title: Brachytherapy versus radical hysterectomy after external beam chemoradiation with gemcitabine plus cisplatin: a randomized, phase III study in IB2-IIB cervical cancer patients.
abstract: BACKGROUND
  The aim of the present study was to demonstrate that radical hysterectomy (RH) leads to improved survival outcomes in FIGO stage IB2-IIB cervical cancer when compared with standard brachytherapy (BCT) after identical external beam chemoradiation (EBRT-CT).
  
  
  METHODS
  EBRT-CT treatment consisted of six courses of cisplatin at 40 mg/m² and gemcitabine at 125 mg/m² per week concurrent with 50.4 Gy of radiation. In the BCT arm, EBRT-CT was followed by BCT to reach a point A dose of 85 Gy, whereas in the experimental arm, a type III RH with bilateral pelvic lymph node dissection and para-aortic lymph node sampling (RH) was carried out within 4-6 weeks after EBRT-CT.
  
  
  RESULTS
  Between May 2004 and June 2009, 211 patients were enrolled (BCT, 100 and RH, 111). At a median follow-up time of 36 months (3-80), progression-free survival (PFS) and overall survival (OS) rates were similar in both the arms. PFS rates were 74.8% and 71.7% in the BCT and RH arms [HR 0.6516 (95% confidence interval (CI) 0.3504-1.2116)], P = 0.186. OS rates were 76.3% in the BCT versus 74.5% in the surgical arm [HR 0.6981 (95% CI 0.3106-1.3439)], P = 0.236. No differences were observed in the pattern of local and systemic failures.
  
  
  CONCLUSIONS
  This study failed to demonstrate that RH after EBRT-CT is superior to standard BCT.
authors.affiliation: Division of Clinical Research, National Cancer Institute, Mexico.
authors.forename: L
authors.initials: L
authors.lastname: Cetina
authors.forename: A
authors.initials: A
authors.lastname: González-Enciso
authors.forename: D
authors.initials: D
authors.lastname: Cantú
authors.forename: J
authors.initials: J
authors.lastname: Coronel
authors.forename: D
authors.initials: D
authors.lastname: Pérez-Montiel
authors.forename: J
authors.initials: J
authors.lastname: Hinojosa
authors.forename: A
authors.initials: A
authors.lastname: Serrano
authors.forename: L
authors.initials: L
authors.lastname: Rivera
authors.forename: A
authors.initials: A
authors.lastname: Poitevin
authors.forename: A
authors.initials: A
authors.lastname: Mota
authors.forename: E
authors.initials: E
authors.lastname: Trejo
authors.forename: G
authors.initials: G
authors.lastname: Montalvo
authors.forename: D
authors.initials: D
authors.lastname: Muñoz
authors.forename: J
authors.initials: J
authors.lastname: Robles-Flores
authors.forename: J
authors.initials: J
authors.lastname: de la Garza
authors.forename: J
authors.initials: J
authors.lastname: Chanona
authors.forename: R
authors.initials: R
authors.lastname: Jiménez-Lima
authors.forename: T
authors.initials: T
authors.lastname: Wegman
authors.forename: A
authors.initials: A
authors.lastname: Dueñas-González
mesh_terms: D000328:Adult; D000368:Aged; D001918:Brachytherapy; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use; D013534:Survival; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy / Q000601:surgery; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D011838:Radiation-Sensitizing Agents; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
keywords: brachytherapy; cervical cancer; chemoradiation; radical hysterectomy; randomized