1-year post-treatment) was observed in the cisplatin group (p=0.002), while not in the gemcitabine group (p=0.667). In a multivariate analysis, it is observed that only CDDP correlates with the decrease in GFR (hazard ratio, 2.42; p=0.012).
Conclusion
In LACC patients with comorbidities, gemcitabine and CDDP show the same efficacy, with different toxicity profiles. Treatment with cisplatin is associated with a significant decrease in GFR during follow-up, compared to treatment with gemcitabine that does not decrease it.

Citations

Citations to this article as recorded by  
  • Medical nanoscale materials for virus-induced cervical cancer therapeutic modalities: For targeting delivery
    Adane Adugna, Mamaru Getinet, Gashaw Azanaw Amare, Mohammed Jemal
    OpenNano.2025; 21: 100221.     CrossRef
  • Chemoradiotherapy treatment with gemcitabine improves renal function in locally advanced cervical cancer patients with renal dysfunction
    Silvia Alarcón-Barrios, Julissa Luvián-Morales, Denisse Castro-Eguiluz, Merari Delgadillo-González, Brenda Olivia Lezcano-Velázquez, Eder Alexandro Arango-Bravo, Laura Flores-Cisneros, Sebastián Aguiar Rosas, Lucely Cetina-Pérez
    Current Problems in Cancer.2024; 48: 101041.     CrossRef
  • Association between body composition phenotypes and treatment toxicity in women with cervical cancer undergoing chemoradiotherapy
    Mariah Azevedo Aredes, Nathália Silva de Paula, Gabriela Villaça Chaves
    Nutrition.2024; 127: 112539.     CrossRef
  • Older adults with cancer and common comorbidities—challenges and opportunities in improving their cancer treatment outcomes
    Weiwei Chen, Rachel D Altshuler, Phil Daschner, Carolina Salvador Morales, Diane C St. Germain, Jennifer Guida, Pataje G S Prasanna, Jeffrey C Buchsbaum
    JNCI: Journal of the National Cancer Institute.2024; 116(11): 1730.     CrossRef
  • 6,950 View
  • 156 Download
  • 3 Web of Science
  • 4 Crossref
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Genitourinary Cancer
Use of Gemcitabine plus Carboplatin is Associated with Poor Outcomes in Urothelial Carcinoma Patients with Chronic Kidney Disease Stage 4-5
Hyung-Don Kim, Hyeon-Su Im, Jwa Hoon Kim, Hyehyun Jeong, Shin Kyo Yoon, Inkeun Park, Jae Lyun Lee
Cancer Res Treat. 2021;53(4):1166-1173.   Published online March 4, 2021
DOI: https://doi.org/10.4143/crt.2021.091
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
This study aimed to investigate the clinical outcomes with gemcitabine-carboplatin (GCb), the standard treatment for patients with advanced urothelial carcinoma (UC) who are ineligible for cisplatin-based regimens, in advanced UC patients with a glomerular filtration rate (GFR) < 30 mL/min.
Materials and Methods
A retrospective cohort study involving GCb-treated advanced UC patients with GFR < 60 mL/min (n=89) was performed. Clinical outcomes were compared between subgroups with GFR < 30 mL/min and GFR ≥ 30 mL/min but < 60 mL/min.
Results
Most baseline characteristics were comparable between the two subgroups. Patients with GFR < 30 mL/min had a significantly lower objective response rate (12.5%) compared to those with higher GFR levels (56.7%) (p=0.004). The number of GCb cycles was significantly lower in patients with GFR < 30 mL/min (median 2 cycles) than in those with higher GFR levels (median 6 cycles) (p=0.002). Compared to those with GFR ≥ 30 mL/min but < 60 mL/min, patients with GFR < 30 mL/min showed significantly worse progression-free survival (PFS) and overall survival (OS) (p < 0.001 for both). Further stratification of patient subgroups according to their GFR (i.e., GFR ≥ 45 mL/min but < 60 mL/min vs. GFR ≥ 30 mL/min but < 45 mL/min vs. GFR < 30 mL/min) revealed significantly different PFS and OS (p < 0.001 for both).
Conclusion
The use of GCb is discouraged in advanced UC patients with GFR < 30 mL/min. Alternative therapeutic approaches with better efficacy are warranted for these patients.

Citations

Citations to this article as recorded by  
  • Onconephrology: mitigation of renal injury in chemotherapy administration
    Umut Selamet, Rebecca S. Ahdoot, Reed Salasnek, Lama Abdelnour, Ramy M. Hanna
    Current Opinion in Nephrology & Hypertension.2024; 33(2): 257.     CrossRef
  • Management of bladder cancer in older patients
    Shingo Hatakeyama, Shintaro Narita, Kazutaka Okita, Takuma Narita, Hiromichi Iwamura, Naoki Fujita, Junichi Inokuchi, Yoshiyuki Matsui, Hiroshi Kitamura, Chikara Ohyama
    Japanese Journal of Clinical Oncology.2022; 52(3): 203.     CrossRef
  • 5,399 View
  • 121 Download
  • 2 Web of Science
  • 2 Crossref
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Gastrointestinal Cancer
Phase II Trial of Postoperative Adjuvant Gemcitabine and Cisplatin Chemotherapy Followed by Chemoradiotherapy with Gemcitabine in Patients with Resected Pancreatic Cancer
Kyung-Hun Lee, Eui Kyu Chie, Seock-Ah Im, Jee Hyun Kim, Jihyun Kwon, Sae-Won Han, Do-Youn Oh, Jin-Young Jang, Jae-Sung Kim, Tae-You Kim, Yung-Jue Bang, Sun Whe Kim, Sung W. Ha
Cancer Res Treat. 2021;53(4):1096-1103.   Published online December 30, 2020
DOI: https://doi.org/10.4143/crt.2020.928
AbstractAbstract PDFPubReaderePub
Purpose
Despite curative resection, the 5-year survival for patients with resectable pancreatic cancer is less than 20%. Recurrence occurs both locally and at distant sites and effective multimodality adjuvant treatment is needed.
Materials and Methods
Patients with curatively resected stage IB-IIB pancreatic adenocarcinoma were eligible. Treatment consisted of chemotherapy with gemcitabine 1,000 mg/m2 on days 1 and 8 and cisplatin 60 mg/m2 on day 1 every 3 weeks for two cycles, followed by chemoradiotherapy (50.4 Gy/28 fx) with weekly gemcitabine (300 mg/m2/wk), and then gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks for four cycles. The primary endpoint was 1-year disease-free survival rate. The secondary endpoints were disease-free survival, overall survival, and safety.
Results
Seventy-four patients were enrolled. One-year disease-free survival rate was 57.9%. Median disease-free and overall survival were 15.0 months (95% confidence interval [CI], 11.6 to 18.4) and 33.0 months (95% CI, 21.8 to 44.2), respectively. At the median follow-up of 32 months, 57 patients (77.0%) had recurrence including 11 patients whose recurrence was during the adjuvant treatment. Most of the recurrences were systemic (52 patients). Stage at the time of diagnosis (70.0% in IIA, 51.2% in IIB, p=0.006) were significantly related with 1-year disease-free survival rate. Toxicities were generally tolerable, with 53 events of grade 3 or 4 hematologic toxicity and four patients with febrile neutropenia.
Conclusion
Adjuvant gemcitabine and cisplatin chemotherapy followed by chemoradiotherapy with gemcitabine and maintenance gemcitabine showed efficacy and good tolerability in curatively resected pancreatic cancer.

Citations

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  • NUDT21 interacts with NDUFS2 to activate the PI3K/AKT pathway and promotes pancreatic cancer pathogenesis
    Xiao-Dong Huang, Yong-Wei Chen, Lv Tian, Li Du, Xiao-Chen Cheng, Yu-Xin Lu, Dong-Dong Lin, Feng-Jun Xiao
    Journal of Cancer Research and Clinical Oncology.2024;[Epub]     CrossRef
  • Efficacy of Cisplatin-Containing Chemotherapy Regimens in Patients of Pancreatic Ductal Adenocarcinoma: A Systematic Review and Meta-analysis
    Obaid Ur Rehman, Eeshal Fatima, Zain Ali Nadeem, Arish Azeem, Jatin Motwani, Habiba Imran, Hadia Mehboob, Alishba Khan, Omer Usman
    Journal of Gastrointestinal Cancer.2024; 55(2): 559.     CrossRef
  • OTUB1/NDUFS2 axis promotes pancreatic tumorigenesis through protecting against mitochondrial cell death
    Xiao-Dong Huang, Li Du, Xiao-Chen Cheng, Yu-Xin Lu, Qiao-Wei Liu, Yi-Wu Wang, Ya-Jin Liao, Dong-Dong Lin, Feng-Jun Xiao
    Cell Death Discovery.2024;[Epub]     CrossRef
  • Impact of obesity on pathological complete remission in early stage breast cancer patients after neoadjuvant chemotherapy: a retrospective study from a German University breast center
    Johannes Felix Englisch, Alexander Englisch, Dominik Dannehl, Kenneth Eissler, Christian Martin Tegeler, Sabine Matovina, Léa Louise Volmer, Diethelm Wallwiener, Sara Y. Brucker, Andreas Hartkopf, Tobias Engler
    Archives of Gynecology and Obstetrics.2024; 311(2): 437.     CrossRef
  • A Photothermal Therapy Study Based on Electrospinning Nanofibers Blended and Coated with Polydopamine Nanoparticles
    Chunhong Sui, Yijia Luo, Xiao Xiao, Jiaxue Liu, Xiaotong Shao, Yingxue Xue, Cheng Wang, Wenliang Li
    ChemistrySelect.2023;[Epub]     CrossRef
  • Ivermectin and gemcitabine combination treatment induces apoptosis of pancreatic cancer cells via mitochondrial dysfunction
    Da Eun Lee, Hyeon Woong Kang, So Yi Kim, Myeong Jin Kim, Jae Woong Jeong, Woosol Chris Hong, Sungsoon Fang, Hyung Sun Kim, Yun Sun Lee, Hyo Jung Kim, Joon Seong Park
    Frontiers in Pharmacology.2022;[Epub]     CrossRef
  • CircLMTK2 Silencing Attenuates Gemcitabine Resistance in Pancreatic Cancer by Sponging miR-485-5p and to Target PAK1
    Yeting Lu, Shuping Zhou, Gong Cheng, Yi Ruan, Yuan Tian, Kaiji Lv, Shuo Han, Xinhua Zhou, Xiangya Ding
    Journal of Oncology.2022; 2022: 1.     CrossRef
  • Effects of Radiotherapy and Chemotherapy on Postoperative Prognosis of Patients Undergoing Radical Surgery for Pancreatic Cancer—Based on SEER Database Analysis
    媛媛 苏
    Advances in Clinical Medicine.2022; 12(10): 9540.     CrossRef
  • Zebrafish Patient-Derived Xenografts Identify Chemo-Response in Pancreatic Ductal Adenocarcinoma Patients
    Alice Usai, Gregorio Di Franco, Margherita Piccardi, Perla Cateni, Luca Emanuele Pollina, Caterina Vivaldi, Enrico Vasile, Niccola Funel, Matteo Palmeri, Luciana Dente, Alfredo Falcone, Dimitri Giunchi, Alessandro Massolo, Vittoria Raffa, Luca Morelli
    Cancers.2021; 13(16): 4131.     CrossRef
  • Hypoxia-Induced ZWINT Mediates Pancreatic Cancer Proliferation by Interacting With p53/p21
    Peng Chen, Zhiwei He, Jie Wang, Jian Xu, Xueyi Jiang, Yankun Chen, Xinyuan Liu, Jianxin Jiang
    Frontiers in Cell and Developmental Biology.2021;[Epub]     CrossRef
  • 6,924 View
  • 153 Download
  • 10 Crossref
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Gastrointestinal cancer
Effect of Combining EGFR Tyrosine Kinase Inhibitors and Cytotoxic Agents on Cholangiocarcinoma Cells
Boonyakorn Boonsri, Kiren Yacqub-Usman, Pakpoom Thintharua, Kyaw Zwar Myint, Thannicha Sae-Lao, Pam Collier, Chinnawut Suriyonplengsaeng, Noppadol Larbcharoensub, Brinda Balasubramanian, Simran Venkatraman, Isioma U. Egbuniwe, Dhanwant Gomez, Abhik Mukherjee, Supeecha Kumkate, Tavan Janvilisri, Abed M Zaitoun, Thiti Kuakpaetoon, Rutaiwan Tohtong, Anna M Grabowska, David O. Bates, Kanokpan Wongprasert
Cancer Res Treat. 2021;53(2):457-470.   Published online October 7, 2020
DOI: https://doi.org/10.4143/crt.2020.585
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The potential of members of the epidermal growth factor receptor (ErbB) family as drug targets in cholangiocarcinoma (CCA) has not been extensively addressed. Although phase III clinical trials showed no survival benefits of erlotinib in patients with advanced CCA, the outcome of the standard-of-care chemotherapy treatment for CCA, gemcitabine/cisplatin, is discouraging so we determined the effect of other ErbB receptor inhibitors alone or in conjunction with chemotherapy in CCA cells. Materials and Methods ErbB receptor expression was determined in CCA patient tissues by immunohistochemistry and digital-droplet polymerase chain reaction, and in primary cells and cell lines by immunoblot. Effects on cell viability and cell cycle distribution of combination therapy using ErbB inhibitors with chemotherapeutic drugs was carried out in CCA cell lines. 3D culture of primary CCA cells was then adopted to evaluate the drug effect in a setting that more closely resembles in vivo cell environments.
Results
CCA tumors showed higher expression of all ErbB receptors compared with resection margins. Primary and CCA cell lines had variable expression of erbB receptors. CCA cell lines showed decreased cell viability when treated with chemotherapeutic drugs (gemcitabine and 5-fluorouracil) but also with ErbB inhibitors, particularly afatinib, and with a combination. Sequential treatment of gemcitabine with afatinib was particularly effective. Co-culture of CCA primary cells with cancer-associated fibroblasts decreased sensitivity to chemotherapies, but sensitized to afatinib. Conclusion Afatinib is a potential epidermal growth factor receptor targeted drug for CCA treatment and sequential treatment schedule of gemcitabine and afatinib could be explored in CCA patients.

Citations

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  • Rational synthesis and evaluation of 2,4-diamino-thieno[2,3-d]pyrimidines as antitumor agents
    Yumeng Gao, Ainv Zhang, Li Li, Fengxu Wu, Yanggen Hu
    Journal of Saudi Chemical Society.2024; 28(1): 101794.     CrossRef
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    Apiwit Sae-fung, Apiwat Mutirangura, Siriporn Jitkaew
    Frontiers in Immunology.2023;[Epub]     CrossRef
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    Kyaw Zwar Myint, Mireia Sueca-Comes, Pamela Collier, Brinda Balasubramanian, Simran Venkatraman, John Gordan, Abed M. Zaitoun, Abhik Mukherjee, Arvind Arora, Noppadol Larbcharoensub, Chinnawut Suriyonplengsaeng, Kanokpan Wongprasert, Tavan Janvilisri, Dha
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    Jinchutha Duangdara, Boonyakorn Boonsri, Apinya Sayinta, Kittiya Supradit, Pakpoom Thintharua, Supeecha Kumkate, Chinnawut Suriyonplengsaeng, Noppadol Larbcharoensub, Somkit Mingphruedhi, Narongsak Rungsakulkij, Paramin Muangkaew, Pongsatorn Tangtawee, Wa
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    Ubonrat Thamrongwaranggoon, Marutpong Detarya, Wunchana Seubwai, Charupong Saengboonmee, Shinjiro Hino, Tomoaki Koga, Mitsuyoshi Nakao, Sopit Wongkham
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    Hao Peng, Erwei Zhu, Yewei Zhang
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    Brinda Balasubramanian, Simran Venkatraman, Tavan Janvilisri, Tuangporn Suthiphongchai, Siriporn Jitkaew, Jittiyawadee Sripa, Rutaiwan Tohtong
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  • 7 Crossref
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Clinical Outcomes of Second-Line Chemotherapy after Progression on Nab-Paclitaxel Plus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma
Kyoungmin Lee, Kyunghye Bang, Changhoon Yoo, Inhwan Hwang, Jae Ho Jeong, Heung-Moon Chang, Dongwook Oh, Tae Jun Song, Do Hyun Park, Sang Soo Lee, Sung Koo Lee, Myung-Hwan Kim, Jin-hong Park, Kyu-pyo Kim, Baek-Yeol Ryoo
Cancer Res Treat. 2020;52(1):254-262.   Published online July 9, 2019
DOI: https://doi.org/10.4143/crt.2019.190
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Since the introduction of nab-paclitaxel plus gemcitabine (nab-P+GEM) as first-line (1L) treatment for metastatic pancreatic adenocarcinoma (mPDAC), optimal second-line (2L) chemotherapy after progression is unclear. We assessed clinical outcomes of 2L chemotherapy for disease that progressed on 1L nab-P+GEM.
Materials and Methods
Among the 203 patients previously treated with 1L nab-P+GEM for mPDAC at Asan Medical Center, between February and December 2016, records of 120 patients receiving 2L chemotherapy after progression on nab-P+GEM were retrospectively reviewed. The response rate and survival were evaluated along with analysis of prognostic factors.
Results
Fluoropyrimidine-oxaliplatin doublets (FOLFOX or XELOX) were used in 78 patients (65.0%), fluoropyrimidine monotherapy in 37 (30.8%), and liposomal irinotecan plus fluorouracil in two (1.7%). The median progression-free survival (PFS) and overall survival (OS) were 3.29 months and 7.33 months from the start of 2L therapy. Fluoropyrimidine-oxaliplatin regimens and fluoropyrimidine monotherapy did not yield significantly different median PFS (2.89 months vs. 3.81 months, p=0.40) or OS (7.04 months vs. 7.43 months, p=0.86). A high neutrophil-lymphocyte ratio (> 2.2) and a short time to progression with 1L nab-P+GEM (< 6.4 months) were independent prognostic factors of poor OS with 2L therapy.
Conclusion
2L fluoropyrimidine-oxaliplatin doublets and fluoropyrimidine monotherapy after failure of 1L nab-P+GEM had modest efficacy, with no differences in treatment outcomes between them. Further investigation is warranted for the optimal 2L chemo-regimens and sequencing of systemic chemotherapy for patients with mPDAC.

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    Sara Cherri, Silvia Noventa, Alberto Zaniboni
    World Journal of Gastroenterology.2021; 27(17): 1847.     CrossRef
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    Mandana Kamgar, Sakti Chakrabarti, Aditya Shreenivas, Ben George
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    Anabela Barros, Catarina Pulido, Manuela Machado, Maria Brito, Nuno Couto, Olga Sousa, Sónia Melo, Hélder Mansinho
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Clinical Benefit of Maintenance Therapy for Advanced Biliary Tract Cancer Patients Showing No Progression after First-Line Gemcitabine Plus Cisplatin
Jaewon Hyung, Bumjun Kim, Changhoon Yoo, Kyo-pyo Kim, Jae Ho Jeong, Heung-Moon Chang, Baek-Yeol Ryoo
Cancer Res Treat. 2019;51(3):901-909.   Published online October 4, 2018
DOI: https://doi.org/10.4143/crt.2018.326
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Gemcitabine plus cisplatin (GemCis) is the standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC). In ABC-02 study, the BTC patients received up to 6-8 cycles of 3-weekly GemCis; however, those without progression often receive more than 6-8 cycles. The clinical benefit of maintenance treatment in patients without progression is uncertain.
Materials and Methods
Advanced BTC patients treated with GemCis between April 2010 and February 2015 at Asan Medical Center, Seoul, Korea, were retrospectively analysed. The patients without progression after 6-8 cycles were stratified according to further treatment i.e., with or without further cycles of GemCis (maintenance vs. observation groups). The primary endpoint was overall survival (OS) and progression-free survival (PFS).
Results
Among the 740 BTC patients in the initial screen, 231 cases (31.2%) were eligible for analysis (111 in the observation group, 120 in the maintenance group). The median OS from the GemCis initiation was 20.5 months (95% confidence interval [CI], 15.4 to 25.6) and 22.4 months (95% CI, 17.0 to 27.8) in the observation and maintenance groups, respectively (p=0.162). The median PFS was 10.4 months (95% CI, 7.0 to 13.8) and 13.2 months (95% CI, 11.3 to 15.2), respectively (p=0.320).
Conclusions
GemCis maintenance is not associated with an improved survival outcome.

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Gemcitabine and Docetaxel Combination for Advanced Soft Tissue Sarcoma: A Nationwide Retrospective Study
Yunjung Choi, Mi Sun Yun, Sang Hee Lim, Jeeyun Lee, Jin-Hee Ahn, Yu Jung Kim, Kyong Hwa Park, Young Suk Park, Ho Yeong Lim, Hyonggin An, Dong-Churl Suh, Yeul Hong Kim
Cancer Res Treat. 2018;50(1):175-182.   Published online March 30, 2017
DOI: https://doi.org/10.4143/crt.2016.535
AbstractAbstract PDFPubReaderePub
Purpose
This nationwide retrospective study was conducted to evaluate the efficacy and safety of combined gemcitabine and docetaxel (GD) as an off-label therapy for advanced soft tissue sarcoma, which has limited treatment options owing to its rare occurrence.
Materials and Methods
A total of 228 patients received GD therapy for advanced soft tissue sarcoma from 2009 to 2014 in Korea. We retrospectively reviewed the clinical medical records and claims data of these patients.
Results
A total of 218 patients in 20 medical centers were included in the final analysis (median age, 50.0 years). The objective response rate was 15.1% (34/218, in the leiomyosarcoma subgroup; 26.3%). The median overall survival and progression-free survival were 10.3 months (95% confidence interval [CI], 8.4 to 12.2) and 3.3 months (95% CI, 2.8 to 4.7), respectively. The treatment was discontinued in 7.8% of patients owing to adverse events; however, there was no adverse event-related death. Neutropenia (35.7%) and anemia (15.1%) were the most frequent grade 3/4 toxicities. Univariate analysis for identifying the predictors of the progression-free survival period revealed that patients aged ≤ 50 years had a hazard ratio of 1.388 (95% CI, 1.027 to 1.875; p < 0.05) relative to those aged > 50 years, and the group with leiomyosarcoma had a hazard ratio of 0.693 (95% CI, 0.493 to 0.975; p < 0.05) relative to the group with other histopathological subtypes.
Conclusion
GD therapy was tolerable and effective for Korean patients with soft tissue sarcoma. In conclusion, for patients with advanced soft tissue sarcoma, especially leiomyosarcoma, GD therapy could be an important therapeutic option.

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Induction Chemotherapy with Gemcitabine and Cisplatin Followed by Simultaneous Integrated Boost–Intensity Modulated Radiotherapy with Concurrent Gemcitabine for Locally Advanced Unresectable Pancreatic Cancer: Results from a Feasibility Study
Sang Myung Woo, Min Kyeong Kim, Jungnam Joo, Kyong-Ah Yoon, Boram Park, Sang-Jae Park, Sung-Sik Han, Ju Hee Lee, Eun Kyung Hong, Yun-Hee Kim, Hae Moon, Sun-Young Kong, Tae Hyun Kim, Woo Jin Lee
Cancer Res Treat. 2017;49(4):1022-1032.   Published online January 19, 2017
DOI: https://doi.org/10.4143/crt.2016.495
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
This study assessed the feasibility and compliance of induction chemotherapy with gemcitabine and cisplatin followed by simultaneous integrated boost–intensity modulated radiotherapy (SIB-IMRT) with concurrent gemcitabine in patients with locally advanced unresectable pancreatic cancer.
Materials and Methods
In this trial, patients received induction chemotherapy consisting of gemcitabine (1,000 mg/m2) and cisplatin (25 mg/m2) on days 1, 8, and 15 of each treatment cycle. Patients were subsequently treated with gemcitabine (300 mg/m2/wk) during SIB-IMRT. The patients received total doses of 55 and 44 Gy in 22 fractions to planning target volume 1 and 2, respectively. As an ancillary study, digital polymerase chain reaction was performed to screen for the seven most common mutations in codons 12 and 13 of the KRAS oncogene of circulating cell free DNA (cfDNA).
Results
Forty-four patients were enrolled between 2012 and 2015. Of these, 33 (75%) completed the treatment. The most common toxicities during induction chemotherapy were grades 3 and 4 neutropenia (18.2%), grade 3 nausea (6.8%) and vomiting (6.8%). The most common toxicities during SIB-IMRT were grade 3 neutropenia (24.2%) and grade 3 anemia (12.1%). Ten patients (23%) underwent a curative resection after therapy. Median overall survival was significantly longer in patients who underwent curative resection (16.8 months vs. 11 months, p < 0.01). The median cfDNA concentration was significantly lower after treatment (108.5 ng/mL vs. 18.4 ng/mL, p < 0.001).
Conclusion
Induction chemotherapy with gemcitabine and cisplatin followed by concurrent SIB-IMRT was well tolerated and active.

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Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup Analysis of the Phase 3, Open-Label, Randomized SQUIRE Study
Keunchil Park, Eun Kyung Cho, Maximino Bello, Myung-Ju Ahn, Sumitra Thongprasert, Eun-Kee Song, Victoria Soldatenkova, Henrik Depenbrock, Tarun Puri, Mauro Orlando
Cancer Res Treat. 2017;49(4):937-946.   Published online January 6, 2017
DOI: https://doi.org/10.4143/crt.2016.423
AbstractAbstract PDFPubReaderePub
Purpose
The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1,093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study.
Materials and Methods
All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m²) and cisplatin (day 1, 75 mg/m²). Patients in the neci+GC arm also received necitumumab (days 1 and 8, 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from stratified Cox proportional hazards models.
Results
In EA patients, there were improvements for neci+GC (n=43) versus GC (n=41) in OS (HR, 0.805; 95% CI, 0.484 to 1.341) and PFS (HR, 0.720; 95% CI, 0.439 to 1.180), consistent with the results for non-EA patients observed in the present study. The overall safety data were consistent between EA and non-EA patients. A numerically higher proportion of patients experienced serious adverse events (AEs), grade ≥ 3 AEs, and AEs with an outcome of death for neci+GC versus GC in EA patients and EA patients versus non-EA patients for neci+GC.
Conclusion
Although limited by the small sample size and post hoc nature of the analysis, these findings are consistent with those of the overall study and suggest that neci+GC offers a survival advantage and favorable benefit/risk for EA patients with advanced squamous NSCLC.

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Prognostic Factors for Risk Stratification of Patients with Recurrent or Metastatic Pancreatic Adenocarcinoma Who Were Treated with Gemcitabine-Based Chemotherapy
Inkeun Park, Seung Joon Choi, Young Saing Kim, Hee Kyung Ahn, Junshik Hong, Sun Jin Sym, Jinny Park, Eun Kyung Cho, Jae Hoon Lee, Yong Ju Shin, Dong Bok Shin
Cancer Res Treat. 2016;48(4):1264-1273.   Published online March 23, 2016
DOI: https://doi.org/10.4143/crt.2015.250
AbstractAbstract PDFPubReaderePub
Purpose
The aim of this study was to verify prognostic factors including sarcopenia in patients with recurrent or metastatic pancreatic cancer receiving gemcitabine-based chemotherapy. Materials and Methods Medical records and computed tomography scan of consecutive patients treated with palliative gemcitabine-based chemotherapy from 2008 to 2014 were reviewed. The lumbar skeletal muscle index at third lumbar spine level was computed, and together with clinicolaboratory factors, univariate and multivariable analyses for overall survival (OS) were performed.
Results
A total of 88 patients were found. Median age was 65 years, and male patients were predominant (67.0%). Most patients had initially metastatic disease (72.7%), and gemcitabine monotherapy was administered in 29 patients (33.0%) while gemcitabine plus erlotinib was administered in 59 patients (67.0%). Seventy-six patients (86.3%) had sarcopenia. With a median follow-up period of 44.3 months (range, 0.6 to 44.3 months), median OS was 5.35 months (95% confidence interval [CI], 4.11 to 6.59). In univariate and multivariable analysis, high carcinoembryonic antigen level (hazard ratio [HR], 4.18; 95% CI, 1.95 to 8.97; p < 0.001), initially metastatic disease (HR, 3.37; 95% CI, 1.55 to 7.32; p=0.002), sarcopenia (HR, 2.97; 95% CI, 1.20 to 7.36; p=0.019), neutrophilia (HR, 2.94; 95% CI, 1.27 to 6.79; p=0.012), and high lactate dehydrogenase level (HR, 1.96; 95% CI, 1.07 to 3.58; p=0.029) were identified as independent prognostic factors for OS. Conclusion Five independent prognostic factors in patients with recurrent or metastatic pancreatic cancer who received gemcitabine-based chemotherapy were identified. These findings may be helpful in prediction of prognosis in clinical practice and can be used as a stratification factor for clinical trials.

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p21-Activated Kinase 4 (PAK4) as a Predictive Marker of Gemcitabine Sensitivity in Pancreatic Cancer Cell Lines
Sung-Ung Moon, Jin Won Kim, Ji Hea Sung, Mi Hyun Kang, Se-Hyun Kim, Hyun Chang, Jeong-Ok Lee, Yu Jung Kim, Keun-Wook Lee, Jee Hyun Kim, Soo-Mee Bang, Jong Seok Lee
Cancer Res Treat. 2015;47(3):501-508.   Published online November 24, 2014
DOI: https://doi.org/10.4143/crt.2014.054
AbstractAbstract PDFPubReaderePub
Purpose
p21-activated kinases (PAKs) are involved in cytoskeletal reorganization, gene transcription, cell proliferation and survival, and oncogenic transformation. Therefore, we hypothesized that PAK expression levels could predict the sensitivity of pancreatic cancer cells to gemcitabine treatment, and PAKs could be therapeutic targets.
Materials and Methods
Cell viability inhibition by gemcitabine was evaluated in human pancreatic cancer cell lines (Capan-1, Capan-2, MIA PaCa-2, PANC-1, Aspc-1, SNU-213, and SNU-410). Protein expression and mRNA of molecules was detected by immunoblot analysis and reverse transcription polymerase chain reaction. To define the function of PAK4, PAK4 was controlled using PAK4 siRNA.
Results
Capan-2, PANC-1, and SNU-410 cells were resistant to gemcitabine treatment. Immunoblot analysis of signaling molecules reported to indicate gemcitabine sensitivity showed higher expression of PAK4 and lower expression of human equilibrative nucleoside transporter 1 (hENT1), a well-known predictive marker for gemcitabine activity, in the resistant cell lines. Knockdown of PAK4 using siRNA induced the upregulation of hENT1. In resistant cell lines (Capan-2, PANC-1, and SNU-410), knockdown of PAK4 by siRNA resulted in restoration of sensitivity to gemcitabine.
Conclusion
PAK4 could be a predictive marker of gemcitabine sensitivity and a potential therapeutic target to increase gemcitabine sensitivity in pancreatic cancer.

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Comparison of the Efficacy between Gemcitabine-Cisplatin and Capecitabine-Cisplatin Combination Chemotherapy for Advanced Biliary Tract Cancer
Jieun Lee, Tae Ho Hong, In Seok Lee, Young Kyoung You, Myung Ah Lee
Cancer Res Treat. 2015;47(2):259-265.   Published online September 12, 2014
DOI: https://doi.org/10.4143/crt.2013.230
AbstractAbstract PDFPubReaderePub
Purpose
Gemcitabine-cisplatin combination chemotherapy has been regarded as standard regimen for advanced or metastatic biliary tract cancer (BTC), based on the ABC-02 trial. To date, however, no studies have compared the efficacies of gemcitabine-platinum and fluoropyrimidine- platinum combination chemotherapy, even though fluoropyrimidine has been widely used as a backbone agent for gastrointestinal cancer. This study compared the efficacy and toxicities of gemcitabine-cisplatin (GP) and capecitabine-cisplatin (XP) combination chemotherapy for treatment of advanced BTC. Materials and Methods We examined 49 patients treated with GP and 44 patients treated with XP from October 2009 to July 2012. All patients had unresectable BTC. The GP regimen comprised gemcitabine (1,000 mg/m2, intravenously [IV], days 1 and 8) and cisplatin (75 mg/m2, IV, day 1). The XP regimen comprised capecitabine (1,250 mg/m2 twice a day, peroral, days 1-14) and cisplatin (60 mg/m2, IV, day 1, every three weeks). We analyzed the response rate (RR), time to progression (TTP), overall survival (OS), and toxicity. Results The RRs were 27.3% and 6.1% in the XP and GP arms, respectively. XP resulted in longer TTP (5.2 months vs. 3.6 months, p=0.016), but OS was not statistically different (10.7 months vs. 8.6 months, p=0.365). Both regimens resulted in grade 3-4 hematologic toxicities, but febrile neutropenia was not noted. Grade 3-4 asthenia, stomatitis, and hand-foot syndrome occurred more frequently in the XP arm. Conclusion XP resulted in a superior TTP and RR compared to GP for treatment of advanced BTC, with comparable toxicity. Conduct of prospective large, randomized trials to evaluate the possibility of XP as another standard therapy is warranted.

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Gemcitabine Combined with Capecitabine Compared to Gemcitabine with or without Erlotinib as First-Line Chemotherapy in Patients with Advanced Pancreatic Cancer
Jae Yun Lim, Jang Ho Cho, Se Joon Lee, Dong Ki Lee, Dong Sup Yoon, Jae Yong Cho
Cancer Res Treat. 2015;47(2):266-273.   Published online August 29, 2014
DOI: https://doi.org/10.4143/crt.2013.158
AbstractAbstract PDFPubReaderePub
Purpose
The purpose of this study is to retrospectively compare the efficacy and tolerability between three regimens for first-line chemotherapy—gemcitabine plus capecitabine (GEM-X), gemcitabine plus erlotinib (GEM-T), and gemcitabine monotherapy (GEM)—in patients with advanced pancreatic cancer. Materials and Methods There was a total of 127 patients who underwent chemotherapy for pancreatic cancer between January 2007 and November 2011 at our institution. Patients were treated with either GEM (gemcitabine 1,000 mg/m2 on days 1, 8, and 15 every 4 weeks), GEM-T (gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks and erlotinib 100 mg daily), or GEM-X (gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks and capecitabine 850 mg/m2 twice daily for 2 weeks followed by 1 week’s rest) as the first-line treatment. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and toxicity were evaluated. Results The patient population was divided into groups depending on their first-line treatment: GEM (n=47), GEM-T (n=44), and GEM-X (n=36). GEM-X significantly improved ORR (21.2% vs. 12.7% and 15.9%), PFS (8.9 vs. 5.2 and 3.9 months; p < 0.001), and OS (12.1 vs. 10.4 and 9.9 months; p = 0.03) compared to GEM and GEM-T, respectively. There were higher incidences of some non-hematologic adverse events with GEM-X and GEM-T compared to GEM, but most were grade 1 or 2. Conclusion GEM-X presented better clinical efficacy and acceptable tolerability than GEM-T and GEM in advanced pancreatic cancers. It is worthy to further investigate which agent has a clinical advantage as a combination drug with gemcitabine in pancreatic cancer and to explore the predictive markers leading to personalize anti-cancer treatment.

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A Phase II Trial of Gemcitabine plus Capecitabine for Patients with Advanced Pancreatic Cancer
Jong Gwon Choi, Jae Hong Seo, Sang Cheul Oh, Chul Won Choi, Jun Suk Kim
Cancer Res Treat. 2012;44(2):127-132.   Published online June 30, 2012
DOI: https://doi.org/10.4143/crt.2012.44.2.127
AbstractAbstract PDFPubReaderePub
PURPOSE
The purpose of this study was to determine the efficacy and safety of treatment using gemcitabine and capecitabine for patients with advanced pancreatic cancer.
MATERIALS AND METHODS
Patients with advanced unresectable pancreatic adenocarcinoma were enrolled in the study. Inclusion criteria included no prior systemic chemotherapy or radiation therapy, at least one radiographically documented and measurable tumor lesion, and adequate patient organ functions. The patients received 1,000 mg/m2 gemcitabine intravenously on days 1, 8 and 15, and 830 mg/m2 of oral capecitabine twice a day on days 1-21 of a 28-day cycle.
RESULTS
Fifty patients with a median age of 53 years (range, 39 to 76 years) were enrolled in the study. The median follow-up was 10.0 months. The objective response rate of the 50 patients was 48.0% (95% CI, 22.5 to 57.1%). The median time to progression and overall survival were 6.5 months (95% CI, 2.3 to 8.7 months) and 10.0 months (95% CI, 5.7 to 16.7 months), respectively. Grade 3-4 toxicities associated with chemotherapy included neutropenia (22%), anemia (8%), thrombocytopenia (6%), and hand-foot syndrome (10%).
CONCLUSION
Combination chemotherapy using gemcitabine and capecitabine was well tolerated and demonstrated promising efficacy in the treatment of advanced pancreatic cancer.

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Weekly Gemcitabine and Docetaxel in Refractory Soft Tissue Sarcoma: A Retrospective Analysis
Ha-young Lee, Sang Joon Shin, Hyo Song Kim, Soo Jung Hong, Jung Woo Han, Seung Taek Lim, Jae Kyung Roh, Sun Young Rha
Cancer Res Treat. 2012;44(1):43-49.   Published online March 31, 2012
DOI: https://doi.org/10.4143/crt.2012.44.1.43
AbstractAbstract PDFPubReaderePub
PURPOSE
The combination of gemcitabine and docetaxel (GD) is used to effectively treat patients with soft tissue sarcoma (STS). It is widely considered that the conventional doses used are too high for long term use and many patients must discontinue GD treatment due to its toxicity. Therefore, to determine the appropriate dose meeting acceptable efficacy results, while minimizing toxic side effects, we treated patients with a weekly infusion of GD (weekly GD).
MATERIALS AND METHODS
A total of 22 patients presenting a variety of STSs were treated at Yonsei Cancer Center. All patients had metastatic or recurrent cancer and had previously received doxorubicin and ifosfamide combination chemotherapy. In all cases, gemcitabine (1,000 mg/m2) and docetaxel (35 mg/m2) were administered intravenously on days 1 and 8 of a 21-day cycle. We retrospectively reviewed the medical records of these patients.
RESULTS
The response rate was 4.5%, with one patient diagnosed with leiomyosarcoma having a partial response, and the disease control rate was 40.9%. The median progression-free survival (PFS) duration was 2.7 months and the PFS was correlated with the treatment response to a weekly GD. The median overall survival (OS) duration was 7.8 months and the OS was correlated with histology. There was no significant difference in OS between patients who received weekly GD as a 2nd line chemotherapy and those who received 3rd line or more. Treatment was generally well tolerated.
CONCLUSION
Weekly GD was well tolerated and showed moderate efficacy, indicating that this could be a reasonable option as a salvage treatment for metastatic STS.

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Gemcitabine Plus Platinum Combination Chemotherapy for Elderly Patients with Advanced Non-small Cell Lung Cancer: A Retrospective Analysis
Sang Hoon Chun, Ji Eun Lee, Mi Hee Park, Jin-Hyoung Kang, Young Kyoon Kim, Young-Pil Wang, Jae Kil Park, Hoon-Kyo Kim
Cancer Res Treat. 2011;43(4):217-224.   Published online December 27, 2011
DOI: https://doi.org/10.4143/crt.2011.43.4.217
AbstractAbstract PDFPubReaderePub
PURPOSE
This study aimed to analyze the efficacy and toxicity of gemcitabine plus platinum chemotherapy for patients aged 70 years or older with advanced non-small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
We reviewed the records of stage IIIB, IV NSCLC patients or surgically inoperable stage II, IIIA NSCLC patients who were aged 70 years or older when treated with gemcitabine (1,250 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) chemotherapy from 2001 to 2010 at Seoul St. Mary's Hospital, Uijeongbu St. Mary's Hospital and St. Vincent's Hospital. Gemcitabine was administered on days 1 and 8, and cisplatin or carboplatin was administered on day 1. Treatments were repeated every 3 weeks for a maximum of 4 cycles.
RESULTS
The median age of the 62 patients was 73.5 years (range, 70 to 84 years). Forty-one (66%) patients exhibited comorbidity. The mean number of treatment cycles was 3.9. The compared average relative dose intensity of gemcitabine plus platinum chemotherapy was 84.8%. The median progression-free survival and overall survival (OS) were 5.0 months and 9.4 months, respectively. Reduced Eastern Cooperative Oncology Group (ECOG) performance status (none vs. > or =1) and weight loss (<5% vs. > or =5%) after treatment were found to have a significant effect on OS (p=0.01).
CONCLUSION
Gemcitabine plus platinum chemotherapy is an effective treatment option with an acceptable level of toxicity in patients aged 70 years or older with good performance status in advanced NSCLC.

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Case Report
A Case of Gemcitabine and Cisplatin Associated Posterior Reversible Encephalopathy Syndrome
Eun Jin Kwon, Se Won Kim, Kwang Ki Kim, Hyung Suk Seo, Do Yeun Kim
Cancer Res Treat. 2009;41(1):53-55.   Published online March 31, 2009
DOI: https://doi.org/10.4143/crt.2009.41.1.53
AbstractAbstract PDFPubReaderePub

A 58-year-old female receiving gemcitabine and cisplatin chemotherapy for stage IV gallbladder cancer developed the clinicoradiologic syndrome, posterior reversible encephalopathy syndrome (PRES). Just before the 4th gemcitabine chemotherapy cycle, she was admitted to the hospital with complaints of headache, dizziness, and generalized tonic-clonic seizures. A MRI was performed on the day when the seizure developed, and the findings showed patchy cortical and subcortical T2 hyperintensity without enhancement that involved both occipital and parietal lobes. Phenytoin loading and maintenance was started for prevention of recurrent seizures, which was successful. The follow-up brain MRI obtained 10 days after the seizure attack showed completely resolved radiologic findings. After the MRI findings revealed complete resolution, phenytoin maintenance was stopped. Even with discontinuation of phenytoin, she had no seizures or other clinical manifestations.

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Original Articles
Gemcitabine and Carboplatin Combination Chemotherapy for Elderly Patients with Advanced Non-small Cell Lung Cancer: A Feasibility Study
Young Jin Yuh, Hyo Rak Lee, Sung Rok Kim
Cancer Res Treat. 2008;40(3):116-120.   Published online September 30, 2008
DOI: https://doi.org/10.4143/crt.2008.40.3.116
AbstractAbstract PDFPubReaderePub
Purpose

Although platinum based chemotherapy is known to improve the survival duration for the patients with non-small cell lung cancer, the role of platinum for elderly patient is not yet clear. We administered gemcitabine and carboplatin combination therapy to elderly patients with NSCLC. The aim of this study was to evaluate the efficacy and toxicities of this regimen for elderly patients.

Materials and Methods

The eligibility criteria were as follows: pathologically confirmed NSCLC, an age ≥65 years, advanced disease with stage IIIB or IV and the patients were chemotherapy-naive. The treatment regimen was as follows; gemcitabine 1,000 mg/m2 was administered on days 1 and 8 and carboplatin AUC=5 was administered on day 1. This regimen was repeated every 3 weeks. The efficacy was evaluated in terms of the response rate, the time to progression and the overall survival duration.

Results

From Dec 2001 to Feb 2005, a total of 20 patients were entered into this study. The median patient age was 68 years (range: 65~75). 19 patients were evaluable for their treatment response. A partial response was obtained in 8 patients (response rate: 42.1%, 95% CI: 19.4~64.8%). The median time to progression and the survival duration were 136 days and 453 days, respectively. Among a total of 65 cycles of treatment, grade 3 or 4 leukopenia and thrombocytopenia were observed in 7.7% and 13.9% of the cycles, respectively. Grade 3 or 4 vomiting was observed in 7.7% of the cycles. Grade 3 skin rash developed in 1.5% of the cycles. 1 patient died of septic shock after chemotherapy.

Conclusions

Gemcitabine and carboplatin combination chemotherapy was relatively safe and effective for treating elderly patients with NSCLC.

Citations

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Phase II Study of Gemcitabine plus Cisplatin in Patients with Anthracycline- and Taxane- Pretreated Metastatic Breast Cancer
Jung Hwan Kim, Sung Yong Oh, Hyuk-Chan Kwon, Suee Lee, Sung-Hyun Kim, Dae-Cheol Kim, Jin-Hwa Lee, Hyung-Sik Lee, Se-Heun Cho, Hyo-Jin Kim
Cancer Res Treat. 2008;40(3):101-105.   Published online September 30, 2008
DOI: https://doi.org/10.4143/crt.2008.40.3.101
AbstractAbstract PDFPubReaderePub
Purpose

Metastatic breast cancer patients are usually exposed to taxane and anthracycline as neoadjuvant, adjuvant and palliative chemotherapeutic agents. This study was designed to determine the efficacy and safety of the use of a gemcitabine and cisplatin (GP) combination treatment in patients with metastatic breast cancer that were pretreated with anthracycline and taxane.

Materials and Methods

We evaluated the use of a GP regimen (1,000 mg/m2 gemcitabine administered on days 1 and 8 plus 60 mg/m2 cisplatin administered on day 1 every 3 weeks) in 38 breast cancer patients who had received prior chemotherapy with anthracycline and taxane as an adjuvant or neoadjuvant therapy, or as a palliative therapy.

Results

The median patient age was 49 years (age range, 35~69 years). The overall response rate was 28.9% in 11 patients (95% confidence interval [CI], 14~44%). The median time to progression was 5.2 months (95% CI, 3.6~6.8 months). Median survival was 19.5 months (95% CI, 11.2~27.8 months). Major grade 3/4 hematological toxicity was due to leukopenia (36 of 157 cycles, 23.1%). Non-hematological toxicity was rarely severe; grade1/2 nausea and vomiting were observed in 37.8% of the patients. There were no treatment related deaths.

Conclusions

Our results suggest that the use of gemcitabine plus cisplatin appears to be effective and has an acceptable toxicity profile in patients with advanced breast cancer that have been pretreated with anthracycline and taxane.

Citations

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Gemcitabine and Vinorelbine Combination Chemotherapy in Anthracycline- and Taxane-pretreated Advanced Breast Cancer
Hye Jin Kim, Jin-Soo Kim, Myung-Deok Seo, So-Yeon Oh, Do-Youn Oh, Jee Hyun Kim, Se-Hoon Lee, Dong-Wan Kim, Seock-Ah Im, Tae-You Kim, Dae Seog Heo, Yung-Jue Bang
Cancer Res Treat. 2008;40(2):81-86.   Published online June 30, 2008
DOI: https://doi.org/10.4143/crt.2008.40.2.81
AbstractAbstract PDFPubReaderePub
Purpose

Anthracycline and taxanes are effective agents in advanced breast cancer and prolong survival times. Some patients achieve prolongation of life with capecitabine, gemcitabine, or vinorelbine, even after failure of both anthracycline and taxanes. We analyzed the efficacy and toxicity of gemcitabine and vinorelbine combination chemotherapy in anthracycline- and taxane-pretreated advanced breast cancer.

Materials and Methods

The medical records of anthracycline- and taxane-pretreated metastatic breast cancer patients who received gemcitabine and vinorelbine combination chemotherapy at the Seoul National University Hospital were reviewed. Gemcitabine (1,000 mg/m2) and vinorelbine (25 mg/m2) were administered intravenously on days 1 and 8 every 3 weeks.

Results

Between 2000 and 2006, 57 patients were eligible (median age, 45 years), and the median number of previous chemotherapy regimens was 3 (range, 1~5). The overall response rate was 30% (95% CI, 18.1~41.9), and the disease control rate was 46% (PR, 30%; SD, 16%). The median duration of follow-up was 33.4 months, the median time-to-progression (TTP) was 3.9 months, and the median overall survival was 10.8 months. None of thepatients with patients with anthracycline and taxane primary resistance showed a response and the median TTP for these patients was significantly shorter than that of other patients (1.9 vs. 4.4 months; p=0.018). Although the efficacy was unsatisfactory in patients with both anthracycline and taxane primary resistance, gemcitabine and vinorelbine combination chemotherapy showed comparable efficacy in anthracycline- and/or taxane-sensitive patients and the patients with secondary resistance, even after failure of second-line therapy. Grade 3/4 hematologic toxicities included neutropenia (18.1%) and febrile neutropenia (0.3%), and non-hematologic toxicities were tolerable.

Conclusion

Gemcitabine and vinorelbine combination chemotherapy in anthracycline- and taxane-pretreated advanced breast cancer was effective and tolerable.

Citations

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Gemcitabine versus Gemcitabine Combined with Cisplatin Treatment Locally Advanced or Metastatic Pancreatic Cancer: A Retrospective Analysis
Jae-Hyuk Choi, Sung Yong Oh, Hyuk-Chan Kwon, Jung Hwan Kim, Jae Hoon Lee, Suee Lee, Dong Mee Lee, Sung-Hyun Kim, Myung Hwan Rho, Young-Hoon Kim, Mee-Sook Rho, Hyo-Jin Kim
Cancer Res Treat. 2008;40(1):22-26.   Published online March 31, 2008
DOI: https://doi.org/10.4143/crt.2008.40.1.22
AbstractAbstract PDFPubReaderePub
Purpose

Gemcitabine is the most active agent to treat unresectable pancreatic cancer. The superiority of combining other drugs with cisplatin is still controversial; therefore, we performed a retrospective analysis of gemcitabine versus gemcitabine combined with cisplatin to determine the treatment outcomes for patients with locally advanced or metastatic pancreatic cancer.

Materials and Methods

From 2001 to 2007, we enrolled 60 patients who were treated with gemcitabine or gemcitabine combined with cisplatin for locally advanced or metastatic pancreatic cancer. Gemcitabine 1, 000 mg/m2 (G) was administrated at day 1 and day 8 every 3 weeks. Cisplatin 60 mg/m2 was added at day 1 every 3 weeks to the gemcitabine schedule (GP).

Results

Number of G: GP was 34: 26, locally advanced to metastatic ratio was 35% to 65% in group G and 46% to 54% in group GP. Median follow up duration was 29 months. The median number of chemotherapy cycles was 4 (range: 2~11) for the G group, and 4 (range: 1~11) for the GP group. The response rate of the G and GP groups was 17% and 11%, respectively. The progression free survival (PFS) was 4.5 months and 2.8 months, respectively, for the G and GP groups. The overall survival (OS) was 10.7 and 8.7 months respectively, for the G and GP groups, but there is no statistically significant difference of the PFS (p=0.2396) and OS (p=0.4643) between the 2 groups. The hematological toxicity profile was similar (the grade III neutropenia and thrombocytopenia was 4.4% and 3.1%, respectively, in G group, and 7.5% and 2.8%, respectively, in the GP group). But non-hematological toxicities such as skin rash, abnormal liver function and nausea/vomiting were observed in 3 patients of the GP group. On the prognostic factor analysis, no factors predicted a longer PFS and OS for both the G and GP groups.

Conclusions

Gemcitabine single treatment might be more tolerable and it had the same efficacy compared to cisplatin combination treatment in this retrospective study.

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    Eric S. Winer, Howard Safran, Boguslawa Karaszewska, Sebastian Bauer, Dilawar Khan, Steffen Doerfel, Paul Burgess, Stacey Kalambakas, Yasser Mostafa Kamel, Frederic Forget
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    Eric S. Winer, Howard Safran, Boguslawa Karaszewska, Donald A. Richards, Lee Hartner, Frederic Forget, Rodryg Ramlau, Kirushna Kumar, Bhabita Mayer, Brendan M. Johnson, Conrad A. Messam, Yasser Mostafa Kamel
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    Qin Li, Zhenyan Yuan, Han Yan, Zhaoyang Wen, Ruixue Zhang, Bangwei Cao
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    Qin Li, Han Yan, Wenting Liu, Hongchao Zhen, Yifan Yang, Bangwei Cao, Jonathan R. Brody
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    Samantha B. Kasloff, Matteo S. Pizzuto, Micol Silic-Benussi, Silvia Pavone, Vincenzo Ciminale, Ilaria Capua, K. L. Beemon
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    Wenbo Zhu, Jingjie Li, Sihan Wu, Shifeng Li, Liang Le, Xingwen Su, Pengxin Qiu, Haiyan Hu, Guangmei Yan
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Gemcitabine Single or Combination Chemotherapy in Post Anthracycline and Taxane Salvage Treatment of Metastatic Breast Cancer: Retrospective Analysis of 124 Patients
Min Kyoung Kim, Sung-Bae Kim, Jin Hee Ahn, Soon Im Lee, Sei-Hyun Ahn, Byung Ho Son, Gyungyub Gong, Hak-Hee Kim, Jung-Shin Lee, Yoon-Koo Kang, Woo Kun Kim
Cancer Res Treat. 2006;38(4):206-213.   Published online December 31, 2006
DOI: https://doi.org/10.4143/crt.2006.38.4.206
AbstractAbstract PDFPubReaderePub
Purpose

To evaluate the efficacy of gemcitabine-based chemotherapy, particularly in patients with anthracycline- and taxane-pretreated 2nd-line or greater metastatic breast cancer, and to compare gemcitabine monotherapy (G) with two gemcitabine-based doublets, gemcitabine/vinorelbine (GV) and gemcitabine/capecitabine (GX).

Materials and Methods

Of 124 consecutive patients who progressed after anthracycline- and taxane-containing chemotherapy, 58 received G alone, 38 received GV, and 28 received GX; their outcomes were analyzed retrospectively.

Results

The median number of prior metastatic chemotherapy regimens was 2 (range 0~4). Visceral metastases were observed in 65 patients (51.4%). The overall response rate was 19.3% (21 partial responses). After a median follow-up period of 21.4 months, the overall survival was 7.6 months (95% CI: 5.5~9.6 months) and the median time to progression was 3.1 months (95% CI: 2.0~4.2 months). Compared with monotherapy (G), com - bination therapy with vinorelbine or capecitabine (GV/GX) was associated with a significantly higher response rate (8.2% vs. 28.3%, p=0.008) and a significantly longer median time to progression (2.8 vs. 3.5 months; p=0.028), but overall survival did not differ between the groups (7.4 vs. 8.2 months, respectively; p=0.54). Most of the adverse treatment-related events were mild to moderate in intensity. The most common adverse event was hematologic toxicity. Multivariate analysis showed that poor performance status and a short disease-free interval were independent prognostic factors for impaired overall survival.

Conclusions

The combination of gemcitabine with vinorelbine or capecitabine was an active and well-tolerated treatment option for taxane- and anthracycline-pretreated 2nd-line or greater metastatic breast cancer patients, and gemcitabine-based doublets were more beneficial than gemcitabine monotherapy in alleviating symptoms for these patients.

Citations

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    Ying-Chun Xu, Hong-Xia Wang, Lei Tang, Yue Ma, Feng-Chun Zhang
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Efficacy of Combined Gemcitabine/Cisplatin Chemotherapy for Locally Advanced or Metastatic Urothelial Cancer
Kwan-Sik Bae, Kyu Il Ahn, Seung Hyun Jeon, Jung-Sik Huh, Sung-Goo Chang
Cancer Res Treat. 2006;38(2):78-83.   Published online April 30, 2006
DOI: https://doi.org/10.4143/crt.2006.38.2.78
AbstractAbstract PDFPubReaderePub
Purpose

We wanted to determine and report on the outcome of combined gemcitabine/cisplatin chemotherapy for patients suffering with locally advanced or metastatic urothelial cancer.

Materials and Methods

Between July 1999 and December 2004, 43 selected patients were enrolled in this study. Group 1 (the adjuvant chemotherapy group) had undergone radical surgery with removal of evident tumor from the following primary sites: bladder (n=8), renal pelvis (n=7) and ureter (n=3). Group 2 (the salvage chemotherapy group) had undergone palliative surgery with a remnant tumor at the following primary sites; bladder (n=23) and renal pelvis (n=2). All the patients were given gemcitabine/ciplatin and they evaluated for the therapeutic effect and toxicity. The patients were initially treated with gemcitabine 1000 mg/m2 intravenously for 30 minutes on days 1, 8 and 15 of a 28-day cycle, and cisplatin 70 mg/m2 was administered intravenously on day 1 using prehydration measures.

Results

Group 1: The median follow-up period was 16.5 months. The mean age was 63 years (males: 15 cases, females: 3 cases), and eleven patients (61%) remained alive. The estimated median relapse-free survival period and 2-year survival rate were 24 months and 63%, respectively. Group 2: the median follow-up period was 20 months, the mean patient age was 63.8 years (males: 22 cases, females: 3 cases), and nine patients (36%) remained alive. The overall response and 2-year survival rates were 36% and 43%, respectively. Toxicities: Grade 3 toxicities developed in 14 cycles during the total 232 cycles. Grade 4 toxicity did not occur.

Conclusions

The results of this study confirm that adjuvant and salvage chemotherapy with using gemcitabine and cisplatin is tolerable and safe.

Citations

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  • Chemotherapy with gemcitabine, cisplatin, and docetaxel in the treatment for patients with muscle-invasive bladder cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG)
    Ioannis Boukovinas, Nikolaos Androulakis, Nikolaos Kentepozidis, Aris Polyzos, Pavlos Papakotoulas, Nikolaos Ziras, Athanasios Kotsakis, Nikolaos Vardakis, Athanasios Karampeazis, Vassilis Markos, Athanasios Kostakopoulos, Constantine A. Constantinides, G
    Cancer Chemotherapy and Pharmacology.2012; 69(2): 351.     CrossRef
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Combination of Gemcitabine and Cisplatin as First-Line Therapy in Advanced Non-Small-Cell Lung Cancer
Nam-Su Lee, Jae-Ho Byun, Sang-Byung Bae, Chan-Kyu Kim, Kyu-Taeg Lee, Sung-Kyu Park, Jong-Ho Won, Dae-Sik Hong, Hee-Sook Park
Cancer Res Treat. 2004;36(3):173-177.   Published online June 30, 2004
DOI: https://doi.org/10.4143/crt.2004.36.3.173
AbstractAbstract PDFPubReaderePub
Purpose

The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC.

Materials and Methods

Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m2, infusion over 30 minutes on days 1, followed by a gemcitabine, 1,250 mg/m2, infusion over 30 minutes on days 1 and 8 every 3 weeks.

Results

The median age of the patients was 64 years (range: 27~75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1~15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8~22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months.

Conclusion

In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC.

Citations

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  • Improved tumor-suppressive effect of OZ-001 combined with cisplatin mediated by mTOR/p70S6K and STAT3 inactivation in A549 human lung cancer cells
    Jeong-Hun Lee, Kyung-Sook Chung, Hwi-Ho Lee, Dohyeong Ko, Minji Kang, Ho Yoo, JooHoon Ahn, Jae Yeol Lee, Kyung-Tae Lee
    Biomedicine & Pharmacotherapy.2021; 142: 111961.     CrossRef
  • Chemotherapy-Induced Myopathy: The Dark Side of the Cachexia Sphere
    Dean G. Campelj, Craig A. Goodman, Emma Rybalka
    Cancers.2021; 13(14): 3615.     CrossRef
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    Mohsen Doostmohammadi, Hamid Forootanfar, Seeram Ramakrishna
    Mini-Reviews in Medicinal Chemistry.2020; 20(13): 1272.     CrossRef
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    Louis T. Curtis, Victor H. van Berkel, Hermann B. Frieboes
    Journal of Theoretical Biology.2018; 448: 38.     CrossRef
  • Has aidi injection the attenuation and synergistic efficacy to gemcitabine and cisplatin in non-small cell lung cancer? A meta-analysis of 36 randomized controlled trials
    Zheng Xiao, Chengqiong Wang, Ling Chen, Xuemei Tang, Lianhong Li, Nana Li, Jing Li, Qihai Gong, Fushan Tang, Jihong Feng, Xiaofei Li
    Oncotarget.2017; 8(1): 1329.     CrossRef
  • Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma
    Nadine Houédé, Laura Dupuy, Aude Fléchon, Philippe Beuzeboc, Gwenaëlle Gravis, Brigitte Laguerre, Christine Théodore, Stéphane Culine, Thomas Filleron, Christine Chevreau
    BJU International.2016; 117(3): 444.     CrossRef
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    Lauren M.J. Buck, Matthew J. Winter, William S. Redfern, Tanya T. Whitfield
    Hearing Research.2012; 284(1-2): 67.     CrossRef
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A 21-day Schedule of Gemcitabine and Cisplatin Administration in the Treatment of Advanced Non-Small Cell Lung Carcinoma: a Phase II Study
Jong-Sung Park, Chang-Min Lee, Shin-Ae Lee, Chang-kil Jung, Sung-Hyun Kim, Hyuk-Chan Kwon, Jae-Seok Kim, Hyo-Jin Kim
Cancer Res Treat. 2004;36(1):62-67.   Published online February 29, 2004
DOI: https://doi.org/10.4143/crt.2004.36.1.62
AbstractAbstract PDFPubReaderePub
Purpose

To evaluate the efficacy and toxicity of gemcitabine and cisplatin combination chemotherapy, we conducted a phase II study of this regimen in patients with advanced non-small cell lung carcinoma (NSCLC).

Materials and Methods

From June 2001 to August 2003, 36 chemotherapy-naive patients with stage IIIB or IV NSCLC were enrolled. The median age was 59 years (range, 42 to 75 years), and performance status was 0 or 1. Eleven patients had stage IIIB disease, and 25 patients had stage IV disease. 1,000 mg/m2 of gemcitabine was administered on day 1 & 8, and 60 mg/m2 of cisplatin was administered on day 1. Each cycle was repeated every 21 days.

Results

Everyone subject who participated were assessable. A total of 160 cycles of chemotherapy were delivered, and the median number of chemotherapy courses was 3.5 (range, 2 to 9). Two patients (5.6%) achieved a complete response, and 14 patients (38.9%) achieved a partial response. The overall response rate was 44.5% (95% confidence interval [CI], 32.5 to 56.5%). The median follow-up duration was 9.3 months. The median time to disease progression was 8.6 months (95% CI 7.4 to 9.9 months), and median survival time was 12.2 months (95% CI, 10.5 to 12.9 months). Grade 3/4 neutropenia occurred in 9 patients (25.0%), neutropenic fever occurred in 3 patients (8.3%), and grade 3/4 thrombocytopenia occurred in 7 patients (19.5%). Mild forms of non-hematologic toxicities, such as nausea, vomiting or skin reactions, were observed.

Conclusion

The combination of gemcitabine and cisplatin in a 21-day schedule is an effective regimen for patients with NSCLC in its advanced stages.

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Phase II Study of Gemcitabine and Vinorelbine as Second-Line Chemotherapy in Non-Small Cell Lung Cancer
Yoon Jae Kim, Joo Hyuk Sohn, Chul Kim, Yong Tai Kim, Hai Jin Kim, Joong Bae Ahn, Se Kyu Kim, Joon Chang, Nae Choon Yoo, Joo Hang Kim, Jae Yong Cho
Cancer Res Treat. 2003;35(4):294-298.   Published online August 31, 2003
DOI: https://doi.org/10.4143/crt.2003.35.4.294
AbstractAbstract PDF
PURPOSE
With the increased use of chemotherapy for non small cell lung cancer (NSCLC), a growing group of patients can now be considered for second-line chemotherapy. However, guidelines for the second line treatment remain to be developed. The objective of this study was to evaluate the efficacy and safety of the gemcitabine and vinorelbine combination therapy in patients with advanced NSCLC, pretreated with taxane and platinum based regimens. Gemcitabine has already demonstrated activity in this patient group, with the combination therapy having been reported to be well tolerated in previous phase I/II studies.
MATERIALS AND METHODS
Forty two patients with advanced NSCLC (stages III/IV), having received prior taxane and platinum based chemotherapy, with an ECOG performance status (PS) 0~2, and unimpaired hematopoietic and organ function, were treated with vinorelbine, 20 mg/m2, followed by gemcitabine, 1, 000 mg/m2, both administered on days 1, 8 and 15, every 4 weeks.
RESULTS
Out of the 42 patients enrolled, 41 were evaluable for their response, and all 42 for their toxicity. The patient's characteristics were as follows; median age=60 years (42~73), median PS=1 (range 0~2), a gender ratio 31: 11 males/females, with stages IIIA, IIIB and IV in 3, 14 and 25 cases. The objective responses included a partial response (PR) 8/41 (19.5%), a stable disease 15/41 (36.6%) and a progressive disease 18/41 (43.9%). The median time-to progression (TTP) and survival were 4 months, ranging from 2 to 14 months, and 8 months, ranging from 2 to 17+ months, respectively. Grade 3 neutropenia was seen in 19% of the patient, and there was no grade 4 neutropenia or episodes of febrile neutropenia. No grade 4 thrombocytopenia or other grade 3/4 non-hematological toxicities were observed.
CONCLUSION
The combination of gemcitabine/vinorelbine is active and well tolerated in patients with advanced NSCLC having failed prior taxane/platinum therapy.
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Gemcitabine and Infusional 5-Fluorouracil in Advanced Pancreatic Cancer: A Clinical Benefit Response-Oriented Phase II Study
Jung Hye Choi, Myung Ju Ahn, Seock Ah Im, Bong Seog Kim, Ho Suk Oh, Heung Woo Lee, Yeung Chul Mun, Chu Myung Seong, Soon Nam Lee, Young Yeul Lee, Il Young Choi, In Soon Kim
Cancer Res Treat. 2003;35(3):213-217.   Published online June 30, 2003
DOI: https://doi.org/10.4143/crt.2003.35.3.213
AbstractAbstract PDF
PURPOSE
Gemcitabine and 5-fluorouracil (5-FU) are two compounds with reproducible activity against advanced pancreatic carcinomas. To evaluate the activity and feasibility of this combination chemotherapy, a multi-institutional phase II study was performed. MATERIALS AND METHODS: Twenty patients (male: female 15: 5, median age: 60.5 years), with histologically verified locally advanced or metastatic pancreatic carcinomas, were enrolled between April 2000 and March 2002. Gemcitabine was administered by intravenous injection at the doses of 1, 000 mg/m2 on days 1, 8 and 15, and 5-FU 800 mg/m2/day, was given by continuous intravenous infusion on days 1~5. The treatment was repeated every 4 weeks. The clinical benefit response (CBR) was a composite of the pain, Karnofsky performance status and body weight change measurement.
RESULTS
Nineteen of the twenty patients were assessable for response. The median follow-up duration was 4.6 months (0.4~15.2 months). Five patients achieved a partial response and eight a stable disease. The overall response rate was 25.0%. The CBR was assessable in 12 patients. The overall CBR was 41.7% (5/12). The median survival of all the patients was 8.0 months. Grade 3~4 toxicities included neutropenia (9.3%) and thrombocytopenia (5.3%). CONCLUSION: This study suggested that gemcitabine, combined with infusional 5-FU, was well tolerated, and produced modest antitumor activity and symptomatic relief in advanced pancreatic cancer patients.
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A Phase II Study of Gemcitabine Monotherapy in Breast Cancer Patients Refractory to Anthracycline and Taxane
Jun Yong Park, Chul Kim, Joo Hyuk Sohn, Yong Tae Kim, Sun Young Rha, Woo Ick Jang, Gwi Eon Kim, Hyun Cheol Chung
Cancer Res Treat. 2002;34(4):274-279.   Published online August 31, 2002
DOI: https://doi.org/10.4143/crt.2002.34.4.274
AbstractAbstract PDF
We performed a phase II trial to evaluate the efficacy and the safety of gemcitabine monotherapy, a pyrimidine antimetabolite, in patients, who had previously failed anthracycline and taxane-based chemotherapy for the treatment of metastatic breast cancer.
MATERIALS AND METHODS
Twenty-one patients with metastatic breast cancer, which was unresponsive to previous chemotherapy, were entered into this study. Gemcitabine was administered at 850 mg/m2, as a 60- minute intravenous infusion on days 1, 8 and 15. This regimen was repeated every 28 days with G-CSF support, but without dose reduction.
RESULTS
Objective responses were seen in 6 of the 20 patients who were able to be evaluated (1 complete response and 5 partial responses), with an objective response rate of 30%. The median time to progression was 5 (1~20) months, and the median overall survival duration was 11 (2~21) months. The actual dose intensity was 566.7 mg/m2/wk (range; 340~637.5 mg/m2/wk) and the relative dose intensity was 0.89 (range; 0.40~1.00). Toxicity was mainly hematological. Toxicities included: grade 3 neutropenia in 20% and anemia in 5%. Grades 3 and 4 thrombocytopenia occurred in 15% of the patients.
CONCLUSION
Gemcitabine monotherapy is an effective and safe treatment for refractory breast cancer patients heavily treated with the anthracycline and taxane- based regimen.

Citations

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  • A phase II study of tipifarnib and gemcitabine in metastatic breast cancer
    Clinton Yam, Rashmi K. Murthy, Vicente Valero, Janio Szklaruk, Girish S. Shroff, Carol J. Stalzer, Aman U. Buzdar, James L. Murray, Wei Yang, Gabriel N. Hortobagyi, Stacy L. Moulder, Banu Arun
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    Woo Sun Kwon, Sun Young Rha, Yeon Ho Choi, Jung Ok Lee, Kyu Hyun Park, Jae Joon Jung, Tae Soo Kim, Hei-Cheul Jeung, Hyun Cheol Chung
    Pharmacogenetics and Genomics.2006; 16(6): 429.     CrossRef
  • Gemcitabine Single or Combination Chemotherapy in Post Anthracycline and Taxane Salvage Treatment of Metastatic Breast Cancer: Retrospective Analysis of 124 Patients
    Min Kyoung Kim, Sung-Bae Kim, Jin Hee Ahn, Soon Im Lee, Sei-Hyun Ahn, Byung Ho Son, Gyungyub Gong, Hak-Hee Kim, Jung-Shin Lee, Yoon-Koo Kang, Woo Kun Kim
    Cancer Research and Treatment.2006; 38(4): 206.     CrossRef
  • Gemcitabine monotherapy as salvage chemotherapy in heavily pretreated metastatic breast cancer
    Sun Young Rha, Yong Hwa Moon, Hei Chul Jeung, Yong Tae Kim, Joo Hyuk Sohn, Woo Ick Yang, Chang Ok Suh, Gwi Eon Kim, Jae Kyung Roh, Hyun Cheol Chung
    Breast Cancer Research and Treatment.2005; 90(3): 215.     CrossRef
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