Large fraction radiotherapy plus misonidazole for treatment of advanced lung cancer: report of a phase I/II trial
- Mallinckrodt Inst. of Radiology, St. Louis, MO
From August 1978 through December 1979, 51 patients with advanced non-oat cell carcinoma of the lung were enrolled in a Phase I/II trial sponsored by the Radiation Therapy Oncology Group (RTOG) employing misonidazole (a 2-nitroimidazole) as a hypoxic cell sensitizer and radiation. The purpose of this study was to test drug and radiation tolerance and to assess the short term efficacy of this unconventional treatment. Tumor doses of 600 rad were given twice weekly for three weeks for a total of 3600 rad, preceded four to six hours by misonidazole in a dose of 2 gm/m/sup 2/ or 1.75 gm/m/sup 2/, administered orally. Forty-nine patients were evaluable. Serious toxicity from this treatment was rare. Grade 2 or 3 peripheral neuro-toxicity occurred in eight of 24 patients (33%) with drug doses of 2 gm/m/sup 2/ and in four of 26 patients (15%) who received 1.75 gm/m/sup 2/. Grade 3 or 4 central nervous system toxicity occurred in two patients. Two patients developed serious late radiation complications: one patient had a transverse myelitis that appeared one year following delivery of 3600 rad to the spinal cord; a second patient developed a tracheoesophageal fistula and pericarditis eight months following treatment. Objective responses were reported in 67% of patients (complete in 18%); 70% of the patients died with a median survival time of nine months. Of 32 patients eligible for 12 month follow-up, 34% survived more than one year. Patterns of relapse after initial treatment and comparison with results from other RTOG trials using conventional fractionation are discussed.
- OSTI ID:
- 6580912
- Journal Information:
- Int. J. Radiat. Oncol., Biol. Phys.; (United States), Journal Name: Int. J. Radiat. Oncol., Biol. Phys.; (United States) Vol. 8:2; ISSN IOBPD
- Country of Publication:
- United States
- Language:
- English
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560151 -- Radiation Effects on Animals-- Man
62 RADIOLOGY AND NUCLEAR MEDICINE
63 RADIATION, THERMAL, AND OTHER ENVIRON. POLLUTANT EFFECTS ON LIVING ORGS. AND BIOL. MAT.
BIOLOGICAL EFFECTS
BIOLOGICAL RADIATION EFFECTS
BODY
CARCINOMAS
CARDIOVASCULAR SYSTEM
CENTRAL NERVOUS SYSTEM
DELAYED RADIATION EFFECTS
DIGESTIVE SYSTEM
DISEASES
DRUGS
ESOPHAGUS
FRACTIONATED IRRADIATION
HEART
IRRADIATION
IRRADIATION PROCEDURES
LUNGS
MEDICINE
MEMBRANES
MYELITIS
NEOPLASMS
NERVOUS SYSTEM
NERVOUS SYSTEM DISEASES
NUCLEAR MEDICINE
ORGANS
PATIENTS
PERICARDIUM
RADIATION EFFECTS
RADIOLOGY
RADIOSENSITIZERS
RADIOTHERAPY
RESPIRATORY SYSTEM
SEROUS MEMBRANES
SIDE EFFECTS
SPINAL CORD
SURVIVAL TIME
SYNERGISM
THERAPY