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- Title
Unexpected Side Effects of a High S-1 Dose: Subanalysis of a Phase III Trial Comparing Gemcitabine, S-1 and Combinatorial Treatments for Advanced Pancreatic Cancer.
- Authors
Kobayashi, Satoshi; Ueno, Makoto; Hara, Hiroki; Irie, Kuniyasu; Goda, Yoshihiro; Moriya, Satoshi; Tezuka, Shun; Tanaka, Masao; Okusaka, Takuji; Ohkawa, Shinichi; Morimoto, Manabu
- Abstract
Objective: In this subanalysis of a phase III trial using three categorized doses of S-1, the influence of the actual doses on safety and efficacy was evaluated. Methods: We compared the efficacy and safety of the S-1 or gemcitabine plus S-1 combination (GS) arm between the top 10% group and the bottom 10% group according to the initial doses of S-1: ≥ 77.6 versus ≤ 65.9 mg/m ² /day (n = 28 vs. 28) in the S-1 arm, and ≥ 65.1 versus ≤ 53.8 mg/m ² /day (n = 27 vs. 28) in the GS arm. Results: Overall and progression-free survival were not significantly different between these two groups: hazard ratios of 0.818 and 0.761 with p values of 0.498 and 0.330 in the S-1 arm, and hazard ratios of 0.836 and 0.759 with p values of 0.557 and 0.323 in the GS arm, respectively. Incidences of grade 3-4 hematological toxicities were significantly higher in the top 10% group than in the bottom 10% group: 42.9 versus 14.3 and 85.2 versus 57.1%, with p values of 0.037 and 0.037 in the S-1 and the GS combination arm, respectively. Conclusions: Higher actual doses of S-1 were associated with a higher incidence of hematological toxicity even in the same dose setting.
- Subjects
ANTIMETABOLITES; ANTINEOPLASTIC agents; DRUG side effects; PANCREATIC tumors; PATIENT safety; PHARMACOKINETICS; PROBABILITY theory; SURVIVAL analysis (Biometry); TREATMENT effectiveness; PHARMACODYNAMICS
- Publication
Oncology, 2016, Vol 91, Issue 3, p117
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000446989