title: Immunotherapy with Sipuleucel-T (APC8015) in patients with metastatic castration-refractory prostate cancer (mCRPC): a systematic review and meta-analysis.
abstract: OBJECTIVE
  To perform a systematic review and meta-analysis of all randomized controlled trials comparing the efficacy of Sipuleucel-T versus placebo for asymptomatic or minimally symptomatic metastatic castration-refractory prostate cancer (mCRPC).
  
  
  METHODS
  Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The endpoints were overall survival (OS), time to progression (TTP) and side effects. We performed a meta-analysis (MA) of the published data. The results are expressed as Hazard Ratio (HR) or Risk Ratio (RR), with their corresponding 95% confidence intervals (CI 95%).
  
  
  RESULTS
  The final analysis included 3 trials comprising 737 patients. The TTP was similar in patients who received Sipuleucel-T or placebo (fixed effect: HR = 0.89; CI 95% = 0.75 to 1.05; p = 0.16), with no heterogeneity detected on this analysis (Chi2 = 2.14, df = 2 (P = 0.34); I2 = 6%). The results showed a higher overall survival in patients treated with Sipuleucel-T (fixed effect: HR = 0.74; CI 95% = 0.61 to 0.89; p = 0.001; NNT = 3). We found no heterogeneity on this analysis either (Chi2 = 1.46, df = 2 (P = 0.48); I2 = 0%). The incidence of adverse events (grade > 3) was the same in both groups.
  
  
  CONCLUSIONS
  Sipuleucel-T prolongs overall survival in patients with asymptomatic or minimally symptomatic mCRPC.
authors.affiliation: Comitê Brasileiro de Estudos em Uro-Oncologia-Evidencias, Rua Santos Dumond 241, Sao Paulo, Brazil. tobias.engel@evidencias.com.br
authors.forename: Tobias Engel Ayer
authors.initials: TE
authors.lastname: Botrel
authors.forename: Otavio
authors.initials: O
authors.lastname: Clark
authors.forename: Antonio C L
authors.initials: AC
authors.lastname: Pompeo
authors.forename: Francisco Flavio Horta
authors.initials: FF
authors.lastname: Bretas
authors.forename: Marcus Vinicius
authors.initials: MV
authors.lastname: Sadi
authors.forename: Ubirajara
authors.initials: U
authors.lastname: Ferreira
authors.forename: Rodolfo Borges dos
authors.initials: RB
authors.lastname: Reis
mesh_terms: D019496:Cancer Vaccines / Q000627:therapeutic use*; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D009919:Orchiectomy; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis; D014020:Tissue Extracts / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019496:Cancer Vaccines; D014020:Tissue Extracts; C511774:sipuleucel-T