HER2+ breast cancer: TRAIN-2 data favor anthracycline-free NACT

  • Lancet Oncol

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

  • Anthracycline-free neoadjuvant chemotherapy (NACT) is as effective, but safer than anthracycline-containing NACT in the presence of dual HER2 blockade in patients with HER2+ early breast cancer enrolled in the TRAIN-2 study.

Why this matters

  • The authors suggest that the anthracycline-free regimen is preferred, but long-term follow-up is needed.

Study design

  • Randomized controlled phase 3 trial (n=438) of:
    • 5-fluorouracil, epirubicin, and cyclophosphamide followed by paclitaxel and carboplatin (anthracycline group) for 6 cycles, or
    • 9 cycles of paclitaxel and carboplatin (anthracycline-free group). 
  • Both NACT regimens were accompanied by dual HER2 blockade with trastuzumab and pertuzumab.
  • Primary outcome was percentage of patients attaining a pathologic complete response (pCR).
  • Funding: Roche Netherlands.

Key results

  • Median follow-up was 19 months (interquartile range, 16-23 months).
  • No difference between groups on % attaining pCR (anthracycline-inclusive, 67% vs anthracycline-free, 68%; P=.95).
  • The anthracycline group had higher rates of grade 3 or worse febrile neutropenia (10% vs 1% in the anthracycline-free group; P<.0001>
  • No difference between groups in symptomatic left ventricular systolic dysfunction (1% vs 0%, respectively).

Limitations

  • Neither of the NACT regimens is widely used today.
  • Open-label design.

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