Comparative Effectiveness Study Sheds Light on Optimal Symptom Improvement in ALK-Positive NSCLC

04/17/18

A study presented at the European Lung Cancer Congress (April 11-14, 2018; Geneva, Switzerland) investigated the effects of multiple therapies on symptom management in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

The phase III trial (ALEX) was designed as a head-to-head comparison of the next-generation tyrosine kinase inhibitor (TKI) alectinib vs the standard-of-care TKI crizotinib in patients with ALK-positive NSCLC. The study previously showed that alectinib has superior efficacy in patients with treatment-naïve ALK-positive NSCLC. For the first time, patient-reported outcomes regarding health-related quality of life and lung cancer-related symptoms with alectinib and crizotinib are reported.

Maurice Pérol, MD, medical oncologist, Centre Léon Bérard (France), and colleagues randomized a total of 103 patients (1:1) to receive alectinib or crizotinib. The EORTC QLQ-C30 questionnaire was utilized to evaluate health-related quality of life and the EORTC QLQ-LC13 questionnaire was used to assess lung cancer-related symptoms. Both questionnaires were completed at baseline, every 4 weeks during treatment, within the four weeks after study withdrawal, and after disease progression.

The pre-specified endpoints were time-to-deterioration in lung cancer symptoms and health-related quality of life, longitudinal analyses of mean score changes from baseline, and proportion of patients with clinically meaningful change (at least 10-point change from baseline) during treatment in the intention-to-treat population and patients with baseline CNS metastases.

Researchers found that the median time-to-deterioration was similar between the treatment arms (HR, 1.10; 95% CI, 0.72-1.68). However, patients in the alectinib group reported a more clinically meaningful improvement in baseline lung cancer symptoms for a longer duration of times compared with those in the crizotinib group.

Differences in lung symptoms between treatment groups favored alectinib, and patients receiving alectinib reported a clinically meaningful improvement from baseline in health-related quality of life for a longer duration of time compared with patients receiving crizotinib (88 vs 68 weeks, respectively).

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Additionally, researchers reported that fewer patients in the alectinib group experienced a clinically meaningful worsening in treatment-related symptoms compared with patients in the crizotinib group.

"The patient-reported outcome data supports the use of alectinib as a new standard of care in the frontline treatment of patients with ALK-positive lung cancer,” said Dr Pérol in his presentation.—Zachary Bessette