title: Evaluation of vinorelbine in persistent or recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.
abstract: OBJECTIVE
  Vinorelbine is being explored by the Gynecologic Oncology Group (GOG) for its possible use in advanced or recurrent squamous cell carcinoma of the uterine cervix. The objective of this Phase II trial was to evaluate a days 1 and 8 every-21-days schedule and determine its activity in patients who had failed standard chemotherapy.
  
  
  METHODS
  Eligible patients with measurable disease and satisfactory baseline bone marrow, liver, and kidney functions were treated with vinorelbine 30 mg/m(2) given on days 1 and 8 every 21 days. A two-stage sampling design was used, proceeding to a second stage accrual if sufficient activity was documented in the first 25 patients.
  
  
  RESULTS
  The study did proceed to the second stage and accrued 44 patients. There were six objective responses (one complete, five partial) for a response rate of 13.7% (95% confidence interval: 5.2-27.4%). There were three patients with response in extra-pelvic sites (including the complete response) and three with response in the pelvis. The overall frequency of grades 3 and 4 neutropenia was 41%, whereas neuropathy was reported in 27% and was severe in three. Treatment-related pain, very severe in two instances, was also reported in 27%.
  
  
  CONCLUSIONS
  Vinorelbine has moderate activity in a pretreated population with squamous cell carcinoma of the cervix. Accordingly, vinorelbine in this days 1 and 8 schedule is being studied further in combination with cisplatin by the GOG.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Kaplan Cancer Center, New York University Medical Center, New York, NY 10016, USA. muggig01@gcrc.med.nyu.edu
authors.forename: Franco M
authors.initials: FM
authors.lastname: Muggia
authors.forename: John A
authors.initials: JA
authors.lastname: Blessing
authors.forename: Michael
authors.initials: M
authors.lastname: Method
authors.forename: David Scott
authors.initials: DS
authors.lastname: Miller
authors.forename: Gary A
authors.initials: GA
authors.lastname: Johnson
authors.forename: Roger B
authors.initials: RB
authors.lastname: Lee
authors.forename: Andrew
authors.initials: A
authors.lastname: Menzin
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine