title: Neoadjuvant accelerated chemotherapy followed by hyperfractionated radiation therapy in patients with operable, locally advanced head and neck carcinoma.
abstract: A prospective phase II trial was carried out to evaluate an accelerated chemotherapy (CT) regimen followed by hyperfractionated radiation therapy (RT) in previously untreated Stage III-IV, operable (total laryngectomy), head and neck cancer patients. The current study evaluates overall survival, loco-regional control, organ preservation rates and toxicity. Between April 1997 and December 2002, 68 patients with advanced head and neck cancer were treated with 3 cycles of induction CT (cisplatin and 5-fluorouracil; days 1, 14, and 28) followed by hyperfractionated RT (7440 cGy/62 fractions). Sixty patients received the planned RT-CT treatment. Two months after the end of RT, 96% of patients had a clinical complete remission of the primary and 66% of the neck disease. At a median follow-up of 32 months, the 3-year overall and disease-free survival rates were 66% and 76%, respectively. Seven patients recurred on the primary site, 1 on the neck and 2 patients only had distant metastases. The organ preservation rate was 73%. Acute grade 3-4 mucositis occurred in 75% of patients and an 18% rate of CT-related cardiotoxicity was reported. The accelerated CT-RT regimen achieves a high rate of larynx preservation albeit with considerable toxicity. The current prospective clinical trial was approved by the Ethics Committee of the Centro di Riferimento Oncologico (C.R.O.) on May 27, 1996, # CRO-02-96. Written informed consent was required from all patients entering the study.
authors.affiliation: Department of Radiation Oncology, Centro di Riferimento Oncologico, National Cancer Institute, 33081 Aviano, Italy. gfranchin@cro.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Franchin
authors.forename: Emanuela
authors.initials: E
authors.lastname: Vaccher
authors.forename: Carlo
authors.initials: C
authors.lastname: Gobitti
authors.forename: Emilio
authors.initials: E
authors.lastname: Minatel
authors.forename: Doriano
authors.initials: D
authors.lastname: Politi
authors.forename: Renato
authors.initials: R
authors.lastname: Talamini
authors.forename: Giampiero
authors.initials: G
authors.lastname: Di Gennaro
authors.forename: Gabriella
authors.initials: G
authors.lastname: Savignano
authors.forename: Mauro G
authors.initials: MG
authors.lastname: Trovò
authors.forename: Umberto
authors.initials: U
authors.lastname: Tirelli
authors.forename: Luigi
authors.initials: L
authors.lastname: Barzan
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects; D013280:Stomatitis / Q000209:etiology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D002945:Cisplatin; D005472:Fluorouracil