Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial

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.

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).

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%).

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.

ClinicalTrials.gov, NCT00720941 , Registered July 22, 2008 ClinicalTrials.gov, NCT01147822 , Registered June 22, 2010.

Journal of hematology & oncology. 2018 May 22*** epublish ***

Jun Guo, Jie Jin, Mototsugu Oya, Hirotsugu Uemura, Shunji Takahashi, Katsunori Tatsugami, Sun Young Rha, Jae-Lyun Lee, Jinsoo Chung, Ho Yeong Lim, Hsi Chin Wu, Yen Hwa Chang, Arun Azad, Ian D Davis, Marlene J Carrasco-Alfonso, Bhupinder Nanua, Jackie Han, Qasim Ahmad, Robert Motzer

Department Urology and Melanoma, Peking University Cancer Hospital and Institute, 52 Fucheng Road, Hai-dian District, Beijing, 100142, China., Department of Urology, Peking University First Hospital, Beijing, China., Department of Urology, Keio University School of Medicine, Tokyo, Japan., Department of Urology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Osakasayama, Osaka, 589-8511, Japan., Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, 135-8550, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan., Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea., Department of Oncology and Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, South Korea., Department of Urology, Center for Prostate Cancer, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10408, South Korea., Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea., Department of Urology, China Medical University Hospital, Taichung, Taiwan., Division of Urology, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan., Department of Medicine, Monash University, 246 Clayton Road, Melbourne, VIC, 3168, Australia., Monash University, Eastern Health Clinical School, Level 2, 5 Arnold St, Box Hill, VIC, 3128, Australia., Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Novartis Pharmaceuticals Corporation, Basel, Switzerland., Department of Medicine, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA. .

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