Published in:
01-01-2016 | Original Article
Phase I study assessing the feasibility of the triple combination chemotherapy of SOXIRI (S-1/oxaliplatin/irinotecan) in patients with unresectable pancreatic ductal adenocarcinoma
Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2016
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Background
The objective of this study was to determine the recommended dose (RD) of a biweekly S-1, oxaliplatin, and irinotecan (SOXIRI) regimen in patients with unresectable pancreatic ductal adenocarcinoma.
Methods
This phase I study used a traditional “3+3” dose-escalation design, with four dose levels. A dose-escalation schedule consisted of two doses of S-1 (60 and 80 mg/m2 twice daily) for 2 weeks in alternate-day administration, three doses of irinotecan (125, 150, and 180 mg/m2) on day 1, and a single dose of oxaliplatin (85 mg/m2) on day 1 of a 2-week cycle. Dose-limiting toxicities (DLTs) were assessed in the first four cycles to determine the maximum tolerated dose. This clinical study was registered at UMIN000014339.
Results
Fifteen patients received this regimen (median, eight cycles; range 4–12). At dose level 3 (S-1, 80 mg/m2; irinotecan, 150 mg/m2), 2/6 patients experienced DLTs of grade 3 fatigue and grade 4 neutropenia. At dose level 4, all three patients experienced DLTs: grade 3 fatigue (n = 1) and grade 4 neutropenia (n = 2). The RD was 80, 85, and 150 mg/m2 of S-1, oxaliplatin, and irinotecan, respectively. We found the following: response rate, 47 %; disease control rate, 80 %; median progression-free survival, 6.7 months; overall survival, 13.4 months.
Conclusions
The SOXIRI regimen’s RD is 80, 85, and 150 mg/m2 of S-1, oxaliplatin, and irinotecan, respectively.