844P - Sorafenib in Patients with Renal Cell Carcinoma (RCC) and Baseline Hypertension or Diabetes: Subanalysis of the Non-Interventional Predict Study

Abstract

ABSTRACT Background Many patients (pts) with advanced RCC have comorbidities (particularly elderly pts), but pts with comorbidities are often underrepresented in clinical trials. PREDICT (NCT 00895674) was a large, non-interventional study of sorafenib (Sor) in pts with advanced RCC in clinical practice. We report findings in pts with baseline comorbidities. Methods Pts diagnosed with advanced RCC and prescribed Sor under compliance of the local product label were eligible. Physician assessments of efficacy and tolerability were collected for ≤12 months. Results The most frequent comorbidities were hypertension (HTN; n = 674) and diabetes (n = 225); baseline characteristics in these pts (71–73% male, 82–87% prior nephrectomy, 82–83% clear cell histology) were similar to the total efficacy population (n = 2311; 71% male, 84% prior nephrectomy, 83% clear cell histology). Pts with HTN (38%; n = 254) and diabetes (38%; n = 85) were more likely to be aged ≥70 years vs the total efficacy population (23%; n = 532). Median duration of therapy (DOT) in pts with HTN (6.7 months) or diabetes (7.0 months) was similar to the total efficacy population (7.3 months). A similar trend was seen for all pts aged ≥70 years (median DOT: total efficacy population, 6.1 months; HTN subset, 6.0 months; diabetes subset, 6.4 months). Best tumor response per RECIST was similar in the total group (complete response [CR], 2%; partial response [PR], 22%; stable disease [SD], 47%; and progressive disease [PD], 4%) and comorbid groups (CR, 1–2%; PR, 22–23%; SD, 43–48%; PD, 4–5%). In general, adverse event (AE) rates were slightly higher in pts with comorbidities than in the total safety population (Table). Conclusions In pts with RCC treated in clinical practice settings, some AE rates were numerically higher in pts with comorbidities. There were no notable differences in duration of Sor therapy. Number (%) pts with AEs (safety population) Comorbidity subset Event Hypertension (n = 760) Diabetes (n = 267) Total population (n = 2599) Any AE 524 (69.0) 177 (66.3) 1479 (56.9) Any drug-related AE 436 (57.4) 146 (54.7) 1240 (47.7) Any SAE 191 (25.1) 71 (26.6) 477 (18.4) Any drug-related SAE 59 (7.8) 20 (7.5) 140 (5.4) Most frequently reported any grade drug-related AEs (preferred term) * Hand–foot skin reaction 173 (22.8) 55 (20.6) 520 (20.0) Diarrhea 177 (23.3) 62 (23.2) 443 (17.1) Rash † 62 (8.2) 14 (5.2) 220 (8.5) Alopecia 49 (6.5) 15 (5.6) 145 (5.6) Hypertension 52 (6.8) 10 (3.8) 110 (4.2) Nausea 33 (4.3) 15 (5.6) 67 (2.6) Other AEs in relevant system organ classes Cardiac disorders 7 (0.9) 1 (0.4) 16 (0.6) Renal and urinary disorders 7 (0.9) 3 (1.1) 13 (0.5) Vascular disorders (excluding hypertension) 7 (0.9) 2 (0.7) 15 (0.6) AE, adverse event; SAE, serious adverse event * Occurring in ≥5% of patients in any subset. † Including rash, rash generalized, rash erythematous, rash maculo-papular, rash pustular, rash macular, rash pruritic, exfoliative rash, rash papular. Disclosure D. Jager: Dirk Jager has received honoraria from Bayer, Amgen, Pfizer, Novartis, Roche, Fresenius Kabi and Hoffmann-La Roche. M. Zemanova: Milada Zemanova has received consulting and lecture fees from Glaxo Smith Kline and Roche. N. Leonhartsberger: Nicolai Leonhartsberger has received honoraria from Bayer, Pfizer and Roche. K. Stauch: Kathrin Stauch is an employee of Bayer HealthCare and owns stock in Bayer Pharma AG. A. Boeckenhoff: Annette Boeckenhoff is an employee of Bayer HealthCare and owns stock in Bayer Pharma AG. J. Yu: Jian Yu is an employee of Bayer HealthCare. J. Mardiak: Jozef Mardiak has received Research Grants from Novartis and has received honoraria from Pfizer and Pierre Fabre. B. Escudier: Bernard Escudier has served in an advisory role for Pfizer, Novartis, Roche, GSK, Bayer and Aveo, and has received honoraria from Pfizer, Novartis, Roche, GSK, Bayer and Aveo. All other authors have declared no conflicts of interest.