Thomas Charles R, Berkey Brian A, Minsky Bruce D, Gaspar Laurie E, Herskovic Arnold, Rich Tyvin A, Gunderson Leonard L
Department of Radiation Oncology, The University of Texas Health Science Center, San Antonio, TX 78229-3900, USA.
Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1405-10. doi: 10.1016/j.ijrobp.2003.09.022.
To analyze the relative contributions of uniformly collected pretreatment patient- and tumor-related variables to survival and to identify the terminal nodes via recursive partitioning analysis (RPA) that could be used as a stratification variable for future Phase III trials.
From two Intergroup trials (85-01, n = 130; and 94-05, n = 218) and one Radiation Therapy Oncology Group trial (92-07, n = 68), we identified 416 patients who were treated with definitive concomitant cisplatin and 5-FU-based chemoradiotherapy and analyzed their data for survival by RPA to define prognostic classes. The following pretreatment factors were evaluated: histologic type, age, weight loss, Karnofsky performance status, gender, race, T stage, tumor location, tumor size, N stage, and degree of dysphagia. The entire data set was considered as the initial node. The criterion for split points was the smallest p value less than unadjusted 0.05.
Of the 416 patients, 336 (81%) were dead at the time of the analysis. The RPA identified only one significant split: pretreatment weight loss in the prior 6 months of <10% vs. > or =10%. After adjusting for multiple comparisons, no other split approached statistical significance.
Unlike our experience with malignant glioma, brain metastases, and locally advanced non-small-cell lung cancer, RPA failed to identify novel prognostic information that could be incorporated into the stratification scheme of future chemoradiotherapy trials for esophageal cancer. Furthermore, our analysis validated the percentage of weight loss as a stratification variable for esophageal cancer.
分析统一收集的治疗前患者及肿瘤相关变量对生存的相对贡献,并通过递归划分分析(RPA)确定可作为未来Ⅲ期试验分层变量的终末节点。
从两项协作组试验(85 - 01,n = 130;94 - 05,n = 218)和一项放射肿瘤学组试验(92 - 07,n = 68)中,我们确定了416例接受顺铂与5 - 氟尿嘧啶同步放化疗的患者,并通过RPA分析他们的生存数据以定义预后类别。评估了以下治疗前因素:组织学类型、年龄、体重减轻、卡氏功能状态、性别、种族、T分期、肿瘤位置、肿瘤大小、N分期和吞咽困难程度。整个数据集被视为初始节点。分割点的标准是小于未校正的0.05的最小p值。
在416例患者中,336例(81%)在分析时已死亡。RPA仅确定了一个显著分割:前6个月治疗前体重减轻<10%与≥10%。在进行多重比较校正后,没有其他分割接近统计学显著性。
与我们在恶性胶质瘤、脑转移瘤和局部晚期非小细胞肺癌方面的经验不同,RPA未能识别出可纳入未来食管癌放化疗试验分层方案的新预后信息。此外,我们的分析验证了体重减轻百分比作为食管癌的分层变量。