美国国立卫生研究院脑肿瘤协作组87-01试验：手术、外照射放疗及卡莫司汀与手术、组织间放疗加量、外照射放疗及卡莫司汀的随机对照比较

The Brain Tumor Cooperative Group NIH Trial 87-01: a randomized comparison of surgery, external radiotherapy, and carmustine versus surgery, interstitial radiotherapy boost, external radiation therapy, and carmustine.

作者信息

Selker Robert G, Shapiro William R, Burger Peter, Blackwood Margaret S, Arena Vincent C, Gilder John C, Malkin Mark G, Mealey John J, Neal John H, Olson Jeffrey, Robertson James T, Barnett Gene H, Bloomfield Stephen, Albright Robert, Hochberg Fred H, Hiesiger Emile, Green Sylvan

出版信息

Neurosurgery. 2002 Aug;51(2):343-55; discussion 355-7.

PMID:12182772

Abstract

OBJECTIVE

The objective of the Brain Tumor Cooperative Group NIH Trial 87-01 trial was to investigate the effect of additional implanted radiation therapy in newly diagnosed patients with pathologically confirmed malignant gliomas.

METHODS

The study involved a randomized comparison of surgery, external beam radiotherapy, and carmustine (BCNU) versus surgery, external beam therapy, interstitial radiotherapy boost, and BCNU in newly diagnosed malignant gliomas. (125)I was chosen as best suited for this effort because it allowed preimplantation planning and postimplantation quality assurance review. Two hundred ninety-nine patients met the eligibility criteria and were randomized into the two arms of the study between December 1987 and April 1994. Follow-up continued for an additional 3 years. Twenty-nine patients were identified as having committed protocol violations and were excluded, resulting in 270 subjects in the Valid Study Group. One hundred thirty-seven patients received external beam radiation and BCNU, and 133 underwent the (125)I implantation plus external beam radiation and BCNU therapy.

RESULTS

The overall median survival for the Valid Study Group was 64.3 weeks. The median survival for patients receiving additional therapy of (125)I was 68.1 weeks, and median survival for those receiving only external beam radiation and BCNU was 58.8 weeks. The cumulative proportion surviving between the two treatment groups was not statistically significantly different (log-rank test, P = 0.101). As in other studies in the literature, age, Karnofsky score, and pathology were predictors of mortality. Additional analyses incorporating an adjustment for these prognostic variables, either in a stratified analysis or Cox proportional hazards model, did not result in statistically significant differences in the cumulative proportion of patients surviving between the two treatment groups.

CONCLUSION

We conclude that there is no long-term survival advantage of increased radiation dose with (125)I seeds in newly diagnosed glioma patients.

摘要

目的

脑肿瘤协作组国立卫生研究院（NIH）87 - 01试验的目的是研究额外植入放射治疗对新诊断的经病理证实的恶性胶质瘤患者的影响。

方法

该研究对新诊断的恶性胶质瘤患者进行了随机对照，一组接受手术、外照射放疗和卡莫司汀（BCNU），另一组接受手术、外照射治疗、间质放疗增强以及BCNU。选择（125）I最适合此项研究，因为它允许植入前规划和植入后质量保证评估。1987年12月至1994年4月期间，299名患者符合入选标准并被随机分为研究的两组。随访持续了另外3年。29名患者被确定违反了方案并被排除，有效研究组有270名受试者。137名患者接受了外照射放疗和BCNU，133名患者接受了（125）I植入加外照射放疗和BCNU治疗。

结果

有效研究组的总体中位生存期为64.3周。接受（125）I额外治疗的患者中位生存期为68.1周，仅接受外照射放疗和BCNU的患者中位生存期为58.8周。两个治疗组之间的累积生存比例无统计学显著差异（对数秩检验，P = 0.101）。与文献中的其他研究一样，年龄、卡诺夫斯基评分和病理是死亡率的预测因素。在分层分析或Cox比例风险模型中纳入对这些预后变量的调整的额外分析，并未导致两个治疗组之间患者累积生存比例的统计学显著差异。