1390P - Patient characteristics in renal cell carcinoma and daily practice treatment with sorafenib (predict) in China

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Ding-Wei Ye
Authors D. Ye1, J. Guo2, A. Zhou3, Y. Huang4, H. Li5, Z. Hu6, C. Fu7, J. Liu8, M. Irwin9, J. Ma10
  • 1Urologic Oncology Surgery, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 2Oncology, Beijing Cancer Hospital, Beijing/CN
  • 3Urologic Oncology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing/CN
  • 4Urologic Surgery, Shang Hai Ren Ji Hospital, Shanghai/CN
  • 5Urologic Surgery, Union Medical College Hospital, Beijing/CN
  • 6Urologic Surgery, Tongji Hospital, Huazhong University of Science and Technology, Wuhan/CN
  • 7Urologic Surgery, 7Liaoning Provincial Tumor Hospital, Shenyang/CN
  • 8Urologic Surgery, Huaxi Hospital of Sichuan University, Chengdu/CN
  • 9Medical, Bayer Healthcare Company Ltd, Beijing/CN
  • 10Urologic Oncology Surgery, Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing/CN

Abstract

Background

Sorafenib is indicated for the treatment of the patients with advanced renal cell carcinoma (RCC). This post-marketing surveillance study was to evaluate patient characteristics in RCC patients as well as the efficacy and safety of Sorafenib under daily-life treatment conditions after its regulatory approval.

Methods

This was a prospective, non-interventional, non-controlled multi-center observational study (NCT00895674). Patients with advanced RCC and the decision taken by the investigator to prescribe sorafenib were involved in the study.

Results

A total of 1033 patients were enrolled. 963 patients were included in the safety and 853 patients in the efficacy statistical analysis. Baseline characteristics were: 71% male; median age 53.0 years (17∼85 years); 91% ECOG 0-2; 88.3% clear-cell histology; 24% high MSKCC risk; 30% >1 location of metastasis; 77.6 % prior nephrectomy; 59.2% prior systemic anticancer treatment. 12.9% of patients had pre-existing hypertension and 5.6% had diabetes mellitus. The median follow-up time of this study was 10.0months (mos).A clinical benefit was observed for 72.8 % of patients (n = 612/841) and radiologically for 71.0 % of patients (n = 597/841) at the last follow-up visit. Median PFS was 10.0mos. The median duration of sorafenib therapy was 10.0 mos, clinically relevant subgroups was as follows : > = 70 years (7.6mos), without nephrectomy (7.9mos), not purely clear histologic subtypes (7.3mos), >1 metastases site (8.6mos). There was no other demographic or baseline characteristics revealing any considerable differences. Treatment was well tolerated. 97.7 % received a daily dose of 800 mg sorafenib, only 5.7% with dose reduction at last visit. Drug-related adverse events (AEs) were 32.61%. The most commonly reported AEs in this study were HFSR or Palmar-plantar erythrodysesthesia (19.4%), rash (7.0%), diarrhea (6.9%), alopecia (4.7%), hypertension (3.0%) and fatigue (1.5%). Most of the AEs reported were mild to moderate (72.1%) according to CTCAE.

Conclusions

This study has shown baseline characteristics and safety of advanced RCC patients treated with sorafenib in Chinese real world setting. The results suggest that sorafenib is broadly beneficial for advanced RCC patients, regardless of baseline clinical charateristics and prior cancer treatment.

Disclosure

All authors have declared no conflicts of interest.