Early breast cancer: nab-paclitaxel prolongs time to invasive disease

  • Untch M & al.
  • J Clin Oncol
  • 13 May 2019

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

Why this matters

  • Nab-paclitaxel (nanoparticle albumin-bound paclitaxel developed to avoid toxicities) may become standard of care for eBCa.

Study design

  • Phase 3 randomized controlled trial (n=1206) of weekly nab-paclitaxel (150 mg/m2) vs weekly sb-paclitaxel (80 mg/m2) followed by, every 3 weeks in both groups, 4 times epirubicin 90 mg/m2+cyclophosphamide 600 mg/m2.
  • Subgroup with human epidermal growth factor receptor 2-positive (HER2+) tumor also received trastuzumab and pertuzumab.
  • Funding: Celgene Germany; Roche Germany.

Key results

  • Median follow-up, 49.6 months.
  • Nab-paclitaxel yielded 34% longer iDFS than sb-paclitaxel (HR, 0.66; P=.002).
    • In subgroup analysis, only hormone receptor-positive (HR+)/HER2 tumors showed prolonged iDFS (P=.030).
  • No difference between groups in OS (P=.260).
  • The nab-paclitaxel group (125 mg/m2) showed a shorter median time to resolve grade 2-4 to grade 1 peripheral sensory neuropathy (PSN) vs nab-paclitaxel (150 mg/m2; 6.4 vs 12.7 weeks; P=.014).

Limitations

  • Open-label design.
  • Possible overestimation of PSN benefit with lower-dose nab-paclitaxel because of the small sample size.

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