Randomized Phase II Study of Consecutive-Day versus Alternate-Day Treatment with S-1 as Second-Line Chemotherapy in Advanced Pancreatic Cancer
| Autor: | Takanori Hirai, Takeshi Hiramatsu, Shinya Maruta, Eizaburo Ohno, Kuroiwa M, Hiroshi Matsubara, Takuya Ishikawa, Masashi Hattori, Tomoyuki Tsuzuki, Koichi Achiwa, Hajime Sumi, Yoshiki Hirooka, Akira Kanamori, Yoji Sasaki, Koji Nonogaki, Masahiko Ando, Hiroki Kawashima, Senju Hashimoto |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty medicine.medical_treatment Phases of clinical research Kaplan-Meier Estimate Gastroenterology Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Internal medicine Pancreatic cancer Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans 030212 general & internal medicine Adverse effect Prospective cohort study Aged Neoplasm Staging Tegafur Response rate (survey) Chemotherapy business.industry Incidence (epidemiology) General Medicine Middle Aged medicine.disease Pancreatic Neoplasms Drug Combinations Oxonic Acid Treatment Outcome Oncology 030220 oncology & carcinogenesis Retreatment Female business |
| Zdroj: | Oncology. 96:1-7 |
| ISSN: | 1423-0232 0030-2414 |
| DOI: | 10.1159/000492388 |
| Popis: | Objective: To evaluate the efficacy and safety of alternate-day administration of S-1 as second-line chemotherapy for unresectable pancreatic cancer in a multicenter, randomized, phase II study. Methods: Patients with histologically proven, unresectable pancreatic cancer treated with chemotherapy not including S-1 as first-line therapy were randomly assigned to receive either daily or alternate-day treatment with S-1. The primary end point was overall survival (OS), and the secondary end points were progression-free survival (PFS), time to treatment failure (TTF), response rate, and adverse events. Results: A total of 77 patients were enrolled, of which 75 were included in the final analysis. The median OS was 4.5 months in the daily group and 4.4 months in the alternate-day group (HR 1.178; 95% CI 0.741–1.875), with no significance in PFS and TTF. The response rate was 2.8% in the daily group and 0% in the alternate-day group. Grade 3 or higher adverse events occurred with significantly higher incidence in the daily group (47.2 vs. 25.6%, p = 0.044). Conclusion: As a second-line chemotherapy for unresectable pancreatic cancer, although the efficacy in both groups was comparable and we can expect fewer toxicities with alternate-day administration of S-1, the noninferiority of alternate-day treatment to daily treatment with S-1 was not verified. |
| Databáze: | OpenAIRE |
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