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01-11-2018 | Clinical trial

Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop & Go study of the Dutch Breast Cancer Research Group (BOOG)

Authors: Anouk K. M. Claessens, Monique E. M. M. Bos, Marta Lopez-Yurda, Jeanette M. Bouma, Jeany M. Rademaker-Lakhai, Aafke H. Honkoop, Hiltje de Graaf, Edith van Druten, Laurence J. C. van Warmerdam, Maurice J. C. van der Sangen, Vivianne C. G. Tjan-Heijnen, Frans L. G. Erdkamp, The Dutch Breast Cancer Research Group (BOOG)

Published in: Breast Cancer Research and Treatment | Issue 2/2018

Abstract

Purpose

We determined if intermittent first-line treatment with paclitaxel plus bevacizumab was not inferior to continuous treatment in patients with HER2-negative, advanced breast cancer.

Methods

Patients were randomized to 2 × 4 cycles or continuous 8 cycles of paclitaxel plus bevacizumab, followed by bevacizumab maintenance treatment until disease progression or unacceptable toxicity. The primary endpoint was overall progression-free survival (PFS). A proportional-hazards regression model was used to estimate the HR. The upper limit of the two-sided 95% CI for the HR was compared with the non-inferiority margin of 1.34.

Results

A total of 420 patients were included with well-balanced characteristics. In the intention-to-treat analysis, median overall PFS was 7.4 months (95% CI 6.4–10.0) for intermittent and 9.7 months (95% CI 8.9–10.3) for continuous treatment, with a stratified HR of 1.17 (95% CI 0.88–1.57). Median OS was 17.5 months (95% CI 15.4–21.7) versus 20.9 months (95% CI 17.8–24.0) for intermittent versus continuous treatment, with a HR of 1.38 (95% CI 1.00-1.91). Safety results and actually delivered treatments revealed longer durations of treatment in the continuous arm, without significant unexpected findings.

Conclusion

Intermittent first-line treatment cannot be recommended in patients with HER2-negative advanced breast cancer.

Clinical trial registration: EudraCT 2010-021519-18; BOOG 2010-02.

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Title: Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop & Go study of the Dutch Breast Cancer Research Group (BOOG)
Authors: Anouk K. M. Claessens
Monique E. M. M. Bos
Marta Lopez-Yurda
Jeanette M. Bouma
Jeany M. Rademaker-Lakhai
Aafke H. Honkoop
Hiltje de Graaf
Edith van Druten
Laurence J. C. van Warmerdam
Maurice J. C. van der Sangen
Vivianne C. G. Tjan-Heijnen
Frans L. G. Erdkamp
The Dutch Breast Cancer Research Group (BOOG)
Publication date: 01-11-2018
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 2/2018
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-018-4906-8

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