title: A Phase II multi-institutional trial of chemoradiation using weekly docetaxel and erythropoietin for high-risk postoperative head and neck cancer patients.
abstract: OBJECTIVE
  To determine efficacy and toxicities of postoperative concurrent chemoradiation using docetaxel in high-risk head and neck cancer.
  
  
  METHODS
  High-risk patients were enrolled 2-8 weeks after surgery. Treatment included 60 Gy for 6 weeks with weekly docetaxel 25 mg/m(2) and erythropoietin alpha 40,000 U for hemoglobin < or =12 g/dL. Primary endpoints included locoregional control (LC), disease-free survival (DFS), and patterns of failure (POF). Secondary endpoints were toxicity and quality of life.
  
  
  RESULTS
  Eighteen patients were enrolled (14 male, 4 female), aged 24-70 years (median, 55 years). Primary site included oropharynx = 7, oral cavity = 8, hypopharynx = 1, and larynx = 2. Pathologic American Joint Committee on Cancer Stage was III = 3 patients, IV = 15 patients. High-risk eligibility included > or =2 positive lymph nodes = 13, extracapsular extension = 10, positive margins = 8 (11 patients with two or more risk factors). Docetaxel was reduced to 20 mg/m(2)/week after 5 patients had prolonged Grade 3 or higher mucositis. Overall, number of doses delivered was 2 of 6 = 1, 3 of 6 = 2, 4 of 6 = 2, 5 of 6 = 4, 6 of 6 = 9 patients. With median follow-up of 30 months (range, 5-66), 10 (56%) patients are alive and have no evidence of disease (NED); POF: three local recurrences (two with distant) and 1 distant only. One-year survival was 76%, median PFS and DFS had not been reached. Three-year LC was 82%. No Grade 3 or higher late toxicities were observed, although a few cases of prolonged mucositis and taste loss (>3 months) were seen, particularly at 25 mg/m(2)/week.
  
  
  CONCLUSIONS
  Postoperative radiation therapy with weekly docetaxel 20 or 25 mg/m(2)/week for high-risk postoperative head and neck cancer caused intolerable mucosal toxicity, prompting early study termination. Further studies should consider 15 mg/m(2). Actuarial 3-year LC is 82%, similar to cisplatin-based chemoradiation regimens. Distant metastasis remains an important issue requiring additional systemic interventions.
authors.affiliation: Department of Radiation Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, USA.
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Willey
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Murphy
authors.forename: James L
authors.initials: JL
authors.lastname: Netterville
authors.forename: Brian B
authors.initials: BB
authors.lastname: Burkey
authors.forename: Yu
authors.initials: Y
authors.lastname: Shyr
authors.forename: Bashar
authors.initials: B
authors.lastname: Shakhtour
authors.forename: Bonnie
authors.initials: B
authors.lastname: Kish
authors.forename: David
authors.initials: D
authors.lastname: Raben
authors.forename: Changhu
authors.initials: C
authors.lastname: Chen
authors.forename: John I
authors.initials: JI
authors.lastname: Song
authors.forename: Madeleine A
authors.initials: MA
authors.lastname: Kane
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Cmelak
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003131:Combined Modality Therapy / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006258:Head and Neck Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D006441:Hemoglobin A; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000528:radiation effects; D011446:Prospective Studies; D011832:Radiation Injuries; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D043823:Taxoids; D004921:Erythropoietin; D000077143:Docetaxel; D006441:Hemoglobin A