دورية أكاديمية
Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: analysis of response and progression-free survival in the RECORD-1 study.
| العنوان: | Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: analysis of response and progression-free survival in the RECORD-1 study. |
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| المؤلفون: | Oudard S; Medical Oncology Department, Georges Pompidou European Hospital, Paris, France. stephane.oudard@egp.aphp.fr, Thiam R, Fournier LS, Medioni J, Lamuraglia M, Scotte F, Fabre E, Kim D, Kpamegan E, Panneerselvam A, Cuenod CA |
| المصدر: | European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2012 Jul; Vol. 48 (10), pp. 1512-8. Date of Electronic Publication: 2012 Feb 16. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Elsevier Science Ltd Original Publication: Oxford ; New York : Pergamon Press, c1990- |
| مواضيع طبية MeSH: | Antineoplastic Agents/*therapeutic use , Carcinoma, Renal Cell/*drug therapy , Immunosuppressive Agents/*therapeutic use , Kidney Neoplasms/*drug therapy , Sirolimus/*analogs & derivatives, Disease-Free Survival ; Everolimus ; Humans ; Proportional Hazards Models ; ROC Curve ; Retrospective Studies ; Sensitivity and Specificity ; Sirolimus/therapeutic use ; Time Factors ; Treatment Outcome |
| مستخلص: | Background and Objectives: Objective response as determined by Response Evaluation Criteria in Solid Tumors (RECIST) is low among patients with metastatic renal cell carcinoma (mRCC) treated with targeted agents, despite significantly improved progression-free survival (PFS). A modified response threshold may be more clinically meaningful than RECIST for identifying patients who may derive a PFS benefit from targeted therapy. Patients and Methods: We performed a retrospective analysis of data from the phase III RECORD-1 trial of everolimus versus placebo in patients with mRCC who had failed sunitinib or sorafenib (ClinicalTrials.gov identifier: NCT00410124). A series of tumour response thresholds, defined by the best change in the sum of the longest tumour diameters (ΔSLD) of target lesions, was evaluated to distinguish 'responders' from 'non-responders' with respect to significant improvement in PFS. Results: The optimal threshold for determining a response to everolimus was -5% ΔSLD. At this threshold, median PFS was 8.4 months in responders and 5.0 months in non-responders (hazard ratio [HR] 2.4, 95% confidence interval [CI] 1.6-3.7). Conclusion: In patients who have failed vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy, everolimus affords superior PFS to placebo, regardless of change in tumour burden. However, a ≥ 5% reduction in SLD is a better predictor of PFS benefit than the classical ≥ 30% reduction used with RECIST. (Copyright © 2012 Elsevier Ltd. All rights reserved.) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00410124 |
| المشرفين على المادة: | 0 (Antineoplastic Agents) 0 (Immunosuppressive Agents) 9HW64Q8G6G (Everolimus) W36ZG6FT64 (Sirolimus) |
| تواريخ الأحداث: | Date Created: 20120221 Date Completed: 20120823 Latest Revision: 20160623 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.ejca.2012.01.027 |
| PMID: | 22342553 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1879-0852 |
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| DOI: | 10.1016/j.ejca.2012.01.027 |