Scherer E, Bamberg M, Godehard E, Calcanis A, Brust V, Herbst M, Karstens J H, Kleibel F, Makoski H B, Prignitz R
Strahlenther Onkol. 1986 Nov;162(11):661-6.
A prospective, randomized clinical study on 91 patients with squamous cell carcinoma of the oesophagus was undertaken in order to investigate the radiosensitizing effect of misonidazole. After histologic verification and extensive diagnosis, the greater tumor region was at first irradiated during 2.5 weeks with ten fractions of 3 Gy each up to a target volume dose of 30 Gy. Prior to each fraction, patients received randomly misonidazole or a placebo in a dose of 1 g/m2 body surface. Then they were presented to the oncologic surgeon in order to decide whether a surgical resection should be performed or not. Following to this operation no further radiotherapy was performed. However, if a surgical intervention did not take place, radiotherapy was continued without administration of misonidazole or placebo up to a target volume dose of 60 to 70 Gy. There was no evidence of neurotoxic side effects or modifications of the blood count and some laboratory parameters caused by misonidazole. As to recurrence-free interval and survival time, no significant differences were found between the different therapy groups, so that a radiosensitizing effect of misonidazole was not demonstrated in this study. Regarding several positive phase II studies with misonidazole, some hopes had been placed in this study because at present the therapeutic situation in oesophagus carcinoma is extremely unsatisfactory. Even the combination of a most sophisticated operation technique prior or following to irradiation could not essentially improve the poor healing rates.
对91例食管鳞状细胞癌患者进行了一项前瞻性随机临床研究，以调查米索硝唑的放射增敏作用。经组织学验证和全面诊断后，首先对较大的肿瘤区域进行2.5周的照射，每次3 Gy，共十次，直至靶体积剂量达到30 Gy。在每次照射前，患者随机接受1 g/m²体表面积的米索硝唑或安慰剂。然后将他们转介给肿瘤外科医生，以决定是否应进行手术切除。此手术后不再进行进一步的放疗。然而，如果未进行手术干预，则继续放疗，不给予米索硝唑或安慰剂，直至靶体积剂量达到60至70 Gy。没有证据表明米索硝唑会引起神经毒性副作用或改变血细胞计数及一些实验室参数。关于无复发生存期和生存时间，不同治疗组之间未发现显著差异，因此本研究未证明米索硝唑有放射增敏作用。鉴于此前几项关于米索硝唑的II期阳性研究，本研究曾寄予一些希望，因为目前食管癌的治疗情况极不理想。即使在放疗之前或之后采用最复杂的手术技术联合治疗，也无法从根本上提高较差的治愈率。
