- Design
- Phase 3, randomised, open-label trial (safety and exploratory HRQoL)
- Population
- 257 patients with resected ALK-positive stage IB–IIIA NSCLC
- Primary outcome
- Safety and SF-36v2 quality of life (DFS previously reported)
- Effect
- Serious treatment-related AEs 2% vs 7%; week-96 PCS 48.8, MCS 49.9 (norm 50)
ALINA randomised 257 patients with resected ALK-positive stage IB–IIIA non-small-cell lung cancer to two years of alectinib or four cycles of platinum-based chemotherapy, and has already shown a disease-free survival benefit. This report covers safety and exploratory quality-of-life outcomes; 56% of patients were Asian.
On alectinib, the commonest grade 3–4 events were raised creatine kinase (6%), ALT (2%) and bilirubin (2%). Serious treatment-related events occurred in 2% on alectinib and 7% on chemotherapy, and discontinuations for adverse events were fewer (5% vs 13%). Physical and mental quality-of-life scores improved meaningfully by week 12 and stayed at general-population levels through 96 weeks.
The practical concern with two years of adjuvant oral therapy was whether patients could live with it. These data suggest they can. Alectinib's cost is the main barrier in Indian practice.
- Test resected stage IB–IIIA non-squamous lung cancers for ALK so adjuvant alectinib can be offered.
- Monitor creatine kinase, liver enzymes and bilirubin during adjuvant alectinib.
- Reassure patients that quality of life on two years of alectinib stayed close to population norms.
- Expect fewer treatment discontinuations than with adjuvant chemotherapy.
Why it matters
It removes tolerability as a reason to hesitate over two years of adjuvant targeted therapy.
Don't overread it
Quality of life was exploratory and the trial open-label; overall survival is not reported here.
The statistics, in plain English
SF-36 scores are standardised so the general population averages 50; scores of 48.8 and 49.9 at week 96 mean patients were functioning close to average. Quality of life was an exploratory end point in an open-label trial, so expectation may have influenced it.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for oncology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free