HER2+ BCa brain mets: neratinib+capecitabine active in TBCRC 022

  • Freedman RA & al.
  • J Clin Oncol
  • 12 Mar 2019

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Neratinib plus capecitabine is associated with a 33% to 49% objective response rate (ORR) against brain metastases in patients with and without prior lapatinib therapy, respectively, for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBCa).

Why this matters

  • 50% of patients with HER2+ mBCa develop brain metastases.

Study design

  • Two phase 2, open-label, single-group cohorts of HER2+ mBCa with brain metastases who were enrolled in TBCRC 022, with 1 cohort comprising lapatinib-naive patients (n=37) and the other cohort lapatinib-experienced (n=12) patients. Both cohorts were given neratinib 240 mg orally once per day plus 750 mg/m2capecitabine 2×/day for 14 days, then 7 days off.
  • ORR required ≥50% reduction in the sum of target central nervous system (CNS) lesion volumes without progression of nontarget lesions, new lesions, escalating steroids, progressive neurologic signs or symptoms, or non-CNS progression.
  • Funding: Puma Biotechnology; several foundations.

Key results

  • Lapatinib-naive patients: ORR, 49% (95% CI, 32%-66%); median PFS, 5.5 months; median OS, 13.3 months.
  • Lapatinib-experienced patients: ORR, 33% (95% CI, 10%-65%); median PFS, 3.1 months; median OS, 15.1 months.
  • The most common toxicity was diarrhea (29%), despite prophylaxis.

Limitations

  • Open-label, observational designs.

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