Comparing targeted therapy to chemotherapy for patients with advanced NSCLC

This trial compared the effectiveness of alectinib (Alecensa) against chemotherapy for treating patients with ALK-positive non-small-cell lung cancer that have progressed passed previous targeted therapy. The authors determined that alectinib was more effective than chemotherapy at treating this subgroup of patients.

Lung cancers due to specific genetic mutations (changes) can be treated with targeted therapies that may be more beneficial than current chemotherapies. For example, crizotinib (Xalkori) is used to treat patients with ALK-mutation positive non-small-cell lung cancer (NSCLC). It is not uncommon, however, for these patients to progress after treatment due to cancer spreading to the central nervous system (CNS). Another ALK targeting drug is alectinib, which has shown potential at treating patients with ALK-positive NSCLC that have progressed passed crizotinib.

This trial examined the effectiveness and safety of alectinib compared to chemotherapy for treating patients with advanced ALK-positive NSCLC who have been pretreated with crizotinib.

107 patients were included and randomly assigned to one of two groups. Group 1 included 72 patients treated with alectinib. Group 2 included 35 patients treated with chemotherapy.

Average progression free survival (PFS, time from beginning trial until disease progression) for group 1 patients was 9.6 months and 1.4 months for group 2 patients. Objective response rate (patients with tumor reduction) was 37.5% for group 1 patients compared to 2.9% for group 2 patients.

In patients whose cancer had spread to the CNS before the trial, the CNS objective response rate (patients with CNS tumor reduction) was 54.2% for group 1 patients and 0% for group 2 patients. Time from beginning trial until CNS progression for those without initial CNS spread was 86% longer for group 1 patients compared to group 2 patients.

Overall, side effects occurred at similar rates between both groups. The rate of serious grade 3 or higher side effects was higher in group 2 at 41.2% compared to 27.1% in group 1.

The authors concluded that alectinib was more effective than chemotherapy at treating patients with ALK-positive NSCLC who had progressed passed crizotinib treatment.

The study received funding from manufacturers of alectinib.