Comparison of Second-Line Treatments in Advanced Pancreatic Cancer After Gemcitabine-Based Chemotherapy


Key Points

  • Progression-free survival did not differ with modified FOLFOX6 vs 5-FU/leucovorin treatment in patients with advanced pancreatic cancer who had received gemcitabine-based chemotherapy.
  • Modified FOLFOX6 was associated with greater toxicity and poorer overall survival.

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.