1. Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer.
- Author
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Yamaue, Hiroki, Shimizu, Atsushi, Hagiwara, Yasuhiro, Sho, Masayuki, Yanagimoto, Hiroaki, Nakamori, Shoji, Ueno, Hideki, Ishii, Hiroshi, Kitano, Masayuki, Sugimori, Kazuya, Maguchi, Hiroyuki, Ohkawa, Shinichi, Imaoka, Hiroshi, Hashimoto, Daisuke, Ueda, Kazuki, Nebiki, Hiroko, Nagakawa, Tatsuya, Isayama, Hiroyuki, Yokota, Isao, and Ohashi, Yasuo
- Subjects
PANCREATIC cancer treatment ,ORAL medication ,ANTINEOPLASTIC agents ,PUBLIC health ,PROGRESSION-free survival ,PNEUMONIA ,CLINICAL trials ,THERAPEUTIC use of antimetabolites ,ANTIMETABOLITES ,ASIANS ,COMBINATION drug therapy ,COMPARATIVE studies ,FLUOROURACIL ,HETEROCYCLIC compounds ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,PANCREATIC tumors ,PROGNOSIS ,QUALITY of life ,RESEARCH ,SURVIVAL analysis (Biometry) ,WHITE people ,EVALUATION research ,RANDOMIZED controlled trials ,KAPLAN-Meier estimator ,PSYCHOLOGY - Abstract
Purpose: Non-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604).Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety.Results: A total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20-2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment.Conclusion: S-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group. [ABSTRACT FROM AUTHOR]- Published
- 2017
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