Adding radiation to chemotherapy regimens may not improve overall survival compared with chemotherapy alone in patients with locally advanced pancreatic cancer, according to results from a clinical trial.
The trial, LAP07 (Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery), enrolled 442 patients diagnosed with pancreatic cancer between 2008 and 2011 with the intention of assessing whether chemoradiotherapy could improve overall survival after 4 months of gemcitabine-based induction chemotherapy or gemcitabine plus erlotinib maintenance therapy. Led by Pascal Hammel, MD, Beaujon Hospital (Clichy, France), investigators published the results of both phases in JAMA.
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In the first phase of the trial, patients were randomly assigned to receive gemcitabine alone (n=223) or gemcitabine plus erlotinib (n=219). In the second phase, patients whose cancer had not progressed after 4 months of treatment were randomly assigned to receive 2 months of additional chemotherapy (n=136) or chemotherapy plus radiation (n=133).
Interim analysis was performed when half of the patients had died (109 in the chemoradiotherapy group and 112 in the chemotherapy group), with a median follow-up of 36.7 months. At this time, researchers observed that the median overall survival was not significantly different between any of the groups.
In patients who received gemcitabine alone, overall survival was 13.6 months compared with 11.9 months in those who had erlotinib added to their treatment. Chemoradiotherapy also did not significantly improve survival compared with chemotherapy alone (15.2 months vs 16.5 months) but was associated with decreased local progression (32% vs 46%) and no increase in grade 3 to 4 toxicity, except for nausea.
Thus, investigators concluded that there was no significant difference in survival between chemoradiotherapy and chemotherapy alone or gemcitabine and gemcitabine with erlotinib.
Based on these results, “chemoradiation need not be a component of standard care,” wrote Deborah Schrag, MD, Dana Farber Cancer Institute (Boston, MA), in an editorial piece that accompanied the article. “However, it is also important to realize that radiation was not inferior to continued chemotherapy.”
She added that, unlike other cancer types, pancreatic cancer mortality rates have not declined significantly over the past decades, necessitating further research.