Highlights
- •S-1 and cisplatin showed the most favourable results in progression-free survival (PFS).
- •Overall survival was similar among the four regimens.
- •All regimens were generally well-tolerated.
- •First-line platinum resulted in better PFS than first-line taxane.
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.
Keywords
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Article info
Publication history
Published online: March 19, 2019
Accepted:
November 25,
2018
Received in revised form:
November 12,
2018
Received:
August 17,
2018
Identification
Copyright
© 2018 Elsevier Ltd. All rights reserved.
