Phase <scp>II</scp> study of <scp>FOLFIRINOX</scp> for chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer

<jats:p>The <jats:styled-content style="fixed-case">FOLFIRINOX</jats:styled-content> combination of chemotherapy drugs had not been fully evaluated for Japanese pancreatic cancer patients. Therefore, we carried out a phase <jats:styled-content style="fixed-case">II</jats:styled-content> study to examine the efficacy and safety of <jats:styled-content style="fixed-case">FOLFIRINOX</jats:styled-content> in chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer. <jats:styled-content style="fixed-case">FOLFIRINOX</jats:styled-content> (i.v. infusion of 85 mg/m<jats:sup>2</jats:sup> oxaliplatin, 180 mg/m<jats:sup>2</jats:sup> irinotecan, and 200 mg/m<jats:sup>2</jats:sup><jats:italic> l</jats:italic>‐leucovorin, followed by a bolus of 400 mg/m<jats:sup>2</jats:sup> fluorouracil and a 46‐h continuous infusion of 2400 mg/m<jats:sup>2</jats:sup> 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 [<jats:styled-content style="fixed-case">CI</jats:styled-content>], 23.1–56.5); median overall survival, 10.7 months (95% <jats:styled-content style="fixed-case">CI</jats:styled-content>, 6.9–13.2); and median progression‐free survival, 5.6 months (95% <jats:styled-content style="fixed-case">CI</jats:styled-content>, 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. <jats:styled-content style="fixed-case">FOLFIRINOX</jats:styled-content> can be a standard regimen showing favorable efficacy and acceptable toxicity profile in chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer.</jats:p>