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Misonidazole combined with radiotherapy in the treatment of inoperable squamous cell carcinoma of the lung. A double-blind randomized trial

Journal Article · · Cancer (Philadelphia); (United States)
; ; ;
Sixty-seven patients with inoperable squamous cell carcinoma of the lung were randomized to receive split-course irradiation therapy, 40 Gy in 10 fractions over 5 weeks plus either placebo or misonidazole 1.200 mg/m2 orally on each treatment day. The target area was the primary tumor, both hilar regions, mediastinum, and both supraclavicular regions. Thirty-three patients received misonidazole, while 34 patients received placebo. Mean observation time for the study was 27 months (range, 17-36+ months. 31% of the patients in the misonidazole group obtained a complete response (CR) or a partial response (PR) as compared to 29% in the placebo group. No difference was demonstrated in the relapse pattern comparing the two groups. The death intensity was significantly higher (P . 0.03) in the misonidazole than in the placebo group, with the median survival being 4.2 and 6.7 months, respectively. Eight patients in the misonidazole group (31%) developed sensoric neuropathy while one patient in the placebo group developed irradiation myelopathy of the Brown-Sequard type. The group of patients who later developed neuropathy had significantly higher plasma misonidazole concentrations on treatment days than the group of patients who did not. It is concluded that the combination of misonidazole and irradiation therapy for inoperable squamous cell carcinoma of the lung has no effect on response rate and relapse pattern, but a significant unexplained adverse effect on survival.
Research Organization:
Department of Chemotherapy R II-V, Finseninstitute, Copenhagen, Denmark
OSTI ID:
5296711
Journal Information:
Cancer (Philadelphia); (United States), Journal Name: Cancer (Philadelphia); (United States) Vol. 52:1; ISSN CANCA
Country of Publication:
United States
Language:
English

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Related Subjects

550600 -- Medicine
550603* -- Medicine-- External Radiation in Therapy-- (1980-)
560306 -- Chemicals Metabolism & Toxicology-- Man-- (-1987)
62 RADIOLOGY AND NUCLEAR MEDICINE
63 RADIATION, THERMAL, AND OTHER ENVIRON. POLLUTANT EFFECTS ON LIVING ORGS. AND BIOL. MAT.
ANTINEOPLASTIC DRUGS
AZOLES
BIOLOGICAL EFFECTS
BIOLOGICAL RADIATION EFFECTS
BODY
CARCINOMAS
CHEMOTHERAPY
COMPARATIVE EVALUATIONS
DISEASES
DOSES
DRUGS
HETEROCYCLIC COMPOUNDS
IMIDAZOLES
INJURIES
LUNGS
MEDICINE
MISONIDAZOLE
NEOPLASMS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANIC NITROGEN COMPOUNDS
ORGANS
RADIATION DOSES
RADIATION EFFECTS
RADIATION INJURIES
RADIOLOGY
RADIOSENSITIVITY
RADIOSENSITIZERS
RADIOTHERAPY
RESPIRATORY SYSTEM
SURVIVAL TIME
THERAPY
TOXICITY