Cancer Research and Treatment

Original Articles

Breast cancer

A Phase II Trial of S-1 and Oxaliplatin in Patients with Metastatic Breast Cancer Previously Treated with Anthracycline and Taxane (KCSG-BR07-03): Dae-Won Lee, Bhumsuk Keam, Keun Seok Lee, Jin-Hee Ahn, Joohyuk Sohn, Jin Seok Ahn, Moon Hee Lee, Jee Hyun Kim, Kyung Eun Lee, Hyo Jung Kim, Si-Young Kim, Yeon Hee Park, Chan-Young Ock, Kyung-Hun Lee, Sae-Won Han, Sung-Bae Kim, Young Hyuck Im, Hyun Cheol Chung, Do-Youn Oh, Seock-Ah Im; Cancer Res Treat. 2023;55(2):523-530. Published online November 8, 2022; DOI: https://doi.org/10.4143/crt.2022.1360

Purpose
This single-arm phase II trial investigate the efficacy and safety of S-1 plus oxaliplatin (SOX) in patients with metastatic breast cancer.
Materials and Methods
Patients with metastatic breast cancer previously treated with anthracyclines and taxanes were enrolled. Patients received S-1 (40-60 mg depending on patient’s body surface area, twice a day, day 1-14) and oxaliplatin (130 mg/m2, day 1) in 3 weeks cycle until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumor 1.1. Secondary endpoints included time-to-progression (TTP), duration-of-response (DoR), overall survival (OS), and adverse events.
Results
A total of 87 patients were enrolled from 11 institutions in Korea. Hormone receptor was positive in 54 (62.1%) patients and six (6.9%) had human epidermal growth factor receptor 2–positive disease. Forty-eight patients (85.1%) had visceral metastasis and 74 (55.2%) had more than three sites of metastases. The ORR of SOX regimen was 38.5% (95% confidence interval [CI], 26.9 to 50.0) with a median TTP of 6.0 months (95% CI, 5.1 to 6.9). Median DoR and OS were 10.3 months (95% CI, 5.5 to 15.1) and 19.4 (95% CI, not estimated) months, respectively. Grade 3 or 4 neutropenia was reported in 28 patients (32.1%) and thrombocytopenia was observed in 23 patients (26.6%).
Conclusion
This phase II study showed that SOX regimen is a reasonable option in metastatic breast cancer previously treated with anthracyclines and taxanes.

Citations

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Unraveling the immune landscape and therapeutic biomarker PMEPA1 for oxaliplatin resistance in colorectal cancer: A comprehensive approach
Zhengguang Zhang, Tianming Lu, Zhe Zhang, Zixian Liu, Ruoning Qian, Ruogu Qi, Fuqiong Zhou, Min Li
Biochemical Pharmacology.2024; 222: 116117. CrossRef
Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study
Pingping Bi, Xi Wang, Rui Liu, Xiuqin Li, Shanrong Wei, Jiawen Zhao, Xin Tan, Fan Zhang, Qing Mao, Ying Zhang, Baoyan Tang, Xueqiong Xun, Rong Guo, Kai Zheng, Shaoqiang Zhou, Shicong Tang
Surgery Open Science.2023; 16: 171. CrossRef

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Sarcoma

Whole-Genome and Transcriptome Sequencing Identified NOTCH2 and HES1 as Potential Markers of Response to Imatinib in Desmoid Tumor (Aggressive Fibromatosis): A Phase II Trial Study: Joonha Kwon, Jun Hyeong Lee, Young Han Lee, Jeeyun Lee, Jin-Hee Ahn, Se Hyun Kim, Seung Hyun Kim, Tae Il Kim, Kum-Hee Yun, Young Suk Park, Jeong Eun Kim, Kyu Sang Lee, Jung Kyoon Choi, Hyo Song Kim; Cancer Res Treat. 2022;54(4):1240-1255. Published online January 17, 2022; DOI: https://doi.org/10.4143/crt.2021.1194

Abstract PDF Supplementary Material PubReader ePub

Purpose
Desmoid tumor, also known as aggressive fibromatosis, is well-characterized by abnormal Wnt/β-catenin signaling. Various therapeutic options, including imatinib, are available to treat desmoid tumor. However, the molecular mechanism of why imatinib works remains unclear. Here, we describe potential roles of NOTCH2 and HES1 in clinical response to imatinib at genome and transcriptome levels.
Materials and Methods
We identified somatic mutations in coding and noncoding regions via whole-genome sequencing. To validate the genetic interaction with expression level in desmoid-tumor condition, we utilized large-scale whole-genome sequencing and transcriptome datasets from the Pan-Cancer Analysis of Whole Genomes project. RNA-sequencing was performed using prospective and retrospective cohort samples to evaluate the expressional relevance with clinical response.
Results
Among 20 patients, four (20%) had a partial response and 14 (66.7%) had stable disease, 11 of which continued for ≥ 1 year. With gene-wise functional analyses, we detected a significant correlation between recurrent NOTCH2 noncoding mutations and clinical response to imatinib. Based on Pan-Cancer Analysis of Whole Genomes data analyses, NOTCH2 mutations affect expression levels particularly in the presence of CTNNB1 missense mutations. By analyzing RNA-sequencing with additional desmoid tumor samples, we found that NOTCH2 expression was significantly correlated with HES1 expression. Interestingly, NOTCH2 had no statistical power to discriminate between responders and non-responders. Instead, HES1 was differentially expressed with statistical significance between responders and non-responders.
Conclusion
Imatinib was effective and well tolerated for advanced desmoid tumor treatment. Our results show that HES1, regulated by NOTCH2, as an indicator of sensitivity to imatinib, and an important therapeutic consideration for desmoid tumor.

Citations

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The Notch signaling pathway in desmoid tumor: Recent advances and the therapeutic prospects
Chuanxi Zheng, Jianghong Huang, Gang Xu, Wei Li, Xin Weng, Shiquan Zhang
Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease.2024; 1870(1): 166907. CrossRef
Long‐term result of 125I seed brachytherapy for pediatric desmoid tumor in the head and neck
Yi‐Wei Zhong, Xiao‐Ming Lyu, Yan Shi, Chuan‐Bin Guo, Jian‐Guo Zhang, Lei Zheng
Pediatric Blood & Cancer.2023;[Epub] CrossRef
Update on Familial Adenomatous Polyposis-Associated Desmoid Tumors
Wanjun Yang, Pei-Rong Ding
Clinics in Colon and Rectal Surgery.2023; 36(06): 400. CrossRef
Multimodality Imaging Assessment of Desmoid Tumors: The Great Mime in the Era of Multidisciplinary Teams
Igino Simonetti, Federico Bruno, Roberta Fusco, Carmen Cutolo, Sergio Venanzio Setola, Renato Patrone, Carlo Masciocchi, Pierpaolo Palumbo, Francesco Arrigoni, Carmine Picone, Andrea Belli, Roberta Grassi, Francesca Grassi, Antonio Barile, Francesco Izzo,
Journal of Personalized Medicine.2022; 12(7): 1153. CrossRef

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Breast Cancer

Talazoparib Versus Chemotherapy in Patients with HER2-negative Advanced Breast Cancer and a Germline BRCA1/2 Mutation Enrolled in Asian Countries: Exploratory Subgroup Analysis of the Phase III EMBRACA Trial: Kyung-Hun Lee, Joohyuk Sohn, Annabel Goodwin, Tiziana Usari, Silvana Lanzalone, Seock-Ah Im, Sung-Bae Kim; Cancer Res Treat. 2021;53(4):1084-1095. Published online March 24, 2021; DOI: https://doi.org/10.4143/crt.2020.1381

Abstract PDF Supplementary Material PubReader ePub

Purpose
We evaluated study outcomes in patients enrolled in Asian regions in the phase III EMBRACA trial of talazoparib vs. chemotherapy.
Materials and Methods
Patients with human epidermal growth factor receptor 2–negative germline BRCA1/2-mutated advanced breast cancer who received prior chemotherapy were randomized 2:1 to talazoparib 1 mg/day or chemotherapy (physician’s choice). Primary endpoint was progression-free survival (PFS) per independent central review in the intent-to-treat (ITT) population. This post-hoc analysis evaluated efficacy/safety endpoints in the ITT population of patients enrolled in Asian regions.
Results
Thirty-three patients were enrolled at Asian sites (talazoparib, n=23; chemotherapy, n=10). Baseline characteristics were generally comparable with the overall EMBRACA population. In Asian patients, median PFS was 9.0 months (95% confidence interval [CI] 3.0, 15.2) for talazoparib and 7.1 months (95% CI, 1.2, not reached) for chemotherapy (hazard ratio [HR] 0.74 [95% CI, 0.22, 2.44]). Objective response rate was numerically higher for talazoparib vs. chemotherapy (62.5% [95% CI, 35.4, 84.8] vs. 25.0% [95% CI, 3.2, 65.1]). Median overall survival was 20.7 months (95% CI, 9.4, 40.1) versus 21.2 months (95% CI, 2.7, 35.0) months (HR, 1.41 [95% CI, 0.49, 4.05]). In Asian patients, fewer grade 3/4 adverse events (AEs), serious AEs (SAEs), grade 3/4 SAEs, and AEs resulting in dose reduction/discontinuation occurred with talazoparib than chemotherapy; for talazoparib, the frequency of these events was lower in Asian patients versus overall EMBRACA population.
Conclusion
In this subgroup analysis, talazoparib numerically improved efficacy versus chemotherapy and was generally well tolerated in Asian patients, with fewer grade 3/4 TEAEs, SAEs, and TEAEs leading to dose modification vs. the overall EMBRACA population.

Citations

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HR-positive/HER2-negative breast cancer arising in patients with or without BRCA2 mutation: different biological phenotype and similar prognosis
Pu-Chun Li, Yi-Fan Zhu, Jia-Ni Pan, Qiao-Yan Zhu, Yu-Yang Liao, Xiao-Wen Ding, Lin-Feng Zheng, Wen-Ming Cao
Therapeutic Advances in Medical Oncology.2024;[Epub] CrossRef
Detection and analysis of the safety profile of talazoparib based on FAERS database
Mufei Tang, Peiyan Liu, Linzhe Du, Yuanyuan Li, Jinjin Chen, Yang Li
Expert Opinion on Drug Safety.2024; : 1. CrossRef
Facing inevitable PARPis resistance: Mechanisms and therapeutic strategies for breast cancer treatment
Haixia Liu, Xiaohui Chen, Yimin Jia, Hengyi Chen, Xiaohui Wang, Guoxiang Liu, Yang Luo
Interdisciplinary Medicine.2023;[Epub] CrossRef
Sustained delivery of PARP inhibitor Talazoparib for the treatment of BRCA-deficient ovarian cancer
Shicheng Yang, Allen Green, Needa Brown, Alexis Robinson, Merline Senat, Bryanna Testino, Daniela M. Dinulescu, Srinivas Sridhar
Frontiers in Oncology.2023;[Epub] CrossRef
Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer
S.-A. Im, A. Gennari, Y.H. Park, J.H. Kim, Z.-F. Jiang, S. Gupta, T.H. Fadjari, K. Tamura, M.Y. Mastura, M.L.T. Abesamis-Tiambeng, E.H. Lim, C.-H. Lin, A. Sookprasert, N. Parinyanitikul, L.-M. Tseng, S.-C. Lee, P. Caguioa, M. Singh, Y. Naito, R.A. Hukom,
ESMO Open.2023; 8(3): 101541. CrossRef
Molecular Biology Mechanisms and Emerging Therapeutics of Triple-Negative Breast Cancer
Zhiying Zhang, Rui Zhang, Donghai Li
Biologics: Targets and Therapy.2023; Volume 17: 113. CrossRef
Development of the PARP inhibitor talazoparib for the treatment of advanced BRCA1 and BRCA2 mutated breast cancer
Evthokia A. Hobbs, Jennifer K. Litton, Timothy A. Yap
Expert Opinion on Pharmacotherapy.2021; : 1. CrossRef

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Gastrointestinal cancer

Targeting Hypoxia Using Evofosfamide and Companion Hypoxia Imaging of FMISO-PET in Advanced Biliary Tract Cancer: Jeesun Yoon, Seo Young Kang, Kyung-Hun Lee, Gi Jeong Cheon, Do-Youn Oh; Cancer Res Treat. 2021;53(2):471-479. Published online October 22, 2020; DOI: https://doi.org/10.4143/crt.2020.577

Abstract PDF Supplementary Material PubReader ePub

Purpose
Hypoxia is widely known as one of the mechanisms of chemoresistance and as an environmental condition which triggers invasion and metastasis of cancer. Evofosfamide is a hypoxia-activated prodrug of the cytotoxin bromo-isophosphoramide mustard conjugated with 2-nitroimidazole. Biliary tract cancer (BTC) is known to contain large hypoxic area. This study evaluated the efficacy and safety of evofosfamide as a second-line treatment of advanced BTC.
Materials and Methods
Patients received evofosfamide at a dose of 340 mg/m² on days 1, 8, and 15 of every 28-day cycle. Primary end-point was progression-free survival (PFS) rate at 4-months (4m-PFSR). Secondary end-points included overall survival (OS), PFS, disease control rate (DCR), metabolic response by ¹⁸F-fluorodeoxyglucose positron emission tomography (PET), hypoxic parameters evaluated by ¹⁸F-fluoromisonidazole (FMISO) PET and toxicity.
Results
Twenty patients were treated with evofosfamide, with 16 response-evaluable patients. There was no objective response; stable disease was observed in nine patients, with a DCR of 56.25%. 4m-PFSR was 40.6%. Median PFS was 3.60 months (95% confidence interval [CI], 1.68 to 5.52). Median OS was 6.37 months (95% CI, 3.94 to 8.79). Reduction of tumor metabolic activity was observed in eight of 15 patients (53.3%). High baseline hypoxic parameters were associated with poor PFS. Change of hypoxic parameters between pretreatment and post-treatment reflected hypoxic-activated drug response. There was no treatment-related death.
Conclusion
Evofosfamide as second-line treatment of advanced BTC showed acceptable safety and comparable efficacy to other agents. Changes in volumetric parameters measured with FMISO PET, showing the degree of tumor hypoxia, reflected the response to evofosfamide based on the mode of action.

Citations

Citations to this article as recorded by

Functional Imaging of Hypoxia: PET and MRI
Ryan C. Perez, DaeHee Kim, Aaron W. P. Maxwell, Juan C. Camacho
Cancers.2023; 15(13): 3336. CrossRef
Phase Ib dose-escalation study of the hypoxia-modifier Myo-inositol trispyrophosphate in patients with hepatopancreatobiliary tumors
Marcel A. Schneider, Michael Linecker, Ralph Fritsch, Urs J. Muehlematter, Daniel Stocker, Bernhard Pestalozzi, Panagiotis Samaras, Alexander Jetter, Philipp Kron, Henrik Petrowsky, Claude Nicolau, Jean-Marie Lehn, Bostjan Humar, Rolf Graf, Pierre-Alain C
Nature Communications.2021;[Epub] CrossRef

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Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies: Myung-Ju Ahn, Ji-Youn Han, Dong-Wan Kim, Byoung Chul Cho, Jin-Hyoung Kang, Sang-We Kim, James Chih-Hsin Yang, Tetsuya Mitsudomi, Jong Seok Lee; Cancer Res Treat. 2020;52(1):284-291. Published online July 23, 2019; DOI: https://doi.org/10.4143/crt.2019.200

Abstract PDF PubReader ePub

Purpose
Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system (CNS) metastases. We present results of a subgroup analysis of Korean patients from the pooled data of two global phase II trials: AURA extension (NCT01802632) and AURA2 (NCT02094261).
Materials and Methods
Enrolled patients had EGFR T790M-positive NSCLC and disease progression during or after EGFR-TKI therapy. Patients received osimertinib 80 mg orally once daily until disease progression. The primary endpoint was objective response rate (ORR).
Results
In total, 66 Korean patients received osimertinib treatment with a median treatment duration of 19 months. In the evaluable-for-response population (n=62), ORR was 74% (95% confidence interval [CI], 61.5 to 84.5) and median duration of response was 9.8 months (95% CI, 7.1 to 16.8). In the full analysis set (n=66), median progression-free survival was 10.9 months (95% CI, 8.3 to 15.0; data cutoff November 1, 2016), and median overall survival was 29.2 months (95% CI, 24.8 to 35.7; data cutoff May 1, 2018). Eight patients with CNS metastases were evaluable for response, none of whom showed CNS progression. The most common adverse events were rash (53%), cough (33%), paronychia, diarrhea, and decreased appetite (each 32%).
Conclusion
Efficacy and safety profiles of osimertinib in this subgroup are consistent with the global phase II pooled population, which supports osimertinib as a recommended treatment for Korean patients with T790M positive NSCLC.

Citations

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Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with oncogene-addicted metastatic non-small-cell lung cancer
S.-H. Lee, J. Menis, T.M. Kim, H.R. Kim, C. Zhou, S.A. Kurniawati, K. Prabhash, H. Hayashi, D.D.-W. Lee, M.S. Imasa, Y.L. Teh, J.C.-H. Yang, T. Reungwetwattana, V. Sriuranpong, C.-E. Wu, Y. Ang, M. Sabando, M. Thiagarajan, H. Mizugaki, V. Noronha, M. Yuli
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Valerio Nardone, Caterina Romeo, Emma D’Ippolito, Pierpaolo Pastina, Maria D’Apolito, Luigi Pirtoli, Michele Caraglia, Luciano Mutti, Giovanna Bianco, Antonella Consuelo Falzea, Rocco Giannicola, Antonio Giordano, Pierosandro Tagliaferri, Claudia Vincigue
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The Relationship Between Short-Term Surrogate Endpoint Indicators and mPFS and mOS in Clinical Trials of Malignant Tumors: A Case Study of Approved Molecular Targeted Drugs for Non-Small-Cell Lung Cancer in China
Mingjun Rui, Zijing Wang, Zhengyang Fei, Yao Wu, Yingcheng Wang, Lei Sun, Ye Shang, Hongchao Li
Frontiers in Pharmacology.2022;[Epub] CrossRef
Efficacy and Safety of SH-1028 in Patients With EGFR T790M-Positive NSCLC: A Multicenter, Single-Arm, Open-Label, Phase 2 Trial
Anwen Xiong, Shengxiang Ren, Huaimin Liu, Liyun Miao, Lei Wang, Jianhua Chen, Wei Li, Runpu Li, Xiang Wang, Zhiwei Lu, Donglin Wang, Xiaohong Wu, Zhihua Liu, Ligang Xing, Yimin Mao, Chunling Liu, Aiping Zeng, Hongrui Niu, Yingying Du, Yuping Sun, Yueyin P
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Treatment of Brain Metastases of Non-Small Cell Lung Carcinoma
Agnieszka Rybarczyk-Kasiuchnicz, Rodryg Ramlau, Katarzyna Stencel
International Journal of Molecular Sciences.2021; 22(2): 593. CrossRef

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Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study: Ki Sun Jung, Su Jin Lee, Se Hoon Park, Jae-Lyun Lee, Se-Hoon Lee, Jae Yun Lim, Jung Hun Kang, Suee Lee, Sun Young Rha, Kyung Hee Lee, Ho Young Kim, Ho Yeong Lim; Cancer Res Treat. 2018;50(2):488-494. Published online May 22, 2017; DOI: https://doi.org/10.4143/crt.2016.584

Abstract PDF Supplementary Material PubReader ePub

Purpose
The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not been analyzed. We therefore designed a single-arm, open-label, phase II study to determine the efficacy and safety of pazopanib in patients with nccRCC.
Materials and Methods
Patientswith locally advanced or metastatic nccRCC, exceptfor collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cyclewas defined as 4weeks and tumorresponsewas evaluated every two cycles. The primary objective was overall response rate (ORR).
Results
A total of 29 eligible patients were enrolled at nine centers in Korea from December 2012 and September 2014. The median age of the patients was 58 years (range, 27 to 76 years) and 21 patients (72%) were male. Regarding histology type, 19 patients had papillary, three had chromophobe, two had unclassified and five had unknown non-clear cell type. Of 28 evaluable patients, eight achieved a confirmed partial response with ORR of 28%. The median progression-free survival was 16.5 months (95% confidence interval, 10.9 to 22.1) and median overall survival was not reached. Sixteen patients (55%) experienced treatment-related toxicity of grade 3 or more, but most adverse events were overcome through dose reduction and delay.
Conclusion
In this prospective phase II study, pazopanib demonstrated promising activity and tolerable safety profile in patients with metastatic nccRCC.

Citations

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An Open-Label, Randomized, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel as First-Line Treatment for Ovarian Cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021): Shin-Wha Lee, Yong-Man Kim, Chi Heum Cho, Young Tae Kim, Seok Mo Kim, Soo Young Hur, Jae-Hoon Kim, Byoung-Gie Kim, Seung-Cheol Kim, Hee-Sug Ryu, Soon Beom Kang; Cancer Res Treat. 2018;50(1):195-203. Published online March 21, 2017; DOI: https://doi.org/10.4143/crt.2016.376

Abstract PDF PubReader ePub

Purpose
Genexol-PM is a biodegradable cremophor EL–free polymeric micelle formulation of paclitaxel. Here,we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment.
Materials and Methods
In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² with 5 area under the curve carboplatin every 3weeks (6 cycles). The primary endpointwas the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR).
Results
Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00±0.00 mg/m² Genexol-PM or 174.24±3.81 mg/m² Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of ≥ grade 3 occurred in one patient receiving Genexol. All toxicities were manageable.
Conclusion
Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.

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Phase II Study of Irinotecan and Cisplatin Combination Chemotherapy in Metastatic, Unresectable Esophageal Cancer: Miso Kim, Bhumsuk Keam, Tae-Min Kim, Hoon-Gu Kim, Jin-Soo Kim, Sung Sook Lee, Seong Hoon Shin, Min Kyoung Kim, Keon Uk Park, Dong-Wan Kim, Hwan Jung Yun, Jong Seok Lee, Dae Seog Heo; Cancer Res Treat. 2017;49(2):416-422. Published online July 28, 2016; DOI: https://doi.org/10.4143/crt.2016.121

Abstract PDF PubReader ePub

Purpose
The objective of this multicenter phase II study was to evaluate the efficacy and safety of irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer.
Materials and Methods
Patients were treated with irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8 of each 21-day treatment cycle. The primary endpoint was response rate, and secondary endpoints were survival, duration of response, initial metabolic response rate, and toxicity.
Results
A total of 27 patients with squamous cell histology were enrolled in the study. The median age of the patients was 61 years. The objective response rate of the 20 patients in the perprotocol group was 30.0% (90% confidence interval [CI], 13.2 to 46.9). The median follow-up duration was 10.0 months, and the median progression-free survival and overall survival were 4.5 months (95% CI, 1.6 to 6.2) and 8.8 months (95% CI, 4.7 to 10.5), respectively. Four of 13 patients (30.8%) evaluated showed initial metabolic response. The median duration of response for partial responders was 5.0 months (range, 3.4 to 8.0 months). The following grade 3/4 treatment-related hematologic toxicities were reported: neutropenia (40.7%), anaemia (22.2%), and thrombocytopenia (7.4%). Two patients experienced febrile neutropenia. The most common grade 3/4 non-hematologic toxicities were asthenia (14.8%) and diarrhoea (11.1%).
Conclusion
Irinotecan and cisplatin combination chemotherapy showed modest anti-tumour activity and manageable toxicity for patients with metastatic, unresectable esophageal cancer.

Citations

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Akira Ooki, Hiroki Osumi, Keisho Chin, Masayuki Watanabe, Kensei Yamaguchi
Therapeutic Advances in Medical Oncology.2023;[Epub] CrossRef
Efficacy and safety of irinotecan combined with raltitrexed or irinotecan monotherapy for salvage chemotherapy of esophageal squamous cell cancer: A prospective, open label, randomized phase II study
Xichao Dai, Leilei Tao, Jinqiu Wang, Wenjuan Wu, Weigang Bian, Xichun Dai, Surong Chen
Cancer Medicine.2023; 12(15): 16108. CrossRef
Cisplatin-based combination therapy for cancer
Minerva, Amrita Bhat, Sonali Verma, Gresh Chander, Rajeshwer Singh Jamwal, Bhawani Sharma, Audesh Bhat, Taruna Katyal, Rakesh Kumar, Ruchi Shah
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The development and progress of nanomedicine for esophageal cancer diagnosis and treatment
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Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study
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Bo Zhang, Ling Qi, Xi Wang, Jianping Xu, Yun Liu, Lan Mu, Xingyuan Wang, Lidan Bai, Jing Huang
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Systemic treatment of advanced esophageal squamous cell carcinoma: chemotherapy, molecular-targeting therapy and immunotherapy
Hidekazu Hirano, Ken Kato
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Yifeng Qin, An Kang, Guisheng Zhou, Huan Wang, Wei Wei, Yujie Cao, Yanyan Chen, Jing Wang, Yajun Shi, Yuping Tang, Jianqin Jiang
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ECRG2 enhances the anti-cancer effects of cisplatin in cisplatin-resistant esophageal cancer cells via upregulation of p53 and downregulation of PNCA
Xin-Fang Hou, Lin-Ping Xu, Hai-Yan Song, Shuai Li, Chen Wu, Ju-Feng Wang
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Oncology Letters.2017;[Epub] CrossRef

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Randomized Phase III Trial of Cisplatin, Epirubicin, Leucovorin, 5-Fluorouracil (PELF) Combination versus 5-fluorouracil Alone as Adjuvant Chemotherapy in Curative Resected Stage III Gastric Cancer: Jae Jin Lee, Si-Young Kim, Im sik Shin, Kyung Sam Cho, Hoong-Zae Joo, Choong Yoon, Yoon Wha Kim, Hwi Joong Yoon; Cancer Res Treat. 2004;36(2):140-145. Published online April 30, 2004; DOI: https://doi.org/10.4143/crt.2004.36.2.140

Abstract PDF PubReader ePub

Purpose

The combination of cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) administration, as adjuvant chemotherapy after curative resection for gastirc cancer, was compared with 5-fluorouracil (5-FU) administration alone. This paper reports the results of a prospective randomized comparison of the two regimens, PELF and 5-FU.

Methods

From August 1996 to July 1999, 54 patients were selected subsequent to being diagnosed with stage III cancer after a curative resection for gastric cancer. The patients were stratified according to stage IIIA/IIIB and subtotal/total gastrectomy, and then they were randomized into each treatment group, i.e. the PELF or 5-FU alone groups.

Results

54 assessable patients were enrolled in this study: 28 received PELF and 26 received 5-FU alone. 12 patients relapsed in each group and the median follow-up duration was 42 months (range: 10~77 months). The overall survival rate and disease-free survival rate (DFS) were not significantly different between two groups, (5-year survival of PELF vs. 5-FU: 57% vs. 64%, 5-year DFS: 54% vs. 51%). The PELF combination was more toxic in terms of anemia, anorexia, nausea and diarrhea than the 5-FU.

Conclusions

This study showed that the PELF combination, as an adjuvant therapy for gastric cancer after a curative resection, was a less effective treatment, and it had more toxic effects than the 5-FU.

Citations

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A Phase II Study of Genexol(R) (paclitaxel) in Metastatic Breast Cancer: Joo Young Jung, Hyun Chul Jeong, Sung Soo Yoon, Jae Hoon Lee, Jun Seok Kim, Hyo Jin Kim, Ki Hyun Kim, Jun O Park, Won Seop Lee, Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim; Cancer Res Treat. 2001;33(6):451-457. Published online December 31, 2001; DOI: https://doi.org/10.4143/crt.2001.33.6.451

Abstract PDF

PURPOSE
Paclitaxel is a very effective agent in the treatment of breast cancer. Samyang Corporation has developed its own process to produce paclitaxel in a large volume using plant cell culture technology. To evaluate the efficacy and safety of Genexol(R) in patients with metastatic breast cancer who have failed to respond to standard therapy, we performed a prospective, multi- center phase II clinical trial.
MATERIALS AND METHODS
Patients with metastatic breast cancer were included in this study. Enrollees were required to have histologically confirmed breast cancer with bidimensionally measurable metastatic disease. Genexol(R) was administered at 175 mg/m2 as a 3-hour intravenous infusion every 3 weeks. All patients were premedicated with hydrocortisone, pheniramine maleate, and H2 blocker 30 minutes prior to paclitaxel. We planned to administer at least 4 courses of paclitaxel unless there was disease progression or unacceptable toxicity and to continue treatment up to a total of 6 courses in cases of objective response following 4 courses.
RESULTS
The median duration of follow-up was 8.9 (2.07~13.7) months. Forty-five patients were registered and 43 were eligible. The performance status of patients was ECOG 0~1 in 39 patients (90.7%) and 2 in 4 (9.3%). The location of metastases at the start of the study were the lung (15 patients), liver (8 patients), lymph nodes (22 patients), and other (7 patients). Among the 40 evaluable patients, 15 patients obtained partial responses (PRs) (37.5%, 95% CI: 22.5~52.5%). The median duration of response was 11.67 (4.1~11.7) months and the median time to progression was 7.73 (2.8~11.7) months. The median survival time was not reached at 13.7 months, and the overall survival rate at 13.7 months was 70.1%. The hematologic toxicity was primarily neutropenia with grade 3 or 4 in 10 patients (23.3%). The grade 3 or 4 non-hematologic toxicities included alopecia (17, 39.5%), myalgia (2, 4.7%), neuropathy (2, 4.7%), and pruritus (1, 2.3%). Mild hypersensitivity reaction was observed in 2 patients, although it did not cause withdrawal of the test drug.
CONCLUSION
The results suggest that the Genexol injection is an effective anticancer formulation for the treatment of metastatic breast cancer and toxicity is acceptable.

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Current status of nanomedicine in the chemotherapy of breast cancer
A. I. Fraguas-Sánchez, C. Martín-Sabroso, A. Fernández-Carballido, A. I. Torres-Suárez
Cancer Chemotherapy and Pharmacology.2019; 84(4): 689. CrossRef
Association of the ABCB1 gene polymorphisms 2677G>T/A and 3435C>T with clinical outcomes of paclitaxel monotherapy in metastatic breast cancer patients
H. Chang, S.Y. Rha, H.-C. Jeung, C.-K. Im, J.B. Ahn, W.S. Kwon, N.C. Yoo, J.K. Roh, H.C. Chung
Annals of Oncology.2009; 20(2): 272. CrossRef

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Phase II Multicenter Trial of Paclitaxel for Metastatic Breast Cancer: Jae Ho Byun, Sung Soo Yoon, Chan Hyung Park, Sung Rok Kim, Si Young Kim, Hyo Jin Kim, Soo Mee Bang, Heung Moon Chang, Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim; J Korean Cancer Assoc. 2000;32(3):545-552.

Abstract PDF: PURPOSE
To evaluate the efficacy and safety of paclitaxel for metastatic breast cancer patients who had received previous chemotherapy, we have performed phase II multicenter trial between December 1997 and December 1998.
MATERIALS AND METHOD
Thirty patients were accrued to this study and paclitaxel was administered at 175 mg/m2 as a 3-hour intravenous infusion every 3 weeks until the progression of the disease.
RESULTS
Objective response were observed in 13 of 30 patients (43.3%). There were 1 complete response (3.3%) and 12 partial responses (40%). Especially, 50% (11/22) of patients who had received prior anthracycline-containing regimens for adjuvant or metastatic disease responded to paclitaxel. Responses were observed in all sites of metastatic disease. One hundred forty-nine cycles of treatment were administered, with a median of six cycles per patient. Grade III and IV toxicities included neutropenia (24%), elevated liver enzyme (10%), peripheral neuropathy (10%), arthralgia/myalgia (23%), and alopecia (87%). No significant hypersensitivity type reaction or cardiac arrhythmia were seen. Median duration of response was 7.2 months.
CONCLUSIONS
These results suggested that paclitaxel is active therapeutic agent in metastatic breast cancer patients and it can be safely administered by 3-hour intravenous infusion with premedication.

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Clinical Trial

Efficacy of Gemcitabine Chemotherpy in Advanced Non-small cell Lung Cancer ( NSCLC ): A Phase 2 Study: Hyuk Jae Chang, Joong Bae Ahn, Jun Gu Lee, Kwang Yong Shim, Sun Young Rha, Sae Kyu Kim, Jun Chang, Sung Kyu Kim, Won Young Lee, Nae Chun Yoo, Hyun Cheol Chung, Jae Kyung Roh, Byung Soo Kim, Sung Jun Choi, Tae Won Kim, Chul Won Suh, Joo Hang Kim; J Korean Cancer Assoc. 1999;31(3):523-532.

Abstract PDF: PURPOSE
To evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite against advanced non-small cell lung cancer (NSCLC).
MATERIALS AND METHODS
Forty patients with unresectable stage IIIb to IV, pathologacally documented NSCLC were evaluated. Patients received gemcitabine 1000 mg/m, as a 30 to 60-min, intravenous infusion on days 1, 8 and 15, which was repeated every 28 days. Responses were assessed every two courses. Twenty-five to fifty percent dose reduction was permitted, ptovided that overall toxicity was severe according to World Health Organization (WHO) toxicity criteria.
RESULTS
Of all 40 patients (32 men, 8 women; age range 37 to 73 years; median 63 years), 3S patients were assessable for response. 15 patients had stage IIIb disease and 25 had stage IV. Nineteen patients were histologically classified as adenocarcinoma (47.5%), 17 as squamous cell carcinoma (42.5%), 1 as large cell carcinoma (2.5%), 1 as mixed carcinoma (2.5%) and 2 as undifferentiated carcinoma (5.0%). The overall response rate was 20%. None of the patients showed complete response while 7 showed partial response (20%), 5 had stable diseases (23%) and 23 had progressive diseases (57%). During a total of 119 courses, hematologic toxicity was negligible. Granulo- cytopenia worse than WHO grade 3 occured in 11.8%, anemia in O.S% and thrombocytopenia in 0.8%, respectively. Non-hematologic toxicity was minor and easily controlled. There was no case of febrile neutropenia or treatment-related death.
CONCLUSION
The single agent efficacy of gemcitabine is comparable to other agents commonly used to treat NSCLC. Gemcitabine has unusually mild side effect profile for such an active agent. This significant activity in conjunction with a very favorable toxicity profile supports further investigation in combination with other agents in patients with inoperable NSCLC.

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