D Jäger1, J H Ma2, J Mardiak3, D W Ye4, E Korbenfeld5, M Zemanova6, H Ahn7, J Guo8, N Leonhartsberger9, K Stauch10, A Böckenhoff11, J Yu12, B Escudier13. 1. National Center for Tumor Diseases, University Medical Center Heidelberg, Heidelberg, Germany. Electronic address: dirk.jaeger@nct-heidelberg.de. 2. Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China. 3. National Cancer Institute, Bratislava, Slovakia. 4. Affiliated Cancer Hospital of Fudan University, Shanghai, China. 5. Hospital Británico de Buenos Aires, Buenos Aires, Argentina. 6. Charles University in Prague, First Faculty of Medicine, Prague, Czech Republic. 7. Asan Medical Center, Seoul, Korea. 8. Beijing Cancer Hospital, Beijing, China. 9. Department of Urology, Medical University Innsbruck, Innsbruck, Austria. 10. Bayer HealthCare, Leverkusen, Germany. 11. Bayer HealthCare, Wuppertal, Germany. 12. Bayer HealthCare, Montville, NJ. 13. Institut Gustave Roussy, Villejuif, France.
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.
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: Enrico Bronte; Giuseppe Bronte; Giuseppina Novo; Fabrizio Bronte; Maria Grazia Bavetta; Giuseppe Lo Re; Giuseppe Brancatelli; Viviana Bazan; Clara Natoli; Salvatore Novo; Antonio Russo Journal: Oncotarget Date: 2015-11-03