Anlotinib Versus Sunitinib as First-Line Treatment for Metastatic Renal Cell Carcinoma: A Randomized Phase II Clinical Trial

摘要: BACKGROUND Anlotinib is a tyrosine kinase inhibitor inhibiting angiogenesis. This multicenter, randomized phase II trial aimed to investigate the efficacy and safety of anlotinib in comparison with sunitinib as first-line treatment for patients metastatic renal cell carcinoma (mRCC). MATERIALS AND METHODS Patients mRCC from 13 clinical centers were randomly assigned 2:1 ratio receive (n = 90) or = 43). was given orally at dose 12 mg once daily (2 weeks on/1 week off), 50 mg (4 weeks on/2 weeks off). The primary endpoint progression-free survival (PFS). Secondary endpoints included overall (OS), objective response rate (ORR), disease control (DCR), safety. RESULTS median PFS similar (17.5 vs. 16.6 months, p > .05). OS (30.9 30.5 months, > .05), ORR (30.3% 27.9%), 6-week DCR (97.8% 93.0%) two groups. Adverse events (AEs) grade 3 4 significantly less frequent than (28.9% 55.8%, < .01), especially terms thrombocytopenia neutropenia. AEs occurring lower frequency hand-foot syndrome, eyelid edema, hair depigmentation, skin yellowing, neutropenia, thrombocytopenia, anemia. incidence serious sunitinib. CONCLUSION that mRCC, but more favorable profile. IMPLICATIONS FOR PRACTICE study evaluated carcinoma. Anlotinib, which developed independently China, new multiple kinases involved angiogenesis tumor proliferation. Results indicated comparable better