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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
DC Field | Value | Language |
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dc.contributor.author | Miles, David | - |
dc.contributor.author | Cameron, David | - |
dc.contributor.author | Bondarenko, Igor | - |
dc.contributor.author | Manzyuk, Lyudmila | - |
dc.contributor.author | Alcedo, Juan Carlos | - |
dc.contributor.author | Lopez, Roberto Ivan | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Canon, Jean-Luc | - |
dc.contributor.author | Shparyk, Yaroslav | - |
dc.contributor.author | Yardley, Denise A. | - |
dc.contributor.author | Masuda, Norikazu | - |
dc.contributor.author | Ro, Jungsil | - |
dc.contributor.author | Denduluri, Neelima | - |
dc.contributor.author | Hubeaux, Stanislas | - |
dc.contributor.author | Quah, Cheng | - |
dc.contributor.author | Bais, Carlos | - |
dc.contributor.author | O'Shaughnessy, Joyce | - |
dc.date.accessioned | 2022-03-22T09:23:46Z | - |
dc.date.available | 2022-03-22T09:23:46Z | - |
dc.date.created | 2018-06-01 | - |
dc.date.created | 2018-06-01 | - |
dc.date.created | 2018-06-01 | - |
dc.date.created | 2018-06-01 | - |
dc.date.created | 2018-06-01 | - |
dc.date.created | 2018-06-01 | - |
dc.date.issued | 2017-01 | - |
dc.identifier.citation | European Journal of Cancer, Vol.70, pp.146-155 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.other | 36821 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177302 | - |
dc.description.abstract | 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. | - |
dc.language | 영어 | - |
dc.publisher | Pergamon Press Ltd. | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1016/j.ejca.2016.09.024 | - |
dc.citation.journaltitle | European Journal of Cancer | - |
dc.identifier.wosid | 000390655400016 | - |
dc.identifier.scopusid | 2-s2.0-85006136818 | - |
dc.citation.endpage | 155 | - |
dc.citation.startpage | 146 | - |
dc.citation.volume | 70 | - |
dc.identifier.sci | 000390655400016 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | LOCALLY RECURRENT | - |
dc.subject.keywordPlus | GROWTH-FACTOR | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | DOCETAXEL | - |
dc.subject.keywordAuthor | Bevacizumab | - |
dc.subject.keywordAuthor | Metastatic breast cancer | - |
dc.subject.keywordAuthor | Predictive | - |
dc.subject.keywordAuthor | Biomarker | - |
dc.subject.keywordAuthor | Double-blind | - |
dc.subject.keywordAuthor | VEGF-A | - |
dc.subject.keywordAuthor | Weekly paclitaxel | - |
dc.subject.keywordAuthor | Prospective | - |
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