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A phase III randomized study of misonidazole plus radiation vs. radiation alone for cervix cancer
Philip Chan1, Michael Milosevic, Anthony Fyles
1Department of Radiation Oncology, Princess Margaret Hospital, 610 University Avenue, Toronto, Ontario, Canada M5G 2M9.
Background And Purpose:
A randomized-controlled study of radical radiotherapy for cervical cancer with or without the hypoxic sensitizer, misonidazole was conducted from 1981 to 1984 to investigate its therapeutic benefit.
Patients And Methods:
Seventy-three patients were accrued from the Princess Margaret Hospital, and St John Regional Cancer Centre and randomized to either misonidazole (MISO, n = 39) or placebo (P, n = 34) in addition to radiotherapy. MISO was given orally each day 4 h prior to external beam radiation treatment (45Gy to midplane in 20 daily fractions) at a dose of 0.45 g/m(2), as well as during intra-uterine brachytherapy (40Gy).
Results:
The 10-year overall survival (OS) for the entire group was 46%, and the disease-free survival (DFS) was 39%. The 10-year OS for patients in the MISO arm was 45%, compared to 49% for the P arm (P = 0.89). The corresponding DFS figures were 36 and 43%, respectively, (P = 0.6). Ten patients (14%) developed severe late complications (grade 3 or 4). The 10-year serious late complication rate was 14% for MISO and 12% for P (P = 0.51).
Conclusions:
Misonidazole failed to improve the outcome of patients with cervix cancer treated with radiotherapy.