title: Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study.
abstract: OBJECTIVE
  Doxorubicin-based treatment is standard therapy for metastatic uterine leiomyosarcoma. There is no standard second-line therapy. We determined activity of fixed-dose rate gemcitabine plus docetaxel as second-line treatment for metastatic uterine leiomyosarcoma.
  
  
  METHODS
  Eligible women with unresectable uterine leiomyosarcoma progressing after prior cytotoxic therapy were treated with gemcitabine 900 mg/m(2) days one and eight over 90 min, plus docetaxel 100 mg/m(2) on day 8 of a 21-day cycle with granulocyte growth factor. Patients with prior pelvic radiation received lower doses. Response Evaluation Criteria in Solid Tumors (RECIST) response was assessed by computed tomography (CT).
  
  
  RESULTS
  Forty-eight of 51 women were evaluable for response (one wrong histology, two never treated). Prior therapy was doxorubicin-based in 90%, and ifosfamide-based in 6%. The overall objective response rate is 27%, with complete response in 6.3% (3/48), and partial response in 20.8% (10/48). An additional 50% (24/48) had stable disease (median duration 5.4 months). The median number of cycles per patient was 5.5 (range 1-22); 73% of patients remained progression-free at 12 weeks and 52% at 24 weeks. The predominant toxicity was uncomplicated myelosuppression: thrombocytopenia grade 3 (29%), grade 4 (10.4%); neutropenia grade 3 (12.5%), grade 4 (8.3%) anemia grade 3 (20.8%), grade 4 (4.2%). While pulmonary toxicity was reported, no patient had drug-related pneumonitis/hypoxia-type toxicity. Median progression-free survival (PFS) was 5.6+ months (range 0.7-27+ months). The median duration of objective response was 9+ months (range 3.9-24.5+ months).
  
  
  CONCLUSIONS
  Fixed-dose rate gemcitabine plus docetaxel is active second-line therapy for uterine leiomyosarcoma.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, Department of Medical Oncology, 1275 York Avenue, New York, NY 10021, USA. hensleym@mskcc.org
authors.forename: Martee L
authors.initials: ML
authors.lastname: Hensley
authors.forename: John A
authors.initials: JA
authors.lastname: Blessing
authors.forename: Koen
authors.initials: K
authors.lastname: Degeest
authors.forename: Ovadia
authors.initials: O
authors.lastname: Abulafia
authors.forename: Peter G
authors.initials: PG
authors.lastname: Rose
authors.forename: Howard D
authors.initials: HD
authors.lastname: Homesley
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014594:Uterine Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine