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 Anticancer agents
Renal Cell Cancer
Therapy
Biological therapy
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.