For patients with advanced lung cancer whose tumors carry EGFR activating mutations, first-line treatment with erlotinib nearly tripled progression-free survival compared to a standard chemotherapy combination, show results from the first prospective Phase-III study to report findings in this setting.
The new results from the OPTIMAL trial were reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.
"Erlotinib is very effective and well tolerated in advanced NSCLC patients who harbor EGFR activating mutations. It is 2 to 3 times more effective than doublet chemotherapy," said study leader Professor Caicun Zhou of Shanghai Pulmonary Hospital, Tongji University, China.
The OPTIMAL study included 165 patients whose lung cancer carried mutations activating the Epithelial Growth Factor Receptor (EGFR). Participants had not received systemic treatment for their cancer.
Of these patients, 83 were randomly assigned to receive erlotinib 150 mg/day, and 82 patients were assigned to receive a 'doublet' combination chemotherapy of gemcitabine and carboplatin. The primary endpoint of the study was progression-free survival.
In his presentation at the ESMO Congress, Prof Zhou reported that the median progression-free survival in the erlotinib arm was 13.1 months, compared to 4.6 months for the chemotherapy arm of the study. The objective response rate with erlotinib was 83%, compared to 36% for gemcitabine plus carboplatin. 31 patients in the erlotinib arm are still under study and progression free compared to only 1 in the chemotherapy arm.
"OPTIMAL is the first reported prospective Phase-III study to confirm the role of erlotinib in advanced NSCLC patients with EGFR activating mutations," Prof Zhou said. "It does much better than the standard doublet chemotherapy and so we should start erlotinib treatment as soon as possible after the diagnosis of advanced NSCLC with EGFR
|Contact: Vanessa Pavinato|
European Society for Medical Oncology