Hyperfractionated radiaton therapy and bis-chlorethyl nitrosourea in the treatment of malignant glioma - possible advantage observed at 72. 0 Gy in 1. 2 Gy B. I. D. fractions: Report of the radiation therapy oncology group protocol 8302

Journal Article · Fri Jan 15 04:00:00 EST 1993 · International Journal of Radiation Oncology, Biology and Physics; (United States)

DOI:https://doi.org/10.1016/0360-3016(93)90340-2· OSTI ID:6877237

Nelson, D F ^[1]; Curran, W J; Powlis, W D ^[2]; Scott, C ^[3]; Nelson, J S ^[4]; Weinstein, A S ^[5]; Ahmad, K ^[6]; Constine, L S ^[7]; Murray, K ^[8]; Mohiuddin, M ^[9]; Fischbach, J ^[10]

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1. Highland Hospital of Rochestor, NY (United States)
2. Fox Chase Cancer Center, Philadelphia, PA (United States)
3. Radiation Therapy Oncology Group Statistical Unit, Philadelphia, PA (United States)
4. Armed Forces Inst. of Pathology, Washington, DC (United States)
5. Moorestown Medical Center, NJ (United States)
6. Wayne State Univ., Detroit, MI (United States)
7. Univ. of Rochester, NY (United States)
8. Medical College of Wisconsin, Milwaukee (United States)
9. Thomas Jefferson Univ., Philadelphia, PA (United States)
10. LDS Hospital, Salt Lake City, UT (United States)

Between January 1983 and November 1987, the Radiation Therapy Oncology Group conducted a prospective, randomized, multi-institutional, dose searching Phase I/II trial to evaluate hyperfractionated radiation therapy in the treatment of supratentorial malignant glioma. Patients with anaplastic astrocytoma, or glioblastoma multiforme, age 18-70 years with a Karnofsky performance status of 40-100 were stratified according to age, Karnofsky performance status, and histology, and were randomized. Initially randomization was to one of three arms: 64.8 Gy, 72.0 Gy, and 76.8 Gy. Fractions of 1.2 Gy were given twice daily, 5 days per week, with intervals of 4 to 8 hr. All patients received bis-chlorethyl nitrosourea (BCNU) 80 mg/m2 on days 3, 4, 5 of radiation therapy and then every 8 weeks for 1 year. After acceptable rates of acute and late effects were found, the randomization was changed to 81.6 Gy and 72.0 Gy with a weighting of 2:1. Out of 466 patients randomized, 435 were analyzed. The distribution of prognostic factors was comparable among the 76.8 Gy arm, 81.6 Gy arm, and the final randomization of the 72 Gy arm. The 64.8 Gy arm and the initial randomization of the 72 Gy arm had somewhat worse prognostic variables. Late radiation toxicity occurred in 1.3-6.8% of the patients, with a modest increase with increasing radiation dose. The best survival occurred in those patients treated with 72 Gy. The Cox proportional hazards model confirmed the prognostic variables of age, histology and Karnofsky performance status. In addition, the longer interval of 4.5-8 hr was associated with a worse prognosis than the 4-4.4 hr interval. The difference in survival between the 81.6 Gy arm and the lower three arms approached significance with inferior survival observed in the 81.6 Gy arm. 72 Gy delivered by 1.2 Gy twice daily is no more toxic than 60 Gy delivered conventionally. 26 refs., 6 figs., 7 tabs.

• OSTI ID: 6877237
• Journal Information: International Journal of Radiation Oncology, Biology and Physics; (United States), Journal Name: International Journal of Radiation Oncology, Biology and Physics; (United States) Vol. 25:2; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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550603* -- Medicine-- External Radiation in Therapy-- (1980-)
62 RADIOLOGY AND NUCLEAR MEDICINE
COMBINED THERAPY
COMPARATIVE EVALUATIONS
DISEASES
DISTRIBUTION
DOSIMETRY
ENERGY RANGE
EVALUATION
GLIOMAS
HAZARDS
HISTOLOGY
MEDICINE
NEOPLASMS
NITROSO COMPOUNDS
NITROSOUREAS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANIC NITROGEN COMPOUNDS
PATIENTS
PERFORMANCE
RADIOLOGY
RADIOTHERAPY
THERAPY
TOXICITY