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30.06.2017 | Original Article | Ausgabe 6/2017 Open Access

International Journal of Clinical Oncology 6/2017

Randomized phase II study of daily and alternate-day administration of S-1 for advanced gastric cancer (JFMC43-1003)

Zeitschrift:
International Journal of Clinical Oncology > Ausgabe 6/2017
Autoren:
Hiroaki Tanaka, Mitsuro Kanda, Satoshi Morita, Masataka Taguri, Kazuhiro Nishikawa, Mitsuo Shimada, Kazuya Muguruma, Keisuke Koeda, Masazumi Takahashi, Mikihito Nakamori, Hiroyuki Konno, Akihito Tsuji, Yoshinori Hosoya, Tetsuhiko Shirasaka, Susumu Yamamitsu, Michio Sowa, Masaki Kitajima, Masazumi Okajima, Michiya Kobayashi, Junichi Sakamoto, Shigetoyo Saji, Kosei Hirakawa

Abstract

Purpose

Although S-1 based chemotherapy for patients with advanced gastric cancer has generally been accepted in Japan, discontinuations of treatment have been reported due to grade 3 or more adverse events. The present randomized phase II study was conducted to test whether alternate-day administration of S-1 would be comparably efficient and reduce adverse events compared with conventional daily administration in the first-line chemotherapy for advanced gastric cancer.

Methods

132 patients with advanced gastric cancer were randomly assigned to 1:2 ratios to receive treatment with daily at a standard dose of 80 mg/m2/day or alternate-day administration group received S-1 on 4 days a week. The primary end point was progression-free survival (PFS), and the secondary end points were safety, overall survival, time to treatment failure (TTF), disease control rate, and response rate.

Results

The 6-month PFS rate of the alternate-day administration group was 20.9% and failed to show significant difference from the pre-specified threshold at 15% (p = 0.117), whereas that of the daily administration group was 39.1% and significantly higher than the threshold (p = 0.001). The hazard ratio of the alternate-day administration group compared with the daily administration group was 1.753 (95% confidence interval (CI) 1.15–2.68, p = 0.010). With regard to OS, the hazard ratio of the alternate-day administration group compared with the daily administration group was 1.487 (95% CI 0.97–2.29, p = 0.072). The median TTF were 4.2 and 2.8 months in the daily and alternate-day administration group, respectively (p = 0.007).

Conclusion

The alternate-day administration of S-1 was not recommended as the first-line therapy for patients with advanced gastric cancer.

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