Panduro J, Kjaer M, Wolff-Jensen J, Hansen H H
Cancer. 1983 Jul 1;52(1):20-4. doi: 10.1002/1097-0142(19830701)52:1<20::aid-cncr2820520105>3.0.co;2-v.
Sixty-seven patients with inoperable squamous cell carcinoma of the lung were randomized to receive split-course irradiation therapy, 40 Gy in 10 fractions over 5 weeks plus either placebo or misonidazole 1.200 mg/m2 orally on each treatment day. The target area was the primary tumor, both hilar regions, mediastinum, and both supraclavicular regions. Thirty-three patients received misonidazole, while 34 patients received placebo. Mean observation time for the study was 27 months (range, 17-36+ months. 31% of the patients in the misonidazole group obtained a complete response (CR) or a partial response (PR) as compared to 29% in the placebo group. No difference was demonstrated in the relapse pattern comparing the two groups. The death intensity was significantly higher (P = 0.03) in the misonidazole than in the placebo group, with the median survival being 4.2 and 6.7 months, respectively. Eight patients in the misonidazole group (31%) developed sensoric neuropathy while one patient in the placebo group developed irradiation myelopathy of the Brown-Sequard type. The group of patients who later developed neuropathy had significantly higher plasma misonidazole concentrations on treatment days than the group of patients who did not. It is concluded that the combination of misonidazole and irradiation therapy for inoperable squamous cell carcinoma of the lung has no effect on response rate and relapse pattern, but a significant unexplained adverse effect on survival.
67例无法手术的肺鳞状细胞癌患者被随机分组，接受分割疗程放疗，在5周内分10次给予40 Gy，且在每次治疗日口服安慰剂或1200 mg/m²米索硝唑。靶区包括原发肿瘤、双侧肺门区、纵隔及双侧锁骨上区。33例患者接受米索硝唑治疗，34例患者接受安慰剂治疗。该研究的平均观察时间为27个月（范围17 - 36 +个月）。米索硝唑组31%的患者获得完全缓解（CR）或部分缓解（PR），而安慰剂组为29%。两组复发模式无差异。米索硝唑组的死亡强度显著高于安慰剂组（P = 0.03），中位生存期分别为4.2个月和6.7个月。米索硝唑组8例患者（31%）出现感觉神经病变，而安慰剂组1例患者出现布朗 - 塞卡尔型放射性脊髓病。后期出现神经病变的患者组在治疗日的血浆米索硝唑浓度显著高于未出现神经病变的患者组。结论是，米索硝唑与放疗联合用于无法手术的肺鳞状细胞癌，对缓解率和复发模式无影响，但对生存期有显著且无法解释的不良影响。
