Results from PROFILE 1014: First-Line Crizotinib Versus Pemetrexed-Platinum in ALK+ NSCLC

There are no reliable data on the first-line treatment with the oral ALK inhibitor crizotinib (C) for advanced NSCLC compared with standard chemotherapy. The PROFILE 1014 study was a phase 3, randomized study of 343 patients with previously untreated, advanced, nonsquamous ALK+ NSCLC in which the patients were randomized to receive C or pemetrexed plus either cisplatin or carboplatin (PPC) (Mok T, et al. ASCO 2014. Abstract 8002). The primary end point for the study was progression-free survival (PFS), with secondary end points of overall response rate (ORR), overall survival (OS), and safety. The median PFS was 10.9 months in the C group compared with 7.0 months in the PPC group (P <.0001). Similarly, ORR was 74% in the C group versus 45% in the PPC group (P <.0001). However, a statistically significant difference in OS between the 2 groups was not demonstrated. Adverse events with C included vision disorder and gastrointestinal symptoms. Do these data establish C as the new standard of care as first-line therapy of advanced ALK+ nonsquamous NSCLC? “It is the duty of oncologists to examine scientific data, but also the value that existing and emerging treatments provide to society.”