title: Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients.
abstract: OBJECTIVE
  To assess the activity, safety and treatment patterns of sunitinib in patients with poor-risk metastatic renal cell carcinoma (mRCC).
  
  
  METHODS
  We retrospectively reviewed the charts of poor risk patients treated with sunitinib from October 2006 to July 2013 who met the eligibility criteria. The primary endpoint was overall survival (OS). Tumor radiological response was measured according to RECIST 1.1 and adverse events (AEs) were assessed through standard criteria.
  
  
  RESULTS
  Median OS was 8.16 months (95% CI, 5.73-10.59). Of the 53 patients included in this analysis, 9 (17.0%) achieved partial response, 12 (22.6%) had stable disease. Median treatment duration was 3.30 months (95% CI: 1.96-4.63) and 26.4% of patients discontinued treatment due to toxicity. Grade 3 or higher AEs occurred in 39.6% of patients, the most common being fatigue (15.1%), neutropenia (9.5%), nausea, vomiting and diarrhea (7.5% each).
  
  
  CONCLUSIONS
  Sunitinib may benefit some unselected poor-risk patients, although the rates of AEs and drug discontinuation suggest a need for careful patient monitoring.
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Romualdo
authors.initials: R
authors.lastname: Barroso-Sousa
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil and Centro de Oncologia, Hospital Sírio-Libanês, São Paulo, Brazil.
authors.forename: Rodrigo R
authors.initials: RR
authors.lastname: Munhoz
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Milena P
authors.initials: MP
authors.lastname: Mak
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Leonardo G
authors.initials: LG
authors.lastname: Fonseca
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Angelo B S
authors.initials: AB
authors.lastname: Fede
authors.affiliation: Centro de Oncologia, Hospital Sírio-Libanês, São Paulo, Brazil.
authors.forename: Rudinei Diogo Marques
authors.initials: RD
authors.lastname: Linck
authors.affiliation: Departament of Radiology and Oncology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Clovis R
authors.initials: CR
authors.lastname: Coelho
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Camila M V
authors.initials: CM
authors.lastname: Moniz
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil and Centro de Oncologia, Hospital Sírio-Libanês, São Paulo, Brazil.
authors.forename: Ciro E
authors.initials: CE
authors.lastname: Souza
authors.affiliation: Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil and Centro de Oncologia, Hospital Sírio-Libanês, São Paulo, Brazil.
authors.forename: Carlos
authors.initials: C
authors.lastname: Dzik
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000556:secondary; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use*; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D000077210:Sunitinib; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib