Early breast cancer: excellent 7-year data for adjuvant paclitaxel, trastuzumab

  • Tolaney SM & al.
  • J Clin Oncol
  • 2 Apr 2019

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

  • Final analysis of the Adjuvant Paclitaxel and Trastuzumab (APT) trial shows excellent 7-year outcomes for small, node-negative, human epidermal growth factor 2 (HER2)-positive early breast cancer (eBCa).
  • The disease-free survival (DFS) was 93%; distant metastasis-free survival was 99%.  

Why this matters

  • 7-year DFS is consistent with previously reported 3-year DFS of 98.7%.
  • Findings suggest that paclitaxel and trastuzumab are good treatment options for tumors of this type.

Study design

  • Phase 2, single-group multicenter prospective cohort (n=410) with small (≤3 cm), node-negative HER2+ eBCa treated with paclitaxel (80 mg/m2) plus trastuzumab for 12 weeks, and 9 more months of trastuzumab.
  • Primary outcome was DFS.
  • Funding: Genentech.

Key results

  • 7-year DFS was 93.3% (95% CI, 90.4%-96.2%); 1% of cohort had distant recurrence.
  • 7-year OS was 95.0% (95% CI, 92.4%-97.7%).
  • 7-year recurrence-free interval was 97.5% (95% CI, 95.9%-99.1%).
  • 66% of tumors were HER2-enriched, 14% were luminal B, and 13% were luminal A tumors, according to analysis by Prediction Analysis of Microarray 50 genes; this intrinsic subtype distribution is consistent with that seen with larger node-negative HER2+ tumors.
  • Treatment-induced peripheral neuropathy grade ≥2 (affecting 10.4% of cohort) was found in association with 1 SNP, rs3012437.

Limitations

  • Single-group, observational design.

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