Bleehen N M, Stenning S P
MRC Clinical Oncology and Radiotherapeutics Unit, MRC Centre, Cambridge, UK.
Br J Cancer. 1991 Oct;64(4):769-74. doi: 10.1038/bjc.1991.396.
A total of 474 adult patients with malignant glioma (astrocytoma) grade 3 or 4 were randomised into an MRC study (BR2) comparing 45 Gy (in 20 fractions over 4 weeks) with 60 Gy (in 30 fractions over 6 weeks) of radiotherapy given post-operatively. Using 2:1 randomisation, 318 patients were allocated the 60 Gy course and 156 the 45 Gy course. Adjuvant chemotherapy was not given. The results show that a 60 Gy course produces a modest lengthening of progression-free and overall survival. They suggest a statistically significant prolongation of median survival from 9 months in the 45 Gy group to 12 months in the 60 Gy group (hazard ratio = 0.75, chi 2 = 7.36, d.f. = 1, P = 0.007). Over 80% of patients reported no morbidity from the radiotherapy, and there was no evidence of increased short-term morbidity in the higher dose group. Late morbidity was not assessed. A prognostic index defined in a previous MRC study was validated in this new cohort. It identifies a group of patients (20% of the total) with a 2 year survival rate of 28% (95% confidence interval 19% to 38%). It was apparent that the survival advantage to the higher dose was maintained even in the poorest prognostic groups defined by this index.
共有474例3级或4级恶性胶质瘤（星形细胞瘤）成年患者被随机纳入医学研究委员会（MRC）的一项研究（BR2），该研究比较了术后给予45 Gy（4周内分20次）与60 Gy（6周内分30次）放疗的效果。采用2:1随机分组，318例患者被分配接受60 Gy疗程，156例接受45 Gy疗程。未给予辅助化疗。结果显示，60 Gy疗程可适度延长无进展生存期和总生存期。结果表明，中位生存期从45 Gy组的9个月显著延长至60 Gy组的12个月（风险比=0.75，卡方=7.36，自由度=1，P=0.007）。超过80%的患者报告放疗后无发病情况，且高剂量组无短期发病增加的证据。未评估晚期发病情况。在之前的MRC研究中定义的一个预后指数在这个新队列中得到了验证。该指数确定了一组患者（占总数的20%），其2年生存率为28%（95%置信区间为19%至38%）。很明显，即使在该指数定义的预后最差的组中，高剂量放疗的生存优势依然存在。
