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

Abstract

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 with metastatic renal cell carcinoma (mRCC).

MATERIALS AND METHODS:

Patients with mRCC from 13 clinical centers were randomly assigned in a 2:1 ratio to receive anlotinib (n = 90) or sunitinib (n = 43). Anlotinib was given orally at a dose of 12 mg once daily (2 weeks on/1 week off), and sunitinib was given orally at 50 mg once daily (4 weeks on/2 weeks off). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.

RESULTS:

The median PFS was similar with anlotinib and sunitinib (17.5 vs. 16.6 months, p > .05). The median OS (30.9 vs. 30.5 months, p > .05), ORR (30.3% vs. 27.9%), and 6-week DCR (97.8% vs. 93.0%) were similar in the two groups. Adverse events (AEs) of grade 3 or 4 were significantly less frequent with anlotinib than with sunitinib (28.9% vs. 55.8%, p < .01), especially in terms of thrombocytopenia and neutropenia. AEs occurring at a lower frequency with anlotinib were hand-foot syndrome, eyelid edema, hair depigmentation, skin yellowing, neutropenia, thrombocytopenia, and anemia. The incidence of serious AEs was lower with anlotinib than with sunitinib.

CONCLUSION:

The clinical efficacy of anlotinib was similar to that of sunitinib as the first-line treatment for mRCC, but with a more favorable safety profile.

IMPLICATIONS FOR PRACTICE:

This study evaluated the efficacy and safety of anlotinib for the first-line treatment of metastatic renal cell carcinoma. Anlotinib, which was developed independently in China, is a new tyrosine kinase inhibitor inhibiting multiple kinases involved in angiogenesis and tumor proliferation. Results indicated that the efficacy of anlotinib is comparable to and the safety is better than that of sunitinib.

• Authors: Ai-Ping Zhou, Yuxian Bai, Yan Song, Hong Luo, Xiu-Bao Ren, Xiuwen Wang, Benkang Shi, Cheng Fu, Ying Cheng, Jiyan Liu, Shukui Qin, Jun Li, Hanzhong Li, Xianzhong Bai, Dingwei Ye, Jinwan Wang, Jianhui Ma
• Journal: The oncologist (Oncologist) Vol. 24 Issue 8 Pg. e702-e708 (08 2019) ISSN: 1549-490X [Electronic] England
• PMID: 30902918 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © AlphaMed Press 2019.

Chemical References

• Antineoplastic Agents
• Indoles
• Protein Kinase Inhibitors
• Quinolines
• anlotinib
• Sunitinib

Topics

• Antineoplastic Agents (administration & dosage, adverse effects)
• Carcinoma, Renal Cell (drug therapy, pathology)
• Disease-Free Survival
• Female
• Humans
• Indoles (administration & dosage, adverse effects)
• Kidney Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Metastasis
• Protein Kinase Inhibitors (administration & dosage, adverse effects)
• Quinolines (administration & dosage, adverse effects)
• Sunitinib (administration & dosage, adverse effects)