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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.
- Source :
-
Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2017 Apr; Vol. 79 (4), pp. 813-823. Date of Electronic Publication: 2017 Mar 01. - Publication Year :
- 2017
-
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).<br />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.<br />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.<br />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.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic adverse effects
Asian People
Disease-Free Survival
Drug Combinations
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Oxonic Acid adverse effects
Pancreatic Neoplasms psychology
Prospective Studies
Quality of Life
Survival Analysis
Tegafur adverse effects
White People
Pancreatic Neoplasms
Antimetabolites, Antineoplastic administration & dosage
Antimetabolites, Antineoplastic therapeutic use
Oxonic Acid administration & dosage
Oxonic Acid therapeutic use
Pancreatic Neoplasms drug therapy
Tegafur administration & dosage
Tegafur therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1432-0843
- Volume :
- 79
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Cancer chemotherapy and pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 28251282
- Full Text :
- https://doi.org/10.1007/s00280-017-3250-8