title: Paclitaxel and carboplatin in patients with completely or optimally resected carcinosarcoma of the uterus: a phase II trial by the Japanese Uterine Sarcoma Group and the Tohoku Gynecologic Cancer Unit.
abstract: OBJECTIVE
  This study aimed to evaluate the efficacy of paclitaxel and carboplatin in patients with completely or optimally resected uterine carcinosarcoma.
  
  
  METHODS
  We conducted a single-arm multicenter prospective phase II trial at 20 Japanese medical facilities. Eligible patients had histologically confirmed uterine carcinosarcoma without prior chemotherapy or radiotherapy. Patients received 6 courses of 175 mg/m (2)paclitaxel over 3 hours, followed by a 30-minute intravenous administration of carboplatin at an area under the serum concentration-time curve of 6.
  
  
  RESULTS
  A total of 51 patients were enrolled in this study, 48 of whom underwent complete resection and 3 of whom underwent optimal resection. At 2 years, the progression-free survival and overall survival rates were 78.2% (95% confidence interval [CI], 64.1%-87.3%) and 87.9% (95% CI, 75.1%-94.4%), respectively. At 4 years, these rates were 67.9% (95% CI, 53.0%-79.0%) and 76.0% (95% CI, 60.5%-86.1%), respectively. Although 15 patients showed disease recurrence during the follow-up period (median, 47.8 months; range, 2.1-72.8 months), a total of 40 (78.4%) patients completed the 6 courses of treatment that had been planned.
  
  
  CONCLUSIONS
  The combination of paclitaxel and carboplatin was a feasible and effective postoperative adjuvant therapy for patients with completely or optimally resected uterine carcinosarcoma.
authors.affiliation: *Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine; †Department of Clinical Research Network, Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai; ‡Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo; §Department of Obstetrics and Gynecology, Hirosaki University Graduate School of Medicine, Hirosaki; ∥Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Nagoya; ¶Department of Obstetrics and Gynecology, Nippon Medical School Chiba Hokusoh Hospital, Chiba; #Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medicine, Nagoya; **Department of Obstetrics and Gynecology, Fukushima Medical University, Fukushima; ††Department of Obstetrics and Gynecology, Fukuoka University Hospital, Fukuoka; ‡‡Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of Ryukyus, Okinawa; §§Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago; ∥∥Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita; ¶¶Department of Obstetrics and Gynecology, Nagasaki Harbour Medical Center City Hospital, Nagasaki; ##Department of Obstetrics and Gynecology, Faculty of Life Sciences Kumamoto University, Kumamoto, Japan.
authors.forename: Ai
authors.initials: A
authors.lastname: Otsuki
authors.forename: Yoh
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nomura
authors.forename: Masayuki
authors.initials: M
authors.lastname: Futagami
authors.forename: Yoshihito
authors.initials: Y
authors.lastname: Yokoyama
authors.forename: Kiyosumi
authors.initials: K
authors.lastname: Shibata
authors.forename: Seiryu
authors.initials: S
authors.lastname: Kamoi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Arakawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishiyama
authors.forename: Takahiro
authors.initials: T
authors.lastname: Katsuta
authors.forename: Wataru
authors.initials: W
authors.lastname: Kudaka
authors.forename: Muneaki
authors.initials: M
authors.lastname: Shimada
authors.forename: Naoki
authors.initials: N
authors.lastname: Sato
authors.forename: Kouhei
authors.initials: K
authors.lastname: Kotera
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Katabuchi
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002296:Carcinosarcoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy; D008197:Lymph Node Excision; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery
chemical_list: D016190:Carboplatin; D017239:Paclitaxel