TY  - JOUR
AU  - Guo, J
AU  - Jin, J
AU  - Oya, M
AU  - Uemura, H
AU  - Takahashi, S
AU  - Tatsugami, K
AU  - Rha, SY
AU  - Lee, J-L
AU  - Chung, J
AU  - Lim, HY
AU  - Wu, HC
AU  - Chang, YH
AU  - Azad, A
AU  - Davis, ID
AU  - Carrasco-Alfonso, MJ
AU  - Nanua, B
AU  - Han, J
AU  - Ahmad, Q
AU  - Motzer, R
Y2  - 2020/12/17
Y1  - 2018/05/22
SN  - 1756-8722
UR  - http://hdl.handle.net/11343/255163
AB  - BACKGROUND: The international, phase 3 COMPARZ study demonstrated that pazopanib and sunitinib have comparable efficacy as first-line therapy in patients with advanced renal cell carcinoma, but that safety and quality-of-life profiles favor pazopanib. Our report analyzed pazopanib and sunitinib safety in Asian and non-Asian subpopulations. METHODS: Patients were randomized 1:1 to receive pazopanib 800 mg once daily (continuous dosing) or sunitinib 50 mg once daily in 6-week cycles (4 weeks on, 2 weeks off). RESULTS: Safety population was composed of 363 Asian patients and 703 non-Asian patients. Asian patients had similar duration of exposure to either drug compared with non-Asian patients, although Asian patients had a higher frequency of dose modifications. Overall, hematologic toxicities, cytopenias, increased AST/ALT, and palmar-plantar erythrodysesthesia (PPE) were more prevalent in Asian patients, whereas gastrointestinal toxicities were more prevalent in non-Asian patients. Among Asian patients, hematologic adverse events and most non-hematologic AEs were more common in sunitinib-treated versus pazopanib-treated patients. Among Asian patients, the most common grade 3/4 AEs with pazopanib were hypertension (grade 3, 22%) and alanine aminotransferase increased (grade 3, 12%; grade 4, 1%); the most common grade 3/4 AEs with sunitinib were thrombocytopenia/platelet count decreased (grade 3, 36%; grade 4, 10%), neutropenia/neutrophil count decreased (grade 3, 24%; grade 4, 3%) hypertension (grade 3, 20%), and PPE (grade 3, 15%). CONCLUSIONS: A distinct pattern and severity of adverse events was observed in Asians when compared with non-Asians with both pazopanib and sunitinib. However, the two drugs were well tolerated in both subpopulations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00720941 , Registered July 22, 2008 ClinicalTrials.gov, NCT01147822 , Registered June 22, 2010.
LA  - English
PB  - BIOMED CENTRAL LTD
T1  - Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial
DO  - 10.1186/s13045-018-0617-1
IS  - Journal of Hematology and Oncology
VL  - 11
IS  - 1
L1  - /bitstream/handle/11343/255163/PMC5964681.pdf?sequence=1&isAllowed=y
ER  -