Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer

• Published in: British journal of cancer 2016-03, Vol.114 (7), p.737-743
• Main Authors: Stein, Stacey M, James, Edward S, Deng, Yanhong, Cong, Xiangyu, Kortmansky, Jeremy S, Li, Jia, Staugaard, Carol, Indukala, Doddamane, Boustani, Ann Marie, Patel, Vatsal, Cha, Charles H, Salem, Ronald R, Chang, Bryan, Hochster, Howard S, Lacy, Jill
• Format: Article
• Language: English
• Subjects: 631/67/1059/99; 631/67/1504/1713; 692/308/2779/109/1941; Adenocarcinoma - drug therapy; Adenocarcinoma - mortality; Adenocarcinoma - pathology; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biomedical and Life Sciences; Biomedicine; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Cancer Research; clinical-study; Drug Resistance; Epidemiology; Female; Fluorouracil - administration & dosage; Follow-Up Studies; Humans; Leucovorin - administration & dosage; Liver Neoplasms - drug therapy; Liver Neoplasms - mortality; Liver Neoplasms - secondary; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - secondary; Lymphatic Metastasis; Male; Middle Aged; Molecular Medicine; Neoplasm Staging; Oncology; Organoplatinum Compounds - administration & dosage; Pancreatic cancer; Pancreatic Neoplasms - drug therapy; Pancreatic Neoplasms - mortality; Pancreatic Neoplasms - pathology; Peritoneal Neoplasms - drug therapy; Peritoneal Neoplasms - mortality; Peritoneal Neoplasms - secondary; Prognosis; Prospective Studies; Survival Rate
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/bjc.2016.45

Background: Modifications of FOLFIRINOX are widely used despite the absence of prospective data validating efficacy in metastatic disease (metastatic pancreatic cancer (MPC)) or locally advanced pancreatic cancer (LAPC). We conducted a multicentre phase II study of modified FOLFIRINOX in advanced pancreatic cancer to assess the impact of dose attenuation in MPC and efficacy in LAPC. Methods: Patients with untreated MPC or LAPC received modified FOLFIRINOX (irinotecan and bolus 5-fluorouracil reduced by 25%). Adverse events (AEs) were compared with full-dose FOLFIRINOX. Response rate (RR), median progression-free survival (PFS) and median overall survival (OS) were determined. Results: In total, 31 and 44 patients with LAPC and MPC were enrolled, respectively. In MPC, efficacy of modified FOLFIRINOX was comparable with FOLFIRINOX with RR 35.1%, OS 10.2 months (95% CI 7.65–14.32) and PFS 6.1 months (95% CI 5.19–8.31). In LAPC, efficacy was notable with RR 17.2%, resection rate 41.9%, PFS 17.8 months (95% CI 11.0–23.9) and OS 26.6 months (95% CI 16.7, NA). Neutropenia ( P