Researchers discovered no survival benefit of chemoradiotherapy over chemotherapy in treating locally advanced pancreatic cancer in the LAP01 Randomized Clinical Trial.1
The role of chemoradiotherapy is controversial and the efficacy of erlotinib (Tarceva), a reversible tyrosine kinase inhibitor, is unknown in treating locally advanced pancreatic cancer.
Researchers first enrolled 449 patients to receive gemcitabine alone (n = 223) or gemcitabine and erlotinib (n = 219). Gemcitabine (Gemzar) is a nucleoside analog used as chemotherapy.
In the second randomization of patients with progression-free disease after 4 months, patients received 2 months of the same chemotherapy (n = 136) or received chemoradiotherapy at 54 Gy plus capecitabine (n = 133). Capecitabine is on the World Health Organization List of Essential Medicines, which enumerates the most essential medications in a basic health care system.
“The primary outcome was overall survival from the date of the first randomization. Secondary outcomes were the effect of erlotinib and quality assurance of radiotherapy on overall survival, progression-free survival of gemcitabine-erlotinib and erlotinib maintenance with gemcitabine alone at the second randomization, and toxic effects,” explained the authors.
There was no survival benefit of chemoradiotherapy over chemotherapy; the overall survival (OS) of the first randomization was 15.2 months and 16.5 months, respectively. Erlotinib also did not confer a survival benefit. The OS of gemcitabine compared to gemcitabine plus erlotinib was 13.6 months and 11.9 months, respectively. Median follow-up was 36.7 months.
“In this open-label, randomized trial involving patients with locally advanced pancreatic cancer with disease controlled after 4 months of induction chemotherapy, there was no significant difference in overall survival with chemoradiotherapy compared with chemotherapy alone and there was no significant difference in overall survival with gemcitabine compared with gemcitabine plus erlotinib used as maintenance therapy,” wrote the authors.
Roche and the French National Institute of Cancer funded this study.
1. Hammel P, Huguet F, van Laethem JL, 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 [published online ahead of print May 3, 2016]. JAMA. doi:10.1001/jama.2016.4324.