Solero C L, Monfardini S, Brambilla C, Vaghi A, Valagussa P, Morello G, Bonadonna G
Cancer Clin Trials. 1979 Spring;2(1):43-8.
From September, 1972 to December, 1976, 102 consecutive patients operated on for glioblastoma multiforme were randomized, after total or subtotal tumor resection, to receive irradiation alone, irradiation plus BCNU or irradiation plus CCNU. BCNU and CCNU adjuvant chemotherapy was repeated every 6--8 weeks as long as the patients remained in complete remission. Patients were comparable for median age, type of surgery, and histological grade III and IV. Radiotherapy was administered at the tumor dose of about 5000 rads in all three groups. The percent of optimal dose administered was 96% for BCNU and 93% for CCNU. In the group treated with radiotherapy alone (32 cases) the median survival was 10.5 months, while in the groups treated with BCNU (34 cases) and CCNU (36 cases) the median survival was 12 and 16 months, respectively. Both relapse-free (P = 0.05) and total survival (P = 0.03) were significantly improved only in patients who were treated with radiotherapy plus CCNU compared to patients receiving radiotherapy alone after surgery. Present results show that in resectable glioblastoma multiforme, a slightly improved survival rate can be achieved by the prolonged use of adjuvant CCNU following maximal surgical resection and radiotherapy. The cure rate was not improved.
1972年9月至1976年12月,102例连续接受多形性胶质母细胞瘤手术的患者,在肿瘤全部或部分切除后,被随机分为三组,分别接受单纯放疗、放疗加卡氮芥(BCNU)或放疗加环己亚硝脲(CCNU)治疗。只要患者仍处于完全缓解状态,BCNU和CCNU辅助化疗每6 - 8周重复一次。患者在年龄中位数、手术类型以及组织学分级III级和IV级方面具有可比性。三组均给予肿瘤剂量约5000拉德的放疗。BCNU组给予最佳剂量的百分比为96%,CCNU组为93%。单纯放疗组(32例)的中位生存期为10.5个月,而接受BCNU治疗的组(34例)和CCNU治疗的组(36例)的中位生存期分别为12个月和16个月。与术后单纯接受放疗的患者相比,只有接受放疗加CCNU治疗的患者无复发生存期(P = 0.【此处原文有误,应为0.05】)和总生存期(P = 0.【此处原文有误,应为0.03】)有显著改善。目前的结果表明,在可切除的多形性胶质母细胞瘤中,最大程度手术切除和放疗后长期使用辅助性CCNU可使生存率略有提高,但治愈率并未提高。