Aflibercept and Docetaxel Versus Docetaxel Alone After Platinum Failure in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer: A Randomized, Controlled Phase III Trial

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dc.contributor.authorRamlau, Rodryg
dc.contributor.authorGorbunova, Vera
dc.contributor.authorCiuleanu, Tudor Eliade
dc.contributor.authorNovello, Silvia
dc.contributor.authorOzguroglu, Mustafa
dc.contributor.authorGoksel, Tuncay
dc.contributor.authorBaldotto, Clarissa
dc.contributor.authorBennouna, Jaafar
dc.contributor.authorShepherd, Frances A.
dc.contributor.authorLe-Guennec, Solenn
dc.contributor.authorRey, Augustin
dc.contributor.authorMiller, Vincent
dc.contributor.authorThatcher, Nicholas
dc.contributor.authorScagliotti, Giorgio
dc.date.accessioned2019-10-27T21:40:58Z
dc.date.available2019-10-27T21:40:58Z
dc.date.issued2012
dc.departmentEge Üniversitesien_US
dc.description.abstractPurpose To compare the efficacy of aflibercept (ziv-aflibercept), a recombinant human fusion protein targeting the vascular endothelial growth factor (VEGF) pathway, with or without docetaxel in platinum-pretreated patients with advanced or metastatic nonsquamous non-small-cell lung cancer. Patients and Methods In this international, double-blind, placebo-controlled phase III trial, 913 patients were randomly assigned to (ziv-)aflibercept 6 mg/kg intravenous (IV; n = 456) or IV placebo (n = 457), both administered every 3 weeks and in combination with docetaxel 75 mg/m(2). The primary end point was overall survival (OS). Other efficacy outcomes, safety, and immunogenicity were also assessed. Results Patient characteristics were balanced between arms; 12.3% of patients had received prior bevacizumab. (Ziv-)Aflibercept did not improve OS (hazard ratio [HR], 1.01; 95% CI, 0.87 to 1.17; stratified log-rank P = .90). The median OS was 10.1 months (95% CI, 9.2 to 11.6 months) for (ziv-) aflibercept and 10.4 months (95% CI, 9.2 to 11.9 months) for placebo. In exploratory analyses, median progression-free survival was 5.2 months (95% CI, 4.4 to 5.6 months) for (ziv-) aflibercept versus 4.1 months (95% CI, 3.5 to 4.3 months) for placebo (HR, 0.82; 95% CI, 0.72 to 0.94; P = .0035); overall response rate was 23.3% of evaluable patients (95% CI, 19.1% to 27.4%) in the (ziv-) aflibercept arm versus 8.9% (95% CI, 6.1% to 11.6%; P < .001) in the placebo arm. Grade >= 3 adverse events occurring more frequently in the (ziv-) aflibercept arm versus the placebo arm were neutropenia (28.0% v 21.1%, respectively), fatigue (11.1% v 4.2%, respectively), stomatitis (8.8% v 0.7%, respectively), and hypertension (7.3% v 0.9%, respectively). Conclusion The addition of (ziv-) aflibercept to standard docetaxel therapy did not improve OS. In exploratory analyses, secondary efficacy end points did seem to be improved in the (ziv-) aflibercept arm. The study regimen was associated with increased toxicities, consistent with known anti-VEGF and chemotherapy-induced events. J Clin Oncol 30:3640-3647. (C) 2012 by American Society of Clinical Oncologyen_US
dc.description.sponsorshipSanofiSanofi-Aventis; Regeneron Pharmaceuticals; sanofi-aventisSanofi-Aventisen_US
dc.description.sponsorshipSupported by Sanofi, in collaboration with Regeneron Pharmaceuticals.; Tuncay Goksel, sanofi-aventisen_US
dc.identifier.doi10.1200/JCO.2012.42.6932en_US
dc.identifier.endpage3647en_US
dc.identifier.issn0732-183X
dc.identifier.issn1527-7755
dc.identifier.issue29en_US
dc.identifier.pmid22965962en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage3640en_US
dc.identifier.urihttps://doi.org/10.1200/JCO.2012.42.6932
dc.identifier.urihttps://hdl.handle.net/11454/46476
dc.identifier.volume30en_US
dc.identifier.wosWOS:000309653600015en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherAmer Soc Clinical Oncologyen_US
dc.relation.ispartofJournal of Clinical Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.titleAflibercept and Docetaxel Versus Docetaxel Alone After Platinum Failure in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer: A Randomized, Controlled Phase III Trialen_US
dc.typeArticleen_US

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