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基于人群倾向评分分析,术前放化疗和手术后 ypTis-2N0 的直肠癌患者接受辅助化疗似乎没有生存获益。

Adjuvant Chemotherapy Seemed Not to Have Survival Benefit in Rectal Cancer Patients with ypTis-2N0 After Preoperative Radiotherapy and Surgery from a Population-Based Propensity Score Analysis.

机构信息

Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.

Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.

出版信息

Oncologist. 2019 Jun;24(6):803-811. doi: 10.1634/theoncologist.2017-0600. Epub 2018 Apr 19.

Abstract

BACKGROUND

Adjuvant chemotherapy is currently offered routinely, as standard, after radical resection for patients with rectal cancer receiving neo-adjuvant chemoradiation. However, the efficacy of adjuvant chemotherapy in patients with ypTis-2N0M0 has not been documented to the same extent, and the survival benefit remained controversial. The purpose of this work was to determine the role of chemotherapy in patients with ypTis-2N0M0 classification.

MATERIALS AND METHODS

Data were obtained from the Surveillance, Epidemiology, and End Results database ( = 4,217). A propensity score model was utilized to balance baseline covariates.

RESULTS

Of the 4,217 included patients, 335 with ypTis-2N0M0 did not receive adjuvant chemotherapy. There were comparable cancer-specific survivals (CSS) between those undergoing adjuvant chemotherapy or not (log-rank test = 0.136,  = .712) in the overall sample. After propensity score matching, the cancer-specific survival did not differ between the chemotherapy and observation groups (log-rank test = 0.089,  = .765). Additionally, the Cox model did not demonstrate adjuvant chemotherapy as the prognostic factor, with hazard ratio = 0.95 (95% confidence interval 0.69-1.32) for CSS. Furthermore, the 10-year cumulative CSS was 78.7% and 79.4% between the chemotherapy and observation groups, indicating no significance, and no impact of adjuvant chemotherapy on survival was observed in different subgroups stratified by T stage, histological grade, histology, lymph nodes, and tumor size.

CONCLUSION

Patients with ypTis-2N0 rectal cancer did not benefit from adjuvant chemotherapy after preoperative radiology and radical surgery in this cohort study. These results provided new insight into the routine use of adjuvant chemotherapy for patients with rectal cancer with completed neo-adjuvant radiotherapy and curative surgery.

IMPLICATIONS FOR PRACTICE

Inconsistent recommendations for patients with rectal cancer receiving neo-adjuvant chemoradiation are offered by clinical guidelines. Adjuvant chemotherapy had no cancer-specific survival benefit, not only in the whole cohort, but also in the propensity score-matched cohort. A Cox model also confirmed adjuvant chemotherapy was not a significant prognostic factor in ypTis-2N0 rectal cancer. No survival benefit conferred by adjuvant chemotherapy was observed, regardless of whether T stage, histological type, grade, lymph nodes and tumor size varied.

摘要

背景

接受新辅助放化疗的直肠癌患者在根治性切除术后常规接受辅助化疗,但 ypTis-2N0M0 患者的辅助化疗疗效尚未得到充分证实,生存获益仍存在争议。本研究旨在确定化疗在 ypTis-2N0M0 患者中的作用。

材料和方法

数据来自监测、流行病学和最终结果数据库( = 4217)。采用倾向评分模型平衡基线协变量。

结果

在纳入的 4217 例患者中,335 例 ypTis-2N0M0 患者未接受辅助化疗。在整个样本中,接受辅助化疗和未接受辅助化疗的患者的癌症特异性生存率(CSS)相似(log-rank 检验 = 0.136,  = .712)。在倾向评分匹配后,化疗组和观察组的癌症特异性生存率无差异(log-rank 检验 = 0.089,  = .765)。此外,Cox 模型也未显示辅助化疗是预后因素,CSS 的风险比为 0.95(95%置信区间 0.69-1.32)。此外,化疗组和观察组的 10 年累积 CSS 分别为 78.7%和 79.4%,无显著性差异,且在按 T 分期、组织学分级、组织学、淋巴结和肿瘤大小分层的亚组中,未观察到辅助化疗对生存的影响。

结论

在本队列研究中,接受术前放射治疗和根治性手术的 ypTis-2N0 直肠患者未从辅助化疗中获益。这些结果为新辅助放化疗后接受根治性手术和放疗的直肠癌患者常规应用辅助化疗提供了新的见解。

临床意义

临床指南为接受新辅助放化疗的直肠癌患者提供了不一致的建议。辅助化疗不仅在整个队列中,而且在倾向评分匹配队列中,均未带来癌症特异性生存获益。Cox 模型也证实辅助化疗不是 ypTis-2N0 直肠癌症的显著预后因素。无论 T 分期、组织学类型、分级、淋巴结和肿瘤大小如何,辅助化疗均未带来生存获益。

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