Prospective randomized comparison of single-dose versus hyperfractionated total-body irradiation in patients with hematologic malignancies

Purpose: Fractionated total-body irradiation (HTBI) is considered to induce less toxicity to normal tissues and probably has the same efficacy as sing le-dose total-body irradiation (STBI) in patients with acute myeloid leukem ia. We decided to determine whether this concept can be applied to a large number of patients with various hematologic malignancies using two dissimil ar fractionation schedules. Patients and Methods: Between December 1986 and October 1994, 160 patients with various hematologic malignancies were randomised to receive either a 1 0-Gy dose of STBI or 14.85-Gy dose of HTBI. Results: One hundred forty-seven patients were assessable. The 8-year overa ll survival rate and cause-specific survival rate in the STBI group was 38% and 63.5%, respectively. Overall survival rate and cause-specific survival rate in the HTBI group was 45% and 77%, respectively. The incidence of int erstitial pneumonitis was similar in both groups. However, the incidence of veno-occlusive disease (VOD) of the liver was significantly higher in the STBI group. In the multivariate analysis with overall survival as the end p oint, the female sex was an independent favorable prognostic factor. On the other hand, when cause-specific survival was considered as the end point, the multivariate analysis demonstrated that sex and TBI were independent pr ognostic factors. Conclusion: The efficacy of HTBI is probably higher than that of STBI. Both regimens induce similar toxicity with the exception of VOD of the liver, t he incidence of which is significantly more pronounced in the STBI group. J Clin Oncol 18:981-986. (C) 2000 by American Society of Clinical Oncology.