Abstract:

Objective To assess the efficacy and safety of apatinib mesylate in the treatment of metastatic renal carcinoma. Methods Between October 2018 and April 2020, 32 patients with metastatic renal carcinoma were enrolled in the Department of Oncology of Shiyan People's Hospital of Hubei Province, Taihe Hospital and Sinopharm Dongfeng General Hospital. Apatinib mesylate was administered at an initial dose of 500 mg once daily. The main research end point was progression-free survival (PFS), secondary study destination included objective response rate (ORR), disease control rate (DCR) and safety. Multivariate analysis of PFS was carried out by Cox regression. Results The median follow-up time was 6.5 months (from 2 to 10). All 32 patients could be evaluated for efficacy. Efficacy evaluation showed 0 cases of complete remission, 14 cases (43.75%) of partial remission, 10 cases (31.25%) of stable disease, 8 cases (25.00%) of progressive disease, the ORR was 43.75% (14/32), and DCR was 75.00% (24/32). The PFS of patients had no significant correlation with gender, age, pathological type and previous surgery (all P>0.05), but was significantly correlated with the site of metastasis (HR=0.032, 95%CI: 0.003-0.411, P=0.008). The median PFS for all patients was 9.5 months (8.3-10.7 months), and there was a significant difference in the median PFS between patients with lung metastasis (n=21) and those with other sites (n=11) (9.5 months vs. 6.2 months, χ ²=14.812, P<0.001). The main adverse reactions were hypertension (37.50%, 12/32), hand-foot syndrome (31.25%, 10/32), proteinuria (18.75%, 6/32), neutropenia (25.00%, 8/32), anemia (28.13%, 9/32), thrombocytopenia (18.75%, 6/32), nausea/vomiting (15.63%, 5/32) and elevated transaminase (15.63%, 5/32), most of which were grade 1 or 2. The incidence of grade 3 adverse reactions was 28.13% (9/32), without grade 4 adverse reactions. After dosage reduction and symptomatic treatment, the symptoms could be controlled. Conclusion Apatinib mesylate can effectively prolong PFS in metastatic renal carcinoma patients with good safety, and can be used as a treatment option for metastatic renal carcinoma.

Key words: Kidney neoplasms, Mesylates, Treatment outcome