title: Docetaxel and irinotecan in recurrent or metastatic head and neck cancer: a phase 2 trial of the Eastern Cooperative Oncology Group.
abstract: BACKGROUND
  Docetaxel and irinotecan have single-agent antitumor activity in squamous cell carcinoma of the head and neck (SCCHN). The authors sought to evaluate their combination in the treatment of patients with recurrent or metastatic SCCHN.
  
  
  METHODS
  Eligibility criteria included recurrent or metastatic SCCHN with measurable disease, good performance status, and adequate laboratory parameters. Patients received docetaxel 35 mg/m(2) and irinotecan 60 mg/m(2), intravenously, on Days 1 and 8, every 21 days, until disease progression. The authors assessed UGT1A1 genotype, vascular endothelial growth factor (VEGF) in serum, and cyclooxygenase-2 and VEGF in baseline tumor tissue.
  
  
  RESULTS
  Fifty-two patients were analyzable: 20 chemotherapy naive (Group A) and 32 previously treated with 1 chemotherapy regimen (Group B); 73% of patients had distant metastasis, and 60% were paclitaxel-exposed. In Group A, 3 (15%) patients achieved a partial response; in Group B, 1 (3%) patient achieved a partial response. Median progression-free survival (PFS) and overall survival were 3.3 and 8.2 months in Group A and 1.9 and 5.0 months in Group B, respectively. Common serious toxicities were diarrhea, fatigue, and anorexia. Patients with high serum VEGF had a median PFS of 2.8 months versus 1.7 months for patients with low VEGF (P = .085).
  
  
  CONCLUSIONS
  Docetaxel and irinotecan had acceptable toxicities, but efficacy results in unselected patients with recurrent or metastatic SCCHN did not suggest an advantage over docetaxel alone or platinum-based regimens.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. argirisae@upmc.edu
authors.forename: Athanassios
authors.initials: A
authors.lastname: Argiris
authors.forename: Ashley
authors.initials: A
authors.lastname: Buchanan
authors.forename: Bruce
authors.initials: B
authors.lastname: Brockstein
authors.forename: Jill
authors.initials: J
authors.lastname: Kolesar
authors.forename: Musie
authors.initials: M
authors.lastname: Ghebremichael
authors.forename: Michael
authors.initials: M
authors.lastname: Pins
authors.forename: Kristine
authors.initials: K
authors.lastname: Hahn
authors.forename: Rita
authors.initials: R
authors.lastname: Axelrod
authors.forename: Arlene
authors.initials: A
authors.lastname: Forastiere
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D051546:Cyclooxygenase 2 / Q000378:metabolism; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D014453:Glucuronosyltransferase / Q000235:genetics; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D043823:Taxoids / Q000008:administration & dosage*; D042461:Vascular Endothelial Growth Factor A / Q000378:metabolism; D000099148:UGT1A1 Enzyme
chemical_list: D002166:Camptothecin; D051546:Cyclooxygenase 2; D000077143:Docetaxel; D014453:Glucuronosyltransferase; D000077146:Irinotecan; D043823:Taxoids; D042461:Vascular Endothelial Growth Factor A; D000099148:UGT1A1 Enzyme; C467484:VEGFA protein, human; C496540:PTGS2 protein, human