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Yoshida K, Iwashita T, Uemura S, et al. A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer. Oncotarget. 2017;8(67):111346-111355doi: 10.18632/oncotarget.22795.
Yoshida, K., Iwashita, T., Uemura, S., Maruta, A., Okuno, M., Ando, N., Iwata, K., Kawaguchi, J., Mukai, T., & Shimizu, M. (2017). A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer. Oncotarget, 8(67), 111346-111355. https://doi.org/10.18632/oncotarget.22795
Yoshida, Kensaku, et al. "A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer." Oncotarget vol. 8,67 (2017): 111346-111355. doi: https://doi.org/10.18632/oncotarget.22795
Yoshida K, Iwashita T, Uemura S, Maruta A, Okuno M, Ando N, Iwata K, Kawaguchi J, Mukai T, Shimizu M. A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer. Oncotarget. 2017 Nov 30;8(67):111346-111355. doi: 10.18632/oncotarget.22795. eCollection 2017 Dec 19. PMID: 29340058; PMCID: PMC5762326.
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Oncotarget. 2017 Nov 30;8(67):111346-111355. doi: 10.18632/oncotarget.22795. eCollection 2017 Dec 19.

A multicenter prospective phase II study of first-line modified FOLFIRINOX for unresectable advanced pancreatic cancer.

Oncotarget

Kensaku Yoshida, Takuji Iwashita, Shinya Uemura, Akinori Maruta, Mitsuru Okuno, Nobuhiro Ando, Keisuke Iwata, Junji Kawaguchi, Tsuyoshi Mukai, Masahito Shimizu

Affiliations

  1. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
  2. Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu, Japan.
  3. Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.

PMID: 29340058 PMCID: PMC5762326 DOI: 10.18632/oncotarget.22795

Abstract

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.

Keywords: adverse events; biliary drainage; dose modification; febrile neutropenia; risk factor

Conflict of interest statement

CONFLICTS OF INTEREST Kensaku Yoshida, Takuji Iwashita, Shinya Uemura, Akinori Maruta, Mitsuru Okuno, Nobuhiro Ando, Keisuke Iwata, Jyunji Kawaguchi, Tsuyoshi Mukai, Masahito Shimizu have nothing to d

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