Medline ® Abstract for Reference 132
of 'Chemotherapy for advanced exocrine pancreatic cancer'
PANCREOX: A Randomized Phase III Study of 5-Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy.
Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WY, Dowden S, Grassin H, Stewart J, Moore M
J Clin Oncol. 2016 Sep;
PURPOSE: The standard of care for second-line therapy in patients with advanced pancreatic cancer after gemcitabine-based therapy is not clearly defined. The CONKO-003 phase III study reported a survival benefit with second-line fluorouracil (FU) and oxaliplatin using the oxaliplatin, folinic acid, and FU (OFF) regimen.(1) PANCREOX was a phase III multicenter trial to evaluate the benefit of FU and oxaliplatin administered as modified FOLFOX6 (mFOLFOX6; infusional fluorouracil, leucovorin, and oxaliplatin) versus infusional FU/leucovorin (LV) inthis setting.
PATIENTS AND METHODS: Patients with confirmed advanced pancreatic cancer who were previously treated with gemcitabine therapy and with an Eastern Cooperative Oncology Group performance status of 0-2 were eligible. A total of 108 patients were randomly assigned to receive biweekly mFOLFOX6 or infusional FU/LV until progression. Progression-free survival (PFS) was the primary end point.
RESULTS: Baseline patient characteristics were similar in both arms. No difference was observed in PFS (median, 3.1 months v 2.9 months; P = .99). Overall survival (OS) was inferior in patients assigned to mFOLFOX6 (median, 6.1 months v 9.9 months; P = .02). Increased toxicity was observed with the addition of oxaliplatin, with grade 3/4 adverse events occurring in 63% of patients who received mFOLFOX6 and 11% of those who received FU/LV. More patients in the mFOLFOX6 arm withdrew from study due to adverse events than in the FU/LV arm (20% v 2%), whereas the use of postprogression therapy was significantly higher in the FU/LV arm (25% v 7%; P = .015). No significant differences were observed in time to deterioration on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 global health scale.
CONCLUSION: No benefit was observed with the addition of oxaliplatin, administered as mFOLFOX6, versus infusional FU/LV in patients with advanced pancreatic cancer previously treated with first-line gemcitabine.
Sharlene Gill and Malcolm Moore, BC Cancer Agency, Vancouver; Muhammad Zulfiqar, BC Cancer Agency, Abbotsford; Thuan Do, BC Cancer Agency, Surrey; Wendy Yin Han Lam, Burnaby Hospital Cancer Centre, Burnaby, British Columbia; Yoo-Joung Ko, Sunnybrook Health Sciences Centre; Malcolm Moore, Princess Margaret Hospital, Toronto; Christine Cripps, Ottawa Hospital Cancer Centre, Ottawa; Sukhbinder Dhesy-Thind, Juravinski Cancer Centre, Hamilton; Pawel Zalewski, RSM Durham Regional Cancer Centre, Oshawa; Pablo Cano, Sudbury Regional Hospital, Sudbury, Ontario; Annie Beaudoin, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke; Helene Grassin and John Stewart, Sanofi Canada, Laval, Quebec; and Scot Dowden, Alberta Health Service, Calgary, Alberta, Canada. email@example.com.