title: Long-term outcomes and toxicity of concurrent paclitaxel and radiotherapy for locally advanced head-and-neck cancer.
abstract: OBJECTIVE
  To report the long-term outcomes and toxicity of a regimen of infusion paclitaxel delivered concurrently with radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck.
  
  
  METHODS
  Between 1995 and 1999, 35 patients with nonmetastatic, Stage III or IV squamous cell carcinoma of the head and neck were treated with three cycles of paclitaxel as a 120-h continuous infusion beginning on Days 1, 21, and 42, concurrent with radiotherapy. The initial 16 patients received 105 mg/m(2)/cycle, and the subsequent 19 patients received 120 mg/m(2)/cycle. External beam radiotherapy was delivered to a dose of 70.2-72 Gy at five fractions weekly. Patients were followed to evaluate the disease outcomes and late toxicity of this regimen.
  
  
  RESULTS
  The median follow-up for all patients was 56.5 months. The median survival was 56.5 months, and the median time to local recurrence was not reached. Of the 35 patients, 15 (43%) developed hypothyroidism. Of the 33 patients who underwent percutaneous endoscopic gastrostomy tube placement, 11 were percutaneous endoscopic gastrostomy tube dependent until death or their last follow-up visit. Also, 5 patients (14%) required a tracheostomy until death, and 3 (9%) developed a severe esophageal stricture. All evaluated long-term survivors exhibited salivary hypofunction. Fibrosis in the radiation field occurred in 24 patients (69%).
  
  
  CONCLUSIONS
  The results of our study have shown that concurrent chemoradiotherapy with a 120-h infusion of paclitaxel provides long-term local control and survival in patients with squamous cell carcinoma of the head and neck. Xerostomia, hypothyroidism, esophageal and pharyngeal complications, and subcutaneous fibrosis were common long-term toxicities; however, the vast majority of toxicities were grade 1 or 2.
authors.affiliation: Radiation Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. citrind@mail.nih.gov
authors.forename: Deborah
authors.initials: D
authors.lastname: Citrin
authors.forename: John
authors.initials: J
authors.lastname: Mansueti
authors.forename: Anna
authors.initials: A
authors.lastname: Likhacheva
authors.forename: Linda
authors.initials: L
authors.lastname: Sciuto
authors.forename: Paul S
authors.initials: PS
authors.lastname: Albert
authors.forename: Susan F
authors.initials: SF
authors.lastname: Rudy
authors.forename: Theresa
authors.initials: T
authors.lastname: Cooley-Zgela
authors.forename: Ana
authors.initials: A
authors.lastname: Cotrim
authors.forename: Beth
authors.initials: B
authors.lastname: Solomon
authors.forename: A Dimitrios
authors.initials: AD
authors.lastname: Colevas
authors.forename: Angelo
authors.initials: A
authors.lastname: Russo
authors.forename: John C
authors.initials: JC
authors.lastname: Morris
authors.forename: Laurie
authors.initials: L
authors.lastname: Herscher
authors.forename: Sharon
authors.initials: S
authors.lastname: Smith
authors.forename: Carter
authors.initials: C
authors.lastname: Van Waes
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy / Q000379:methods; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005355:Fibrosis; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011832:Radiation Injuries / Q000473:pathology; D011879:Radiotherapy Dosage; D012867:Skin / Q000528:radiation effects; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel