Erschienen in:
01.04.2014 | Original Article
A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer
verfasst von:
Toshikazu Moriwaki, Shinji Hirai, Shuichi Hironaka, Kenji Amagai, Atsuko Soeda, Mikio Sato, Takeshi Nihei, Mitsuaki Hirose, Kenji Matsuda, Atsushi Ohkawara, Taketo Yamaguchi, Mitsuharu Ozeki, Takashi Mamiya, Tetsuya Murashita, Ichinosuke Hyodo
Erschienen in:
Gastric Cancer
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Ausgabe 2/2014
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Abstract
Background
S-1 plus weekly split-dose cisplatin demonstrated promising results in previous phase I and II studies for advanced gastric cancer (AGC) patients.
Methods
In this randomized phase II study, the efficacy and safety of S-1 plus weekly split-dose cisplatin (SWP, S-1 daily oral dose of 80–120 mg according to body surface area on days 1–14, and cisplatin 20 mg/m2 i.v. on days 1 and 8 every 3 weeks) were compared with those of S-1 plus standard-dose cisplatin (SP) as first-line chemotherapy for AGC patients. The primary endpoint was 1-year survival rate.
Results
Patients were randomized into two groups: 18 in the SWP arm and 19 in the SP arm. This trial was terminated early because of low patient enrollment. The 1-year survival rate was 61 % [95 % confidence interval (CI), 36–86 %] and 53 % (95 % CI, 30–75 %) in the SWP and SP arms, respectively. However, the median survival time was 12.3 months (9.9–14.6 months) and 15.7 months (4.0–27.4 months), respectively (P = 0.064). Progression-free survival was significantly shorter in the SWP arm than in the SP arm (P = 0.047). Toxicity tended to be milder in the SWP arm than in the SP arm. For approximately 40 % of patients in the SWP arm, cisplatin was omitted on day 8 and treatment delayed because of prolonged myelosuppression.
Conclusions
No clear benefits of adding cisplatin to S-1 in the SWP arm were demonstrated in this study. At this point, split-dose cisplatin combined with S-1 cannot be recommended for use in clinical practice.