title: Phase II trial of hyperfractionated intensity-modulated radiation therapy and concurrent weekly cisplatin for Stage III and IVa head-and-neck cancer.
abstract: OBJECTIVE
  To investigate a novel chemoradiation regimen designed to maximize locoregional control (LRC) and minimize toxicity for patients with advanced head-and-neck squamous cell carcinoma (HNSCC).
  
  
  METHODS
  Patients received hyperfractionated intensity modulated radiation therapy (HIMRT) in 1.25-Gy fractions b.i.d. to 70 Gy to high-risk planning target volume (PTV). Intermediate and low-risk PTVs received 60 Gy and 50 Gy, at 1.07, and 0.89 Gy per fraction, respectively. Concurrent cisplatin 33 mg/m(2)/week was started Week 1. Patients completed the Quality of Life Radiation Therapy Instrument pretreatment (PRE), at end of treatment (EOT), and at 1, 3, 6, 9, and 12 months. Overall survival (OS), progression-free (PFS), LRC, and toxicities were assessed.
  
  
  RESULTS
  Of 39 patients, 30 (77%) were alive without disease at median follow-up of 37.5 months. Actuarial 3-year OS, PFS, and LRC were 80%, 82%, and 87%, respectively. No failures occurred in the electively irradiated neck and there were no isolated neck failures. Head and neck QOL was significantly worse in 18 of 35 patients (51%): mean 7.8 PRE vs. 3.9 EOT. By month 1, H&N QOL returned near baseline (mean 6.2, SD = 1.7). The most common acute Grade 3+ toxicities were mucositis (38%), fatigue (28%), dysphagia (28%), and leukopenia (26%).
  
  
  CONCLUSIONS
  Hyperfractionated IMRT with low-dose weekly cisplatin resulted in good LRC with acceptable toxicity and QOL. Lack of elective nodal failures despite very low dose per fraction has led to an attempt to further minimize toxicity by reducing elective nodal doses in our subsequent protocol.
authors.affiliation: Department of Radiation Oncology, New Hanover Regional Medical Center, Wilmington, NC 28401, USA. pmaguire@nhroc.com
authors.forename: Patrick D
authors.initials: PD
authors.lastname: Maguire
authors.forename: Michael
authors.initials: M
authors.lastname: Papagikos
authors.forename: Sue
authors.initials: S
authors.lastname: Hamann
authors.forename: Charles
authors.initials: C
authors.lastname: Neal
authors.forename: Martin
authors.initials: M
authors.lastname: Meyerson
authors.forename: Neil
authors.initials: N
authors.lastname: Hayes
authors.forename: Peter
authors.initials: P
authors.lastname: Ungaro
authors.forename: Kenneth
authors.initials: K
authors.lastname: Kotz
authors.forename: Marion
authors.initials: M
authors.lastname: Couch
authors.forename: Hoke
authors.initials: H
authors.lastname: Pollock
authors.forename: Joel
authors.initials: J
authors.lastname: Tepper
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D047368:Tumor Burden
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin