title: Results of a European Organization for Research and Treatment of Cancer/Early Clinical Studies Group phase II trial of first-line irinotecan in patients with advanced or recurrent squamous cell carcinoma of the cervix.
abstract: OBJECTIVE
  To determine the efficacy and tolerability of irinotecan (CPT-11) in advanced or recurrent cervical carcinoma.
  
  
  METHODS
  Eligible patients had histologically confirmed, inoperable, progressive, metastatic or recurrent squamous cell cervical carcinoma and had received no radiotherapy in the preceding 3 months and had never received chemotherapy. The initial irinotecan dosage of 350 mg/m(2) every 3 weeks was modifiable according to toxicity. Treatment continued for six cycles after complete response, or until disease progression or excessive toxicity after partial response, or for three additional cycles in the case of stable disease. Patients were stratified into group A (>/= one measurable lesion in a previously unirradiated area, with or without progressive disease in irradiated fields) or group B (measurable new lesion[s] in an irradiated field).
  
  
  RESULTS
  Fifty-one of 55 enrolled patients were eligible for inclusion (median age, 47 years; range, 30 to 71 years). The response rate was 15.7% (95% confidence interval [CI], 7.0% to 28.6%) overall, 23.5% (95% CI, 10.7% to 41.2%) for group A (complete response, 2.9%), and zero for group B. The median time to progression and median survival were 4.0 and 8.2 months for group A and 2.5 and 4.2 months for group B, respectively. The major grade 3/4 toxicities for groups A and B were diarrhea (24.3% and 55.5%, respectively) and neutropenia (24.3% and 33.3%, respectively). There were four toxicity-related deaths, three in group B. Patients with no prior external pelvic irradiation experienced fewer grade 3 and 4 adverse events.
  
  
  CONCLUSIONS
  Irinotecan is effective in treating cervical squamous cell carcinoma if disease is located in an unirradiated area. Because of toxicity, a reduced dose is advised for patients previously treated with external pelvic irradiation.
authors.affiliation: Institut G. Roussy, Villejuif, France. lhomme@igr.fr
authors.forename: C
authors.initials: C
authors.lastname: Lhommé
authors.forename: P
authors.initials: P
authors.lastname: Fumoleau
authors.forename: P
authors.initials: P
authors.lastname: Fargeot
authors.forename: Y
authors.initials: Y
authors.lastname: Krakowski
authors.forename: V
authors.initials: V
authors.lastname: Dieras
authors.forename: J
authors.initials: J
authors.lastname: Chauvergne
authors.forename: P
authors.initials: P
authors.lastname: Vennin
authors.forename: P
authors.initials: P
authors.lastname: Rebattu
authors.forename: H
authors.initials: H
authors.lastname: Roche
authors.forename: J L
authors.initials: JL
authors.lastname: Misset
authors.forename: M A
authors.initials: MA
authors.lastname: Lentz
authors.forename: M
authors.initials: M
authors.lastname: Van Glabbeke
authors.forename: A
authors.initials: A
authors.lastname: Matthieu-Boué
authors.forename: D
authors.initials: D
authors.lastname: Mignard
authors.forename: B
authors.initials: B
authors.lastname: Chevallier
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin