847P - Clinical efficacy of sunitinib as post-operative adjuvant therapy in patients with high-risk renal cell carcinoma

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Xu Zhang
Authors X. Zhang1, J.Y. Yuan2, L. Wang2, L. Chen3, J. Pan4, L. Ye5, X. Xiao6, J. Qiu7, K. Zhang8, G. Ye9
  • 1The General Hospital of the People's Liberation Army, Beijing/CN
  • 2Urology Department, Xijin Hospital, the Fourth Military Medical University, Xian/CN
  • 3Urology Department, 307 Hospital of PLA, Beijing/CN
  • 4Urology Department, Southwest Hospital, the Third Military Medical University, Chongqing/CN
  • 5Urology Department, 304 Hospital of PLA, Beijing/CN
  • 6Urology Department, General Hospital of Armed Police Forces, Beijing/CN
  • 7Urology Department, Bethune International Peace Hospital of PLA, Jilin/CN
  • 8Urology Department, Daping Hospital, the Third Military Medical University, Chongqing/CN
  • 9Urology Department, Xinqiao Hospital, the Third Military Medical University, Chongqing/CN

Abstract

Objective

To evaluate the efficacy and safety of Sunitinib as post-operative adjuvant therapy in patients with high-risk renal cell carcinoma (RCC).

Methods

A total of 60 patients with resected, histologically confirmed clear cell RCC were enrolled in this study. Patients received orally Sunitinib either at a dose of 50mg on treatment schedule 4/2 (once daily for 4 weeks followed by 2 weeks off) or at a dose of 37.5mg once daily for three 6-week cycles from 1 month after surgery.

Results

All 60 patients tolerated Sunitinib treatment well and no patient discontinued treatment due to adverse events. Most adverse events were grade I to II. The most frequently reported adverse events were neutropenia (56.7%), thrombocytopenia (53.3%), leucopenia (48.3%), hand-foot syndrome (46.7%) and hypertension (36.7%). The most frequently reported grade 3 or 4 toxicities were thrombocytopenia (25%), neutropenia (15%), hand-foot syndrome (11.7%) and leucopenia (8.3%). The majority of adverse events occurred within the first 1-2 cycles of Sunitinib treatment, and was ameliorated 1 month after 3 cycles finished. No irreversible adverse event was observed. As of April 5, 2012, no recurrence occurred in patients except one death due to cerebrovascular accident unrelated to treatment, with both 6-month and 9-month disease-free survival (DFS) rate of 100%.

Conclusion

Myelosuppression occurred less frequently in high-risk RCC patients treated with Sunitinib as operative adjuvant therapy than in advanced RCC patients, with a better benefit trend. However, long-term follow-up data are needed to further confirm the efficacy of Sunitinib in the adjuvant setting.

Disclosure

All authors have declared no conflicts of interest.