title: Paclitaxel-carboplatin for advanced or recurrent carcinosarcoma of the uterus: the Japan Uterine Sarcoma Group and Tohoku Gynecologic Cancer Unit Study.
abstract: BACKGROUND
  Paclitaxel and carboplatin (PC) have shown antitumor activity in carcinosarcoma of the uterus (CS). The purpose of this prospective multi-institutional study was to determine the response rate (RR), progression-free survival (PFS) and overall survival (OS) and to assess the toxicity of paclitaxel and carboplatin in patients with CS.
  
  
  METHODS
  We conducted a phase II study in which patients were administered paclitaxel 175 mg/m(2) over a 3-h period followed by carboplatin (area under the serum concentration-time curve = 6) intravenously over a 30-min period on day 1 of each treatment cycle (3 weeks) until disease progression or adverse effects prohibited further therapy. Eligible patients had histologically confirmed, advanced stage (III or IV), persistent or recurrent measurable disease, and no prior chemotherapy.
  
  
  RESULTS
  Six patients were enrolled between February 2006 and April 2009. The median age of the patients was 61 (range 48-77) years; one patient was stage IIIC (17 %) and five were stage IVB (83 %). Three patients (50 %) (1 at stage IIIC and 2 at stage IVB) received total abdominal hysterectomy plus bilateral salpingo-oophorectomy as part of the initial treatment; five (83 %) had homologous tumors and one (17 %) had a heterologous tumor. The median cycle number administered was 4.8 (range 2-7). The RR was 66.7 % (complete response, 2; partial response, 2); the PFS was 9.1 months and OS was not reached. The frequently observed Grade 4 toxicities were neutropenia (3 patients, 50 %). Manageable neutropenic sepsis developed in one patient.
  
  
  CONCLUSIONS
  This is the first prospective multi-institutional study in Asia showing that PC may be effective and tolerable for the treatment of advanced or recurrent CS.
authors.affiliation: Clinical Research, Innovation, and Education Center, Tohoku University Hospital (CRIETO), 1-1 Seiryo-machi, Aoba Ward, Sendai, Miyagi, 980-8574, Japan, ttakano@med.tohoku.ac.jp.
authors.forename: Tadao
authors.initials: T
authors.lastname: Takano
authors.forename: Takeo
authors.initials: T
authors.lastname: Otsuki
authors.forename: Hideki
authors.initials: H
authors.lastname: Tokunaga
authors.forename: Masafumi
authors.initials: M
authors.lastname: Toyoshima
authors.forename: Hiroki
authors.initials: H
authors.lastname: Utsunomiya
authors.forename: Satoru
authors.initials: S
authors.lastname: Nagase
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Niikura
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ito
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
authors.forename: Hidekazu
authors.initials: H
authors.lastname: Yamada
authors.forename: Toru
authors.initials: T
authors.lastname: Tase
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kagabu
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Shoji
authors.forename: Toru
authors.initials: T
authors.lastname: Sugiyama
authors.forename: Naoki
authors.initials: N
authors.lastname: Sato
authors.forename: Toshio
authors.initials: T
authors.lastname: Fujimoto
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Terada
authors.forename: Kenji
authors.initials: K
authors.lastname: Nakahara
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Kurachi
authors.forename: Yoshihito
authors.initials: Y
authors.lastname: Yokoyama
authors.forename: Hideki
authors.initials: H
authors.lastname: Mizunuma
authors.forename: Shu
authors.initials: S
authors.lastname: Soeda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishiyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Shinya
authors.initials: S
authors.lastname: Sato
authors.forename: Muneaki
authors.initials: M
authors.lastname: Shimada
authors.forename: Junzo
authors.initials: J
authors.lastname: Kigawa
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002296:Carcinosarcoma / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007564:Japan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging / Q000379:methods; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014599:Uterus / Q000187:drug effects / Q000473:pathology
chemical_list: D016190:Carboplatin; D017239:Paclitaxel