دورية أكاديمية
Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): A double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation
| العنوان: | Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): A double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation |
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| المؤلفون: | Miles, David, Cameron, David, Bondarenko, Igor, Manzyuk, Lyudmila, Alcedo, Juan Carlos, Lopez, Roberto Ivan, Im, Seock-Ah, Canon, Jean-Luc, Shparyk, Yaroslav, Yardley, Denise A., Masuda, Norikazu, Ro, Jungsil, Denduluri, Neelima, Hubeaux, Stanislas, Quah, Cheng, Bais, Carlos, O'Shaughnessy, Joyce |
| المساهمون: | 임석아, Im, Seock-Ah |
| بيانات النشر: | Pergamon Press Ltd. |
| سنة النشر: | 2018 |
| المجموعة: | Seoul National University: S-Space |
| مصطلحات موضوعية: | LOCALLY RECURRENT, GROWTH-FACTOR, OPEN-LABEL, CHEMOTHERAPY, COMBINATION, DOCETAXEL, Bevacizumab, Metastatic breast cancer, Predictive, Biomarker, Double-blind, VEGF-A, Weekly paclitaxel, Prospective |
| الوصف: | Aim: MERiDiAN evaluated plasma vascular endothelial growth factor-A (pVEGF-A) prospectively as a predictive biomarker for bevacizumab efficacy in metastatic breast cancer (mBC). Methods: In this double-blind placebo-controlled randomised phase III trial, eligible patients had HER2-negative mBC previously untreated with chemotherapy. pVEGF-A was measured before randomisation to paclitaxel 90 mg/m(2) on days 1, 8 and 15 with either placebo or bevacizumab 10 mg/kg on days 1 and 15, repeated every 4 weeks until disease progression, unacceptable toxicity or consent withdrawal. Stratification factors were baseline pVEGF-A, prior adjuvant chemotherapy, hormone receptor status and geographic region. Co-primary end-points were investigator-assessed progression-free survival (PFS) in the intent-to-treat and pVEGF-A(high) populations. Results: Of 481 patients randomised (242 placeboepaclitaxel; 239 bevacizumab-paclitaxel), 471 received study treatment. The stratified PFS hazard ratio was 0.68 (99% confidence interval, 0.51-0.91; log-rank p = 0.0007) in the intent-to-treat population (median 8.8 months with placeboepaclitaxel versus 11.0 months with bevacizumab-paclitaxel) and 0.64 (96% confidence interval, 0.47-0.88; log-rank p = 0.0038) in the pVEGF-A(high) subgroup. The PFS treatment-by-VEGF-A interaction p value (secondary end-point) was 0.4619. Bevacizumab was associated with increased incidences of bleeding (all grades: 45% versus 27% with placebo), neutropenia (all grades: 39% versus 29%; grade >= 3: 25% versus 13%) and hypertension (all grades: 31% versus 13%; grade >= 3: 11% versus 4%). Conclusion: The significant PFS improvement with bevacizumab is consistent with previous placebo-controlled first-line trials in mBC. Results do not support using baseline pVEGF-A to identify patients benefitting most from bevacizumab. (C) 2016 Published by Elsevier Ltd. ; N ; 1 |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| تدمد: | 0959-8049 |
| العلاقة: | European Journal of Cancer, Vol.70, pp.146-155; 36821; https://hdl.handle.net/10371/177302Test; 000390655400016; 2-s2.0-85006136818 |
| DOI: | 10.1016/j.ejca.2016.09.024 |
| الإتاحة: | https://doi.org/10.1016/j.ejca.2016.09.024Test https://hdl.handle.net/10371/177302Test |
| رقم الانضمام: | edsbas.8A36B329 |
| قاعدة البيانات: | BASE |
| تدمد: | 09598049 |
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| DOI: | 10.1016/j.ejca.2016.09.024 |