A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer
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Kensaku Yoshida1, Takuji Iwashita1, Shinya Uemura1, Akinori Maruta1, Mitsuru Okuno1, Nobuhiro Ando2, Keisuke Iwata2, Junji Kawaguchi3, Tsuyoshi Mukai3 and Masahito Shimizu1
1First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan
2Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan
3Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan
Takuji Iwashita, email: email@example.com
Keywords: adverse events; febrile neutropenia; dose modification; biliary drainage; risk factor
Received: August 24, 2017 Accepted: November 13, 2017 Published: November 30, 2017
Background: FOLFIRINOX (FX) has been reported as an effective treatment for unresectable advanced pancreatic cancer. However, FX is associated with a high incidence of adverse events (AEs). A previous phase II study in Japan showed high incidences of hematological AEs, including febrile neutropenia (22.2%). A modified FX regimen (mFX) may decrease the rates of AEs and be more effective than FX by improving the treatment compliance.
Aims: To assess the safety and efficacy of first-line mFX for unresectable advanced pancreatic cancer.
Patients and methods: This was as a multicenter prospective phase II study in chemotherapy-naïve Japanese patients with pathologically confirmed unresectable advanced pancreatic adenocarcinoma or adenosquamous carcinoma. Treatment with mFX (85 mg/m2 oxaliplatin, 150 mg/m2 irinotecan, and 200 mg/m2 l-leucovorin, followed by 46-h continuous infusion of 2400 mg/m2 5-fluorouracil) was administered every 2 weeks. The primary endpoint was the response rate. The secondary endpoints were overall survival, progression-free survival, and safety.
Results: Thirty-one patients (18 men; median age, 64 years) were enrolled. A median of 13 treatment cycles were administered during a median follow-up period of 14.2 months. The response rate, median overall survival, and median progression-free survival were 38.7%, 14.9 months, and 7.0 months, respectively. Grade 3 or 4 AEs included neutropenia (83.9%), febrile neutropenia (16.1%), peripheral sensory neuropathy (9.7%), thrombocytopenia (6.5%), diarrhea (6.5%), anorexia (6.5%), and vomiting (3.2%).
Conclusion: Compared to FX, mFX may result in fewer Grade 3 or 4 non-hematological AEs, with a comparable response rate. However, further efforts might be required to reduce hematological AEs.
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