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新辅助放化疗时代的直肠评分风险分层:长期结果数据的验证。

Risk Stratification Using Neoadjuvant Rectal Score in the Era of Neoadjuvant Chemoradiotherapy: Validation With Long-term Outcome Data.

机构信息

Department of Radiation Oncology, Kyung Hee University College of Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.

Department of Radiation Oncology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

出版信息

Dis Colon Rectum. 2021 Jan;64(1):60-70. doi: 10.1097/DCR.0000000000001777.

DOI:10.1097/DCR.0000000000001777
PMID:33306532
Abstract

BACKGROUND

Despite the widespread use of neoadjuvant chemoradiotherapy, there is no prognostic surrogate marker established in locally advanced rectal cancer.

OBJECTIVE

This study evaluated the role of neoadjuvant rectal score as a prognostic factor to stratify individual-level risks of survival and tumor recurrence.

DESIGN

This is a retrospective study.

SETTINGS

This study was conducted at the Seoul National University Hospital.

PATIENTS

A total of 397 patients who underwent chemoradiotherapy plus total mesorectal excision were analyzed.

INTERVENTIONS

There was no intervention.

MAIN OUTCOME MEASURES

Harrell C statistic and receiver operating characteristic analysis, as well as Cox regression analysis, were used to assess the prognostic strength.

RESULTS

The low (<8), intermediate (8-16), and high (>16) neoadjuvant rectal score groups included 91 (23%), 208 (52%), and 98 patients (25%). A high neoadjuvant rectal score was independently associated with inferior overall survival and disease-free survival (p = 0.011 and 0.008). Regarding the prognostic models adjusted for neoadjuvant rectal score (I) and ypT/N stage (II), the c-index was higher in model I (0.799 and 0.787, p = 0.009 for overall survival; 0.752 and 0.743, p = 0.093 for disease-free survival). The predictive ability of the neoadjuvant rectal score was superior to tumor regression grade, ypT, and ypN in the receiver operating characteristic analyses (p < 0.05 for all). Adjuvant chemotherapy was associated with better overall and disease-free survival (p = 0.003 and 0.052) in the high neoadjuvant rectal score group.

LIMITATIONS

Potential selection bias attributed to the retrospective study design was a limitation.

CONCLUSIONS

We verified the applicability of the neoadjuvant rectal score to stratify the relapse risk at the individual level for patients with stage II/III rectal cancer undergoing neoadjuvant chemoradiotherapy. Additional studies are needed to validate the usability of neoadjuvant rectal score levels as a determinant of adjuvant strategy. See Video Abstract at http://links.lww.com/DCR/B354. ESTRATIFICACIÓN DE RIESGO UTILIZANDO LA PUNTUACIÓN RECTAL NEOADYUVANTE EN LA ERA DE LA QUIMIORRADIOTERAPIA NEOADYUVANTE: VALIDACIÓN CON DATOS DE RESULTADOS A LARGO PLAZO: A pesar del uso generalizado de la quimiorradioterapia neoadyuvante, no existe un marcador subrogado pronóstico establecido en el cáncer de recto localmente avanzado.Este estudio evaluó el papel de la puntuación rectal neoadyuvante como factor pronóstico para estratificar los riesgos a nivel individual de supervivencia y recurrencia tumoral.Este es un estudio retrospectivo.Este estudio se realizó en el Hospital de la Universidad Nacional de Seúl.Se analizaron un total de 397 pacientes que se sometieron a quimiorradioterapia más escisión mesorrectal total.No hubo intervención.El análisis estadístico C de Harrell y las características operativas del receptor, así como el análisis de regresión de Cox, se utilizaron para evaluar la fuerza pronóstica.Los grupos de puntaje rectal neoadyuvante bajo (<8), intermedio (8-16) y alto (> 16) incluyeron 91 (23%), 208 (52%) y 98 (25%) pacientes, respectivamente. Una puntuación rectal neoadyuvante alta se asoció independientemente con una supervivencia general y una supervivencia libre de enfermedad inferiores (p = 0.011 y 0.008, respectivamente). Con respecto a los modelos pronósticos ajustados por la puntuación rectal neoadyuvante (I) y el estadio ypT/N (II), el índice c fue mayor en el modelo I (0.799 y 0.787, p = 0.009 para la supervivencia general; 0.752 y 0.743, p = 0.093 para supervivencia libre de enfermedad). La capacidad predictiva de la puntuación rectal neoadyuvante fue superior al grado de regresión tumoral, ypT y ypN en los análisis de características operativas del receptor (p <0.05 para todos). La quimioterapia adyuvante se asoció con una mejor supervivencia global y libre de enfermedad (p = 0.003 y 0.052, respectivamente) en el grupo de puntaje rectal neoadyuvante alto.El sesgo de selección potencial debido al diseño retrospectivo del estudio fue la limitación.Verificamos la aplicabilidad de la puntuación rectal neoadyuvante para estratificar el riesgo de recurrencia a nivel individual para pacientes con cáncer rectal en estadio II/III sometidos a quimiorradioterapia neoadyuvante. Se necesitan más estudios para validar la usabilidad de los niveles de puntuación rectal neoadyuvante como determinante de la estrategia adyuvante. Consulte Video Resumen en http://links.lww.com/DCR/B354.

摘要

背景

尽管新辅助放化疗得到广泛应用,但局部晚期直肠癌仍缺乏明确的预后替代标志物。

目的

本研究旨在评估新辅助直肠评分作为一种预后因素,以分层个体水平的生存和肿瘤复发风险。

设计

这是一项回顾性研究。

地点

本研究在首尔国立大学医院进行。

患者

共分析了 397 例接受放化疗联合全直肠系膜切除术的患者。

干预措施

无干预措施。

主要观察指标

Harrell C 统计量和接受者操作特征分析,以及 Cox 回归分析,用于评估预后强度。

结果

低(<8)、中(8-16)和高(>16)新辅助直肠评分组分别包括 91(23%)、208(52%)和 98 例患者(25%)。高新辅助直肠评分与总生存和无病生存较差独立相关(p=0.011 和 0.008)。关于调整新辅助直肠评分(I)和 ypT/N 分期(II)的预后模型,I 模型的 C 指数更高(0.799 和 0.787,p=0.009 用于总生存;0.752 和 0.743,p=0.093 用于无病生存)。新辅助直肠评分的预测能力在接受者操作特征分析中优于肿瘤退缩分级、ypT 和 ypN(所有 p<0.05)。在高新辅助直肠评分组中,辅助化疗与更好的总生存(p=0.003)和无病生存(p=0.052)相关。

局限性

研究设计的回顾性导致潜在选择偏倚是一个限制。

结论

我们验证了新辅助直肠评分在分层接受新辅助放化疗的 II/III 期直肠癌患者复发风险方面的适用性。需要进一步的研究来验证新辅助直肠评分水平作为辅助策略决定因素的可用性。请观看视频摘要,网址:http://links.lww.com/DCR/B354。

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