OBJECTIVES: The Phase II ATALK study aimed to assess the efficacy and the safety of patients with Anaplastic Lymphoma Kinase-rearranged NSCLC, treated with alectinib after disease progression on crizotinib. The primary endpoint was the best overall response. This abstract focus on the HRQoL secondary endpoint.

METHODS: HRQoL were collected at baseline, week 4 (W4), W8 and then every 8 weeks using the EORTC QLQ-C30, QLQ-LC13, QLQ-BN20 and EQ-5D-5L. Scores were summarized using means and standard deviations (SD). A difference of at least 10 points from baseline was considered as the minimal important difference. Change between baseline and score was calculated and categorized between improvement, stability and worsening. The time to first HRQoL deterioration (TTD) was used as a modality of longitudinal analysis. TTD was defined as the time between inclusion and the first HRQoL score deterioration, or death as compared to the baseline score. Median TTD and 95% confidence interval (CI) were estimated using the Kaplan-Meier estimation method.

RESULTS: Among the 44 patients included in the study, 27 (61.4%) patients had central nervous system metastases. At baseline, 43 (98%) patients completed HRQoL questionnaires. Global Health Status (GHS) mean score was 57.4 (SD 25.0) at baseline, 65.5 (SD 20.5) at W24 (n=37) and 69.2 (SD 19.6) at W48 (n=26). Up to 51.9% of patients improved GHS score (at W40, n=27) and up to 20.0% worsened (at W16, n=40) during the study. Median TTD for GHS, physical functioning and pain were 15 months [95%CI 6.3-NA], 10.5 months [95%CI 3.7-NA], 6.3 months [95%CI 3.7-NA], respectively.

CONCLUSIONS: ALK-rearranged NSCLC patients have high symptom burden and severe morbidity, HRQoL is therefore important to take into consideration. In the ATALK study, QLQ-C30 global health status and functional scores increased during the study while symptoms score decreased (except for constipation).