Findings from an open-label, multicenter, randomized phase III trial in China suggest the oral non-chemotherapy agent erlotinib (Tarceva) is suitable for first-line treatment in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC).
The analysis from the OPTIMAL study was based on 154 confirmed EGFR mutation-positive patients that were randomized into 2 arms. The first arm of the trial contained 82 patients receiving oral erlotinib (150 mg/day). The second arm included 72 patients receiving up to 4 cycles of gemcitabine plus carboplatin.
Median progression-free survival (PFS) was shown to be longer in the erlotinib arm (HR 0.16, P
<.0001 ). The chemotherapy arm experienced a greater occurrence of 3/4 grade toxicity, including neutropenia (42%) and thrombocytopenia (40%). The most common 3/4 grade events in the erlotinib arm were an increased alanine aminotransferase concentration (4%) and a skin rash (2%).
"If approved for treatment of lung cancer with EGFR activating mutations, Tarceva will offer patients with this type of advanced lung cancer a significant benefit when used as their first-line treatment,” said Hal Barron MD, chief medical officer and head of Global Product Development at Genentech, a member of the Roche Group, in South San Francisco, California.
Other EGFR inhibitors, such as gefitinib, are also being investigated for first-line treatment of NSCLC patients with EGFR overexpression. Both gefitinib and erlotinib are tyrosine kinase inhibitors with similar mechanism of actions.
"EGFR mutations occur in about 20,000 patients annually in the US," according to Mark G. Kris, chief of Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center in New York City. He goes on to state, "if you have a mutation in EGFR you can virtually guarantee a response to gefitinib or erlotinib."
Zhou C, Wu Y, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol [published online ahead of print July 22, 2011]. doi:10.1016/S1470-2045(11)70184-X.