胰腺癌辅助治疗后，切除术后CA19-9和切缘状态作为复发预测指标：NRG肿瘤学RTOG 9704试验分析
Postresection CA19-9 and margin status as predictors of recurrence after adjuvant treatment for pancreatic carcinoma: Analysis of NRG oncology RTOG trial 9704.
作者信息
Regine William F, Winter Kathryn, Abrams Ross A, Safran Howard, Kessel Ivan L, Chen Yuhchyau, Fugazzi James A, Donnelly Eric D, DiPetrillo Thomas A, Narayan Samir, Plastaras John P, Gaur Rakesh, Delouya Guila, Suh John H, Meyer Joshua E, Haddock Michael G, Didolkar Mukund S, Padula Gilbert D A, Johnson David, Hoffman John P, Crane Christopher H
机构信息
University of Maryland School of Medicine, Baltimore, Maryland.
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
出版信息
Adv Radiat Oncol. 2018 Feb 9;3(2):154-162. doi: 10.1016/j.adro.2018.01.003. eCollection 2018 Apr-Jun.
PURPOSE
NRG Oncology RTOG 9704 was the first adjuvant trial to validate the prognostic value of postresection CA19-9 levels for survival in patients with pancreatic carcinoma. The data resulting from this study also provide information about predictors of recurrence that may be used to tailor individualized management in this disease setting. This secondary analysis assessed the prognostic value of postresection CA19-9 and surgical margin status (SMS) in predicting patterns of disease recurrence.
METHODS AND MATERIALS
This multicenter cooperative trial included participants who were enrolled as patients at oncology treatment sites in the United States and Canada. The study included 451 patients analyzable for SMS, of whom 385 were eligible for postresection CA19-9 analysis. Postresection CA19-9 was analyzed at cut points of 90, 180, and continuously. Patterns of disease recurrence included local/regional recurrence (LRR) and distant failure (DF). Multivariable analyses included treatment, tumor size, and nodal status. To adjust for multiple comparisons, a value of ≤ .01 was considered statistically significant and > .01 to ≤ .05 to be a trend.
RESULTS
For CA19-9, 132 (34%) patients were Lewis antigen-negative (no CA19-9 expression), 200 (52%) had levels <90, and 220 (57%) had levels <180. A total of 188 patients (42%) had negative margins, 152 (34%) positive, and 111 (25%) unknown. On univariate analysis, CA19-9 cut at 90 was associated with increases in LRR (trend) and DF. Results were similar at the 180 cut point. SMS was not associated with an increase in LRR on univariate or multivariate analyses. On multivariable analysis, CA19-9 ≥ 90 was associated with increased LRR and DF. Results were similar at the 180 cut point.
CONCLUSIONS
In this prospective evaluation, postresection CA19-9 was a significant predictor of both LRR and DF, whereas SMS was not. These findings support consideration of adjuvant radiation therapy dose intensification in patients with elevated postresection CA19-9.
目的
NRG肿瘤学RTOG 9704是首个验证切除术后CA19-9水平对胰腺癌患者生存预后价值的辅助试验。该研究所得数据还提供了关于复发预测因素的信息，这些信息可用于在这种疾病背景下制定个体化治疗方案。这项二次分析评估了切除术后CA19-9和手术切缘状态（SMS）在预测疾病复发模式方面的预后价值。
方法和材料
这项多中心合作试验纳入了在美国和加拿大肿瘤治疗机构登记的患者。该研究包括451例可分析手术切缘状态的患者，其中385例符合切除术后CA19-9分析的条件。切除术后CA19-9在90、180的切点以及连续水平上进行分析。疾病复发模式包括局部/区域复发（LRR）和远处转移（DF）。多变量分析包括治疗、肿瘤大小和淋巴结状态。为校正多重比较，P值≤0.01被认为具有统计学意义，>0.01至≤0.05被视为有趋势。
结果
对于CA19-9，132例（34%）患者为Lewis抗原阴性（无CA19-9表达），200例（52%）水平<90，220例（57%）水平<180。共有188例患者（42%）切缘阴性，152例（34%）阳性，111例（25%）未知。单因素分析中，CA19-9切点为90与局部/区域复发（趋势）和远处转移增加相关。在切点为180时结果相似。手术切缘状态在单因素或多因素分析中与局部/区域复发增加无关。多变量分析中，CA19-9≥90与局部/区域复发和远处转移增加相关。在切点为180时结果相似。
结论
在这项前瞻性评估中，切除术后CA19-9是局部/区域复发和远处转移的重要预测指标，而手术切缘状态不是。这些发现支持对切除术后CA19-9升高的患者考虑强化辅助放疗剂量。
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