title: A pilot feasibility study for cisplatin plus S-1 for the treatment for advanced or recurrent cervical cancer.
abstract: OBJECTIVE
  To evaluate the feasibility of a cisplatin and S-1 combination regimen for the treatment for metastatic and recurrent cervical cancers, we performed this study prior to a randomized phase III trial to evaluate the clinical benefits of a cisplatin and S-1 combination regimen compared with cisplatin alone.
  
  
  METHODS
  Cisplatin (50 mg/m(2), intravenously on day 1) and S-1 (80-120 mg/m(2), orally twice a day between days 1 and 14) were administered every 21 days for 6 cycles in patients with advanced or recurrent uterine cervical cancer.
  
  
  RESULTS
  A total of 10 patients were enrolled in this trial. A total of 46 treatment cycles (median 6; range 1-6) were administered. All grade 3 or 4 hematologic toxicities were recorded in the 6 patients: 2 patients experienced anemia, 5 experienced neutropenia, 1 experienced thrombocytopenia, and 2 experienced febrile neutropenia. All grade 3 non-hematologic toxicities were recorded in the 6 patients, and no grade 4 non-hematologic toxicities occurred; the most frequent toxicities were hyponatremia in 3 patients, diarrhea in 2 patients, and infection in 2 patients. The patients with grade 3 diarrhea had received prior radiotherapy. All the patients recovered from the toxicities after receiving appropriate supportive care, and no treatment-related deaths occurred. Five patients (50 %) achieved a partial response, and 1 patient (10 %) had a stable disease.
  
  
  CONCLUSIONS
  A cisplatin and S-1 combination regimen was feasible for patients with recurrent cervical cancer. Since patients who receive prior radiotherapy may experience severe diarrhea, these patients may require an S-1 dose reduction.
authors.affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. myunokaw@ncc.go.jp
authors.forename: Mayu
authors.initials: M
authors.lastname: Yunokawa
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Katsumata
authors.forename: Harukaze
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Makoto
authors.initials: M
authors.lastname: Kodaira
authors.forename: Kan
authors.initials: K
authors.lastname: Yonemori
authors.forename: Chikako
authors.initials: C
authors.lastname: Shimizu
authors.forename: Masashi
authors.initials: M
authors.lastname: Ando
authors.forename: Kenji
authors.initials: K
authors.lastname: Tamura
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage; D010865:Pilot Projects; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin