There was no significant difference in overall survival between chemoradiotherapy and chemotherapy alone in patients with locally advanced pancreatic cancer with disease controlled after 4 months of induction chemotherapy, a study published in JAMA has shown.1
Because the role of chemoradiotherapy is controversial in locally advanced pancreatic cancer, researchers sought to evaluate whether chemoradiotherapy improved survival of patients controlled after 4 months gemcitabine-based induction chemotherapy. As the efficacy of erlotinib in this treatment setting remains unknown, researchers also evaluated the effect of erlotinib on survival.
For the international, open-label, phase 3 trial, researchers enrolled 442 patients with locally advanced pancreatic cancer. Participants were randomly assigned to receive gemcitabine 1000 mg/m2 intravenously weekly or gemcitabine plus erlotinib 100 mg/day orally. The 269 patients with progression-free disease after 4 months were then randomly assigned to undergo the same chemotherapy for 2 months or chemoradiotherapy consisting of capecitabine plus 54 Gy.
Results showed that median overall survival from the date of the first randomization was 16.5 months (95% CI, 14.5 – 18.5) with chemotherapy alone compared with 15.2 months (95% CI, 13.9 – 17.3) with chemoradiotherapy (HR, 1.03; 95% CI, 0.79 – 1.34; P = .83).
Further, researchers found that median overall survival from the date of first randomization was 13.6 months (95% CI, 12.3 – 15.3) for gemcitabine vs 11.9 months (95% CI, 10.4 – 13.5) for gemcitabine plus erlotinib (HR, 1.19; 95% CI, 0.97 – 1.45; P = .09).
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Although there was no significant difference in median overall survival between chemoradiotherapy and chemotherapy alone, the study demonstrated that chemoradiotherapy was associated with decreased local progression (P = .03) and no increase in grade 3 to 4 toxicity, except for nausea.
- Hammel P, Huguet F, van Laethem J-L, et al. Effect of chemoradiotherapy vs chemotherapy on survival in patients with locally advanced pancreatic cancer controlled after 4 months of gemcitabine with or without erlotinib: the LAP07 randomized clinical trial. JAMA. 2016;315(17):1844-1853.