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LAP07 tested whether adding radiotherapy after four months of chemotherapy helps people whose pancreatic cancer has not spread but cannot be removed; it did not lengthen life, although it did keep the tumour in check locally for longer, and adding erlotinib to gemcitabine did not help either.
LAP07 was an international open-label phase 3 trial run by GERCOR in 449 patients with locally advanced pancreatic cancer. Patients were first randomised to gemcitabine or gemcitabine with erlotinib for four months; the 269 whose disease was controlled were then randomised to capecitabine-based chemoradiotherapy or two more months of the same chemotherapy. The primary endpoint was overall survival.
The trial stopped for futility at the interim analysis: median overall survival was 16.5 months with chemotherapy and 15.2 months with chemoradiotherapy (hazard ratio 1.03), and 13.6 months with gemcitabine against 11.9 months with gemcitabine plus erlotinib (hazard ratio 1.19). Chemoradiotherapy did reduce local progression (32 against 46 percent) without more grade 3 to 4 toxicity except nausea. The corpus's locally advanced pancreatic cancer page cites LAP07 for better local control without longer survival.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
449 registered.
95% CI 13.9 to 17.3; 269 patients in the second randomisation · 95% CI 14.5 to 18.5
Source95% CI 12.3 to 15.3 · 95% CI 10.4 to 13.5
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival from first randomisation, chemoradiotherapy against chemotherapy (second randomisation)primary | Capecitabine-based chemoradiotherapy after 4 months of chemotherapy | - | 15.2 months | 1.03 (0.79 to 1.34) | 0.83 | link |
| Two further months of chemotherapy | - | 16.5 months | ||||
| Overall survival, gemcitabine against gemcitabine plus erlotinib (first randomisation) | Gemcitabine | 223 | 13.6 months | 1.19 (0.97 to 1.45) | 0.09 | link |
| Gemcitabine + erlotinib | 219 | 11.9 months | ||||
| Local progression | Capecitabine-based chemoradiotherapy | - | 32% | - | 0.03 | link |
| Chemotherapy alone | - | 46% |
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