title: Phase II trial of gemcitabine as first line chemotherapy in patients with metastatic or unresectable soft tissue sarcoma.
abstract: OBJECTIVE
  The availability of effective chemotherapy agents or regimens for soft tissue sarcomas (STS) is limited. Response to available first line regimens is generally poor and response to second line regimens is rare. Considering the poor response of STS to available cytotoxic therapy, and the need to adequately evaluate the effectiveness of new agents, first line investigation of promising new agents is justified. Gemcitabine, a relatively new agent, has demonstrated effectiveness in several solid tumors. Limited clinical trials have suggested modest activity in STS. A multi-institutional study of gemcitabine in patients with STS, without prior chemotherapy for metastatic disease, was initiated in the Southwest Oncology Group May 1, 1998 and completed March 15, 1999.
  
  
  METHODS
  Patients were required to have metastatic or unresectable STS with no prior chemotherapy for metastatic disease. Gastrointestinal leiomyosarcomas and stromal tumors were not eligible. Patients were required to have a performance status of 0-2, measurable disease, adequate renal, hepatic, and hematologic function. The patients were given Gemcitabine 1000 mg/M2 iv over 30 minutes on days 1, 8, and 15, 22, 29, 36, 43, 57, 64, and 71. Dosage reduction was performed for cytopenias and/or other grade 3 or 4 toxicity.
  
  
  RESULTS
  Forty-eight patients were registered to the study. The median age was 62 years (range, 30-80) with 21 male and 25 female patients. Two patients were ineligible (1 GI stromal tumor and 1 nerve sheath tumor). Forty-six patients are evaluable for response, toxicity, and survival. There were 2 treatment-related deaths (1 renal failure and 1 hemolytic uremic syndrome). Six additional patients experienced grade 4 toxicity (3 neutropenia, 2 dyspnea, 1 vomiting, and 1 renal failure). Three of the 46 eligible patients had a partial response (7%: 95% confidence interval 1-18%) and 8 patients had stable disease (20%). Nine patients had inadequate assessments to define response. Forty-five patients have died with a median survival of 6 months (95% confidence interval 5-10 months).
  
  
  CONCLUSIONS
  Gemcitabine has minimal activity as a single agent at this dose and schedule in advanced STS. The low response rate does not justify further investigation of gemcitabine as a single agent in STS.
authors.affiliation: Feist Weiller Cancer Center, Louisiana State University Health Science Center-Shreveport, Shreveport, LA 71130, USA. gburto@isuhsc.edu
authors.forename: Gary
authors.initials: G
authors.lastname: Von Burton
authors.forename: Cathy
authors.initials: C
authors.lastname: Rankin
authors.forename: Mark M
authors.initials: MM
authors.lastname: Zalupski
authors.forename: Glen M
authors.initials: GM
authors.lastname: Mills
authors.forename: Ernest C
authors.initials: EC
authors.lastname: Borden
authors.forename: Antman
authors.initials: A
authors.lastname: Karen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine