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

Autor: Claessens AKM; Department of Medical Oncology, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Geleen, The Netherlands., Bos MEMM; Department of Medical Oncology, Erasmus Medical Centre, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands., Lopez-Yurda M; Department of Biometrics, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Bouma JM; Department of Trial Registration, Comprehensive Cancer Centre the Netherlands, Vasteland 78, 3011 BN, Rotterdam, The Netherlands., Rademaker-Lakhai JM; Dutch Breast Cancer Research Group, BOOG Study Centre, IJsbaanpad 9, 1076 CV, Amsterdam, The Netherlands., Honkoop AH; Department of Medical Oncology, Isala Clinic, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands., de Graaf H; Department of Medical Oncology, Leeuwarden Medical Centre, Henri Dunantweg 2, 8934 AD, Leeuwarden, The Netherlands., van Druten E; Department of Oncologic Research, Reinier de Graaf Hospital, Reinier de Graafweg 5, 8934 AD, Delft, The Netherlands., van Warmerdam LJC; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands., van der Sangen MJC; Department of Medical Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.; Department of Radiation Oncology, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands., Tjan-Heijnen VCG; Department of Medical Oncology, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands., Erdkamp FLG; Department of Medical Oncology, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Geleen, The Netherlands. f.erdkamp@zuyderland.nl.; Department of Internal Medicine - Medical Oncology, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Geleen, The Netherlands. f.erdkamp@zuyderland.nl.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2018 Nov; Vol. 172 (2), pp. 413-423. Date of Electronic Publication: 2018 Aug 18.
DOI: 10.1007/s10549-018-4906-8
Abstrakt: 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.
Databáze: MEDLINE
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