NSCLC: low-dose afatinib does well in phase 2 study

  • Lung Cancer
  • 1 Sep 2019

  • curated by Craig Hicks
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Nonrandomized.
  • Small sample size.
  • Short follow-up.
  • Serum afatinib levels not captured.

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