title: Hyperfractionated radiotherapy concomitant with cisplatin and granulocyte colony-stimulating factor (filgrastim) for laryngeal carcinoma.
abstract: An open-label, non-randomized study evaluated the feasibility and efficacy of filgrastim (recombinant methionyl human granulocyte colony-stimulating factor, r-metHuG-CSF) to prevent mucositis induced by accelerated hyperfractionated radiotherapy (1.6 Gy b.i.d., total dose 67.2 Gy in six weeks with a two-week split) and concomitant chemotherapy (cisplatin, 20 mg/m2/day, days 1-5 by continuous intravenous infusion) in patients with laryngeal carcinoma. Filgrastim 300 microg/day was administered on days 1, 3, and 5 in weeks 2-6 of radiotherapy, after the second fraction. Twenty patients (three stage II, six stage III, and eleven stage IV, according to AJCC) were enrolled in the trial. Oral mucosal toxicity was grade 2 in nine patients (45%), grade 3 in eight (40%), and grade 4 in three (15%). Severe hematological toxicity (WHO criteria) was uncommon. Nineteen patients (95%) completed the treatment in the planned time. Overall survival was 55% at three years. The administration of filgrastim with this regimen was feasible, and it appeared to reduce the severity and duration of mucositis induced by the combined treatment.
authors.affiliation: Department of Oncology, Hospital de Navarra, Pamplona, Spain. jj.valerdi.alvarez@cf.navarra.es
authors.forename: M
authors.initials: M
authors.lastname: Tejedor
authors.forename: J J
authors.initials: JJ
authors.lastname: Valerdi
authors.forename: F
authors.initials: F
authors.lastname: Arias
authors.forename: M A
authors.initials: MA
authors.lastname: Dominguez
authors.forename: E
authors.initials: E
authors.lastname: Pruja
authors.forename: L
authors.initials: L
authors.lastname: Mendez
authors.forename: J J
authors.initials: JJ
authors.lastname: Illarramendi
mesh_terms: D000328:Adult; D000368:Aged; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D007822:Laryngeal Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects*; D011832:Radiation Injuries / Q000209:etiology / Q000517:prevention & control*; D011994:Recombinant Proteins; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*; D015996:Survival Rate
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim; D002945:Cisplatin