Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial
Abstract 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 suniti...
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| Format: | Article |
| Language: | English |
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BMC
2018-05-01
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| Series: | Journal of Hematology & Oncology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13045-018-0617-1 |
| _version_ | 1818996408508743680 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jun Guo |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-12-20T21:29:16Z |
| format | Article |
| id | doaj.art-33806d909a3a413a8fa582382894db97 |
| institution | Directory Open Access Journal |
| issn | 1756-8722 |
| language | English |
| last_indexed | 2024-12-20T21:29:16Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Hematology & Oncology |
| spelling | doaj.art-33806d909a3a413a8fa582382894db972022-12-21T19:26:05ZengBMCJournal of Hematology & Oncology1756-87222018-05-0111111010.1186/s13045-018-0617-1Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trialJun Guo0Jie Jin1Mototsugu Oya2Hirotsugu Uemura3Shunji Takahashi4Katsunori Tatsugami5Sun Young Rha6Jae-Lyun Lee7Jinsoo Chung8Ho Yeong Lim9Hsi Chin Wu10Yen Hwa Chang11Arun Azad12Ian D. Davis13Marlene J. Carrasco-Alfonso14Bhupinder Nanua15Jackie Han16Qasim Ahmad17Robert Motzer18Department Urology and Melanoma, Peking University Cancer Hospital and InstituteDepartment of Urology, Peking University First HospitalDepartment of Urology, Keio University School of MedicineDepartment of Urology, Kindai University Faculty of MedicineDepartment of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer ResearchDepartment of Urology, Graduate School of Medical Sciences, Kyushu UniversityYonsei Cancer Center, Yonsei University College of MedicineDepartment of Oncology and Internal Medicine, Asan Medical Center, University of Ulsan College of MedicineDepartment of Urology, Center for Prostate Cancer, National Cancer CenterDivision of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan UniversityDepartment of Urology, China Medical University HospitalDivision of Urology, Department of Surgery, Taipei Veterans General HospitalDepartment of Medicine, Monash UniversityMonash University, Eastern Health Clinical SchoolNovartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationNovartis Pharmaceuticals CorporationDepartment of Medicine, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer CenterAbstract 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, 2010http://link.springer.com/article/10.1186/s13045-018-0617-1Renal cell carcinomaPazopanibSunitinib |
| spellingShingle | 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 Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial Journal of Hematology & Oncology Renal cell carcinoma Pazopanib Sunitinib |
| title | Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial |
| title_full | Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial |
| title_fullStr | Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial |
| title_full_unstemmed | Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial |
| title_short | Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial |
| title_sort | safety of pazopanib and sunitinib in treatment naive patients with metastatic renal cell carcinoma asian versus non asian subgroup analysis of the comparz trial |
| topic | Renal cell carcinoma Pazopanib Sunitinib |
| url | http://link.springer.com/article/10.1186/s13045-018-0617-1 |
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