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9 "Moon Hee Lee"
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Original Articles
Safety and Effectiveness of Eribulin in Patients with Advanced or Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes in Real-World Clinical Practice: A 6-Year Post-Marketing Surveillance Study in South Korea
Yee Soo Chae, Kyung A Kwon, Moon Hee Lee, Mi Sun Ahn, Kyung-Hun Lee, Su-Jin Koh, Joohyuk Sohn, Keon Uk Park, Min Young Kim, Youngji Pyo, Bo Young Kim, Kyung Hae Jung
Received November 27, 2024  Accepted April 26, 2025  Published online April 28, 2025  
DOI: https://doi.org/10.4143/crt.2024.1142    [Accepted]
AbstractAbstract PDF
Purpose
This 6-year post-marketing surveillance (PMS) study was conducted in South Korea to evaluate the real-world safety and effectiveness of eribulin in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes.
Materials and Methods
During the study period (17 August 2012 to 16 August 2018), case-report files (CRFs) of patients receiving eribulin were collected. The main study endpoint was to assess the safety of eribulin. Evaluation of the effectiveness of eribulin was an exploratory endpoint. Patients were followed for 1 year after eribulin initiation.
Results
CRFs were collected from 64 investigators at 64 sites for 1079 patients. The safety analysis set (SAS) included 1,001 eribulin recipients; effectiveness was assessed in 244 patients. In the SAS, patients were predominantly female (99.6%), with a median age of 53.0 years, and diagnosed with metastatic breast cancer (92.0%). Eribulin was administered as a median 4th line chemotherapy. A total of 2,124 TEAEs were reported in 661 patients (66.0%). Neutropenia was the most common TEAE (32.5% of patients), occurring at a median of 9–11 days from initial eribulin administration. Overall response and disease control rates were 31.7% and 95.6%, respectively, and the median duration of eribulin use (time to treatment failure) was 3.0 months.
Conclusion
This large real-world PMS analysis in patients with advanced or metastatic breast cancer demonstrated the effectiveness of eribulin and found no new safety concerns relative to safety information from prior clinical and real-world studies, and approvals in South Korea and other countries.
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Breast cancer
Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies
Yong Wha Moon, Seung Ki Kim, Keun Seok Lee, Moon Hee Lee, Yeon Hee Park, Kyong Hwa Park, Gun Min Kim, Seungtaek Lim, Seung Ah Lee, Jae Duk Choi, Eunhye Baek, Hyesun Han, Seungjae Baek, Seock-Ah Im
Cancer Res Treat. 2023;55(3):766-777.   Published online January 19, 2023
DOI: https://doi.org/10.4143/crt.2022.987
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.
Materials and Methods
Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.
Results
Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.
Conclusion
This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

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  • Comparison of Prophylactic Efficacy of Eflapegrastim and Pegteograstim for Chemotherapy-induced Neutropenia in Pancreatic Cancer Patients Receiving FOLFIRINOX/mFOLFIRINOX
    Eui Seon Lee, Min Jung Geum, Jong Hee Ko, Jae Song Kim, Eun Sun Son, Yun Mi Yu
    Journal of Korean Society of Health-System Pharmacists.2024; 41(3): 253.     CrossRef
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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
AbstractAbstract PDFPubReaderePub
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

Citations to this article as recorded by  
  • 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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S-1 Based Doublet as an Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer: Results from the Randomized Phase III POST Trial
Choong-kun Lee, Minkyu Jung, Hyo Song Kim, Inkyung Jung, Dong Bok Shin, Seok Yun Kang, Dae Young Zang, Ki Hyang Kim, Moon Hee Lee, Bong-Seog Kim, Kyung Hee Lee, Jae-Ho Cheong, Woo Jin Hyung, Sung Hoon Noh, Hyun Cheol Chung, Sun Young Rha
Cancer Res Treat. 2019;51(1):1-11.   Published online February 5, 2018
DOI: https://doi.org/10.4143/crt.2018.028
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
We conducted a randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) as adjuvant chemotherapy for stage III gastric cancer patients.
Materials and Methods
Stage III gastric cancer patients who had received curative gastrectomy with D2 lymphadenectomy were randomized into equal groups to receive adjuvant chemotherapy of eight cycles of DS (S-1 70 mg/m2 /day on days 1-14 plus docetaxel 35 mg/m2 on days 1 and 8) every 3 weeks or SP (S-1 70 mg/m2 /day on days 1-14 plus cisplatin 60 mg/m2 on day 1) every 3 weeks. The primary endpoint was 3-year disease-free survival (DFS) rate.
Results
Between November 2010 and July 2013, 153 patients (75 patients to DS and 78 patients to SP) were enrolled from 8 institutions in Korea. After the capecitabine plus oxaliplatin was approved based on the CLASSIC study, itwas decided to close the study early. With a median follow-up duration of 56.9 months, the 3-year DFS rate between two groups was not significantly different (49.14% in DS group vs. 52.5% in SP group). The most common grade 3-4 adverse event was neutropenia (42.7% in DS and 38.5% in SP, p=0.351). SP group had more grade 3-4 anemia (1.3% vs. 11.5%, p=0.037), whereas grade 3-4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common in DS group. Fifty-one patients (68%) in DS group and 52 (66.7%) in SP group finished planned treatment.
Conclusion
Our findings suggest that SP or DS is an effective and tolerable option for patients with curatively resected stage III gastric cancer.

Citations

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  • Efficacy and safety of docetaxel plus S-1-based therapy in gastric cancer: a quantitative evidence synthesis of randomized controlled trials
    Hui-Fen Lv, Li-Feng Qin, Rui-Zhi Ran, Xue-Ping Jiang, Fang-Yu Zhao, Bo Li
    Frontiers in Pharmacology.2024;[Epub]     CrossRef
  • A novel method of bedside hyperthermic intraperitoneal chemotherapy as adjuvant therapy for stage-III gastric cancer
    Lili Liu, Li Sun, Ning Zhang, Cheng-gong Liao, Haichuan Su, Jie Min, Yang Song, Xue Yang, Xiaofeng Huang, Dongxu Chen, Yu Chen, Hong-wei Zhang, Helong Zhang
    International Journal of Hyperthermia.2022; 39(1): 239.     CrossRef
  • Comment on “post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial”
    Qiang Hu, Yuanshui Sun
    Clinical Nutrition.2021; 40(3): 1438.     CrossRef
  • THE ROLE OF ADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED GASTRIC CANCER
    A. A. Bobryshev, M. M. Davudov, M. N. Narimanov, S. B. Polycarpova, V. Y. Kirsanov, V. N. Blindar
    Siberian journal of oncology.2021; 20(1): 133.     CrossRef
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    Kotaro Sugawara, Yoshikuni Kawaguchi, Yasuyuki Seto, Jean-Nicolas Vauthey
    Surgical Oncology.2021; 38: 101599.     CrossRef
  • Surgery alone, adjuvant tegafur/gimeracil/octeracil (S-1), or platinum-based chemotherapies for resectable gastric cancer: real-world experience and a propensity score matching analysis
    Chih-Chieh Yen, Yan-Shen Shan, Ying-Jui Chao, Ting-Kai Liao, I-Shu Chen, Hsuan-Yi Huang, I-Ting Liu, Chia-Jui Yen
    BMC Cancer.2021;[Epub]     CrossRef
  • Treatment of Locally Advanced Gastric Cancer (LAGC): Back to Lauren’s Classification in Pan–Cancer Analysis Era?
    Ina Valeria Zurlo, Michele Basso, Antonia Strippoli, Maria Alessandra Calegari, Armando Orlandi, Alessandra Cassano, Mariantonietta Di Salvatore, Giovanna Garufi, Emilio Bria, Giampaolo Tortora, Carlo Barone, Carmelo Pozzo
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    Long Ge, Liangying Hou, Qingxia Yang, Yiting Wu, Xiue Shi, Jiang Li, Kehu Yang
    Medicine.2019; 98(7): e14478.     CrossRef
  • Prognostic and Predictive Factors for the Curative Treatment of Esophageal and Gastric Cancer in Randomized Controlled Trials: A Systematic Review and Meta-Analysis
    Tom van den Ende, Emil ter Veer, Rosa M. A. Mali, Mark I. van Berge Henegouwen, Maarten C. C. M. Hulshof, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Cancers.2019; 11(4): 530.     CrossRef
  • COMplot, A Graphical Presentation of Complication Profiles and Adverse Effects for the Curative Treatment of Gastric Cancer: A Systematic Review and Meta-Analysis
    Tom van den Ende, Frank A. Abe Nijenhuis, Héctor G. van den Boorn, Emil ter Veer, Maarten C. C. M. Hulshof, Suzanne S. Gisbertz, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Frontiers in Oncology.2019;[Epub]     CrossRef
  • Cutting-edge evidence of adjuvant treatments for gastric cancer
    Dai Shimizu, Mitsuro Kanda, Yasuhiro Kodera, Junichi Sakamoto
    Expert Review of Gastroenterology & Hepatology.2018; 12(11): 1109.     CrossRef
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Case Reports
A Case of Blastic Plasmacytoid Dendritic Cell Neoplasm Initially Mimicking Cutaneous Lupus Erythematosus
Hye Jung Chang, Myung Dong Lee, Hyeon Gyu Yi, Joo Han Lim, Moon Hee Lee, Jeong Hyun Shin, Suk Jin Choi, Yeonsook Moon, Chung Hyun Nahm, Chul Soo Kim
Cancer Res Treat. 2010;42(4):239-243.   Published online December 31, 2010
DOI: https://doi.org/10.4143/crt.2010.42.4.239
AbstractAbstract PDFPubReaderePub

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare disease. The prognosis is poor in most cases with rapid progression despite administering chemotherapy. A 67-year-old man complained of skin rashes on his back and this spread to the trunk, face, arms and thighs, and he was initially diagnosed with cutaneous lupus erythematosus according to the skin biopsy. The skin rashes then became aggravated on a trial of low dose methylprednisolone for 3 months. Repeated skin biopsy revealed a diffuse infiltration of lymphoid cells with medium sized nuclei, positive for CD4 and CD56, negative for Epstein-Barr virus (EBV), indicating a diagnosis of BPDCN. Further workups confirmed stage IVA BPDCN involving the skin, multiple lymph nodes, the peripheral blood and the bone marrow. He was treated with six cycles of combination chemotherapy consisting of ifosphamide, methotrexate, etoposide, prednisolone and L-asparaginase, and he achieved a partial response. Herein we report on a rare case of BPDCN that was initially misinterpreted as cutaneous lupus erythematosus.

Citations

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  • Blastic plasmacytoid dendritic cell neoplasm misdiagnosed and treated as acute febrile neutrophilic dermatosis
    Yuqing Song, Yingying Dong, Lin Gong
    Indian Journal of Dermatology, Venereology and Leprology.2025; 0: 1.     CrossRef
  • Blastic Plasmacytoid Dendritic Cell Neoplasm, from a Dermatological Point of View
    Cosimo Di Raimondo, Flavia Lozzi, Pier Paolo Di Domenico, Claudia Paganini, Elena Campione, Marco Galluzzo, Luca Bianchi
    International Journal of Molecular Sciences.2024; 25(13): 7099.     CrossRef
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    Michael Haddadin, Justin Taylor
    Hematology/Oncology Clinics of North America.2020; 34(3): 539.     CrossRef
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    Nikolaos J. Tsagarakis, Georgios Paterakis
    Current Oncology Reports.2020;[Epub]     CrossRef
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    Marie Jeong-Min Kim, Ahmed Nasr, Bilaal Kabir, Joseph de Nanassy, Ken Tang, Danielle Menzies-Toman, Donna Johnston, Dina El Demellawy
    Journal of Pediatric Hematology/Oncology.2017; 39(7): 528.     CrossRef
  • Simultaneous deletion of 3′ETV6 and 5′EWSR1 genes in blastic plasmacytoid dendritic cell neoplasm: case report and literature review
    Zhenya Tang, Guilin Tang, Sa A. Wang, Xinyan Lu, Ken H. Young, Carlos E. Bueso-Ramos, Yesid Alvarado, L. Jeffrey Medeiros, Joseph D. Khoury
    Molecular Cytogenetics.2016;[Epub]     CrossRef
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    Clinical oncohematology.2016; 9(2): 208.     CrossRef
  • Blastic plasmacytoid dendritic neoplasm (BPDN) or BPDN-like lesion presenting after influenza vaccination and resolving with topical high potency steroid
    Jonathan Yao, Joanna Dong, James Strauchen, Rajendra Singh
    JAAD Case Reports.2015; 1(4): 203.     CrossRef
  • Lupus mimickers
    Omar-Javier Calixto, Juan-Sebastian Franco, Juan-Manuel Anaya
    Autoimmunity Reviews.2014; 13(8): 865.     CrossRef
  • Diagnostic and Therapeutic Advances in Blastic Plasmacytoid Dendritic Cell Neoplasm: A Focus on Hematopoietic Cell Transplantation
    Mohamed A. Kharfan-Dabaja, Hillard M. Lazarus, Taiga Nishihori, Rami A. Mahfouz, Mehdi Hamadani
    Biology of Blood and Marrow Transplantation.2013; 19(7): 1006.     CrossRef
  • Cutaneous blastic plasmacytoid dendritic cell neoplasm occurring after spontaneous remission of acute myeloid leukemia: a case report and review of literature
    Wanzhuo Xie, Yanmin Zhao, Ling Cao, Weijia Huang, Yanli Wang, He Huang
    Medical Oncology.2012; 29(4): 2417.     CrossRef
  • Cutaneous lupus erythematosus: a great imitator
    Ashok Kumar Khare
    Expert Review of Dermatology.2011; 6(6): 555.     CrossRef
  • 12,485 View
  • 81 Download
  • 12 Crossref
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Plasmablastic Lymphoma in the Anal Canal
Joo Han Lim, Moon Hee Lee, Man Jong Lee, Chul Soo Kim, Jin Soo Lee, Suk Jin Choi, Hyeon Gyu Yi
Cancer Res Treat. 2009;41(3):182-185.   Published online September 28, 2009
DOI: https://doi.org/10.4143/crt.2009.41.3.182
AbstractAbstract PDFPubReaderePub

Plasmablastic lymphoma (PBL) of the oral cavity is an acquired immunodeficiency syndrome-related lymphoma. The immunophenotype of this disease is associated with poor expression of B-cell markers but a positive reactivity for plasma cell markers. PBL is highly aggressive and responds poorly to treatment. Although originally described in the oral cavity, this disease can occur in other body niches. Here, we describe a very rare case of PBL in the anal canal of a 40-year-old woman with human immunodeficiency virus infection. The malignant cells were positive for Epstein-Barr virus and human herpes virus 8.

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    Xibo Liu, Hongliang Chen
    Discover Oncology.2023;[Epub]     CrossRef
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    Nihon Rinsho Geka Gakkai Zasshi (Journal of Japan Surgical Association).2023; 84(4): 620.     CrossRef
  • Anorectal pathology in the HIV population: a guide for radiologists
    Derek Vos, Margaret Wang, Sita Ramaiya, Elias G. Kikano, Sree H. Tirumani, Daniel A. Smith
    Abdominal Radiology.2022; 47(5): 1762.     CrossRef
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    British Journal of Dermatology.2016; 174(2): 398.     CrossRef
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    Satoru Umegae, Koichi Matsumoto, Tatsushi Kitagawa, Midori Noji, Takayuki Yamamoto, Masaaki Ishii, Kiyoshi Narita, Takahiro Torii, Tomonori Himan, Manabu Yamazaki
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Original Articles
A Phase 2 Study with Vinorelbine and Ifosfamide in the Inoperable Non - small Cell Lung Cancer
Moon Hee Lee, Young Jin Yoo, Soo Mi Bang, Gyung Hae Joung, Hyo Jin Kim, Dong Bok Shin, Soon Nam Lee, Seong Rok Kim, Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim
J Korean Cancer Assoc. 1999;31(5):972-978.
AbstractAbstract PDF
PURPOSE
A phase II study of vinorelbine and ifosfamide combination chemotherapy in patients with advanced or recurrent non-small cell lung cancer (NSCLC) was conducted to assess response rate, response duration, and toxicites.
MATERIALS AND METHODS
Patients with advanced NSCLC who had no prior systemic chemotherapy were eligible. They have no central nervous system metastasis and recurrent or progressive disease after surgery or radiotherapy. Each cycle consisted of vinorelbine 25 mg/m' i.v. days 1 & 8, and ifosfamide 2 g/m i.v. days 1, 2 & 3 with Mesna and treatments were repeated every 21 days.
RESULTS
Forty patients with advanced or recurrent NSCLC were treated at multi center between March, 1997 and March, 1998. Six patients were not evaluable because five patients refused therapy after the first course and one patient was protocol violation. Of 34 evaluable patients, objective responses were seen in 11 (32.4%) patients (CR 0%, PR 32.4%). The median duration of response was 16.4 weeks. The median overall survival was 9.5 months. The toicities of this regimen were acceptable without treatment related toxic death.
CONCLUSION
We concluded that combination regimen of vinorelbine and ifosfamide was effective and tolerable in the treatment of advanced non-small cell lung cancer.
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A Phase 2 Study of VP-16 , Ifosfamide , and Cisplatin ( VIP ) Combination Chemotherapy Plus Concurrent Thoracic Irradiation for Limited Small Cell Lung Cancer
Seok Ah Im, Moon Hee Lee, Chul Won Jung, Dae Seog Heo, Yung Jue Bang, Young Soo Shim, Chan Il Park, Noe Kyeong Kim
J Korean Cancer Assoc. 1999;31(2):306-312.
AbstractAbstract PDF
PURPOSE
A phase II study of etoposide, ifosfamide, cisplatin combination chemotherapy and concurrent thoracic irradiation in patients with untreated limited small cell lung cancer (SCLC) was conducted to assess toxicities, response rate, response duration, and median survival.
MATERIALS AND METHODS
Patients with histologically confirmed SCLC with a ECOG criteria 2 and adequate renal function and bone marrow reserve were eligible. Each cycle consisted of VP-16 100 mg/m i.v, days 1-3, ifosfamide 1,200 mg/m i.v. days 1-3 with Mesna, and cisplatin 30 mg/m i.v. days 1-3. Cycles were repeated every 21 days. Concutrent thoracic itradiation was given as total 40-45 Gy for 4-5 weeks beginning within 24 hours of the third cycle. Patients with complete remission received prophylactic cranial irradiation after the 6th cycle.
RESULT
Forty two patients with limited SCLC were treated at Seoul National University Hospital between December 1993 and August 1996. Three patients were not evaluable because of lost to follow up (2 patients) and one treatment-related early death. Of 39 evaluable patients, responses were seen in 38 (97%) patients including 22 (56%) complete responses and 16 (41%) partial responses. The median remission duration was 65 wks. The median disease free survival was 60 wks. The median overall survival was not reached and 2-year survival was 69% with median duration of follow up of 63.5 wks. Hematologic side effects (WHO Gr>III/IV) of evaluable 228 cycles of chemotherapy were leukopenia in 34%, thrombocytopenia in 16%. One patient expired after prolonged leukopenia and sepsis. Nonhematologic side effects (WHO Gr>II) included nausea and vomiting (17%) and peripheral neuropathy (2%).
CONCLUSION
VIP combination chemotherapy with concurrent thoracic irradiation is effective and tolerable in limited SCLC.
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Phase 2 Trial of FLP ( 5-FU , Leucovorin , Cisplatin ) Combination Chemotherapy for Advanced Gastric Cancer
Young Iee Park, Moon Hee Lee, Sung Woo Han, Woo Jung Park, Dong Gyu Kim, Jin Lee, Jin Seok Ahn, Jung Ae Rhee, In Sook Woo, Young Suk Park
J Korean Cancer Assoc. 1998;30(1):55-62.
AbstractAbstract PDF
PURPOSE
Advanced gastric cancer, the most common malignancy in Korea is a kind of systemic disease. At dignosis, 50~80% of patients have systemic cancer. Therefore, the most patients require systemic chemotherapy. Cisplatin and 5-FU have been suggested to be active in the treatment of gastric cancer, a high response rate was observered with a combination of 5-FU infusion and cisplatin, and the biochemical modulation of 5-FU by leucovorin has been demonstrated to enhance the activity of 5-FU in gastrointestinal tract cancer.
MATERIALS AND METHODS
The patients with advanced gastric cancer whose disease had relapsed or unresectable were treated with 5-FU(800 mg/m2 12 hr IV infusion, D 1~5), leucovorin(20 mg/m2 IV, D 1~5, max. 30 mg), cisplatin(100 mg/m2 15min IV dripping, D1). The cycles of treatment were repeated at 3-weeks intervals.
RESULTS
Between Sep. 1994 and Aug. 1996, previously untreated 44 patients(39 eligible patients) were admitted to this study, the median age was 55 years(range 17~73) and male to female ratio was 20:19. The rate of complete remission was 5%(2/39), the rate of partial remission was 21%(8/39). The median-response duration was 26 weeks(5+~38+ ). The median-time to progression was 25 weeks(4+~62+). The range of overall survival time was from 4 to 62+ weeks. 24 weeks survival rate was 71.5% but the median survival time was not reached. The leukopenia and anemia were the main hematologic toxicities. Non-hematologic side effects were nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy. These toxicities were observed commnonly, but tolerable. Two treatment-related deaths were associated with sepsis.
CONCLUSION
Based on these results, FLP combination chemotherapy seems to be a moderate efficacy for advanced gastric cancer with tolerable toxicities. To confirm the efficacy further, the long-term follow up and a large scale of clinical studies are needed.
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Cancer Res Treat : Cancer Research and Treatment
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