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Intermittent versus continuous first-line treatment for HER2-negative metastatic breast cancer: the Stop & Go study of the Dutch Breast Cancer Research Group (BOOG).
- Source :
-
Breast cancer research and treatment [Breast Cancer Res Treat] 2018 Nov; Vol. 172 (2), pp. 413-423. Date of Electronic Publication: 2018 Aug 18. - Publication Year :
- 2018
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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.<br />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.<br />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.<br />Conclusion: Intermittent first-line treatment cannot be recommended in patients with HER2-negative advanced breast cancer.<br />Clinical Trial Registration: EudraCT 2010-021519-18; BOOG 2010-02.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Breast Neoplasms genetics
Breast Neoplasms pathology
Capecitabine
Female
Humans
Longitudinal Studies
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Netherlands epidemiology
Progression-Free Survival
Bevacizumab administration & dosage
Breast Neoplasms drug therapy
Paclitaxel administration & dosage
Receptor, ErbB-2 genetics
Subjects
Details
- Language :
- English
- ISSN :
- 1573-7217
- Volume :
- 172
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Breast cancer research and treatment
- Publication Type :
- Academic Journal
- Accession number :
- 30121808
- Full Text :
- https://doi.org/10.1007/s10549-018-4906-8