The activity of standard chemotherapy in ALK-positive non-small cell lung cancer has not been established. This Phase III open-label randomised control trial was conducted to compare crizotinib (n=173) with standard chemotherapy (n=174) in patients with advanced, previously treated ALK-positive non-small-cell lung cancer.
The authors reported that the median progression-free survival, as determined by independent radiologic review, was 7.7 months (95% CI, 6.0 to 8.8) in the crizotinib group, as compared with 3.0 months (95% CI, 2.6 to 4.3) in the chemotherapy group (hazard ratio for disease progression or death with crizotinib, 0.49; 95% CI, 0.37 to 0.64; P<0.001). In subgroup analyses, there was significant improvement in progression-free survival with crizotinib as compared with pemetrexed (hazard ratio for disease progression or death, 0.59; 95% CI, 0.43 to 0.80; P<0.001) and as compared with docetaxel (hazard ratio for disease progression or death, 0.30; 95% CI, 0.21 to 0.43; P<0.001).
The authors concluded that the study showed crizotinib, as compared with chemotherapy, prolonged progression-free survival, increased response rates, and improved the quality of life in patients with advanced, previously treated ALK-positive non–small-cell lung cancer.
NICE is in the process of developing guidance on the use of crizotinib for the treatment of previously treated non-small-cell lung cancer associated with an anaplastic lymphoma kinase fusion gene. Guidance is expected in September 2013.