A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab plu
PUBLISHED: 2015-11-30  277 total views, 1 today

Jun Guo1Xinan Sheng1, Zhihong Chi1, Chuanliang Cui1, Lu Si1, Siming Li1, Lili Mao1Bin Lian1, Bixia Tang1, Xieqiao Yan1, Xuan Wang1, Yan Kong1Jie Dai1, FJ Zhou2, DW Ye3, ZS He4

1Beijing, China Peking University Cancer Hospital & Institute

2Guangzhou, China Sun Yat-sen University Cancer Center

3Shanghai, China Fudan Universityl Shanghai Cancer Center

4Beijing, China Peking University First Hospital



ObjectiveThereis no standard treatment in patients with renal cell carcinoma that waspreviously treated with VEGF-targeted therapies and mTOR inhibitors. From theGold study, Sorafenib might be an option for the third-line treatment. The Besttrial demonstrated that bevacizumab/sorafenib had best efficacy in advancedrenal cancer. This study aimed to compare bevacizumab plus sorafenib versussorafenib for the third-line treatment of patients with metastatic renal cellcarcinoma. MethodThisstudy is an open-label, multi-center, randomized phase II trial. Eligiblepatients had metastatic renal cell carcinoma with clear cell, and had received1st line treatment of sunitinib and 2nd line treatment of everolimus beforeenrollment. Additional inclusion criteria included: ≥1 measurable disease, ECOGPS 0/1, and adequate hematological, renal, and hepatic functions. Patients wererandomly allocated in a 1:1 ratio to receive bevacizumab plus sorafenib(bevacizumab 5mg/kg intravenously every two weeks plus sorafenib 400mg twicedaily) or sorafenib alone (sorafenib 400mg, orally, twice daily). Treatment wascontinued for both groups until occurrence of disease progression, unacceptabletoxicity, death, or withdrawal of consent. The primary study endpoint is PFS.Overall survival, disease control rate, and safety will also be assessed. ResultThefirst patient visit was on October 1, 2013. Thirty-three of a planned 106evaluable 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 receivedbevacizumab plus sorafenib, and 15 patients had received sorafenib alone. Theobjective response rate was 11.1% and 0% respectively. The medianprogression-free survival was 6.5 months and 3.5 months respectively. Themedian overall survival has not been reached. Treatment emergent grade 3 or 4adverse events were fatigue (11.1%), hypertension (5.6%), proteinuria (5.6%) inthe bevacizumab plus sorafenib group; palmar-plantar erythrodysaesthesia (6.7%)in the sorafenib group. ConclusionBevacizumabplus sorafenib might be beneficial for the advanced renal cancer patients whohave failed to sunitinib as 1st and everolimus as 2nd line treatment. Morepatients will be enrolled in next year.


Key WordsRenal


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