BACKGROUND: Sunitinib, a multi-targeted receptor tyrosine kinase inhibitor, has demonstrated survival benefit in patients with metastatic renal cell carcinoma (mRCC); however, significant adverse events (AEs) have been associated with its use. The significant variation in the reported incidences of AEs has prompted this meta-analysis to quantify the risk and explore associated predictors. METHODS: According to predefined selection criteria, a literature search identified 12 studies that were included in the analyses. RESULTS: The meta-analysis included 5,658 patients; 66 % patients had prior systemic therapy whereas the remaining patients (34 %) received sunitinib in the first-line setting. For any grade toxicity, skin rash, fatigue, diarrhea, and mucositis were the most frequently encountered events (81, 52, 45, and 33 %, respectively). Anemia, neutropenia, or thrombocytopenia of any grade occurred in more than one-third of patients, although grades 3 or 4 were less common. Any grade raised by liver enzymes or serum creatinine occurred in 40 and 44 % of patients, respectively. Meta-regression analyses showed that study size was inversely related to the risk of experiencing fatigue, diarrhea, mucositis, anemia, and thrombocytopenia. In particular, the incidence of AEs was higher when sunitinib was used in pretreated versus naive patients; however, there was no significant difference between the two groups concerning the incidence of laboratory abnormalities. We addressed the limitations of reporting AEs in clinical studies. CONCLUSIONS: The present meta-analysis quantified sunitinib-associated AEs. The derived estimates would be similar to that to be expected from the use of sunitinib in community practice in unselected patients with metastatic renal cell carcinoma (mRCC).
BACKGROUND:Sunitinib, a multi-targeted receptor tyrosine kinase inhibitor, has demonstrated survival benefit in patients with metastatic renal cell carcinoma (mRCC); however, significant adverse events (AEs) have been associated with its use. The significant variation in the reported incidences of AEs has prompted this meta-analysis to quantify the risk and explore associated predictors. METHODS: According to predefined selection criteria, a literature search identified 12 studies that were included in the analyses. RESULTS: The meta-analysis included 5,658 patients; 66 % patients had prior systemic therapy whereas the remaining patients (34 %) received sunitinib in the first-line setting. For any grade toxicity, skin rash, fatigue, diarrhea, and mucositis were the most frequently encountered events (81, 52, 45, and 33 %, respectively). Anemia, neutropenia, or thrombocytopenia of any grade occurred in more than one-third of patients, although grades 3 or 4 were less common. Any grade raised by liver enzymes or serum creatinine occurred in 40 and 44 % of patients, respectively. Meta-regression analyses showed that study size was inversely related to the risk of experiencing fatigue, diarrhea, mucositis, anemia, and thrombocytopenia. In particular, the incidence of AEs was higher when sunitinib was used in pretreated versus naive patients; however, there was no significant difference between the two groups concerning the incidence of laboratory abnormalities. We addressed the limitations of reporting AEs in clinical studies. CONCLUSIONS: The present meta-analysis quantified sunitinib-associated AEs. The derived estimates would be similar to that to be expected from the use of sunitinib in community practice in unselected patients with metastatic renal cell carcinoma (mRCC).
Authors: Christian Kollmannsberger; Georg Bjarnason; Patrick Burnett; Patricia Creel; Mellar Davis; Nancy Dawson; Darren Feldman; Suzanne George; Jerome Hershman; Thomas Lechner; Amy Potter; Eric Raymond; Nathaniel Treister; Laura Wood; Shenhong Wu; Ronald Bukowski Journal: Oncologist Date: 2011-04-13
Authors: Robert J Motzer; Thomas E Hutson; Piotr Tomczak; M Dror Michaelson; Ronald M Bukowski; Olivier Rixe; Stéphane Oudard; Sylvie Negrier; Cezary Szczylik; Sindy T Kim; Isan Chen; Paul W Bycott; Charles M Baum; Robert A Figlin Journal: N Engl J Med Date: 2007-01-11 Impact factor: 91.245
Authors: Tammy F Chu; Maria A Rupnick; Risto Kerkela; Susan M Dallabrida; David Zurakowski; Lisa Nguyen; Kathleen Woulfe; Elke Pravda; Flavia Cassiola; Jayesh Desai; Suzanne George; Jeffrey A Morgan; David M Harris; Nesreen S Ismail; Jey-Hsin Chen; Frederick J Schoen; Annick D Van den Abbeele; George D Demetri; Thomas Force; Ming Hui Chen Journal: Lancet Date: 2007-12-15 Impact factor: 79.321
Authors: C Narjoz; A Cessot; A Thomas-Schoemann; J L Golmard; O Huillard; P Boudou-Rouquette; A Behouche; F Taieb; J P Durand; A Dauphin; R Coriat; M Vidal; M Tod; J Alexandre; M A Loriot; F Goldwasser; B Blanchet Journal: Invest New Drugs Date: 2014-10-25 Impact factor: 3.850