RANDOMIZED COMPARISONS OF RADIOTHERAPY AND NITROSOUREAS FOR THE TREATMENT OF MALIGNANT GLIOMA AFTER SURGERY

RANDOMIZED COMPARISONS OF RADIOTHERAPY AND NITROSOUREAS FOR THE TREATMENT OF MALIGNANT GLIOMA AFTER SURGERY
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DOI:
10.1056/nejm198012043032303
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发表时间:
1980-01-01
影响因子:
158.5
通讯作者:
STRIKE, TA
STRIKE, TA
中科院分区:
医学1区
文献类型:
--
作者:
WALKER, MD;GREEN, SB;STRIKE, TA

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467例经病理证实的恶性胶质瘤患者在术后3周内随机接受以下4种治疗方案之一:司莫司汀(MeCCNU)、放疗、卡莫司汀(BCNU)+放疗或司莫司汀+放疗。分析了总随机化人群和符合初始方案规范的358例患者(有效研究组)的数据。观察到的毒性包括继发于放疗的可接受的皮肤反应和化疗引起的可逆性白细胞减少症和血小板减少症。与司莫司汀单药治疗相比,单独使用放疗或与亚硝基脲联合使用放疗可显著改善生存率。卡莫司汀+放疗组生存率最好,但卡莫司汀+放疗组与司莫司汀+放疗组之间的生存率差异无统计学意义。卡莫司汀联合放疗在长期(18个月)中产生了适度的益处。与单纯放疗相比,生存曲线之间的差异在0.05水平上不显著。恶性胶质瘤的术后治疗最好采用放射治疗,并继续寻找除放射治疗外的有效化疗方案。
Within 3 wk of definitive surgical intervention, 467 patients with histologically proved malignant glioma were randomized to receive 1 of the following 4 treatment regimens: semustine (MeCCNU), radiotherapy, carmustine (BCNU) plus radiotherapy, or semustine plus radiotherapy. The data for the total randomized population and for the 358 patients in whom the initial protocol specifications were met (the valid study group) were analyzed. Observed toxicity included acceptable skin reactions secondary to radiotherapy and reversible leukopenia and thrombocytopenia due to chemotherapy. Radiotherapy used alone or in combination with a nitrosourea significantly improved survival in comparison with semustine alone. The group receiving carmustine plus radiotherapy had the best survival, but the difference in survival between the groups receiving carmustine plus radiotherapy and semustine plus radiotherapy was not statistically significant. The combination of carmustine plus radiotherapy produced a modest benefit in long-term (18 mo.) survival as compared with radiotherapy alone; the difference between survival curves was not significant at the 0.05 level. It is best to use radiotherapy in the postsurgical treatment of malignant glioma and to continue the search for an effective chemotherapeutic regimen to use in addition to radiotherapy.