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

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*, Dutch Breast Canc Res Grp BOOG

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

PurposeWe determined if intermittent first-line treatment with paclitaxel plus bevacizumab was not inferior to continuous treatment in patients with HER2-negative, advanced breast cancer.MethodsPatients were randomized to 2x4 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.ResultsA total of 420 patients were included with well-balanced characteristics. In the intention-to-treat analysis, median overall PFS was 7.4months (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.ConclusionIntermittent first-line treatment cannot be recommended in patients with HER2-negative advanced breast cancer. Clinical trial registration: EudraCT 2010-021519-18; BOOG 2010-02.
Original languageEnglish
Pages (from-to)413-423
Number of pages11
JournalBreast Cancer Research and Treatment
Volume172
Issue number2
DOIs
Publication statusPublished - 1 Nov 2018

Keywords

  • Metastatic breast cancer
  • Chemotherapy
  • Scheduling
  • Duration
  • Paclitaxel
  • Bevacizumab
  • BEVACIZUMAB PLUS PACLITAXEL
  • PHASE-III TRIAL
  • LOCALLY RECURRENT
  • OPEN-LABEL
  • DOUBLE-BLIND
  • CHEMOTHERAPY
  • THERAPY
  • CAPECITABINE
  • SURVIVAL
  • EFFICACY

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