EGFR-Targeted Drug Effective for Some Lung Cancer Patients - July 12, 2011 • Volume 8 / Number 14

EGFR-Targeted Drug Effective for Some Lung Cancer Patients
July 12, 2011 • Volume 8 / Number 14

Patients with advanced non-small cell lung cancer (NSCLC) whose tumors have specific mutations in the EGFR gene lived longer without their disease progressing when treated with the drug erlotinib (Tarceva) than patients who received chemotherapy alone, according to results from a phase III trial presented last week at the 2011 World Conference on Lung Cancer in Amsterdam.

Based on a recommendation from its independent data monitoring committee, the 174-patient EURTAC trial was halted in January after an interim analysis found that it had met its primary endpoint of improved progression-free survival.

Other trials have also shown that patients whose tumors have EGFR mutations have better outcomes when treated with an EGFR-targeted agent such as erlotinib or gefitinib (Iressa), which are both tyrosine kinase inhibitors. However, those trials included only Asian patients, and only one trial to date, called OPTIMAL, limited enrollment to participants whose tumors had EGFR mutations. The EURTAC trial was the first to enroll patients from Western countries (primarily Europe) with advanced NSCLC whose tumors had EGFR mutations, explained the lead investigator Dr. Radj Gervais of Centre François Baclesse in France.

Patients were randomly assigned to receive, as their initial treatment, either erlotinib or a chemotherapy regimen containing a platinum drug until their disease progressed. Patients treated with erlotinib lived a median of 9.7 months without their disease progressing compared with 5.2 months for patients treated with chemotherapy. There was also a very high response rate in the patients treated with erlotinib, Dr. Gervais reported, with 58 percent experiencing substantial tumor shrinkage compared with only 15 percent of patients who received chemotherapy.

Overall survival was slightly better in patients treated with erlotinib, but the improvement was not statistically significant. An overall survival improvement may never be seen, Dr. Gervais explained during a press briefing, because patients treated with chemotherapy as their first-line therapy were switched to erlotinib once their disease began to progress, which is in line with current clinical practice.

Because of this crossover to treatment with erlotinib, “showing a survival improvement will be a difficult task,” agreed Dr. Roy Herbst, a leading lung cancer researcher at the University of Texas M. D. Anderson Cancer Center, during the briefing.

As early as the end of the year, Astellas Pharma expects to submit an application to the FDA seeking approval for erlotinib as a first-line treatment in patients with NSCLC who have EGFR mutations. Roche funded the EURTAC trial.

NCI Cancer Bulletin for July 12, 2011 - National Cancer Institute: "July 12, 2011 • Volume 8 / Number 14 - Enviado mediante la barra Google"