Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer

Chan Kim, Hong Jae Chon, Joo Hoon Kim, Minkyu Jung, Chung Mo Nam, Hyo Song Kim, Beodeul Kang, Hyuncheol Chung, SunYoung Rha

Research output: Contribution to journalArticle

Abstract

Introduction: Consensus has not been reached regarding the standard regimen for front-line chemotherapy of recurrent/metastatic gastric cancer. In this randomised phase II study, we compared four doublet regimens: S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF) and paclitaxel and 5-FU (PF). Patients and methods: Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer were randomised evenly to each regimen. The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), response rate (RR) and safety profile. Results: A total of 179 Korean patients were enrolled from March 2010 to May 2015. The study was prematurely terminated because of slow accrual. At data cut-off, the median PFS was 8.4 months for SP, 5.8 months for FOLFOX, 5.7 months for DF and 4.2 months for PF (P = 0.023). The median OS was 14.7 months for SP, 11.3 months for FOLFOX, 11.7 months for DF and 10.8 months for PF (P = 0.143). RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively. The platinum group displayed a longer PFS trend than the taxane group (7.2 versus 4.9 months, P = 0.058), but no significant difference in OS was found. Notably, 105 patients were exposed to all three drugs (platinum, taxane and fluoropyrimidine) throughout the treatment course, and OS was identical whether starting with platinum or taxane (13.3 versus 13.3 months, P = 0.997). All regimens were well tolerated. Conclusion: SP showed the most favourable results in PFS, whereas a significant difference in OS was not observed among the four regimens.

Original languageEnglish
Pages (from-to)20-28
Number of pages9
JournalEuropean Journal of Cancer
Volume112
DOIs
Publication statusPublished - 2019 May 1

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docetaxel
Fluorouracil
Stomach Neoplasms
Paclitaxel
Disease-Free Survival
Platinum
oxaliplatin
Survival
Drug Therapy
Cisplatin
Survival Rate
Safety
Pharmaceutical Preparations
taxane

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Kim, Chan ; Chon, Hong Jae ; Kim, Joo Hoon ; Jung, Minkyu ; Nam, Chung Mo ; Kim, Hyo Song ; Kang, Beodeul ; Chung, Hyuncheol ; Rha, SunYoung. / Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer. In: European Journal of Cancer. 2019 ; Vol. 112. pp. 20-28.
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title = "Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer",
abstract = "Introduction: Consensus has not been reached regarding the standard regimen for front-line chemotherapy of recurrent/metastatic gastric cancer. In this randomised phase II study, we compared four doublet regimens: S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF) and paclitaxel and 5-FU (PF). Patients and methods: Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer were randomised evenly to each regimen. The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), response rate (RR) and safety profile. Results: A total of 179 Korean patients were enrolled from March 2010 to May 2015. The study was prematurely terminated because of slow accrual. At data cut-off, the median PFS was 8.4 months for SP, 5.8 months for FOLFOX, 5.7 months for DF and 4.2 months for PF (P = 0.023). The median OS was 14.7 months for SP, 11.3 months for FOLFOX, 11.7 months for DF and 10.8 months for PF (P = 0.143). RR was 18{\%}, 23{\%}, 16{\%} and 32{\%} for SP, FOLFOX, DF and PF, respectively. The platinum group displayed a longer PFS trend than the taxane group (7.2 versus 4.9 months, P = 0.058), but no significant difference in OS was found. Notably, 105 patients were exposed to all three drugs (platinum, taxane and fluoropyrimidine) throughout the treatment course, and OS was identical whether starting with platinum or taxane (13.3 versus 13.3 months, P = 0.997). All regimens were well tolerated. Conclusion: SP showed the most favourable results in PFS, whereas a significant difference in OS was not observed among the four regimens.",
author = "Chan Kim and Chon, {Hong Jae} and Kim, {Joo Hoon} and Minkyu Jung and Nam, {Chung Mo} and Kim, {Hyo Song} and Beodeul Kang and Hyuncheol Chung and SunYoung Rha",
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Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer. / Kim, Chan; Chon, Hong Jae; Kim, Joo Hoon; Jung, Minkyu; Nam, Chung Mo; Kim, Hyo Song; Kang, Beodeul; Chung, Hyuncheol; Rha, SunYoung.

In: European Journal of Cancer, Vol. 112, 01.05.2019, p. 20-28.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer

AU - Kim, Chan

AU - Chon, Hong Jae

AU - Kim, Joo Hoon

AU - Jung, Minkyu

AU - Nam, Chung Mo

AU - Kim, Hyo Song

AU - Kang, Beodeul

AU - Chung, Hyuncheol

AU - Rha, SunYoung

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Introduction: Consensus has not been reached regarding the standard regimen for front-line chemotherapy of recurrent/metastatic gastric cancer. In this randomised phase II study, we compared four doublet regimens: S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF) and paclitaxel and 5-FU (PF). Patients and methods: Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer were randomised evenly to each regimen. The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), response rate (RR) and safety profile. Results: A total of 179 Korean patients were enrolled from March 2010 to May 2015. The study was prematurely terminated because of slow accrual. At data cut-off, the median PFS was 8.4 months for SP, 5.8 months for FOLFOX, 5.7 months for DF and 4.2 months for PF (P = 0.023). The median OS was 14.7 months for SP, 11.3 months for FOLFOX, 11.7 months for DF and 10.8 months for PF (P = 0.143). RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively. The platinum group displayed a longer PFS trend than the taxane group (7.2 versus 4.9 months, P = 0.058), but no significant difference in OS was found. Notably, 105 patients were exposed to all three drugs (platinum, taxane and fluoropyrimidine) throughout the treatment course, and OS was identical whether starting with platinum or taxane (13.3 versus 13.3 months, P = 0.997). All regimens were well tolerated. Conclusion: SP showed the most favourable results in PFS, whereas a significant difference in OS was not observed among the four regimens.

AB - Introduction: Consensus has not been reached regarding the standard regimen for front-line chemotherapy of recurrent/metastatic gastric cancer. In this randomised phase II study, we compared four doublet regimens: S-1 and cisplatin (SP); oxaliplatin and 5-FU (FOLFOX); docetaxel and 5-FU (DF) and paclitaxel and 5-FU (PF). Patients and methods: Patients without prior history of chemotherapy for recurrent/metastatic gastric cancer were randomised evenly to each regimen. The primary end-point was progression-free survival (PFS). The secondary end-points were overall survival (OS), response rate (RR) and safety profile. Results: A total of 179 Korean patients were enrolled from March 2010 to May 2015. The study was prematurely terminated because of slow accrual. At data cut-off, the median PFS was 8.4 months for SP, 5.8 months for FOLFOX, 5.7 months for DF and 4.2 months for PF (P = 0.023). The median OS was 14.7 months for SP, 11.3 months for FOLFOX, 11.7 months for DF and 10.8 months for PF (P = 0.143). RR was 18%, 23%, 16% and 32% for SP, FOLFOX, DF and PF, respectively. The platinum group displayed a longer PFS trend than the taxane group (7.2 versus 4.9 months, P = 0.058), but no significant difference in OS was found. Notably, 105 patients were exposed to all three drugs (platinum, taxane and fluoropyrimidine) throughout the treatment course, and OS was identical whether starting with platinum or taxane (13.3 versus 13.3 months, P = 0.997). All regimens were well tolerated. Conclusion: SP showed the most favourable results in PFS, whereas a significant difference in OS was not observed among the four regimens.

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