Everolimus in metastatic renal cell carcinoma patients intolerant to previous VEGFr-TKI therapy: A RECORD-1 subgroup analysis Journal Article
| Authors: | Bracarda, S.; Hutson, T. E.; Porta, C.; Figlin, R. A.; Calvo, E.; Grünwald, V.; Ravaud, A.; Motzer, R.; Kim, D.; Anak, O.; Panneerselvam, A.; Escudier, B. |
| Article Title: | Everolimus in metastatic renal cell carcinoma patients intolerant to previous VEGFr-TKI therapy: A RECORD-1 subgroup analysis |
| Abstract: | Background: A relevant percentage of patients with metastatic renal cell carcinoma develop intolerance to vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFr-TKIs) and require careful selection of subsequent treatment. This retrospective analysis evaluated the safety and efficacy of everolimus in patients enrolled in the phase-III RECORD-1 trial who discontinued previous VEGFr-TKI therapy because of toxicity. Methods: Patients with an adverse event (AE) as their primary reason for discontinuation of previous VEGFr-TKI therapy were included. Median progression-free survival (PFS) for VEGFr-TKI-intolerant patients in each arm was estimated using the Kaplan-Meier method, and effect on PFS (hazard ratio (HR)) was calculated using the Cox proportional hazard model. Results: In VEGFr-TKI-intolerant patients (n58, 14%), median PFS was 5.4 months with everolimus and 1.9 months with placebo (HR: 0.32; P=0.004). In sunitinib-intolerant patients (n26), median PFS was 5.1 months with everolimus and 2.8 months with placebo (HR: 0.28; P=0.033). Grade 3/4 AEs reported with everolimus in VEGFr-TKI-intolerant patients included infections (16%), fatigue (7%) and stomatitis (4%). The toxicity profile of everolimus was similar in the VEGFr-TKI-intolerant and overall study populations. Conclusion: Everolimus is well tolerated and efficacious with no increased toxicity in patients intolerant to VEGFr-TKI therapy. © 2012 Cancer Research UK All rights reserved. |
| Keywords: | adult; clinical article; treatment outcome; aged; aged, 80 and over; middle aged; survival rate; retrospective studies; fatigue; salvage therapy; sorafenib; placebo; sunitinib; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; drug withdrawal; side effect; receptors, vascular endothelial growth factor; cancer patient; lymphatic metastasis; progression free survival; drug eruption; thrombocyte; mucosa inflammation; nausea; retrospective study; kidney carcinoma; kidney neoplasms; asthenia; drug hypersensitivity; pneumonia; protein kinase inhibitors; proportional hazards model; carcinoma, renal cell; peripheral edema; sepsis; kaplan meier method; kidney cancer; drug substitution; double-blind method; lymphocyte; everolimus; candidiasis; sirolimus; immunosuppressive agents; international agencies; aspergillosis; mtor inhibitor; rad001; mouth ulcer; aphthous stomatitis; vegf-targeted therapy; intolerance; tongue ulcer |
| Journal Title: | British Journal of Cancer |
| Volume: | 106 |
| Issue: | 9 |
| ISSN: | 0007-0920 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2012-04-24 |
| Start Page: | 1475 |
| End Page: | 1480 |
| Language: | English |
| DOI: | 10.1038/bjc.2012.89 |
| PROVIDER: | scopus |
| PMCID: | PMC3341863 |
| PUBMED: | 22441644 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 4 June 2012" - "CODEN: BJCAA" - "Source: Scopus" |
