Bund J, Eberhardt K, Hartmann W, Habermalz H J
Radiologische Klinik, Medizinischer Bereich Strahlentherapie, Zentralkrankenhauses Sankt-Jürgen-Strasse Bremen.
Strahlenther Onkol. 1998 Jun;174(6):300-5. doi: 10.1007/BF03038543.
In-vitro and in-vivo studies demonstrated the radiosensitizing effect of interferon beta on malignant tumor tissue as well as simultaneously a radioprotective effect on normal lung tissue. In this phase II study the outcome of combining radiotherapy with interferon beta in patients with advanced non-small cell lung cancer was evaluated.
From February 1994 until November 1996 14 patients with non-small cell lung cancer, stage IIIB were treated with locoregional radiation up to 59.4 Gy, with daily doses of 1.8 Gy and 5 fractions per week. Five million units of interferon beta (Fiblaferon) were given intravenously immediately preceding radiotherapy on the first 3 days of week 1, 3 and 5.
Four of 14 patients (28.6%) showed complete response and 7 patients (50%) partial response, resulting in an overall response rate of 78.6%. After a mean follow-up time of 23.3 months the 1-, 2- and 3-year survival rates were 56.3%, 37.5% and 37.5%, respectively. The median survival time was 13 months. Three of 14 patients (21.4%) suffered from 7 Grade-3 acute side effects and 2 patients (14.3%) from 1 Grade-3 late toxicity in each case. One further patient, whose right lung was resected 3 months after completion of radiotherapy, developed as a consequence of this operation 2 Grade-4 complications.
Considering the toxicity and the preliminary results of combining irradiation and interferon beta in the treatment of locally advanced non-small cell lung cancer it seems, that this procedure is worth to be tested in a phase III study.
体外和体内研究均表明，β-干扰素对恶性肿瘤组织具有放射增敏作用，同时对正常肺组织具有放射保护作用。在这项II期研究中，评估了晚期非小细胞肺癌患者放疗联合β-干扰素的疗效。
1994年2月至1996年11月，14例IIIB期非小细胞肺癌患者接受局部放疗，总剂量达59.4 Gy，每日剂量1.8 Gy，每周5次。在第1、3和5周的前3天，每次放疗前立即静脉注射500万单位的β-干扰素（Fiblaferon）。
14例患者中，4例（28.6%）完全缓解，7例（50%）部分缓解，总缓解率为78.6%。平均随访23.3个月后，1年、2年和3年生存率分别为56.3%、37.5%和37.5%。中位生存时间为13个月。14例患者中有3例（21.4%）出现7次3级急性不良反应，2例（14.3%）各出现1次3级晚期毒性反应。另有1例患者在放疗结束3个月后右肺切除，术后出现2次4级并发症。
考虑到放疗联合β-干扰素治疗局部晚期非小细胞肺癌的毒性及初步结果，该治疗方法值得在III期研究中进行验证。
