844P - Sorafenib in patients with renal cell carcinoma (RCC) and baseline hypertension or diabetes: subanalysis of the non-interventional predict study

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Cancer in Special Situations
Presenter Dirk Jäger
Authors D. Jäger1, J. Guo2, E. Korbenfeld3, M. Zemanova4, N. Leonhartsberger5, K. Stauch6, A. Boeckenhoff7, J. Yu8, J. Mardiak9, B. Escudier10
  • 1University Medical Center Heidelberg, 69120 - Heidelberg/DE
  • 2Renal Cancer And Melanoma Unit, Peking University Cancer Hospital and Institute, Beijing/CN
  • 3Oncology, Hospital Británico de Buenos Aires, Buenos Aires/AR
  • 4Department Of Oncology, Charles University, Prague/CZ
  • 5Department Of Urology, Medical University Innsbruck, Innsbruck/AT
  • 6Global Non-interventional Studies, Bayer HealthCare, Leverkusen/DE
  • 7Global Development - Global Clinical Development, Bayer HealthCare, Wuppertal/DE
  • 8Global Medical Affairs, Bayer HealthCare, Montville/US
  • 9Department Of Medical Oncology, National Cancer Institute, 833 10 - Bratislava/SK
  • 10Institut Gustave Roussy, 94805 - Villejuif/FR

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)

*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. AE, adverse event; SAE, serious adverse event

Disclosure

D. Jäger: Dirk Jäger 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.