- Low starting dose treatment with frontline afatinib shows promising clinical efficacy and good tolerability in epidermal growth factor receptor-positive (EGFR+) NSCLC.
Why this matters
- Afatinib often requires dose adjustment in response to severe diarrhea, liver toxicity, and other adverse events.
- Single-group, open-label phase 2 Japanese trial of 46 patients with advanced EGFR+ NSCLC (median age, 73 [range, 43-86] years; 72% women) receiving afatinib at a starting dose of 20 mg daily, increased as tolerated in 10 mg increments up to 50 mg daily.
- 54% had exon 19 deletion subtype, 46% had Leu858Arg point mutation subtype.
- Median follow-up: 18.9 (range, 8.2-28.9) months.
- Funding: None disclosed.
- Median PFS: 15.2 months (95% CI, 13.2%-not estimable).
- 1-year OS rate: 95.6% (95% CI, 89.7%-100%).
- Objective response rate: 81.8% (95% CI, 67.3%-91.8%).
- Grade ≥3 adverse event rate: 30.4%, including rash/acne (8.7%), paronychia (8.7%), and diarrhea (4.3%).
- Small sample size.
- Short follow-up.
- Serum afatinib levels not captured.