HR+/HER2- advanced breast cancer: palbociclib-letrozole is safe, effective in Japanese patients

  • Takahashi M & al.
  • Cancer Med
  • 18 May 2020

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

  • A phase 2 trial of patients in Japan showed that first-line palbociclib-letrozole treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2) advanced breast cancer (ABC) is safe and effective, with PFS probability at 1 year of 75.6%.

Why this matters

  • Japanese patients were not included in the PALOMA-1 clinical trial, the first major clinical trial to evaluate palbociclib-letrozole for ABC.

Study design

  • Phase 2 multicenter, open-label, single-group clinical trial of 42 patients.
  • Primary outcome: probability of 1-year PFS.
  • Health-related quality of life evaluated by Functional Assessment of Cancer Therapy-Breast and Trial Outcome Index.
  • Funding: Pfizer Inc.

Key results

  • Median duration of treatment, 33.0 (range, 1.8-49.2) months.
  • Probability of PFS at 1 year, 75.6% (90% CI, 62.4%-84.7%).
  • Median PFS was 35.7 (95% CI, 21.7-46.7) months.
  • Objective response rate: 47.6% (95% CI, 32.0%-63.6%).
  • Disease control rate: 85.7% (95% CI, 71.5%-94.6%).
  • Most common treatment-related adverse events (all grades; grades 3/4):
    • Neutropenia (100.0%; 92.9%).
    • Leukopenia (83.3%; 59.5%).
    • Stomatitis (76.2%; 0%).
  • Health-related QoL was stable throughout the trial, with no clinically meaningful deterioration.

Limitations

  • Single-group, open-label design.