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

• Published in: Breast cancer research and treatment Vol. 172; no. 2; pp. 413 - 423
• Main Authors: Claessens, Anouk K. M., Bos, Monique E. M. M., Lopez-Yurda, Marta, Bouma, Jeanette M., Rademaker-Lakhai, Jeany M., Honkoop, Aafke H., de Graaf, Hiltje, van Druten, Edith, van Warmerdam, Laurence J. C., van der Sangen, Maurice J. C., Tjan-Heijnen, Vivianne C. G., Erdkamp, Frans L. G.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.11.2018; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Bevacizumab; Bevacizumab - administration & dosage; BOOG; BOOG2010-02; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - genetics; Breast Neoplasms - pathology; Cancer metastasis; Cancer research; Cancer therapies; Capecitabine; Care and treatment; Clinical Trial; Comparative analysis; Development and progression; ErbB-2 protein; EudraCT; EudraCT2010-021519-18; Female; Humans; Immunotherapy; Longitudinal Studies; Medicine; Medicine & Public Health; Metastases; Middle Aged; Monoclonal antibodies; Motivation; Neoplasm Metastasis; Neoplasm Staging; Netherlands - epidemiology; Oncology; Paclitaxel; Paclitaxel - administration & dosage; Patients; Progression-Free Survival; Receptor, ErbB-2 - genetics; Targeted cancer therapy; Toxicity; Netherlands; Metastatic breast cancer; Chemotherapy; Scheduling; Duration; Paclitaxel; Bevacizumab
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-018-4906-8

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.