The addition of oxaliplatin to fluorouracil and leucovorin (mFOLFOX6) did not improve progression-free survival, and was associated with inferior overall survival compared with infusional fluorouracil plus leucovorin alone, among previously treated patients with advanced pancreatic cancer, according to a study published in the Journal of Clinical Oncology.1
The standard of care for second-line therapy among patients with advanced pancreatic cancer who have received gemcitabine-based therapy is unclear. Researchers compared the efficacy and safety of mFOLFOX6 with infusional fluorouracil plus leucovorin in this setting.
For the multicenter, phase 3 PANCREOX trial, researchers enrolled 108 patients, who were randomly assigned to receive biweekly mFOLFOX6 or infusional fluorouracil and leucovorin.
Median progression-free survival was 3.1 months with oxaliplatin, compared with 2.9 months with fluorouracil and leucovorin alone (P = .99).
Median overall survival was 6.1 months and 9.9 months with mFOLFOX6 and fluorouracil plus leucovorin, respectively (P = .02), suggesting that mFOLFOX6 was inferior for overall survival.
The addition of oxaliplatin was associated with a higher rate of grade 3 to 4 adverse events (63% versus 11%), and more patients receiving mFOLFOX6 withdrew from the study due to adverse events.
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There was no significant difference in time to deterioration between the 2 treatment arms, as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 global health scale.
- Gill S, Ko Y-J, Cripps C, et al. 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. J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.68.5776 [Epub ahead of print]