title: A Phase II evaluation of weekly topotecan as a single agent second line therapy in persistent or recurrent carcinoma of the cervix: a Gynecologic Oncology Group study.
abstract: OBJECTIVE
  To estimate antitumor activity and toxicity of weekly topotecan hydrochloride in patients with persistent or recurrent cervical carcinoma who failed prior treatment.
  
  
  METHODS
  Women entered on study had or failed one prior chemotherapy regimen in addition to radiosensitizing chemotherapy, performance status less than 3, and adequate hematologic, renal, hepatic, and neurological function. Topotecan was infused at 3.0 mg/m(2) on days 1, 8, and 15 every 28 days.
  
  
  RESULTS
  Twenty-seven patients were enrolled onto this study with 25 evaluable. Twenty-two patients had received radiation and chemotherapy prior to study. A median of two and mean of three courses of chemotherapy was given (range, one to eight courses). The most frequently severe adverse events were grade 3 anemia (28%) and grade 4 (4%) along with grade 3 neutropenia (8%) and grade 4 (8%). Two patients had grade 4 thrombocytopenia. There were no complete or partial responders. Ten patients (40%) had stable disease, twelve (48%) had increasing disease, and response could not be assessed in three (12%). The median progression-free survival was 2.4 months for the patients with increasing disease and 6.2 months (3.5-8.8 months) for those with stable disease. Disease location was equally divided within and outside the irradiated field. The 12 patients with increasing disease were more likely to have disease outside the pelvic radiation field.
  
  
  CONCLUSIONS
  There were no complete or partial responders to weekly topotecan among the 25 patients in this study.
authors.affiliation: Sarasota Memorial Hospital, 1888 Hillview Street, Sarasota, FL 34239, USA. james-fiorica@SMH.com
authors.forename: James V
authors.initials: JV
authors.lastname: Fiorica
authors.forename: John A
authors.initials: JA
authors.lastname: Blessing
authors.forename: Louis V
authors.initials: LV
authors.lastname: Puneky
authors.forename: Angeles Alvarez
authors.initials: AA
authors.lastname: Secord
authors.forename: James S
authors.initials: JS
authors.lastname: Hoffman
authors.forename: S Diane
authors.initials: SD
authors.lastname: Yamada
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Buekers
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Bell
authors.forename: Jeanne M
authors.initials: JM
authors.lastname: Schilder
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D019772:Topotecan