Outcome and Safety of Sorafenib in Metastatic Renal Cell Carcinoma Dialysis Patients: A Systematic Review

Alessandro Leonetti, Melissa Bersanelli, Bruno Castagneto, Cristina Masini, Giovanni Di Meglio, Benedetta Pellegrino, Sebastiano Buti

Research output: Contribution to journalReview article

Abstract

Few data are available about sorafenib use in patients with metastatic renal cell carcinoma (mRCC) undergoing hemodialysis. No systematic review has been previously performed about this issue. The objective of the present review is to investigate pharmacokinetics and clinical outcomes of sorafenib in mRCC patients undergoing hemodialysis. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, all the literature about mRCC dialysis patients receiving sorafenib, published from January 1946 to August 2015, was evaluated. Applying inclusion/exclusion criteria, 11 articles were selected for the analysis; 1 patient from our department was also included. The investigated outcomes were pharmacokinetics, toxicity, response rate, progression-free survival, and overall survival where available. A total of 36 patients were included. Median treatment duration was 6.0 months on overall population; median progression-free survival was 6.3 months (calculated on 19 patients); response rate was 22% (on 29 patients); median overall survival was 14.9 months (on 28 patients). Of note, 24 patients started sorafenib at reduced dose; 6 of 36 patients (17%) required dose reduction due to adverse events (AEs). Sorafenib treatment was discontinued in 7 patients (19%) because of AEs. Most of AEs were Grade 1-2; severe toxicities (Grade 4-5) included G4 anemia (1 case), G4 hypertension (1 case), G4 cerebellar hemorrhage (1 patient), and a case of G5 subarachnoid hemorrhage. This review confirmed the efficacy of sorafenib treatment in mRCC patients receiving hemodialysis. Nevertheless, drug toxicity seems to be increased in these patients, despite the initiation of therapy at reduced doses; therefore, sorafenib should be used with caution in dialysis patients.

Original languageEnglish
Pages (from-to)277-283
Number of pages7
JournalClinical Genitourinary Cancer
Volume14
Issue number4
DOIs
Publication statusPublished - Aug 1 2016

Fingerprint

Renal Cell Carcinoma
Dialysis
Safety
Renal Dialysis
sorafenib
Disease-Free Survival
Pharmacokinetics
Survival
Subarachnoid Hemorrhage
Drug-Related Side Effects and Adverse Reactions
Meta-Analysis
Anemia
Therapeutics

Keywords

  • Hemodialysis
  • RCC
  • Renal failure
  • TKI
  • Treatment

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Outcome and Safety of Sorafenib in Metastatic Renal Cell Carcinoma Dialysis Patients : A Systematic Review. / Leonetti, Alessandro; Bersanelli, Melissa; Castagneto, Bruno; Masini, Cristina; Di Meglio, Giovanni; Pellegrino, Benedetta; Buti, Sebastiano.

In: Clinical Genitourinary Cancer, Vol. 14, No. 4, 01.08.2016, p. 277-283.

Research output: Contribution to journalReview article

Leonetti, Alessandro ; Bersanelli, Melissa ; Castagneto, Bruno ; Masini, Cristina ; Di Meglio, Giovanni ; Pellegrino, Benedetta ; Buti, Sebastiano. / Outcome and Safety of Sorafenib in Metastatic Renal Cell Carcinoma Dialysis Patients : A Systematic Review. In: Clinical Genitourinary Cancer. 2016 ; Vol. 14, No. 4. pp. 277-283.
@article{779dcf4cfe524e6eb6046f3e9fbffdc2,
title = "Outcome and Safety of Sorafenib in Metastatic Renal Cell Carcinoma Dialysis Patients: A Systematic Review",
abstract = "Few data are available about sorafenib use in patients with metastatic renal cell carcinoma (mRCC) undergoing hemodialysis. No systematic review has been previously performed about this issue. The objective of the present review is to investigate pharmacokinetics and clinical outcomes of sorafenib in mRCC patients undergoing hemodialysis. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, all the literature about mRCC dialysis patients receiving sorafenib, published from January 1946 to August 2015, was evaluated. Applying inclusion/exclusion criteria, 11 articles were selected for the analysis; 1 patient from our department was also included. The investigated outcomes were pharmacokinetics, toxicity, response rate, progression-free survival, and overall survival where available. A total of 36 patients were included. Median treatment duration was 6.0 months on overall population; median progression-free survival was 6.3 months (calculated on 19 patients); response rate was 22{\%} (on 29 patients); median overall survival was 14.9 months (on 28 patients). Of note, 24 patients started sorafenib at reduced dose; 6 of 36 patients (17{\%}) required dose reduction due to adverse events (AEs). Sorafenib treatment was discontinued in 7 patients (19{\%}) because of AEs. Most of AEs were Grade 1-2; severe toxicities (Grade 4-5) included G4 anemia (1 case), G4 hypertension (1 case), G4 cerebellar hemorrhage (1 patient), and a case of G5 subarachnoid hemorrhage. This review confirmed the efficacy of sorafenib treatment in mRCC patients receiving hemodialysis. Nevertheless, drug toxicity seems to be increased in these patients, despite the initiation of therapy at reduced doses; therefore, sorafenib should be used with caution in dialysis patients.",
keywords = "Hemodialysis, RCC, Renal failure, TKI, Treatment",
author = "Alessandro Leonetti and Melissa Bersanelli and Bruno Castagneto and Cristina Masini and {Di Meglio}, Giovanni and Benedetta Pellegrino and Sebastiano Buti",
year = "2016",
month = "8",
day = "1",
doi = "10.1016/j.clgc.2016.01.010",
language = "English",
volume = "14",
pages = "277--283",
journal = "Clinical Genitourinary Cancer",
issn = "1558-7673",
publisher = "Elsevier Inc.",
number = "4",

}

TY - JOUR

T1 - Outcome and Safety of Sorafenib in Metastatic Renal Cell Carcinoma Dialysis Patients

T2 - A Systematic Review

AU - Leonetti, Alessandro

AU - Bersanelli, Melissa

AU - Castagneto, Bruno

AU - Masini, Cristina

AU - Di Meglio, Giovanni

AU - Pellegrino, Benedetta

AU - Buti, Sebastiano

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Few data are available about sorafenib use in patients with metastatic renal cell carcinoma (mRCC) undergoing hemodialysis. No systematic review has been previously performed about this issue. The objective of the present review is to investigate pharmacokinetics and clinical outcomes of sorafenib in mRCC patients undergoing hemodialysis. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, all the literature about mRCC dialysis patients receiving sorafenib, published from January 1946 to August 2015, was evaluated. Applying inclusion/exclusion criteria, 11 articles were selected for the analysis; 1 patient from our department was also included. The investigated outcomes were pharmacokinetics, toxicity, response rate, progression-free survival, and overall survival where available. A total of 36 patients were included. Median treatment duration was 6.0 months on overall population; median progression-free survival was 6.3 months (calculated on 19 patients); response rate was 22% (on 29 patients); median overall survival was 14.9 months (on 28 patients). Of note, 24 patients started sorafenib at reduced dose; 6 of 36 patients (17%) required dose reduction due to adverse events (AEs). Sorafenib treatment was discontinued in 7 patients (19%) because of AEs. Most of AEs were Grade 1-2; severe toxicities (Grade 4-5) included G4 anemia (1 case), G4 hypertension (1 case), G4 cerebellar hemorrhage (1 patient), and a case of G5 subarachnoid hemorrhage. This review confirmed the efficacy of sorafenib treatment in mRCC patients receiving hemodialysis. Nevertheless, drug toxicity seems to be increased in these patients, despite the initiation of therapy at reduced doses; therefore, sorafenib should be used with caution in dialysis patients.

AB - Few data are available about sorafenib use in patients with metastatic renal cell carcinoma (mRCC) undergoing hemodialysis. No systematic review has been previously performed about this issue. The objective of the present review is to investigate pharmacokinetics and clinical outcomes of sorafenib in mRCC patients undergoing hemodialysis. According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, all the literature about mRCC dialysis patients receiving sorafenib, published from January 1946 to August 2015, was evaluated. Applying inclusion/exclusion criteria, 11 articles were selected for the analysis; 1 patient from our department was also included. The investigated outcomes were pharmacokinetics, toxicity, response rate, progression-free survival, and overall survival where available. A total of 36 patients were included. Median treatment duration was 6.0 months on overall population; median progression-free survival was 6.3 months (calculated on 19 patients); response rate was 22% (on 29 patients); median overall survival was 14.9 months (on 28 patients). Of note, 24 patients started sorafenib at reduced dose; 6 of 36 patients (17%) required dose reduction due to adverse events (AEs). Sorafenib treatment was discontinued in 7 patients (19%) because of AEs. Most of AEs were Grade 1-2; severe toxicities (Grade 4-5) included G4 anemia (1 case), G4 hypertension (1 case), G4 cerebellar hemorrhage (1 patient), and a case of G5 subarachnoid hemorrhage. This review confirmed the efficacy of sorafenib treatment in mRCC patients receiving hemodialysis. Nevertheless, drug toxicity seems to be increased in these patients, despite the initiation of therapy at reduced doses; therefore, sorafenib should be used with caution in dialysis patients.

KW - Hemodialysis

KW - RCC

KW - Renal failure

KW - TKI

KW - Treatment

UR - http://www.scopus.com/inward/record.url?scp=84990961233&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84990961233&partnerID=8YFLogxK

U2 - 10.1016/j.clgc.2016.01.010

DO - 10.1016/j.clgc.2016.01.010

M3 - Review article

AN - SCOPUS:84990961233

VL - 14

SP - 277

EP - 283

JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

SN - 1558-7673

IS - 4

ER -