title: Nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and pharynx carcinoma. First report from the Danish Head and Neck Cancer Study (DAHANCA) protocol 5-85.
abstract: Between January 1986 and September 1990, 442 patients with pharynx and supraglottic larynx carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p less than 0.05) for sex (females 52% vs males 34%), tumor size (T1-T2 47% vs T3-T4 32%) and pre-irradiation hemoglobin (Hb) concentration (high 41% vs low 34%). Overall, the NIM group showed a significantly better local-regional control rate than the placebo group (46% vs 32%). There was an apparent additive effect of Hb concentration and NIM. Thus, in the male group, placebo patients with low Hb had a 23% control rate compared to 46% in NIM treated patients with Hb above 9 mmol/l (p less than 0.05). The similar effect in females could not be evaluated due to the small number of women with this disease. NIM was well tolerated and drug-related side effects were minor and tolerable, with transient nausea and vomiting as the most frequent complication. A final conclusion of the study must await an evaluation including all patients and a longer observation time.
authors.affiliation: Danish Cancer Society, Dept. of Experimental Clinical Oncology, Radiumstationen, Aarhus.
authors.forename: J
authors.initials: J
authors.lastname: Overgaard
authors.forename: H
authors.initials: H
authors.lastname: Sand Hansen
authors.forename: B
authors.initials: B
authors.lastname: Lindeløv
authors.forename: M
authors.initials: M
authors.lastname: Overgaard
authors.forename: K
authors.initials: K
authors.lastname: Jørgensen
authors.forename: B
authors.initials: B
authors.lastname: Rasmusson
authors.forename: A
authors.initials: A
authors.lastname: Berthelsen
mesh_terms: D002277:Carcinoma / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003718:Denmark; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D009554:Nimorazole / Q000627:therapeutic use*; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*
chemical_list: D011838:Radiation-Sensitizing Agents; D009554:Nimorazole