Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina, Charleston.
Department of Public Health Sciences, Medical University of South Carolina, Charleston.
JAMA Otolaryngol Head Neck Surg. 2020 May 1;146(5):455-464. doi: 10.1001/jamaoto.2020.0222.
The standard of care for initiation of postoperative radiotherapy (PORT) in head and neck squamous cell carcinoma (HNSCC) is within 6 weeks of surgical treatment. Delays in guideline-adherent PORT initiation are common, associated with mortality, and a measure of quality care, but patient-specific tools to estimate the risk of these delays are lacking.
To develop and validate 2 nomograms (that use presurgical and postsurgical data) for predicting delayed PORT initiation.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study obtained patient data from January 1, 2004, to December 31, 2015, from the National Cancer Database. Adults aged 18 years or older with a newly diagnosed HNSCC who underwent surgical treatment and PORT at a Commission on Cancer-accredited facility were included. Data analysis was conducted from June 2, 2019, to January 29, 2020.
Surgical treatment and PORT.
The primary outcome measure was PORT initiation more than 6 weeks after the surgical intervention. Multivariable logistic regression models were created in a random selection of 80% of the sample (derivation cohort) and were internally validated with bootstrapping, assessed for discrimination by calibration plots and the concordance (C) index, and externally validated in the remaining 20% of the sample (validation cohort).
The study included 60 766 adults with HNSCC who were grouped into derivation and validation cohorts. The derivation cohort comprised 48 625 patients (mean [SD] age, 59.59 [11.3] years; 36 825 men [75.7%]) selected randomly from the full sample, whereas 12 151 patients (mean [SD] age, 59.63 [11.2] years; 9266 men [76.3%]) composed the validation cohort. The rate of PORT delay was 55.8% (n=27140) in the derivation cohort and 56.7% (n=6900) in the validation cohort. Both nomograms created to predict the risk of PORT initiation delay used variables, including race/ethnicity, insurance type, tumor site, and facility type. The nomogram based on presurgical variables included clinical stage and severity of comorbidity, whereas the nomogram with postsurgical variables included US region, length of stay, and care fragmentation between surgical and radiotherapy facilities. For the presurgical nomogram, the concordance indices were 0.670 (95% CI, 0.664-0.676) in the derivation cohort and 0.674 (95% CI, 0.662-0.685) in the validation cohort. For the nomogram with postsurgical variables, the concordance indices were 0.691 (95% CI, 0.686-0.696) in the derivation cohort and 0.694 (95% CI, 0.685-0.704) in the validation cohort.
This study found that a nomogram developed with presurgical data to generate personalized estimates of PORT initiation delay may improve pretreatment counseling and the delivery of interventions to patients at high risk for such a delay. A nomogram including postsurgical data can drive institutional quality improvement initiatives and enhance risk-adjusted comparisons of delay rates across facilities.
头颈部鳞状细胞癌(HNSCC)术后放疗(PORT)的标准是在手术治疗后 6 周内开始。遵循指南的 PORT 起始延迟很常见,与死亡率有关,也是衡量护理质量的一个标准,但缺乏用于估计这些延迟风险的患者特定工具。
开发并验证 2 个列线图(使用术前和术后数据)来预测 PORT 起始延迟。
设计、地点和参与者:本队列研究从 2004 年 1 月 1 日至 2015 年 12 月 31 日从国家癌症数据库中获取患者数据。纳入了在癌症委员会认可的机构接受手术治疗和 PORT 的新诊断为 HNSCC 的 18 岁或以上成年人。数据分析于 2019 年 6 月 2 日至 2020 年 1 月 29 日进行。
手术治疗和 PORT。
主要结局是 PORT 起始时间比手术干预后超过 6 周。在随机选择的 80%的样本(推导队列)中创建多变量逻辑回归模型,并通过自举进行内部验证,通过校准图和一致性(C)指数评估区分度,并在剩余的 20%的样本(验证队列)中进行外部验证。
本研究纳入了 60766 名患有 HNSCC 的成年人,他们被分为推导和验证队列。推导队列由 48625 名患者(平均[SD]年龄,59.59[11.3]岁;36825 名男性[75.7%])随机选自全样本,而 12151 名患者(平均[SD]年龄,59.63[11.2]岁;9266 名男性[76.3%])组成验证队列。推导队列中 PORT 延迟的发生率为 55.8%(n=27140),验证队列中为 56.7%(n=6900)。为预测 PORT 起始延迟风险而创建的两个列线图都使用了变量,包括种族/民族、保险类型、肿瘤部位和机构类型。基于术前变量的列线图包括临床分期和合并症严重程度,而基于术后变量的列线图包括美国地区、住院时间和手术与放疗机构之间的护理碎片化。对于术前列线图,推导队列的一致性指数为 0.670(95%CI,0.664-0.676),验证队列的一致性指数为 0.674(95%CI,0.662-0.685)。对于术后变量的列线图,推导队列的一致性指数为 0.691(95%CI,0.686-0.696),验证队列的一致性指数为 0.694(95%CI,0.685-0.704)。
本研究发现,使用术前数据生成 PORT 起始延迟个性化估计的列线图可能会改善治疗前咨询,并为高延迟风险患者提供干预措施。包含术后数据的列线图可以推动机构质量改进计划,并增强设施间延迟率的风险调整比较。