title: Induction chemotherapy and radiotherapy of advanced cancer of the cervix: a pilot study and phase III randomized trial.
abstract: OBJECTIVE
  This study assessed the effectiveness and toxicity of induction chemotherapy (CT) and radiation therapy (RT) in the treatment of locally advanced carcinoma of the cervix with data provided by a pilot study and a randomized trial.
  
  
  METHODS
  Eighty-six patients with International Federation of Gynecology and Obstetrics (FIGO) Stage IB-IVA (Stage IB >4-cm tumor diameter) (Group A) were entered in a pilot study and treated with cisplatin (50 mg/m2), vincristine (1 mg/m2 on days 1, 11, and 21), bleomycin (25 mg/m2 infusion on days 1-3, 11-13, and 21-23), and standard RT. Ninety-six patients were randomized to either this same CT regimen and RT, or RT alone (Group B: CT plus RT or RT).
  
  
  RESULTS
  In Group A, 58% responded to induction CT. With a mean follow-up of 78 months, 73% achieved pelvic control (LRC), and 55% were disease-free survivors. Response to CT was not a marker for ultimate LRC or increased disease-free survival (DFS). In Group B, 62% responded to CT. With a mean follow-up of 43 months, LRC was 68% and 65% for all randomized patients in the CT plus RT and RT arms, respectively (p = NS). In patients who completed treatment, 78% and 70%, respectively, achieved LRC (p = NS). Disease-free survival rates were 38% and 49% for randomized patients in the CT plus RT and RT arms (p = NS), respectively, and 44% and 52% in those patients completing treatment (p = NS), respectively. Complications were acceptable.
  
  
  CONCLUSIONS
  Data from this study did not prove the efficacy of induction CT before definitive RT in locally advanced cancer of the cervix. Induction CT with the currently used combinations and modes of administration should not be considered standard therapy.
authors.affiliation: Department of Radiation Oncology, Hospital Pereira Rossell, Montevideo, Uruguay.
authors.forename: F
authors.initials: F
authors.lastname: Leborgne
authors.forename: J H
authors.initials: JH
authors.lastname: Leborgne
authors.forename: R
authors.initials: R
authors.lastname: Doldán
authors.forename: E
authors.initials: E
authors.lastname: Zubizarreta
authors.forename: B
authors.initials: B
authors.lastname: Ortega
authors.forename: J
authors.initials: J
authors.lastname: Maisonneuve
authors.forename: E
authors.initials: E
authors.lastname: Musetti
authors.forename: L
authors.initials: L
authors.lastname: Hekimian
authors.forename: J
authors.initials: J
authors.lastname: Mezzera
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D012074:Remission Induction; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D001761:Bleomycin; D014750:Vincristine; D002945:Cisplatin