mBCa: 5-year data back paclitaxel with trastuzumab-pertuzumab

  • Wang R & al.
  • Oncologist
  • 2 Jan 2019

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

  • 5-year follow-up of a phase 2 trial continues to support the safety and efficacy of weekly paclitaxel with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBCa).

Why this matters

  • Combination has been endorsed as front-line combination therapy by the National Comprehensive Cancer Network.

Study design

  • Single-arm phase 2 trial of adults with HER2+ mBCa (n=69) who received either no prior therapy (74%) or 1 prior therapy (26%).
  • Dosing: intravenous paclitaxel (80 mg/m2 weekly) with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks), given in 21-day cycles.
  • Funding: Roche-Genentech.

Key results

  • Median follow-up, 59 months.
  • 6-month PFS, 86% (95% CI, 76%-93%).
  • Median PFS was 24.2 months (95% CI, 17-35) overall.
    • 25.7 months (95% CI, 17-not reached) for the no prior therapy group.
    • 20.1 months (95% CI, 8.5-33.0) for the 1 prior therapy group.
  • Median OS was not reached overall.
    • Not reached for the no prior therapy group.
    • 39.7 months (95% CI, 32.9-66.7) for the 1 prior therapy group.
  • No new safety concerns emerged.

Limitations

  • Small sample.
  • No randomization.

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