Phase II study of FOLFIRINOX for chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer

The FOLFIRINOX combination of chemotherapy drugs had not been fully evaluated for Japanese pancreatic cancer patients. Therefore, we carried out a phase II study to examine the efficacy and safety of FOLFIRINOX in chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer. FOLFIRINOX (i.v. infusion of 85 mg/m2 oxaliplatin, 180 mg/m2 irinotecan, and 200 mg/m2 l‐leucovorin, followed by a bolus of 400 mg/m2 fluorouracil and a 46‐h continuous infusion of 2400 mg/m2 fluorouracil) was given every 2 weeks. The primary endpoint was the response rate. The 36 enrolled patients received a median of eight (range, 1–25) treatment cycles. The response rate was 38.9% (95% confidence interval [CI], 23.1–56.5); median overall survival, 10.7 months (95% CI, 6.9–13.2); and median progression‐free survival, 5.6 months (95% CI, 3.0–7.8). Major grade 3 or 4 toxicities included neutropenia (77.8%), febrile neutropenia (22.2%), thrombocytopenia (11.1%), anemia (11.1%), anorexia (11.1%), diarrhea (8.3%), nausea (8.3%), elevated alanine aminotransferase levels (8.3%), and peripheral sensory neuropathy (5.6%). Febrile neutropenia occurred only during the first cycle. There were no treatment‐related deaths. FOLFIRINOX can be a standard regimen showing favorable efficacy and acceptable toxicity profile in chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer. FOLFIRINOX showed favorable results regarding RR (38.9%), PFS (5.6 months) and OS (10.7 months) in Japanese patients with metastatic pancreatic cancer. This regimen can be a new first‐line standard treatment.