- 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.
- 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.
- 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.
- Single-group, observational design.