In the Canadian phase III PANCREOX trial reported in the Journal of Clinical Oncology, Gill et al found no benefit of modified FOLFOX6 (infusional fluorouracil [5-FU], leucovorin, and oxaliplatin) vs infusional 5-FU/leucovorin as second-line treatment in patients with advanced pancreatic cancer who had received gemcitabine-based chemotherapy.
Study Details
In the trial, 108 patients from 12 sites in Canada were randomized between May 2010 and December 2012 to receive biweekly modified FOLFOX6 (n = 54) or infusional 5-FU/leucovorin (n = 54) until disease progression. The study was closed before reaching target enrollment of 128 patients due to slow accrual. The primary endpoint was progression-free survival in the intent-to-treat population.
Outcomes and Adverse Events
After a median follow-up of 8.8 months, median progression-free survival was 3.1 months in the modified FOLFOX6 group vs 2.9 months in the 5-FU/leucovorin group (hazard ratio [HR] = 1.00, P = .989). Median overall survival was 6.1 months vs 9.9 months (HR = 1.78, P = .024). The objective response rate was 13.2% vs 8.5% (all partial responses; P = .361). Post-progression treatment was more common in the 5-FU/leucovorin group (25% vs 7%).
Grade 3 or 4 adverse events occurred in 63% of patients who received modified FOLFOX6 and 11% of patients who received 5-FU/leucovorin, with adverse events leading to treatment discontinuation in 20% vs 2%, respectively.
The investigators concluded: “No benefit was observed with the addition of oxaliplatin, administered as [modified FOLFOX6], versus infusional [5-FU/leucovorin] in patients with advanced pancreatic cancer previously treated with first-line gemcitabine.”
The study was supported by Sanofi Canada.
Sharlene Gill, MD, MPH, of the British Columbia Cancer Agency, is the corresponding author of the Journal of Clinical Oncology article.
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