title: Chemotherapy for cervical carcinoma: factors determining response and implications for clinical trial design.
abstract: OBJECTIVE
  To identify characteristics that predict response to chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the cervix.
  
  
  METHODS
  Between January 1986 and May 1996, 190 chemotherapy-naive patients with advanced or recurrent squamous cell carcinoma of the cervix not amenable to curative radiation therapy or surgery were treated on 14 different chemotherapy protocols at M.D. Anderson Cancer Center. Patient's charts were retrospectively reviewed for patient demographics, tumor and treatment characteristics, and patterns of response and survival.
  
  
  RESULTS
  Of 190 patients, 22 had advanced or persistent disease and 168 had recurrent disease. Patients were treated with platinum-based (n=95) and non-platinum-based (n=95) regimens. The overall response rate was 20.0% (4.2% complete response; 15.8% partial response), with a median response duration of 4.8 months. Race, socioeconomic class, tumor stage and grade, mode of primary treatment, time from primary diagnosis to disease recurrence, initial performance status, and use of platinum-based therapy were not significant predictors of response. Age at time of chemotherapy (P=.001) and site of recurrence (P=.044) were significant determinants by multivariate analysis. Patients who were older were more likely to respond to therapy, and the response rate for patients in whom disease recurred outside the irradiated field was 25.2%, compared with a 5.3% response rate for patients with recurrent disease limited to a previously irradiated field.
  
  
  CONCLUSIONS
  The site of disease recurrence and patient age should be taken into account when designing chemotherapy trials and also when considering chemotherapy in the patient with recurrent cervix cancer.
authors.affiliation: Department of Gynecologic Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, USA. kbrader@hsc.usc.edu
authors.forename: K R
authors.initials: KR
authors.lastname: Brader
authors.forename: M
authors.initials: M
authors.lastname: Morris
authors.forename: C
authors.initials: C
authors.lastname: Levenback
authors.forename: L
authors.initials: L
authors.lastname: Levy
authors.forename: K R
authors.initials: KR
authors.lastname: Lucas
authors.forename: D M
authors.initials: DM
authors.lastname: Gershenson
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local; D012107:Research Design; D012189:Retrospective Studies; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*