Chassagne D, Charreau I, Sancho-Garnier H, Eschwege F, Malaise E P
Radiotherapy Department, Institut Gustave-Roussy, Villejuif, France.
Int J Radiat Oncol Biol Phys. 1992;22(3):581-4. doi: 10.1016/0360-3016(92)90881-h.
From July 1987 to July 1990, 374 patients were randomized in a multicenter trial coordinated by the Gustave-Roussy Institute. Patients were treated either by radiotherapy alone (RT) or by combined etanidazole with radiotherapy (ETA). The same radiotherapy protocol was used in both arms. Major deviations from the protocol occurred in 16% of the patients. Etanidazole was given at a dose of 2 g/m2, 3 times per week, for a total of 30-34 g/m2. Seventeen percent of the patients received less than 14 injections (4% refused, 12% presented a toxicity, 1% died before beginning). The rate of neuropathy was 28% in the ETA arm and 3% in the RT arm. Acute radiotherapy reactions occurred in similar proportions in both arms. The 3-month rates of complete regression are presently 75.3% in the RT alone group and 77.6% in the ETA group; this difference is not significant. No definitive results are presently available and we must wait for the two-year survival results. In addition, if a meta-analysis could be performed with the parallel RTOG study, the results would be more valid.
1987年7月至1990年7月，374例患者在古斯塔夫-鲁西研究所协调的一项多中心试验中被随机分组。患者要么接受单纯放疗（RT），要么接受依托硝唑联合放疗（ETA）。两组采用相同的放疗方案。16%的患者出现了与方案的重大偏差。依托硝唑的给药剂量为2 g/m²，每周3次，总量为30 - 34 g/m²。17%的患者接受的注射少于14次（4%拒绝，12%出现毒性反应，1%在开始治疗前死亡）。ETA组的神经病变发生率为28%，RT组为3%。两组急性放疗反应的发生率相似。目前，单纯放疗组3个月的完全缓解率为75.3%，ETA组为77.6%；这种差异不显著。目前尚无确切结果，我们必须等待两年生存率结果。此外，如果能与RTOG的平行研究进行荟萃分析，结果将更具说服力。
