Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: An exploratory analysis of the outcomes of elderly patients in the RECORD-1 trial Journal Article
| Authors: | Porta, C.; Calvo, E.; Climent, M. A.; Vaishampayan, U.; Osanto, S.; Ravaud, A.; Bracarda, S.; Hutson, T. E.; Escudier, B.; Grünwald, V.; Kim, D.; Panneerselvam, A.; Anak, O.; Motzer, R. J. |
| Article Title: | Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: An exploratory analysis of the outcomes of elderly patients in the RECORD-1 trial |
| Abstract: | Background: Elderly patients with metastatic renal cell carcinoma (mRCC) may require special treatment considerations, particularly when comorbidities are present. An understanding of the efficacy and safety of targeted agents in elderly patients with mRCC is essential to provide individualized therapy. Objective: To evaluate the efficacy and safety of everolimus in elderly patients (those ≥65 and ≥70 yr of age) enrolled in RECORD-1. Design, setting, and participants: The multicenter randomized RECORD-1 phase 3 trial (Clinicaltrials.gov identifier, NCT00410124; http://www.clinicaltrials.gov) enrolled patients with mRCC who progressed during or within 6 mo of stopping sunitinib and/or sorafenib treatment (n = 416). Intervention: Everolimus 10 mg once daily (n = 277) or placebo (n = 139) plus best supportive care. Treatment was continued until disease progression or unacceptable toxicity. Measurements: Median progression-free survival (PFS), median overall survival (OS), and time to deterioration in Karnofsky performance status (TTD-KPS) were assessed using the Kaplan-Meier method; the log-rank test was used to compare treatment arms. Other outcomes evaluated included reduction in tumor burden, overall response rate (ORR), and safety. Results and limitations: In RECORD-1, 36.8% of patients were ≥65 yr and 17.5% were ≥70 yr of age. PFS, OS, TTD-KPS, reduction in tumor burden, and ORR were similar in the elderly and the overall RECORD-1 population. Everolimus was generally well tolerated in elderly patients, and most adverse events were grade 1 or 2 in severity. The toxicity profile of everolimus was generally similar in older patients and the overall population; however, peripheral edema, cough, rash, and diarrhea were reported more frequently in the elderly regardless of treatment. The retrospective nature of the analyses was the major limitation. Conclusions: Everolimus is effective and tolerable in elderly patients with mRCC. When selecting targeted therapies in these patients, the specific toxicity profile of each agent and any patient comorbidities should be considered. © 2011 European Association of Urology. |
| Keywords: | controlled study; treatment outcome; treatment response; aged; aged, 80 and over; disease-free survival; retrospective studies; major clinical study; overall survival; disease course; drug tolerability; fatigue; placebo; diarrhea; drug dose reduction; drug efficacy; drug safety; side effect; antineoplastic agents; united states; anorexia; metastasis; progression free survival; infection; neutrophil count; anemia; tumor volume; mucosa inflammation; nausea; randomized controlled trial; stomatitis; vomiting; risk factors; randomized controlled trials as topic; creatinine blood level; hemoglobin blood level; age factors; retrospective study; kidney carcinoma; kidney neoplasms; time factors; risk assessment; alanine aminotransferase blood level; aspartate aminotransferase blood level; asthenia; coughing; dyspnea; fever; hyperglycemia; lymphocytopenia; pneumonia; pruritus; rash; protein kinase inhibitors; europe; karnofsky performance status; carcinoma, renal cell; clinical trials, phase iii as topic; multicenter study; peripheral edema; thrombocyte count; limb pain; glucose blood level; cholesterol blood level; triacylglycerol blood level; headache; phase 3 clinical trial; kaplan meier method; kidney cancer; dry skin; epistaxis; everolimus; sirolimus; multicenter studies as topic; lymphocyte count; dysgeusia; log rank test; mtor inhibitor; pneumonitis; kaplan-meier estimate; adverse events; molecular targeted therapy; phosphate blood level; tor serine-threonine kinases |
| Journal Title: | European Urology |
| Volume: | 61 |
| Issue: | 4 |
| ISSN: | 0302-2838 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2012-04-01 |
| Start Page: | 826 |
| End Page: | 833 |
| Language: | English |
| DOI: | 10.1016/j.eururo.2011.12.057 |
| PROVIDER: | scopus |
| PUBMED: | 22297244 |
| PMCID: | PMC4142675 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 2 April 2012" - "CODEN: EUURA" - "Source: Scopus" |
