- Design
- Phase 3, randomised, open-label trial; safety and exploratory quality-of-life analysis
- Population
- 257 patients with resected ALK-positive stage IB–IIIA NSCLC
- Primary outcome
- Safety and SF-36v2 quality of life (DFS reported previously)
- Effect
- Serious treatment-related AEs 2% vs 7%; week-96 PCS 48.8, MCS 49.9 (norm 50)
ALINA randomised 257 patients with resected stage IB to IIIA ALK-positive non-small-cell lung cancer (NSCLC) to alectinib for 24 months or four cycles of platinum chemotherapy. Disease-free survival benefit was reported earlier; this analysis covers safety and quality of life.
The commonest grade 3–4 events with alectinib were raised creatine kinase (6%), ALT and bilirubin (2% each), against neutropenia and nausea with chemotherapy. Serious treatment-related adverse events occurred in 2% against 7%, and discontinuation for adverse events in 5% against 13%. Physical and mental quality-of-life scores improved within 12 weeks and stayed near population norms over 2 years.
Two years of daily targeted therapy was a concern for tolerability. These data support offering it: patients generally felt well on treatment. The main practical tasks are testing every resected non-squamous NSCLC for ALK and monitoring muscle and liver enzymes.
- Test resected stage IB–IIIA non-squamous NSCLC for ALK and EGFR before adjuvant decisions
- Offer adjuvant alectinib to ALK-positive patients
- Check CK, liver tests and bilirubin regularly
- Ask about myalgia, oedema and weight gain
Why it matters
Tolerability was the main reservation about two years of adjuvant targeted therapy, and this addresses it.
Don't overread it
Quality of life was exploratory in an open-label trial, and the chemotherapy group was followed for a much shorter period.
The statistics, in plain English
SF-36 scores are standardised so the population average is 50. Scores of 48.8 and 49.9 at week 96 mean patients were close to typical health. Open-label reporting may favour the oral arm, since patients knew they had avoided intravenous chemotherapy.
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