title: A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). A study of the French Sarcoma Group.
abstract: BACKGROUND
  There is no proven benefit of adjuvant treatment of uterine sarcoma (US). SARCGYN phase III study compared adjuvant polychemotherapy followed by pelvic radiotherapy (RT) (arm A) versus RT alone (arm B) conducted to detect an increase ≥ 20% of 3-year PFS.
  
  
  METHODS
  Patients with FIGO stage ≤ III US, physiological age ≤ 65 years; chemotherapy: four cycles of doxorubicin 50 mg/m&sup2; d1, ifosfamide 3 g/m&sup2;/day d1-2, cisplatin 75 mg/m&sup2; d3, (API) + G-CSF q 3 weeks. Study was stopped because of lack of recruitment.
  
  
  RESULTS
  Eighty-one patients were included: 39 in arm A and 42 in arm B; 52 stage I, 16 stage II, 13 stage III; 53 leiomyosarcomas, 9 undifferenciated sarcomas, 19 carcinosarcomas. Gr 3-4 toxicity during API (/37 patients): thrombopenia (76%), febrile neutropenia (22%) with two toxic deaths; renal gr 3 (1 patient). After a median follow-up of 4.3 years, 41/81 patients recurred, 15 in arm A, 26 in arm B. The 3 years DFS is 55% in arm A, 41% in arm B (P = 0.048). The 3-year overall survival (OS) is 81% in arm A and 69% in arm B (P = 0.41).
  
  
  CONCLUSIONS
  API adjuvant CT statistically increases the 3 year-DFS of patients with US.
authors.affiliation: Department of Medical Oncology, Institut Gustave-Roussy, Villejuif, Cedex, France. pautier@igr.fr
authors.forename: P
authors.initials: P
authors.lastname: Pautier
authors.forename: A
authors.initials: A
authors.lastname: Floquet
authors.forename: L
authors.initials: L
authors.lastname: Gladieff
authors.forename: E
authors.initials: E
authors.lastname: Bompas
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.forename: S
authors.initials: S
authors.lastname: Piperno-Neumann
authors.forename: F
authors.initials: F
authors.lastname: Selle
authors.forename: C
authors.initials: C
authors.lastname: Guillemet
authors.forename: B
authors.initials: B
authors.lastname: Weber
authors.forename: R
authors.initials: R
authors.lastname: Largillier
authors.forename: F
authors.initials: F
authors.lastname: Bertucci
authors.forename: P
authors.initials: P
authors.lastname: Opinel
authors.forename: F
authors.initials: F
authors.lastname: Duffaud
authors.forename: A
authors.initials: A
authors.lastname: Reynaud-Bougnoux
authors.forename: C
authors.initials: C
authors.lastname: Delcambre
authors.forename: N
authors.initials: N
authors.lastname: Isambert
authors.forename: P
authors.initials: P
authors.lastname: Kerbrat
authors.forename: G
authors.initials: G
authors.lastname: Netter-Pinon
authors.forename: N
authors.initials: N
authors.lastname: Pinto
authors.forename: P
authors.initials: P
authors.lastname: Duvillard
authors.forename: C
authors.initials: C
authors.lastname: Haie-Meder
authors.forename: C
authors.initials: C
authors.lastname: Lhommé
authors.forename: A
authors.initials: A
authors.lastname: Rey
mesh_terms: D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008875:Middle Aged; D009367:Neoplasm Staging; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D004317:Doxorubicin; D002945:Cisplatin; D007069:Ifosfamide