No survival benefit with chemoradiotherapy in locally advanced pancreatic cancer

Last Updated: 2016-05-03

By Reuters Staff

NEW YORK (Reuters Health) - Patients with locally advanced pancreatic cancer who received chemoradiotherapy didn't live longer than their peers who received chemotherapy alone in the LAP07 trial.

The trial also found no marked difference in survival with gemcitabine alone or with erlotinib.

"In locally advanced pancreatic cancer, the role of chemoradiotherapy is controversial and the efficacy of erlotinib is unknown," Dr. Pascal Hammel of Beaujon Hospital, Clichy, France, and colleagues note in JAMA May 3. The LAP07 study investigated both issues.

A total of 442 patients were first randomized to gemcitabine (n=223) or gemcitabine with erlotinib (n=219). After four months of treatment, patients free of disease progression were then randomly allocated to either continue their chemotherapy (n=136) or start chemoradiation (54 Gy plus capecitabine; n=133).

With a median follow-up exceeding three years, there was no survival benefit to chemoradiotherapy compared with just chemotherapy. Median overall survival from the date of the first randomization was 15.2 months with chemoradiation and 16.5 months with chemotherapy (hazard ratio 1.03; 95% CI: 0.79-1.34).

There was also no significant difference in overall survival with gemcitabine versus gemcitabine plus erlotinib (13.6 vs 11.9 months) and patients on erlotinib experienced added toxicity.

In a linked editorial, Dr. Deborah Schrag of Dana Farber Cancer Institute in Boston says, "The rationale for chemoradiation in locally advanced pancreas cancer stems from its potential to halt distant spread and convert radiosensitive disease from unresectable to resectable." However, "only 4% of patients in the study responded to treatment sufficiently to enable pancreatectomy, and this proportion did not differ between those who did or did not receive chemoradiation."

Dr. Schrag adds, "Clinical trials that find no difference between groups never garner as much excitement as trials with positive findings. However, clear negative results chart the path forward by informing the design of next-generation studies and hastening retirement of ineffective therapies. The results of the LAP07 trial are persuasive that contemporary chemoradiation does not add a survival advantage to chemotherapy alone."

"Ideally, future pancreatic cancer trials will identify molecular markers that better predict responsiveness to specific treatments including radiation and will allow for more focused approaches to treatment selection. In the meantime, chemoradiation need not constitute an essential component of the therapeutic backbone," she concludes.

The study was supported by Roche and the French National Institute of Cancer. Several authors made conflicts of interest disclosures.

SOURCE: http://bit.ly/1SZps6W and http://bit.ly/1TIJdNh

JAMA 2016.