title: Phase II study of S-1, an oral fluoropyrimidine, in patients with advanced or recurrent cervical cancer.
abstract: BACKGROUND
  S-1 is an oral fluoropyrimidine. This phase II study was designed to evaluate the efficacy and safety of S-1 in patients with advanced or recurrent uterine cervical cancer.
  
  
  METHODS
  S-1 35 mg/m(2) was given twice daily for 28 days repeated every 6 weeks. Eligible patients were women aged 20-74 years, who had Eastern Cooperative Oncology Group performance status of zero or one, who had stage IVB or recurrent uterine cervical cancer, and who had received no more than one platinum-containing chemotherapy regimen for stage IVB or recurrent disease. The primary end point was overall response rate (ORR) determined by RECIST.
  
  
  RESULTS
  A total of 37 patients were enrolled in the trial and 36 were eligible. The median number of cycles administered was 4. The confirmed ORR was 30.6% (95% confidence interval 15.5% to 45.6%). The response rate for patients who had received platinum-based treatment including chemoradiotherapy was 31.8% (7 of 22). After a median follow-up duration of 25 months, the median time to progression and the median survival time were 5.2 and 15.4 months, respectively. The most frequent grade 3 or 4 adverse events were anemia (16%), anorexia (16%), and diarrhea (22%).
  
  
  CONCLUSIONS
  This phase II study of S-1 in cervical cancer suggests a promising response rate and a contribution toward prolonging survival, with modest toxic effects. Phase III studies of S-1 in patients with advanced or recurrent cervical cancer are thus warranted.
authors.affiliation: Department of Medical Oncology, National Cancer Center Hospital, Tokyo. Electronic address: nkatsuma@ncc.go.jp.
authors.forename: N
authors.initials: N
authors.lastname: Katsumata
authors.affiliation: Department of Gynecology, Cancer Institute Hospital Ariake, Tokyo.
authors.forename: Y
authors.initials: Y
authors.lastname: Hirai
authors.affiliation: Department of Gynecology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.
authors.forename: S
authors.initials: S
authors.lastname: Kamiura
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University, Iwate.
authors.forename: T
authors.initials: T
authors.lastname: Sugiyama
authors.affiliation: Department of Obstetrics and Gynecology, Wakayama Medical University Hospital, Wakayama.
authors.forename: K
authors.initials: K
authors.lastname: Kokawa
authors.affiliation: Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima.
authors.forename: M
authors.initials: M
authors.lastname: Hatae
authors.affiliation: Department of Gynecology, Hyogo Cancer Center, Hyogo.
authors.forename: R
authors.initials: R
authors.lastname: Nishimura
authors.affiliation: Department of Obstetrics and Gynecology, The Jikei University, School of Medicine, Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ochiai
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid