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

Autor:	van Rossum AGJ; Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Mandjes IAM; Data Center, Netherlands Cancer Institute, Amsterdam, The Netherlands., van Werkhoven E; Biometrics Department, Netherlands Cancer Institute, Amsterdam, The Netherlands., van Tinteren H; Biometrics Department, Netherlands Cancer Institute, Amsterdam, The Netherlands., van Leeuwen-Stok AE; Dutch Breast Cancer Research Group, BOOG Study Center, Amsterdam, The Netherlands., Nederlof P; Department of Molecular Diagnostics, Netherlands Cancer Institute, Amsterdam, The Netherlands., Portielje JEA; Department of Medical Oncology, HagaZiekenhuis, The Hague, The Netherlands.; Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands., van Alphen RJ; Department of Medical Oncology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands., Platte E; Clinical Chemical Laboratory, Netherlands Cancer Institute, Amsterdam, The Netherlands., van den Broek D; Clinical Chemical Laboratory, Netherlands Cancer Institute, Amsterdam, The Netherlands., Huitema A; Pharmacy, Netherlands Cancer Institute, Amsterdam, The Netherlands., Kok M; Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Linn SC; Division of Molecular Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands.; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.; Department of Pathology, University Medical Center, Utrecht, The Netherlands., Oosterkamp HM; Department of Medical Oncology, Haaglanden Medisch Centrum, The Hague, The Netherlands.
Jazyk:	angličtina
Zdroj:	Breast care (Basel, Switzerland) [Breast Care (Basel)] 2021 Dec; Vol. 16 (6), pp. 598-606. Date of Electronic Publication: 2021 Jan 22.
DOI:	10.1159/000512200
Abstrakt:	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. Competing Interests: 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. (Copyright © 2021 by S. Karger AG, Basel.)
Databáze:	MEDLINE
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