title: A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas: a study of the Mayo phase 2 consortium (P2C).
abstract: BACKGROUND
  The primary goal of this trial was to evaluate the confirmed response rate of temsirolimus (CCI-779), a mammalian target of rapamycin in patients with advanced soft tissue sarcomas (STS).
  
  
  METHODS
  Patients ≥18 years with measurable advanced STS, no prior chemotherapy for metastatic disease (adjuvant and neoadjuvant chemotherapy allowed), adequate organ function, and performance status of ≤2 were eligible. After premedication with an antihistamine, CCI-779 was given intravenously at 25 mg over 30 minutes on Days 1, 8, 15, and 22, repeated every 4 weeks. The primary endpoint was confirmed response rate per Response Evaluation Criteria in Solid Tumors.
  
  
  RESULTS
  Between June 2004 and November 2005, a total of 41 patients were enrolled and began treatment; 40 patients are evaluable for response and adverse events. The median age was 62 years (range, 28-72 years) with 56% women. Eighty percent had high-grade STS, and 22% had prior adjuvant chemotherapy. There were 2 patients (5%; 95% confidence interval [CI], 1-17) (undifferentiated fibrosarcoma and uterine leiomyosarcoma) who achieved a confirmed partial response lasting 3 and 17 months, respectively. Thirty-nine (95%) patients have progressed, with a median time to progression of 2.0 months (95% CI, 1.8-3.5). The median overall survival was 7.6 months (95% CI, 6.1-15.9). Forty-three percent experienced grade 3+ adverse events that were possibly related to therapy.
  
  
  CONCLUSIONS
  Temsirolimus in this patient population of STS had limited clinical activity and had moderate toxicities.
authors.affiliation: Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. Okuno.scott@mayo.edu
authors.forename: Scott
authors.initials: S
authors.lastname: Okuno
authors.forename: Howard
authors.initials: H
authors.lastname: Bailey
authors.forename: Michelle R
authors.initials: MR
authors.lastname: Mahoney
authors.forename: Douglas
authors.initials: D
authors.lastname: Adkins
authors.forename: William
authors.initials: W
authors.lastname: Maples
authors.forename: Tom
authors.initials: T
authors.lastname: Fitch
authors.forename: David
authors.initials: D
authors.lastname: Ettinger
authors.forename: Charles
authors.initials: C
authors.lastname: Erlichman
authors.forename: Jann N
authors.initials: JN
authors.lastname: Sarkaria
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy*; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; C401859:temsirolimus; D020123:Sirolimus