Peking University Cancer Hospital & Institute, Beijing, China
Jun Guo , Xi Nan Sheng , Zhihong Chi , Chuanliang Cui , Lu Si , Si Ming Li , Li Li Mao , BIN LIAN , Bixia Tang , Xieqiao Yan , Xuan Wang , Fang-Jian Zhou , Dingwei Ye , Zhisong He
Background: There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF-targeted therapies and mTOR inhibitors. From the Gold study, Sorafenib might be an option for the third-line treatment. This study aimed to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with metastatic renal cancer. Methods: This study is an open-label, multi-center, randomized phase II trial. Eligible patients had metastatic renal cell carcinoma with clear cell, and had received 1st line treatment of sunitinib and 2nd line treatment of everolimus before enrollment. Additional inclusion criteria included: ≥ 1 measurable disease, ECOG PS 0/1, and adequate hematological, renal, and hepatic functions. Patients were randomly allocated in a 1:1 ratio to receive bevacizumab plus sorafenib (bevacizumab 5mg/kg intravenously every two weeks plus sorafenib 400 mg twice daily) or sorafenib alone (sorafenib 400 mg, orally, twice daily). Treatment was continued for both groups until occurrence of disease progression, unacceptable toxicity, death, or withdrawal of consent. The primary study endpoint is PFS. Overall survival, disease control rate, and safety will also be assessed. Results: The first patient visit was on October 1, 2013. Thirty-three of a planned 106 evaluable pts have been enrolled: 76% male, median age 63, 100% PS 0/1 and 33% favorable/55% intermediate by Heng’s criteria. 18 patients had received bevacizumab plus sorafenib, and 15 patients had received sorafenib alone. The objective response rate was 11.1% and 0% respectively. The median progression-free survival was 6.5 months and 3.5 months respectively. The median overall survival has not been reached. Treatment emergent grade 3 or 4 adverse events were fatigue (11.1%), hypertension (5.6%), proteinuria(5.6%) in bevacizumab group; palmar-plantar erythrodysaesthesia (6.7%) in sorafenib alone group Conclusions: Bevacizumab plus sorafenib might be beneficial for the advanced renal cancer patients who have failed to sunitinib as 1st and everolimus as 2nd line treatment. Clinical trial information: NCT02330783
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