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

Camillo Porta, Emiliano Calvo, Miguel A. Climent, Ulka Vaishampayan, Susanne Osanto, Alain Ravaud, Sergio Bracarda, Thomas E. Hutson, Bernard Escudier, Viktor Grünwald, Dennis Kim, Ashok Panneerselvam, Oezlem Anak, Robert J. Motzer

Research output: Contribution to journalArticle

44 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)826-833
Number of pages8
JournalEuropean Urology
Volume61
Issue number4
DOIs
Publication statusPublished - Apr 2012

Fingerprint

Renal Cell Carcinoma
Safety
Karnofsky Performance Status
Tumor Burden
Therapeutics
Disease-Free Survival
Comorbidity
Everolimus
Survival
Proxy
Exanthema
Cough
Population
Disease Progression
Diarrhea
Edema
Placebos

Keywords

  • Adverse events
  • Kidney cancer
  • mTOR inhibitor
  • Pneumonitis

ASJC Scopus subject areas

  • Urology

Cite this

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. / Porta, Camillo; Calvo, Emiliano; Climent, Miguel A.; Vaishampayan, Ulka; Osanto, Susanne; Ravaud, Alain; Bracarda, Sergio; Hutson, Thomas E.; Escudier, Bernard; Grünwald, Viktor; Kim, Dennis; Panneerselvam, Ashok; Anak, Oezlem; Motzer, Robert J.

In: European Urology, Vol. 61, No. 4, 04.2012, p. 826-833.

Research output: Contribution to journalArticle

Porta, C, Calvo, E, Climent, MA, Vaishampayan, U, Osanto, S, Ravaud, A, Bracarda, S, Hutson, TE, Escudier, B, Grünwald, V, Kim, D, Panneerselvam, A, Anak, O & Motzer, RJ 2012, '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', European Urology, vol. 61, no. 4, pp. 826-833. https://doi.org/10.1016/j.eururo.2011.12.057
Porta, Camillo ; Calvo, Emiliano ; Climent, Miguel A. ; Vaishampayan, Ulka ; Osanto, Susanne ; Ravaud, Alain ; Bracarda, Sergio ; Hutson, Thomas E. ; Escudier, Bernard ; Grünwald, Viktor ; Kim, Dennis ; Panneerselvam, Ashok ; Anak, Oezlem ; Motzer, Robert J. / 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. In: European Urology. 2012 ; Vol. 61, No. 4. pp. 826-833.
@article{ea9264c8748d40898292280922214ce3,
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.",
keywords = "Adverse events, Kidney cancer, mTOR inhibitor, Pneumonitis",
author = "Camillo Porta and Emiliano Calvo and Climent, {Miguel A.} and Ulka Vaishampayan and Susanne Osanto and Alain Ravaud and Sergio Bracarda and Hutson, {Thomas E.} and Bernard Escudier and Viktor Gr{\"u}nwald and Dennis Kim and Ashok Panneerselvam and Oezlem Anak and Motzer, {Robert J.}",
year = "2012",
month = "4",
doi = "10.1016/j.eururo.2011.12.057",
language = "English",
volume = "61",
pages = "826--833",
journal = "European Urology",
issn = "0302-2838",
publisher = "Elsevier B.V.",
number = "4",

}

TY - JOUR

T1 - Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma

T2 - An exploratory analysis of the outcomes of elderly patients in the RECORD-1 trial

AU - Porta, Camillo

AU - Calvo, Emiliano

AU - Climent, Miguel A.

AU - Vaishampayan, Ulka

AU - Osanto, Susanne

AU - Ravaud, Alain

AU - Bracarda, Sergio

AU - Hutson, Thomas E.

AU - Escudier, Bernard

AU - Grünwald, Viktor

AU - Kim, Dennis

AU - Panneerselvam, Ashok

AU - Anak, Oezlem

AU - Motzer, Robert J.

PY - 2012/4

Y1 - 2012/4

N2 - 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.

AB - 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.

KW - Adverse events

KW - Kidney cancer

KW - mTOR inhibitor

KW - Pneumonitis

UR - http://www.scopus.com/inward/record.url?scp=84862777361&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84862777361&partnerID=8YFLogxK

U2 - 10.1016/j.eururo.2011.12.057

DO - 10.1016/j.eururo.2011.12.057

M3 - Article

C2 - 22297244

AN - SCOPUS:84862777361

VL - 61

SP - 826

EP - 833

JO - European Urology

JF - European Urology

SN - 0302-2838

IS - 4

ER -