LAP07
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.
Overview
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.
- Median 15.2 vs 16.5 months with Capecitabine-based chemoradiotherapy after 4 months of chemotherapy compared with Two further months of chemotherapy; about 1.3 months shorter for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 3 percent higher chance of the event at any given time (hazard ratio 1.03, likely range 0.79 to 1.34).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Median 13.6 vs 11.9 months with Gemcitabine compared with Gemcitabine + erlotinib; about 1.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 19 percent higher chance of the event at any given time (hazard ratio 1.19, likely range 0.97 to 1.45).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 32 vs 46 out of 100 reached this endpoint with Capecitabine-based chemoradiotherapy compared with Chemotherapy alone; 14 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.03) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Locally advanced unresectable pancreatic cancer: a first randomisation to four months of gemcitabine with or without erlotinib, then for patients without progression a second randomisation to capecitabine-based chemoradiotherapy (54 Gy) or two further months of chemotherapy. People in a different situation may not see the same effect.
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% |
Similar pages
not linked directly; found by shared links- TrialESPAC-5
Shares Capecitabine, Gemcitabine, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialESPAC-4
Shares Capecitabine, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialCONKO-001
Shares Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialESPAC-3
Shares Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialCONTINUUM
Shares Gemcitabine, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialSJMB12
Shares Gemcitabine, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialCLASSIC
Shares Capecitabine, Cytotoxic chemotherapy and the tag soc-trials.
- TrialAALL1521
Shares Cytotoxic chemotherapy, Small-molecule kinase inhibitors and the tag soc-trials.