Advanced HR+/HER2- breast cancer: final results of German IMPROVE trial

  • Decker T & al.
  • BMC Cancer
  • 6 Apr 2020

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

  • Patients and physicians prefer capecitabine+bevacizumab (chemo- plus antiangiogenic therapy; Cap+Bev) over everolimus+exemestane (antihormonal therapy; Eve+Exe) as first-line therapy for hormone receptor-positive (HR+)/HER2-negative advanced breast cancer.
  • Cap+Bev revealed longer first-line PFS; QoL was similar.

Why this matters

  • Cap+Bev is favored therapy, in contrast to Exe+Eve, which is first-line therapy according to guidelines.

Study design

  • Open-label, randomized, controlled, multicenter, 2-group, cross-over, phase 4 IMPROVE trial conducted at 26 German sites (N=77).
  • Group A: Cap+Bev for 12 weeks, cross-over to Eve+Exe for another 12 weeks.
  • Group B: Eve+Exe for 12 weeks, cross-over to Cap+Bev for 12 weeks.
  • Funding: Novartis Pharma GmbH.

Key results

  • According to the Patient Preference Questionnaire, patients preferred Cap+Bev (61.5%) over Eve+Exe (15.4%); 23.1% were indecisive.
  • According to the Physician Preference Questionnaire, physicians preferred Cap+Bev (58.1%) over Eve+Exe (32.3%).
  • Group A had longer median first-line PFS (11.1 months for group A vs 3.5 months for group B; P=.0008)
  • No differences between groups in median second-line PFS (3.7 vs 3.6 months for group B; P=.8345) and median OS (28.8 months for group A and 24.7 months for group B; P=.2088).
  • QoL was similar across groups.
  • No new safety concerns were reported.

Limitations

  • Relatively few patients because of low recruitment rate.
  • Open-label design.