Retrospective analyses of patient characteristics having predictive impact on survival under everolimus

TY - JOUR

T1 - Retrospective analyses of patient characteristics having predictive impact on survival under everolimus

AU - Seidel, Christoph

AU - Fenner, Martin

AU - Reuter, Christoph

AU - Merseburger, Axel S

AU - Ganser, Arnold

AU - Grünwald, Viktor

N1 - Copyright © 2011 S. Karger AG, Basel.

PY - 2011

Y1 - 2011

N2 - BACKGROUND: Everolimus is the standard second-line therapy for patients with metastatic renal cell carcinoma (mRCC). We evaluated whether the response to first-line therapy with a tyrosine kinase inhibitor (TKI) has predictive impact on the progression-free survival (PFS) and overall survival (OS) under everolimus. In addition, patient characteristics were evaluated for their predictive impact on the response under everolimus.METHODS: 42 patients with mRCC treated with everolimus (RAD001) within a clinical trial were analyzed. Prior to everolimus, every patient had received at least 1 TKI therapy. Another TKI for second line was given to 15 patients. PFS and OS were estimated according to the Kaplan-Meier method and compared with the log-rank test.RESULTS: Median PFS during everolimus therapy was 5.2 months (range 1.3-17.8). 27 patients (64%) achieved stable disease (SD) or partial remission (PR). Patients with a beneficial PFS under first-line TKI achieved a better OS after start of everolimus treatment (p = 0.05) and so did TKI responders (p = 0.04). A reduced OS was associated with liver metastases (p = 0.04) and high tumor burden (p = 0.01).CONCLUSIONS: A beneficial outcome under prior TKI therapy is predictive for a superior survival in patients treated with everolimus, while high tumor burden and liver metastases impair the OS.

AB - BACKGROUND: Everolimus is the standard second-line therapy for patients with metastatic renal cell carcinoma (mRCC). We evaluated whether the response to first-line therapy with a tyrosine kinase inhibitor (TKI) has predictive impact on the progression-free survival (PFS) and overall survival (OS) under everolimus. In addition, patient characteristics were evaluated for their predictive impact on the response under everolimus.METHODS: 42 patients with mRCC treated with everolimus (RAD001) within a clinical trial were analyzed. Prior to everolimus, every patient had received at least 1 TKI therapy. Another TKI for second line was given to 15 patients. PFS and OS were estimated according to the Kaplan-Meier method and compared with the log-rank test.RESULTS: Median PFS during everolimus therapy was 5.2 months (range 1.3-17.8). 27 patients (64%) achieved stable disease (SD) or partial remission (PR). Patients with a beneficial PFS under first-line TKI achieved a better OS after start of everolimus treatment (p = 0.05) and so did TKI responders (p = 0.04). A reduced OS was associated with liver metastases (p = 0.04) and high tumor burden (p = 0.01).CONCLUSIONS: A beneficial outcome under prior TKI therapy is predictive for a superior survival in patients treated with everolimus, while high tumor burden and liver metastases impair the OS.

KW - Adult

KW - Age Distribution

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents

KW - Carcinoma, Renal Cell

KW - Female

KW - Germany

KW - Humans

KW - Immunosuppressive Agents

KW - Kidney Neoplasms

KW - Male

KW - Middle Aged

KW - Prevalence

KW - Risk Assessment

KW - Risk Factors

KW - Sex Distribution

KW - Sirolimus

KW - Survival Analysis

KW - Survival Rate

KW - Treatment Outcome

U2 - 10.1159/000324668

DO - 10.1159/000324668

M3 - SCORING: Journal article

C2 - 21358215

VL - 34

SP - 111

EP - 114

JO - ONKOLOGIE

JF - ONKOLOGIE

SN - 0378-584X

IS - 3

ER -