title: Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329.
abstract: BACKGROUND
  A phase I study and an institutional pilot study in patients with metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) utilizing biweekly gemcitabine and paclitaxel (GEMTAX), showed an overall response rate of 53%. 1 This phase II trial was conducted to determine the feasibility, tolerability, and efficacy of this combination.
  
  
  METHODS
  Patients with metastatic/recurrent SCCHN were treated with gemcitabine (3000 mg/m2) and paclitaxel (150 mg/m2) on days 1 and 15 of every 28-day cycle.
  
  
  RESULTS
  In 57 patients with measurable disease, median progression-free survival (PFS) was 4 months and median overall survival (OS) was 8 months. Overall response rate of 28% and disease stabilization in 19% were seen. There were no treatment-related deaths with grade 3/4 hematologic toxicity seen in 20% of the patients.
  
  
  CONCLUSIONS
  Biweekly GEMTAX is feasible, well tolerated, and demonstrated reasonable efficacy. This may be an alternative for patients who are not candidates for platinum-based chemotherapy.
authors.affiliation: Department of Hematology Oncology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Binu
authors.initials: B
authors.lastname: Malhotra
authors.forename: James
authors.initials: J
authors.lastname: Moon
authors.forename: Omar
authors.initials: O
authors.lastname: Kucuk
authors.forename: Joseph I
authors.initials: JI
authors.lastname: Clark
authors.forename: Susan G
authors.initials: SG
authors.lastname: Urba
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Wolf
authors.forename: Francis P
authors.initials: FP
authors.lastname: Worden
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage*; D000077195:Squamous Cell Carcinoma of Head and Neck; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine
keywords: gemcitabine; metastatic; paclitaxel; recurrent; squamous cell carcinoma of the head and neck