title: Phase II trial of paclitaxel and nedaplatin in patients with advanced/recurrent uterine cervical cancer: a Kansai Clinical Oncology Group study.
abstract: OBJECTIVE
  A multicenter phase II trial was conducted to evaluate the activity and toxicity of paclitaxel and nedaplatin (cis-diammineglycolatoplatonum) in patients with advanced/recurrent uterine cervical cancer.
  
  
  METHODS
  Patients were required to have measurable disease. Histologic confirmation of the primary diagnosis as uterine cervical cancer was mandatory. The treatment consisted of paclitaxel 175 mg/m(2) over 3 hours and nedaplatin 80 mg/m(2) intravenously over 1 hour on day 1 every 28 days until progressive disease or adverse effects prohibited further therapy.
  
  
  RESULTS
  Fifty patients were enrolled into the study protocol from October 2007 to February 2010. 45 patients(90%) were eligible for assessment of response (RECIST version 1.0) to treatment; 31 patients (62%) received prior radiotherapy and 23 patients (46%) received prior chemotherapy. The overall response rate was 44.4% (11 complete responses and 8 partial responses) with 22.2% of patients having stable disease. Grades 3 or 4 adverse events (NCI-CTCAE ver 3) included neutropenia (n=16, 32.7%), febrile neutropenia (n=1, 2.0%), anemia (n=9, 18.4%), but there was no significant thrombocytopenia. Non-hematologic toxicity was generally not serious and without a dominant pattern. The median progression-free survival was 7.5 months (95% C.I., 5.7, 9.4) and overall survival was 15.7 months (95% C.I., 9.4, 21.9).
  
  
  CONCLUSIONS
  Paclitaxel 175 mg/m(2) and nedaplatin 80 mg/m(2) intravenously on day 1 every 28 days in patients with advanced/recurrence uterine cervical cancer demonstrated easy administration, favorable antitumor activity, and the toxicity profile of this regimen would be decreased compared with cisplatin-containing combinations. Evaluation of this regimen in phase III trials is warranted.
authors.affiliation: Division of gynecology, Shizuoka Cancer Center Hospital, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan. m.takekuma@scchr.jp
authors.forename: Munetaka
authors.initials: M
authors.lastname: Takekuma
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Hirashima
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Ito
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsubamoto
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tabata
authors.forename: Atsushi
authors.initials: A
authors.lastname: Arakawa
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Itani
authors.forename: Naoto
authors.initials: N
authors.lastname: Furukawa
authors.forename: Homare
authors.initials: H
authors.lastname: Murakoshi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takeuchi
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D009944:Organoplatinum Compounds; C053989:nedaplatin; D017239:Paclitaxel