Open AccessCarboplatin-Cyclophosphamide or Paclitaxel without or with Bevacizumab as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (BOOG 2013-01)
Author(s) -
Annelot G.J. van Rossum,
Ingrid A.M. Mandjes,
Erik van Werkhoven,
Harm van Tinteren,
A. Elise van Leeuwen-Stok,
Petra M. Nederlof,
J.E.A. Portielje,
Robbert J. van Alphen,
Els Platte,
Daan van den Broek,
Alwin D. R. Huitema,
Marleen Kok,
Sabine C. Linn,
Hendrika M. Oosterkamp
Publication year - 2021
Publication title -
breast care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.767
H-Index - 30
eISSN - 1661-3805
pISSN - 1661-3791
DOI - 10.1159/000512200
Subject(s) - bevacizumab , medicine , carboplatin , triple negative breast cancer , oncology , paclitaxel , cyclophosphamide , chemotherapy , breast cancer , metastatic breast cancer , cancer , cisplatin
Background: The addition of bevacizumab to chemotherapy conferred a modest progression-free survival (PFS) benefit in metastatic triple-negative breast cancer (mTNBC). However, no overall survival (OS) benefit has been reported. Also, its combination with carboplatin-cyclophosphamide (CC) has never been investigated. Methods: The Triple-B study is a multicenter, randomized phase IIb trial that aims to prospectively validate predictive biomarkers, including baseline plasma vascular endothelial growth factor receptor-2 (pVEGFR-2), for bevacizumab benefit. mTNBC patients were randomized between CC and paclitaxel (P) without or with bevacizumab (CC ± B or P ± B). Here we report on a preplanned safety and preliminary efficacy analysis after the first 12 patients had been treated with CC+B and on the predictive value of pVEGFR-2. Results: In 58 patients, the median follow-up was 22.1 months. Toxicity was manageable and consistent with what was known for each agent separately. There was a trend toward a prolonged PFS with bevacizumab compared to chemotherapy only (7.0 vs. 5.2 months; adjusted HR = 0.60; 95% CI 0.33–1.08; p = 0.09), but there was no effect on OS. In this small study, pVEGFR-2 concentration did not predict a bevacizumab PFS benefit. Both the intention-to-treat analysis and the per-protocol analysis did not yield a significant treatment-by-biomarker test for interaction ( p interaction = 0.69). Conclusions: CC and CC+B are safe first-line regimens for mTNBC and the side effects are consistent with those known for each individual agent. pVEGFR-2 concentration did not predict a bevacizumab PFS benefit.