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, Hyun Cheol Chung, Sun Young Rha

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    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 (US)
    Pages (from-to)20-28
    Number of pages9
    JournalEuropean Journal of Cancer
    Volume112
    DOIs
    StatePublished - May 2019

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    Keywords

    • Advanced gastric cancer
    • First-line treatment
    • Platinum
    • Taxane

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

    Cite this

    Kim, C., Chon, H. J., Kim, J. H., Jung, M., Nam, C. M., Kim, H. S., Kang, B., Chung, H. C., & Rha, S. Y. (2019). Randomised phase II trial comparing four front-line doublets in Asian patients with metastatic gastric cancer. European Journal of Cancer, 112, 20-28. https://doi.org/10.1016/j.ejca.2018.11.029