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; Ingrid A M Mandjes; Erik van Werkhoven; Harm van Tinteren; A Elise van Leeuwen-Stok; Petra Nederlof; Johanna E A Portielje; Robbert J van Alphen; Els Platte; Daan van den Broek; Alwin Huitema; Marleen Kok; Sabine C Linn; Hendrika M Oosterkamp

doi:10.1159/000512200

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
, Ingrid A M Mandjes
, Erik van Werkhoven
, Harm van Tinteren
, A Elise van Leeuwen-Stok
, Petra Nederlof
, Johanna E A Portielje
, Robbert J van Alphen
, Els Platte
, Daan van den Broek
, Alwin Huitema
, Marleen Kok
, Sabine C Linn
, Hendrika M Oosterkamp

Research output: Contribution to journal › Article › Academic › peer-review

8 Citations (Scopus)

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.

Original language	English
Pages (from-to)	598-606
Number of pages	9
Journal	Breast Care
Volume	16
Issue number	6
DOIs	https://doi.org/10.1159/000512200
Publication status	Published - Dec 2021
Externally published	Yes

Bibliographical note

Copyright © 2021 by S. Karger AG, Basel.

Funding Sources:
The Triple-B trial was funded by an unrestricted research grant
from Roche to the legal sponsor BOOG. The funding source had
no role in the design and conduction of this study; collection, management, analysis, and interpretation of the data; preparation or
approval of this paper; or the decision to submit this paper for
publication.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

10.1159/000512200

Cite this

van Rossum, A. G. J., Mandjes, I. A. M., van Werkhoven, E., van Tinteren, H., van Leeuwen-Stok, A. E., Nederlof, P., Portielje, J. E. A., van Alphen, R. J., Platte, E., van den Broek, D., Huitema, A., Kok, M., Linn, S. C., & Oosterkamp, H. M. (2021). Carboplatin-Cyclophosphamide or Paclitaxel without or with Bevacizumab as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (BOOG 2013-01). Breast Care, 16(6), 598-606. https://doi.org/10.1159/000512200

@article{d6c4c9b531cf4d1a9263dba71e748384,

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

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.",

author = "\{van Rossum\}, \{Annelot G J\} and Mandjes, \{Ingrid A M\} and \{van Werkhoven\}, Erik and \{van Tinteren\}, Harm and \{van Leeuwen-Stok\}, \{A Elise\} and Petra Nederlof and Portielje, \{Johanna E A\} and \{van Alphen\}, \{Robbert J\} and Els Platte and \{van den Broek\}, Daan and Alwin Huitema and Marleen Kok and Linn, \{Sabine C\} and Oosterkamp, \{Hendrika M\}",

note = "Copyright {\textcopyright} 2021 by S. Karger AG, Basel. Funding Sources: The Triple-B trial was funded by an unrestricted research grant from Roche to the legal sponsor BOOG. The funding source had no role in the design and conduction of this study; collection, management, analysis, and interpretation of the data; preparation or approval of this paper; or the decision to submit this paper for publication.",

year = "2021",

month = dec,

doi = "10.1159/000512200",

language = "English",

volume = "16",

pages = "598--606",

journal = "Breast Care",

issn = "1661-3791",

publisher = "Karger",

number = "6",

}

van Rossum, AGJ, Mandjes, IAM, van Werkhoven, E, van Tinteren, H, van Leeuwen-Stok, AE, Nederlof, P, Portielje, JEA, van Alphen, RJ, Platte, E, van den Broek, D, Huitema, A, Kok, M, Linn, SC & Oosterkamp, HM 2021, 'Carboplatin-Cyclophosphamide or Paclitaxel without or with Bevacizumab as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (BOOG 2013-01)', Breast Care, vol. 16, no. 6, pp. 598-606. https://doi.org/10.1159/000512200

TY - JOUR

T1 - Carboplatin-Cyclophosphamide or Paclitaxel without or with Bevacizumab as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (BOOG 2013-01)

AU - van Rossum, Annelot G J

AU - Mandjes, Ingrid A M

AU - van Werkhoven, Erik

AU - van Tinteren, Harm

AU - van Leeuwen-Stok, A Elise

AU - Nederlof, Petra

AU - Portielje, Johanna E A

AU - van Alphen, Robbert J

AU - Platte, Els

AU - van den Broek, Daan

AU - Huitema, Alwin

AU - Kok, Marleen

AU - Linn, Sabine C

AU - Oosterkamp, Hendrika M

N1 - Copyright © 2021 by S. Karger AG, Basel. Funding Sources: The Triple-B trial was funded by an unrestricted research grant from Roche to the legal sponsor BOOG. The funding source had no role in the design and conduction of this study; collection, management, analysis, and interpretation of the data; preparation or approval of this paper; or the decision to submit this paper for publication.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

U2 - 10.1159/000512200

DO - 10.1159/000512200

M3 - Article

C2 - 35087363

SN - 1661-3791

VL - 16

SP - 598

EP - 606

JO - Breast Care

JF - Breast Care

IS - 6

ER -

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

Abstract

Bibliographical note

UN SDGs

Access to Document

Fingerprint

Cite this