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| |  FOLFIRINOX Shows Promise as Treatment Option for Patients With Metastatic Pancreatic Cancer: Presented at ESMO-GI By Chris Berrie BARCELONA, Spain -- July 2, 2010 -- Although more toxic, the combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) provides significantly improved progression-free survival (PFS) and overall survival (OS), compared with gemcitabine, in patients with metastatic adenocarcinoma of the pancreas. Thierry Conroy, MD, Centre Alexis Vautrin, University of Nancy, Nancy, France, presented the final results of the PRODIGE 4/ACCORD 11 trial on June 30 during a late-breaking presentation at the European Society for Medical Oncology's 12th World Congress on Gastrointestinal Cancer (ESMO-GI). As he noted, as an incurable disease, metastatic pancreatic ductal adenocarcinoma has few good treatment options at present, with single-agent gemcitabine remaining the cornerstone of treatment. Following promise shown by FOLFIRINOX in a phase 2 trial, the researchers investigated its potential further in 342 patients aged 18 to 75 years with metastatic pancreatic cancer with no prior cytotoxic chemotherapy or abdominal radiotherapy. Patients were randomised to an intravenous infusion of gemcitabine 1,000 mg/m2 over 30 minutes, once weekly for 7 of 8 weeks, and then for 3 of 4 weeks repeating every 4 weeks, or to FOLFIRINOX (oxaliplatin 85 mg/m2 IV infusion over 2 hours, then leucovorin 400 mg/m2 IV infusion over 2 hours with irinotecan 180 mg/m2 IV infusion over 1.5 hours, then 5-fluorouracil 400 mg/m2 IV bolus plus 2,400 mg/m2 IV infusion over 46 hours, repeated every 2 weeks). Computed tomography (CT) scans were carried out every 2 months. With a median follow-up of 26.6 months, as an intention-to-treat analysis, the primary endpoint of median OS was significantly improved for patients receiving FOLFIRINOX (11.1 vs 6.8 months for gemcitabine; P < .0001). Objective response rate was 50.9% in the gemcitabine arm versus 70.2% in the FOLFIRINOX arm (P = .0003) and PFS was 6.4 vs 3.3 months, respectively (P < .0001). "Looking at the time to quality-of-life degradation, this also favoured the FOLFIRINOX arm [P = .001]," Dr. Conroy noted. Compared with gemcitabine, grade 3/4 adverse events were significantly greater with FOLFIRINOX. These included neutropenia (18.1%/0.6% vs 29.9%/16.1%; P = .0001); febrile neutropenia (0.0%/0.6% vs 4.2%/1.2%; P = .009); vomiting (4.1%/0.6% vs 13.9%/0.6%; P = .002); fatigue (13.6%/0.6% vs 21.2%/1.8%; P = .036); and diarrhoea (1.2%/0.0% vs 10.9%/1.8%; P = .0001). Dr Conroy also indicated 1 toxic death in each treatment arm. "This new regime could be one of the standards of care for patients with metastatic pancreatic cancer, but only in patients with normal bilirubin and with a good performance status [ECOG-PS 0-1]," said Dr. Conroy. Funding for this study was provided by sanofi-aventis and Pfizer. [Presentation title: Randomized Phase III Trial Comparing FOLFIRINOX (5FU/ Leucovorin, Irinotecan and Oxaliplatin) vs Gemcitabine as First-Line Treatment for Metastatic Pancreatic Adenocarcinoma. Prodige 4 - ACCORD 11/0402 Trial: Final Results. Late-Breaking Presentation]
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