Chan Philip, Milosevic Michael, Fyles Anthony, Carson John, Pintilie Melania, Rauth Michael, Thomas Gillian
Department of Radiation Oncology, Princess Margaret Hospital, 610 University Avenue, Toronto, Ontario, Canada M5G 2M9.
Radiother Oncol. 2004 Mar;70(3):295-9. doi: 10.1016/j.radonc.2003.11.018.
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.
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).
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).
Misonidazole failed to improve the outcome of patients with cervix cancer treated with radiotherapy.
1981年至1984年开展了一项关于宫颈癌根治性放疗联合或不联合低氧增敏剂米索硝唑的随机对照研究，以探究其治疗效果。
从玛格丽特公主医院和圣约翰地区癌症中心招募了73例患者，随机分为米索硝唑组（MISO，n = 39）或安慰剂组（P，n = 34），两组均接受放疗。米索硝唑在每次外照射治疗（中平面剂量45Gy，分20次每日照射）前4小时口服，剂量为0.45g/m²，在子宫内近距离放疗（40Gy）期间也同样给药。
整个队列的10年总生存率（OS）为46%，无病生存率（DFS）为39%。米索硝唑组患者的10年总生存率为45%，安慰剂组为49%（P = 0.89）。相应的无病生存率分别为36%和43%（P = 0.6）。10例患者（14%）出现严重晚期并发症（3级或4级）。米索硝唑组的10年严重晚期并发症发生率为14%，安慰剂组为12%（P = 0.51）。
米索硝唑未能改善接受放疗的宫颈癌患者的治疗结局。
