title: A phase II trial to assess the activity of gemcitabine and docetaxel as first line chemotherapy treatment in patients with unresectable leiomyosarcoma.
abstract: BACKGROUND
  Gemcitabine and docetaxel have been shown to be active in pre-treated relapsed leiomyosarcoma. This study investigated the combination as first line treatment in patients with unresectable locally advanced/metastatic leiomyosarcoma.
  
  
  METHODS
  Patients received gemcitabine 900 mg/m(2) days 1 and 8, and docetaxel 100 mg/m(2) day 8, administered 3-weekly for up to 8 cycles, with GCSF support on days 9-15. Patients who had received previous radiotherapy were treated at 75% dose. Patients were evaluated for response by RECIST 1.0 after cycles 2, 4, 6 and 8, and 3-monthly after completing treatment.
  
  
  RESULTS
  Forty-four patients were evaluable for response. Eligible patients had histologically proven leiomyosarcoma of the uterus (54.5%) or other sites (45.5%). Thirty-nine patients (84.4%) had metastatic disease, and 5 (15.6%) had locally advanced disease. Six patients (13.6%) had grade 1 disease, and 23 (75%) had grade 2/3 disease. All patients had demonstrated disease progression prior to trial entry. Responses were as follows: partial response 11 (25.0%), stable disease (confirmed) 16 (36.6%), stable disease (unconfirmed) 7 (15.9%), progressive disease 10 (22.7%). Median progression-free survival and overall survival were 7.1 months (95% CI 5.7-8.3) and 17.9 months (95% CI 10.6-25.2), respectively. Progression free rates at 3 and 6 months were 70.5% (95% CI 56.7-84.2%) and 59.1% (95% CI 44.3-73.9%).
  
  
  CONCLUSIONS
  This study demonstrates gemcitabine and docetaxel to be active in locally advanced/metastatic leiomyosarcoma in the first line setting. Further investigation comparing with current standard therapies for leiomyosarcoma is warranted.
authors.affiliation: Sarcoma Unit, University College Hospital, 1st Floor Central, 250 Euston Road, London, NW1 2PG UK.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Seddon
authors.affiliation: Sarcoma Unit, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Scurr
authors.affiliation: Sarcoma Unit, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ UK.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Jones
authors.affiliation: Sarcoma Unit, University College Hospital, 1st Floor Central, 250 Euston Road, London, NW1 2PG UK.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Wood
authors.affiliation: Sarcoma Unit, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ UK.
authors.forename: Cerys
authors.initials: C
authors.lastname: Propert-Lewis
authors.affiliation: Sarcoma Unit, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ UK.
authors.forename: Cyril
authors.initials: C
authors.lastname: Fisher
authors.affiliation: Department of Histopathology, Royal National Orthopaedic Hospital, Brockley Hill, Stanmore, Middlesex HA7 4LP UK.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Flanagan
authors.affiliation: Sarcoma Unit, University College Hospital, 1st Floor Central, 250 Euston Road, London, NW1 2PG UK.
authors.forename: Jonanthan
authors.initials: J
authors.lastname: Sunkersing
authors.affiliation: ICR Clinical Trials and Statistics Unit, Institute of Cancer Research, 15 Cotswold Road, Sutton, SM2 5NG UK.
authors.forename: Roger
authors.initials: R
authors.lastname: A'Hern
authors.affiliation: Sarcoma Unit, University College Hospital, 1st Floor Central, 250 Euston Road, London, NW1 2PG UK.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Whelan
authors.affiliation: Sarcoma Unit, Royal Marsden Hospital, Fulham Road, London, SW3 6JJ UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Judson
keywords: Docetaxel; Gemcitabine; Leiomyosarcoma