title: A phase 2 study of platinum and gemcitabine in patients with advanced salivary gland cancer: a trial of the NCIC Clinical Trials Group.
abstract: BACKGROUND
  Salivary gland cancers are rare, histologically diverse, and varied in their biologic behavior and responsiveness to systemic therapy. To the authors' knowledge, there currently is no standard chemotherapy for these tumors, but cisplatin-based regimens are often used. This phase 2 trial evaluated the combination of gemcitabine with cisplatin (carboplatin in those with protocol-defined contraindications to cisplatin).
  
  
  METHODS
  Fit, consenting adult patients had advanced, metastatic, or locoregionally recurrent salivary gland cancer (any histologic subtype) that was not suitable for radiation or surgery. Therapy was comprised of gemcitabine at a dose of 1000 mg/m(2) administered intravenously on Days 1 and 8, and cisplatin at a dose of 70 mg/m(2) on Day 2, of a 21-day cycle. If carboplatin was substituted, it was administered on Day 1, targeted to an area under the concentration-time curve of 5 mg/mL/s. Response was assessed every 2 cycles according to Response Evaluation Criteria In Solid Tumors. Patients received up to 6 cycles. The primary endpoint was objective response. A 2-stage design was used, with a response rate of 45% required to declare the regimen active.
  
  
  RESULTS
  Thirty-three eligible patients were enrolled, of whom 30 were response evaluable. Eight objective responses were observed (1 complete and 7 partial) for a response rate of 24% (95% confidence interval, 11-42%), with responses observed in all histologic subtypes. Toxicity was within that expected for this combination.
  
  
  CONCLUSIONS
  This regimen did not meet the predefined criteria to be declared active in advanced salivary gland cancers. Enrollment of patients with these rare cancers into well-designed clinical trials remains an urgent priority.
authors.affiliation: Department of Medical Oncology, Ottawa Hospital Cancer Centre, University of Ottawa, 501 Smyth Road, Ottawa ON K1H 8L6, Canada. slaurie@ottawahospital.on.ca
authors.forename: Scott A
authors.initials: SA
authors.lastname: Laurie
authors.forename: Lillian L
authors.initials: LL
authors.lastname: Siu
authors.forename: Eric
authors.initials: E
authors.lastname: Winquist
authors.forename: Andrew
authors.initials: A
authors.lastname: Maksymiuk
authors.forename: Erica L
authors.initials: EL
authors.lastname: Harnett
authors.forename: Wendy
authors.initials: W
authors.lastname: Walsh
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Tu
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Parulekar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D013997:Time Factors; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine