Sorafenib treatment of advanced renal cell carcinoma patients in daily practice: the large international PREDICT study.

Abstract

BACKGROUND:

Patients with advanced renal cell carcinoma in routine clinical practice can differ considerably from those in phase III studies.

PATIENTS AND METHODS:

PREDICT (Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with sorafenib) was a prospective, noninterventional study of open-label sorafenib for the treatment of advanced RCC conducted in 18 countries. Patient characteristics, therapy duration, tumor status, and tolerability were assessed at baseline and during routine follow-up.

RESULTS:

Overall, 2599 patients were evaluable for safety and 2311 for efficacy. The diverse population included patients with brain metastases (5%), non-clear-cell histologies (17%), high Memorial Sloan-Kettering Cancer Center risk score (11%), poor Eastern Cooperative Oncology Group performance status (PS ≥ 2, 29%), and patients with no previous nephrectomy (16%) or no previous systemic therapy (37%). The median duration of sorafenib therapy was 7.3 months and was similar in clinically relevant subgroups (eg, patients with PS 2, brain metastases, or concomitant hypertension or diabetes [range, 6.7-7.0 months]). The median duration of therapy was shorter for patients with PS 3 or non-clear-cell histologies (4.6 and 4.8 months, respectively). The most common drug-related adverse events were hand-foot skin reaction (20%), diarrhea (17%), and rash (8%).

CONCLUSION:

Sorafenib was generally well tolerated and provided clinical benefit in a large, diverse population of patients with advanced RCC treated in routine clinical practice.

• Authors: D Jäger, J H Ma, J Mardiak, D W Ye, E Korbenfeld, M Zemanova, H Ahn, J Guo, N Leonhartsberger, K Stauch, A Böckenhoff, J Yu, B Escudier
• Journal: Clinical genitourinary cancer (Clin Genitourin Cancer) Vol. 13 Issue 2 Pg. 156-64.e1 (Apr 2015) ISSN: 1938-0682 [Electronic] United States
• PMID: 25444666 (Publication Type: Clinical Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antineoplastic Agents
• Phenylurea Compounds
• Niacinamide
• Sorafenib

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Ambulatory Care Facilities
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Renal Cell (drug therapy, ethnology, pathology)
• Female
• Humans
• Kidney Neoplasms (drug therapy, ethnology, pathology)
• Male
• Middle Aged
• Neoplasm Metastasis
• Niacinamide (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Phenylurea Compounds (administration & dosage, adverse effects, therapeutic use)
• Prospective Studies
• Sorafenib
• Treatment Outcome
• Young Adult