Gaspar L E, Scott C, Murray K, Curran W
University of Colorado Health Science Center, Denver, CO, USA.
Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):1001-6. doi: 10.1016/s0360-3016(00)00547-2.
The Radiation Therapy Oncology Group (RTOG) previously developed three prognostic classes for brain metastases using recursive partitioning analysis (RPA) of a large database. These classes were based on Karnofsky performance status (KPS), primary tumor status, presence of extracranial system metastases, and age. An analysis of RTOG 91-04, a randomized study comparing two dose-fractionation schemes with a comparison to the established RTOG database, was considered important to validate the RPA classes.
A total of 445 patients were randomized on RTOG 91-04, a Phase III study of accelerated hyperfractionation versus accelerated fractionation. No difference was observed between the two treatment arms with respect to survival. Four hundred thirty-two patients were included in this analysis. The majority of the patients were under age 65, had KPS 70-80, primary tumor controlled, and brain-only metastases. The initial RPA had three classes, but only patients in RPA Classes I and II were eligible for RTOG 91-04.
For RPA Class I, the median survival time was 6. 2 months and 7.1 months for 91-04 and the database, respectively. The 1-year survival was 29% for 91-04 versus 32% for the database. There was no significant difference in the two survival distributions (p = 0.72). For RPA Class II, the median survival time was 3.8 months for 91-04 versus 4.2 months for the database. The 1-year survival was 12% and 16% for 91-04 and the database, respectively (p = 0.22).
This analysis indicates that the RPA classes are valid and reliable for historical comparisons. Both the RTOG and other clinical trial organizers should currently utilize this RPA classification as a stratification factor for clinical trials.
放射治疗肿瘤学组(RTOG)先前利用一个大型数据库的递归分割分析(RPA)为脑转移瘤制定了三种预后类别。这些类别基于卡诺夫斯基体能状态(KPS)、原发肿瘤状态、颅外系统转移的存在情况以及年龄。对RTOG 91 - 04进行分析被认为对验证RPA类别很重要,RTOG 91 - 04是一项比较两种剂量分割方案并与已建立的RTOG数据库进行对比的随机研究。
共有445例患者被纳入RTOG 91 - 04的随机分组,这是一项关于加速超分割与加速分割的III期研究。在生存方面,两个治疗组之间未观察到差异。本分析纳入了432例患者。大多数患者年龄在65岁以下,KPS为70 - 80,原发肿瘤得到控制,且仅有脑转移。最初的RPA有三个类别,但只有RPA I类和II类的患者符合RTOG 91 - 04的入组条件。
对于RPA I类,91 - 04研究中的中位生存时间为6.2个月,数据库中的为7.1个月。91 - 04研究的1年生存率为29%,数据库中的为32%。两种生存分布无显著差异(p = 0.72)。对于RPA II类,91 - 04研究中的中位生存时间为3.8个月,数据库中的为4.2个月。91 - 04研究和数据库的1年生存率分别为12%和16%(p = 0.22)。
该分析表明RPA类别对于历史比较是有效且可靠的。RTOG和其他临床试验组织者目前都应将此RPA分类用作临床试验的分层因素。