Crizotinib, an inhibitor of the anaplastic lymphoma kinase (ALK) gene, has shown significant response rates in patients with advanced non–small-cell lung cancer (NSCLC) and the ALK rearrangement. A new study compared the response rates of standard chemotherapy with crizotinib in patients with ALK-positive advanced NSCLC (Shaw AT, et al. N Engl J Med. 2013;368:2385-2394).
This phase 3, open-label clinical trial included 374 patients with locally advanced or metastatic ALK-positive NSCLC who had previously received 1 platinum-based regimen. The patients were randomized in a 1:1 ratio to oral crizotinib 250 mg twice daily or to intravenous chemotherapy with pemetrexed or with docetaxel every 3 weeks. The patients receiving chemotherapy whose disease progressed were allowed to cross over to receive crizotinib as a separate study. The study primary end point was progression-free survival (PFS).
The median PFS was 7.7 months with crizotinib versus 3.0 months with chemotherapy. The response rates were 65% (95% CI, 58-72) with crizotinib versus 20% with chemotherapy (P <.001).
At the time of the data cutoff, the median follow-up for overall survival was similar between the 2 groups: 12.2 months in the crizotinib group and 12.1 months in the chemotherapy group.
Overall, 58 patients receiving crizotinib continued therapy beyond the predefined period of progression compared with 17 of the patients receiving chemotherapy, and the therapy duration was also longer with crizotinib than with chemotherapy—a median of 15.9 weeks versus a median of 6.9 weeks, respectively.