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Breast cancer, metastatic

1833 - Efficacy of two times four versus continuous eight cycles of paclitaxel/bevacizumab as first-line chemotherapy in metastatic breast cancer: the Stop&Go study of the Dutch Breast Cancer Research Group (BOOG)

Date

10 Sep 2017

Session

Breast cancer, metastatic

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

Anouk Claessens

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

A. Claessens1, M. Bos2, S. de Groot3, E. van Leeuwen - Stok4, M. Lopez-Yurda5, A. Honkoop6, H. de Graaf7, E. van Druten8, L. van Warmerdam9, M. van der Sangen10, V. Tjan-Heijnen11, F. Erdkamp1

Author affiliations

  • 1 Internal Medicine / Medical Oncology, Zuyderland Medical Center-Sittard-Geleen, 6130 MB - Sittard/NL
  • 2 Medical Oncology, Erasmus Medical Centre Cancer Institute, 3008 AE - Rotterdam/NL
  • 3 Clinical Research, Comprehensive Cancer Centre of the Netherlands, 3511 DT - Utrecht/NL
  • 4 Boog Study Centre, Dutch Breast Cancer Research Group BOOG, 1076 CV - Amsterdam/NL
  • 5 Biometrics, Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
  • 6 Internal Medicine / Medical Oncology, Isala Klinieken, 8025 AB - Zwolle/NL
  • 7 Oncology Centre Leeuwarden, Leeuwarden Medical Centre, 8934 AD - Leeuwarden/NL
  • 8 Oncologic Research Unit, Reinier de Graaf Hospital (Gasthuis), 2625 AD - Delft/NL
  • 9 Catharina Cancer Institute, Catharina Hospital, 5623 EJ - Eindhoven/NL
  • 10 Radiation Oncology, Catharina Hospital, 5623 EJ - Eindhoven/NL
  • 11 Medical Oncology, Maastricht University Medical Center (MUMC), 6202 AZ - Maastricht/NL
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Resources

Abstract 1833

Background

The primary goal of this non-inferiority trial was to determine if an intermittent treatment regimen was not inferior to a continuous regimen, in first-line treatment of patients with HER2-negative, incurable, metastatic or unresectable locally advanced breast cancer.

Methods

Patients were randomised to receive 8 cycles or 2x4 cycles of paclitaxel/bevacizumab on days 1, 8 and 15 every 4 weeks, both with continuation of bevacizumab once every 21 days until disease progression or unacceptable toxicity. If progressive disease occurred ≥ 3 months after the initial 4 cycles with paclitaxel/bevacizumab in the intermittent arm, another 4 cycles were given. If progressive disease occurred in the continuous arm or 

Results

The intention-to-treat population comprised of 420 patients. The total median PFS in first-line treatment was 10.7 months (95% CI 7.03 - 12.42) for the intermittent regimen and 9.7 months (95% CI 8.94 - 10.28) for the continuous regimen (HR for disease progression or death [intermittent vs. continuous], 1.006; 95% CI 0.743 - 1.361). Results on OS were similar with a HR of 1.312 (95% CI 0.959 - 1.794). The per-protocol analysis showed comparable results. Safety results and actually delivered treatments did not reveal unexpected findings and will be presented at the meeting.

Conclusions

Intermittent first-line treatment with paclitaxel/bevacizumab is not non-inferior to continuous scheduling regarding PFS in patients with HER2-negative incurable locally advanced or metastatic breast cancer. Analysis of the secondary endpoint OS supported this conclusion. Therefore, intermittent first-line treatment cannot be recommended over continuous scheduling.

Clinical trial identification

EudraCT 2010-021519-18; BOOG 2010-02.

Legal entity responsible for the study

Dutch Breast Cancer Research Group (BOOG)

Funding

F. Hoffmann-La Roche Ltd, The Netherlands; TEVA Nederland B.V.

Disclosure

V. Tjan-Heijnen: Financial support from the Dutch Breast Research Group during the conduct of the study; Grants and non-financial support from Roche/Pfizer/Novartis/AstraZeneca, grants from Esai, outside the submitted work. F. Erdkamp: Advisory board Roche. All other authors have declared no conflicts of interest.

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