Abstract 3994
Background
S-1 is a commonly used agent in first line therapy of advanced gastric cancer in Japan. Several randomised studies compared S-1 monotherapy and various S-1 combination for gastric cancer. However, there has been no analysis of the relation of overall survival (OS), progression free survival (PFS), post progression survival (PPS) and response rate (RR) in gastric cancer trials.
Methods
Data from four randomized Japanese Phase III trials (START, SPIRITS, GC0301/TOP-002, G-SOX) were combined to evaluate the relation of OS, PFS, PPS and RR. The correlation between OS and PFS and OS and PPS was evaluated. OS, PFS and PPS was also evaluated for each of the RECIST categories and responders were defined as patients with complete response (CR) or partial response (PR).
Results
A total of 1911 patient data was available for analysis. 424 patients had either missing or not available RECIST data and were excluded leaving 1487 patients for analysis of which 678 patients were defined as responders (22 CR and 656 PR). 1276 patient data was used for the analysis of PPS. The correlation of OS and PFS was moderate with a Spearman`s correlation coefficient of 0.611. The correlation of OS and PPS was strong with a Spearman`s correlation coefficient of 0.8705. As the RECIST categories worsened, OS, PFS, PPS shortened. The median OS for the responders and non-responders (530.5 days, 272 days p-value<0.005) the median PFS for responders and non-responders (207 days, 82.5 days p-value<0.005) and the median PPS for responders was significantly longer than non-responders (316 days, 179 days p-value<0.005).
Conclusions
Although there are limitations, the analysis shows positive linear correlation between OS and PFS as well as OS and PPS. Patients in better RECIST categories have longer time to OS, PFS and PPS. From the correlation observed, response rate may be a surrogate endpoint to OS, PFS and PPS. Formal validation of the surrogacy of response rate to OS, PFS, and PPS in gastric cancer patients will be analyzed and presented using joint modeling of the survival data.
Clinical trial identification
UMIN000019519.
Legal entity responsible for the study
Japan Clinical Cancer Research Organization (JACCRO).
Funding
Japan Clinical Cancer Research Organization (JACCRO).
Editorial Acknowledgement
Disclosure
M. Takeuchi: Travel grants: Taiho Pharmaceutical; Consulting fees: AnGes. W. Ichikawa: Research funding: Takeda, Taiho Pharmaceutical, Chugai Pharma; Honoraria: Merck Serono, Taiho Pharmaceutical, Chugai Pharma, Takeda. K. Shitara: Funding: Chugai Pharma, Daiichi Sankyo, Eli Lilly Japan, Taiho Pharmaceutical, MSD, Ono Pharmaceutical. Y. Sunakawa: Honoraria: Merck Serono, Yakult Honsha, Takeda, Chugai Pharma, Taiho Pharmaceutical. Y. Sakata: Honoraria Taiho Pharmaceutical M. Takeuchi: Consulting fees: Hisamitsu Pharmaceutical, Kowa, Shionogi Pharma, Abbvie, Astellas. M. Fujii: Travel grants: Japan Clinical Cancer Research Organization. All other authors have declared no conflicts of interest.
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