Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial

Frontiers in Oncology

Shukui Qin¹  Xianzhong Bai²  Cheng Fu³  Jinwan Wang⁴  Jiyan Liu⁵  Xiubao Ren⁶  Yuxian Bai⁷  Yan Song⁸  Ai-Ping Zhou⁸  Xiaodong Xie⁹  Hong Luo^1,10  Dingwei Ye^1,11  Jianhui Ma^1,12  Jianzhong Shou^1,12  Hanzhong Li^1,13 

[1] Institute, Shenyang, China;0Department of Urinary Surgery, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China;;1Department of Urology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital &2Cancer Center, Jinling Hospital, Nanjing, China;Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, China;Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer/Key Laboratory of Cancer Prevention and Therapy, Tianjin/Tianjin's Clinical Research Center for Cancer, Tianjin, China;Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China;Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China;Department of Oncology, General Hospital of Northern Theater Command, Shenyang, China;Department of Urology and Oncology, Chongqing University Cancer Hospital, Chongqing Cancer Hospital, Chongqing, China;Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China;Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China;Department of Urology, Peking Union Medical College Hospital, Beijing, China;

关键词: anlotinib;    metastatic renal cell carcinoma;    tyrosine kinase inhibitor;    second-line;    FGFR;   

DOI  :  10.3389/fonc.2020.00664

来源: DOAJ

【 摘 要 】

Introduction: Sequential therapy with vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) is effective in some patients with metastatic renal cell carcinoma (mRCC) progressed from or were intolerant to a prior TKIs. Anlotinib is a multi-kinase inhibitor targeting VEGFR1/2/3, PDGFR and FGFR, which has demonstrated efficacy and safety in first-line treatment of mRCC. This study assessed the potential of anloitnib as second-line treatment for patients with mRCC after prior one VEGFR-TKI.Methods: This is a single-arm, open-label, phase 2 study. Patients progressed after or were intolerant to sorafenib or sunitinib were enrolled. Anlotinib was administrated orally 12 mg once daily for 14 days every 3 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), safety and quality of life (QoL).Results: Forty three patients were enrolled and 42 received anlotinib, of whom 32 progressed after and 10 were intolerant to sorafenib or sunitinib. Median PFS were 14.0 months (95% CI 8.3–20.3) and 8.5 months (95% CI 5.6–16.6) for overall population and patients progressed after a previous VEGFR-TKI, respectively. Median OS was 21.4 months (95% CI 16.0–34.5), confirmed ORR and DCR were 16.7 and 83.3% in overall population. The most common adverse events included diarrhea (47.6%), hypertension (45.2%), hand and foot syndrome (42.9%), and fatigue (40.5%). Grade 3 hematological adverse events occurred in four cases, while no grade 4 hematological adverse events was observed.Conclusions: Anlotinib showed promising efficacy as well as favorable safety as second-line treatment for patients with mRCC.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02072044.

【 授权许可】

Unknown