ALINA Trial Analyzes Impact of Alectinib on Health-Related Quality of Life in ALK-Positive NSCLC

Alectinib was associated with improved health-related quality of life (HRQoL) in patients with ALK-positive non-small cell lung cancer (NSCLC) within 3 months of treatment initiation, data from the ALINA trial showed.

Makoto Nishio, MD, of the Cancer Institute Hospital of the Japanese Foundation for Cancer Research, presented the ALINA trial analysis at the 2024 American Society of Clinical Oncology Annual Meeting.

Patients were randomly selected to either receive oral alectinib 600 mg twice a day for 2 years or four 21-day cycles of chemotherapy (cisplatin, vinorelbine, gemcitabine, pemetrexed, or carboplatin).

All patients (n=257) enrolled in the phase 3 global, open-label, randomized trial had stage IB–IIIA, ALK-positive NSCLC that had been completely resected. In addition, Eastern Cooperative Oncology Group (ECOG) performance scores were either 0 or 1.

The researchers used the Short Form-36 version 2 (SF-36v2) health survey to determine HRQoL at baseline and every 3 weeks until week 12, and then every 12 weeks until disease recurrence, withdrawal of consent, death, or week 96. The SF-36v2 helps clinicians assess functional health and well-being in patients across 8 domains and the aggregated physical and mental component summary scores. More than 90% of participants completed the SF-36v2 throughout the study.

At baseline, the mean scores were <50 and were similar between the 2 groups. However, by week 96, those who received alectinib saw mean scores of ≥50 for the bodily pain, mental health, and vitality domains. This suggests that patients functioned as well as the general population on these aspects, the researchers said.

By week 12, the mean change from baseline met or exceeded minimal important differences for 5 domains and MCS. Furthermore, by week 96, scores also exceeded minimal important differences for 6 domains and in aggregated physical and mental component summary scores.

Although, mean SF-36v2 scores were low in the group receiving chemotherapy during treatment, the scores improved after chemotherapy. In the post-chemotherapy period, a final assessment showed mean scores were ≥50 for the Bodily Pain, Mental Health, and Vitality domains, and minimal important differences were met or exceeded for physical and mental component summary scores, and in 5 domains.

“Together with the disease-free survival benefit seen in ALINA, these data support alectinib as an important new adjuvant treatment for patients with resected ALK-positive NSCLC,” the researchers concluded.

Reference

Nishio M, Wu Y-L, Barlesi F, et al. Health-related quality of life (HRQoL) results for adjuvant alectinib vs chemotherapy in patients with resected ALK+ non-small cell lung cancer (NSCLC): Data from ALINA. Abstract #8006. Presented at the 2024 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024, Chicago, Illinois.