Safety and effectiveness of alectinib in a real-world surveillance study in patients with ALK-positive NSCLC in Japan.

We conducted a large-scale surveillance study as a post-marketing commitment to investigate safety and effectiveness of alectinib in patients with ALK-positive non-small-cell lung cancer (NSCLC) in Japan. Patients receiving 300mg twice-daily alectinib (September 2014 to June 2015) were monitored until termination of alectinib or completion of 18 months of treatment at 519 Japanese study sites. The primary endpoint was the incidence of adverse drug reactions (ADRs), which are important identified risks for alectinib in Japanese patients. Overall survival (OS), a key secondary endpoint, was assessed according to information on outcome. Overall, 1,251 patients were enrolled. The median patient age was 62.0 years; 12.9% of patients were aged ≥75 years. At baseline, 63.0% of patients had received crizotinib and 40.6% had brain metastases. Altogether, 1,512 ADRs occurred in 654 patients (53.6%), with 164 grade ≥3 ADRs in 123 patients (10.1%). Commonly occurring ADRs were hepatic disorders (all grade, 19.8%; grade ≥3, 2.0%), decreased neutrophil and/or white blood cell count (all grade, 7.6%; grade ≥3, 1.1%), and interstitial lung disease (all grade, 3.8%; grade ≥3, 0.7%). Median OS was not estimable. The 18-month cumulative OS rate was longer in patients with ECOG performance status ≤1 (versus 2 or ≥3; 83.7% versus 44.5% or 27.2%), without prior crizotinib (versus with; 81.1% versus 73.4%), receiving first-line alectinib (versus second and third or later line; 83.0% versus 79.2% or 71.9%), without brain metastases (versus with; 79.5% versus 71.5%). These data confirm the favorable safety and effectiveness of alectinib in patients with ALK-positive NSCLC in Japan. This article is protected by copyright. All rights reserved.