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. 2021 Dec;16(6):598-606.
doi: 10.1159/000512200. Epub 2021 Jan 22.

Carboplatin-Cyclophosphamide or Paclitaxel without or with Bevacizumab as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (BOOG 2013-01)

Annelot G J van Rossum  1 , Ingrid A M Mandjes  2 , Erik van Werkhoven  3 , Harm van Tinteren  3 , A Elise van Leeuwen-Stok  4 , Petra Nederlof  5 , Johanna E A Portielje  6   7 , Robbert J van Alphen  8 , Els Platte  9 , Daan van den Broek  9 , Alwin Huitema  10 , Marleen Kok  11   12 , Sabine C Linn  1   12   13 , Hendrika M Oosterkamp  14
Affiliations

Carboplatin-Cyclophosphamide or Paclitaxel without or with Bevacizumab as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (BOOG 2013-01)

Annelot G J van Rossum et al. Breast Care (Basel). 2021 Dec.

Abstract

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 (pinteraction = 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.

Keywords: Bevacizumab; Biomarker trial; Carboplatin-cyclophosphamide; Metastatic triple-negative breast cancer; Paclitaxel; Plasma vascular endothelial growth factor receptor-2.

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Conflict of interest statement

S.C.L. is an advisory board member for Cergentis, IBM, Novartis, Pfizer, Roche, and Sanofi and received institutional research support funding from Amgen, AstraZeneca, Genentech, Roche, Sanofi, and TESARO. H.M.O. is an advisory board member for Roche, Pfizer, and Novartis and received institutional research support funding from Roche. M.K. is an advisory board member for BMS and received institutional research support funding from Roche and BMS. All of the other authors declare no potential conflict of interests.

Figures

Fig. 1
Fig. 1
CONSORT diagram.
Fig. 2
Fig. 2
Association between treatment and the PFS (a–c) and OS (d–f) of the ITT population.
See this image and copyright information in PMC

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