SATURN Trial Shows Erlotinib Improves Survival in NSCLC

According to data from the Sequential Tarceva in Unresectable NSCLC (SATURN) trial, which was presented at the 13th World Conference on Lung Cancer, maintenance therapy with erlotinib improved overall survival in patients with advanced NSCLC after initially successful chemotherapy. These new data involve the secondary endpoint of the trial. Earlier this year at the 2009 Annual ASCO Meeting, researchers reported that erlotinib had met its primary endpoint of improving progression-free survival in chemotherapy-naïve patients with both squamous and nonsquamous cell lung cancer by 41% compared with placebo (ASCO abstract 8001).

The SATURN trial included 889 patients who had stable disease after 4 cycles of platinum-based chemotherapy. Of these patients, 438 were randomized to receive erlotinib maintenance therapy at a dose of 150 mg daily and 451 were randomized to placebo. Patients who received erlotinib had a median survival of approximately 12 months compared with 11 months for those who received placebo. The risk of progression was also reduced by 19%, and the clinical benefit extended across the majority of patient subgroups, regardless of smoking status, race, and whether the tumor was positive or negative for epidermal growth factor receptor.

The tolerability profile of erlotinib was consistent with previous trials, and no new safety signals were observed. Patients on erlotinib also showed no deterioration in their quality of life compared with those on placebo, and there was a low rate of therapy discontinuation.

According to SATURN’s lead investigator, Federico Cappuzzo, MD, professor and vice director of the Instituto Clinico Humanitas in Milan, Italy, while the survival benefit of 1 month seen with erlotinib may seem insignificant, there was a 10% absolute difference in survival between the treatment and placebo groups at 3 years. He also noted that the results of this study broaden the patient population for whom erlotinib can be effective.