LAP07: chemoradiotherapy versus chemotherapy after four months of gemcitabine in locally advanced pancreatic cancer
Adding radiotherapy after four months of chemotherapy did not help people with unresectable, non-metastatic pancreatic cancer live longer, though it delayed local growth; adding erlotinib to gemcitabine did not help either.
Overview
International open-label phase 3 trial: 449 patients with locally advanced pancreatic cancer were randomised to gemcitabine with or without erlotinib for four months; 269 with controlled disease were then randomised to capecitabine-based chemoradiotherapy or two more months of chemotherapy.
The trial stopped for futility: median overall survival was 16.5 months with chemotherapy and 15.2 months with chemoradiotherapy (hazard ratio 1.03, p 0.83), and 13.6 months with gemcitabine against 11.9 months with gemcitabine plus erlotinib (hazard ratio 1.19). Chemoradiotherapy reduced local progression (32 against 46 percent) with no extra grade 3 to 4 toxicity except nausea.
- Median overall survival 15.2 months (95% CI 13.9 to 17.3) with chemoradiotherapy versus 16.5 months (14.5 to 18.5) with chemotherapy; hazard ratio 1.03 (0.79 to 1.34).
- Gemcitabine 13.6 months versus gemcitabine plus erlotinib 11.9 months; hazard ratio 1.19 (0.97 to 1.45).
- Local progression 32 versus 46 percent (p 0.03).
Consolidation chemoradiotherapy is optional in locally advanced pancreatic cancer, used for local control rather than survival; erlotinib has no role.
- Conventional radiotherapy with capecitabine; modern regimens (FOLFIRINOX induction, stereotactic radiotherapy) were not tested.
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