title: Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan.
abstract: BACKGROUND
  Uterine leiomyosarcoma (LMS) and undifferentiated endometrial sarcoma (UES) are rare, aggressive malignancies. Both are treated similarly; however, few chemotherapy agents are effective. Recently, the combination of gemcitabine (900 mg/m(2), days 1 and 8) plus docetaxel (100 mg/m(2), day 8) with granulocyte colony-stimulating factor (G-CSF, 150 μg/m(2), days 9-15) has been shown to have activity in LMS. In Japan, neither prophylactic G-CSF at a dose of 150 μg/m(2) nor docetaxel at a dose of 100 mg/m(2) are approved for use. For this reason, we evaluated the combination of 900 mg/m(2) gemcitabine plus 70 mg/m(2) docetaxel regimen without prophylactic G-CSF support in advanced or recurrent LMS and UES in Japanese patients.
  
  
  METHODS
  Eligible women with advanced or recurrent LMS and UES were treated with 900 mg/m(2) gemcitabine on days 1 and 8, plus 70 mg/m(2) docetaxel on day 8, every 3 weeks. The primary endpoint was overall response rate, defined as a complete or partial response.
  
  
  RESULTS
  Of the eleven women enrolled, 10 were evaluated for a response. One complete response and 2 partial responses were observed (30 %) with an additional 4 (40 %) having stable disease. Mean progression-free survival was 5.4 months (range 1.3-24.8 months), and overall survival was 14 months (range 5.3-38.4 months). Grade 4 neutropenia was the major toxicity (50 %). The median number of cycles was 5 (range 2-18). Twenty-two cycles (44 %) employed G-CSF.
  
  
  CONCLUSIONS
  The gemcitabine plus docetaxel regimen without prophylactic G-CSF support was tolerable and highly efficacious in Japanese patients with advanced or recurrent LMS and UES.
authors.affiliation: Clinical Research, Innovation, and Education Center, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan, ttakano@med.tohoku.ac.jp.
authors.forename: Tadao
authors.initials: T
authors.lastname: Takano
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Niikura
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ito
authors.forename: Satoru
authors.initials: S
authors.lastname: Nagase
authors.forename: Hiroki
authors.initials: H
authors.lastname: Utsunomiya
authors.forename: Takeo
authors.initials: T
authors.lastname: Otsuki
authors.forename: Masafumi
authors.initials: M
authors.lastname: Toyoshima
authors.forename: Hideki
authors.initials: H
authors.lastname: Tokunaga
authors.forename: Michiko
authors.initials: M
authors.lastname: Kaiho-Sakuma
authors.forename: Naomi
authors.initials: N
authors.lastname: Shiga
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Nagai
authors.forename: Sota
authors.initials: S
authors.lastname: Tanaka
authors.forename: Ai
authors.initials: A
authors.lastname: Otsuki
authors.forename: Hiroki
authors.initials: H
authors.lastname: Kurosawa
authors.forename: Shogo
authors.initials: S
authors.lastname: Shigeta
authors.forename: Keita
authors.initials: K
authors.lastname: Tsuji
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Nobuo
authors.initials: N
authors.lastname: Yaegashi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D000077143:Docetaxel; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000235:genetics; D006801:Humans; D007564:Japan; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008875:Middle Aged; D018203:Sarcoma, Endometrial Stromal / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D000093542:Gemcitabine