From the Department of Surgery; Division of Hematology/Oncology, Department of Medicine; and Department of Radiation Oncology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
J Natl Compr Canc Netw. 2015 May;13(5):531-41. doi: 10.6004/jnccn.2015.0073.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer recommend adjuvant chemotherapy with or without radiotherapy following after resection of gastric adenocarcinoma (GA) for patients who have not received neoadjuvant therapy. Despite frequent noncompliance with NCCN Guidelines nationally, risk factors underlying adjuvant therapy omission (ATom) have not been well characterized. We developed an internally validated preoperative instrument stratifying patients by incremental risk of ATom. The National Cancer Data Base was queried for patients with stage IB-III GA undergoing gastrectomy; those receiving neoadjuvant therapy were excluded. Multivariable models identified factors associated with ATom between 2006 and 2011. Internal validation was performed using bootstrap analysis; model discrimination and calibration were assessed using k-fold cross-validation and Hosmer-Lemeshow procedures, respectively. Using weighted β-coefficients, a simplified Omission Risk Score (ORS) was created to stratify ATom risk. The impact of ATom on overall survival (OS) was examined in ORS risk-stratified cohorts. In 4,728 patients (median age, 70 years; 64.8% male), 53.7% had ATom. The bootstrap-validated model identified advancing age, comorbidity, underinsured/uninsured status, proximal tumor location, and clinical T1/2 and N0 tumors as independent ATom predictors, demonstrating good discrimination. The simplified ORS, stratifying patients into low-, moderate-, and high-risk categories, predicted incremental risk of ATom (30% vs 53% vs 80%, respectively) and progressive delay to adjuvant therapy initiation (median time, 51 vs 55 vs 61 days, respectively). Patients at moderate/high-risk of ATom demonstrated worsening risk-adjusted mortality compared with low-risk patients (median OS, 26.4 vs 29.2 months). This ORS may aid in rational selection of multimodality treatment sequence in GA.
NCCN 临床肿瘤学实践指南（NCCN 指南）建议在胃腺癌（GA）切除术后对未接受新辅助治疗的患者进行辅助化疗，联合或不联合放疗。尽管全国范围内经常不遵守 NCCN 指南，但辅助治疗遗漏（ATom）的相关风险因素尚未得到很好的描述。我们开发了一种内部验证的术前工具，根据 ATom 的增量风险对患者进行分层。从国家癌症数据库中查询接受胃切除术的 IB-III 期 GA 患者；排除接受新辅助治疗的患者。使用多变量模型确定了 2006 年至 2011 年期间与 ATom 相关的因素。使用 bootstrap 分析进行内部验证；分别使用 k 折交叉验证和 Hosmer-Lemeshow 程序评估模型区分度和校准度。使用加权β系数，创建了一个简化的遗漏风险评分（ORS），以分层 ATom 风险。在 ORS 风险分层队列中检查了 ATom 对总生存（OS）的影响。在 4728 例患者（中位年龄 70 岁；64.8%为男性）中，53.7%的患者存在 ATom。经 bootstrap 验证的模型确定了年龄增长、合并症、保险不足/无保险状态、近端肿瘤位置以及临床 T1/2 和 N0 肿瘤是独立的 ATom 预测因素，具有良好的区分度。简化的 ORS 将患者分为低危、中危和高危人群，预测了 ATom 的增量风险（分别为 30%、53%和 80%）和辅助治疗开始时间的逐渐延迟（中位时间分别为 51、55 和 61 天）。与低危患者相比，中/高危 ATom 患者的风险调整死亡率恶化（中位 OS，26.4 与 29.2 个月）。该 ORS 可能有助于合理选择 GA 的多模式治疗顺序。
