title: Results of the GYNECO 02 study, an FNCLCC phase III trial comparing hysterectomy with no hysterectomy in patients with a (clinical and radiological) complete response after chemoradiation therapy for stage IB2 or II cervical cancer.
abstract: BACKGROUND
  Concomitant chemoradiation (CRT) (including brachytherapy) is considered the standard management for stage IB2 or II cervical cancer in many countries. Nevertheless, some of them discuss completion surgery (hysterectomy [HT]) after CRT. The aim of this study was to investigate the therapeutic impact of such surgery.
  
  
  METHODS
  A randomized trial was opened in France in 2003 to evaluate the interest in HT after CRT. Inclusion criteria were: (a) stage IB2 or II cervical cancer without extrapelvic disease on conventional imaging; (b) pelvic external radiation therapy (45 Gy with or without parametrial or nodal boost) with concomitant cisplatin chemotherapy (40 mg/m2 per week) followed by uterovaginal brachytherapy (15 Gy to the intermediate risk clinical target volume); and (c) complete clinical and radiological response 6-8 weeks after brachytherapy. Patients were randomized between HT (arm A) and no HT (arm B). Unfortunately this trial was closed because of poor accrual: 61 patients were enrolled (in 2003-2006) and are reported on here.
  
  
  RESULTS
  Thirty one and 30 patients were enrolled, respectively, in arm A and arm B. Twelve patients recurred (five of them died): respectively, eight and four in arm A and arm B. The 3-year event-free survival rates were 72% (standard error [SE], 9%) and 89% (SE, 6%) (not significant [NS]) in arm A and arm B, respectively. The 3-year overall survival rates were 86% (SE, 6%) and 97% (SE, 3%) (NS) in arm A and arm B, respectively.
  
  
  CONCLUSIONS
  Results of the current trial seem to suggest that completion HT had no therapeutic impact in patients with clinical and radiological complete response after CRT (but this conclusion is limited by the lack of power).
authors.affiliation: Institut Gustave Roussy, 39 Rue Camille Desmoulins, 94805 Villejuif, France. morice@igr.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Morice
authors.forename: Philippe
authors.initials: P
authors.lastname: Rouanet
authors.forename: Annie
authors.initials: A
authors.lastname: Rey
authors.forename: Pascale
authors.initials: P
authors.lastname: Romestaing
authors.forename: Gilles
authors.initials: G
authors.lastname: Houvenaeghel
authors.forename: Jean Charles
authors.initials: JC
authors.lastname: Boulanger
authors.forename: Jean
authors.initials: J
authors.lastname: Leveque
authors.forename: Didier
authors.initials: D
authors.lastname: Cowen
authors.forename: Patrice
authors.initials: P
authors.lastname: Mathevet
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Malhaire
authors.forename: Guillaume
authors.initials: G
authors.lastname: Magnin
authors.forename: Eric
authors.initials: E
authors.lastname: Fondrinier
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Berille
authors.forename: Christine
authors.initials: C
authors.lastname: Haie-Meder
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001918:Brachytherapy; D059186:Chemoradiotherapy, Adjuvant; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin