title: Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma.
abstract: BACKGROUND
  Sunitinib is an approved treatment for metastatic renal cell carcinoma (mRCC). The safety profile and efficacy of sunitinib were confirmed in a global expanded access trial (ClinicalTrials.gov identifier: NCT00130897). This report presents a subanalysis of the final trial data from patients in Latin America.
  
  
  METHODS
  Treatment-naïve or previously treated mRCC patients aged ≥18 years received oral sunitinib at a starting dose of 50 mg/day on a 4-weeks-on/2-weeks-off schedule. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. Safety was assessed regularly, and tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors).
  
  
  RESULTS
  In total, 348 patients from Latin America received sunitinib. Overall, 75% of patients had two or more sites of metastatic disease, 28% were aged ≥65 years, 14% had an Eastern Cooperative Oncology Group performance status ≥2, 9% had brain metastases, 9% had no prior nephrectomy, and 5% had non-clear cell RCC. Median treatment duration was 8 months, and median follow-up was 15.1 months. In total, 326 patients (94%) discontinued treatment, primarily due to death (41%) or lack of efficacy (22%). Most treatment-related adverse events were of mild to moderate severity (grade 1/2). Mucosal inflammation (reported in 54% of patients), diarrhea (53%), and asthenia (41%) were the most common any-grade treatment-related adverse events. Asthenia (12%), neutropenia (10%), and fatigue and thrombocytopenia (both 9%) were the most common grade 3/4 treatment-related adverse events. In total, 311 patients were included for tumor response, of whom eight (3%) had a complete response and 46 (15%) a partial response, yielding an objective response rate of 17%. Median duration of response, progression-free survival, and overall survival were 26.7, 12.1, and 16.9 months, respectively.
  
  
  CONCLUSIONS
  The efficacy and safety profile of sunitinib in patients with mRCC from Latin America was comparable to that in the entire cohort of the global expanded access trial.
authors.affiliation: Department of Medicine, PUCRS School of Medicine, Porto Alegre.
authors.forename: Carlos H
authors.initials: CH
authors.lastname: Barrios
authors.affiliation: Division of Clinical Oncology, Instituto Nacional do Câncer, Rio de Janeiro, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Herchenhorn
authors.affiliation: Clinical Oncology, Alexander Fleming Institute, Buenos Aires, Argentina.
authors.forename: Matías
authors.initials: M
authors.lastname: Chacón
authors.affiliation: Department of Medical Oncology, Instituto Nacional de Cancerología, México, Centro Oncológico Issemym Edomex, México.
authors.forename: Paula
authors.initials: P
authors.lastname: Cabrera-Galeana
authors.affiliation: Pfizer Oncology, New York, NY.
authors.forename: Peter
authors.initials: P
authors.lastname: Sajben
authors.affiliation: Pfizer Oncology, La Jolla, CA, USA.
authors.forename: Ke
authors.initials: K
authors.lastname: Zhang
keywords: Latin America; expanded-access trial; kidney cancer; sunitinib; tyrosine kinase inhibitor