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.
Bibliographical noteFunding Information:
This study was supported by grants from the National R&D Program for Cancer Control, Ministry of Health and Welfare , Republic of Korea ( 1520190 to S.Y.R.) by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning ( 2017R1A2B2005772 to S.Y.R. and 2016R1C1B2014671 to C.K.) and by the Bio & Medical Technology Development Program of the National Research Foundation ( NRF-2016M3A9E8941664 to H.C). The authors really appreciate Hyon Jung Park for her continued support for this work. All grants support the acquisition of data and analysis.
© 2018 Elsevier Ltd
All Science Journal Classification (ASJC) codes
- Cancer Research