Division of Surgical Oncology, Department of Surgery, Duke University Medical Center, 2817, Durham, NC, 27710, USA.
Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.
J Gastrointest Surg. 2019 Aug;23(8):1614-1622. doi: 10.1007/s11605-018-04079-8. Epub 2019 Jan 11.
Controversy exists over the use of adjuvant chemotherapy for locally advanced (stages II-III) rectal cancer (LARC) patients who demonstrate pathologic complete response (pCR) following neoadjuvant chemoradiation. We conducted a retrospective analysis to determine whether adjuvant chemotherapy imparts survival benefit among this population.
The National Cancer Database (NCDB) was queried to identify LARC patients with pCR following neoadjuvant chemoradiation. The cohort was stratified by receipt of adjuvant chemotherapy. Multiple imputation and a Cox proportional hazards model were employed to estimate the effect of adjuvant chemotherapy on overall survival.
There were 24,418 patients identified in the NCDB with clinically staged II or III rectal cancer who received neoadjuvant chemoradiation. Of these, 5606 (23.0%) had pCR. Among patients with pCR, 1401 (25%) received adjuvant chemotherapy and 4205 (75%) did not. Patients who received adjuvant chemotherapy were slightly younger, more likely to have private insurance, and more likely to have clinically staged III disease, but did not differ significantly in comparison to patients who did not receive adjuvant chemotherapy with respect to race, sex, facility type, Charlson comorbidity score, histologic tumor grade, procedure type, length of stay, or rate of 30-day readmission following surgery. On adjusted analysis, receipt of adjuvant chemotherapy was associated with a lower risk of death at a given time compared to patients who did not receive adjuvant chemotherapy (HR 0.808; 95% CI 0.679-0.961; p = 0.016).
Supporting existing NCCN guidelines, the findings from this study suggest that adjuvant chemotherapy improves survival for LARC with pCR following neoadjuvant chemoradiation.
对于接受新辅助放化疗后病理完全缓解（pCR）的局部晚期（II-III 期）直肠腺癌（LARC）患者，辅助化疗的应用存在争议。我们进行了一项回顾性分析，以确定在这部分人群中辅助化疗是否能带来生存获益。
我们查询了国家癌症数据库（NCDB），以确定接受新辅助放化疗后 pCR 的 LARC 患者。该队列按接受辅助化疗的情况进行分层。我们采用多重插补和 Cox 比例风险模型来估计辅助化疗对总生存期的影响。
NCDB 中有 24418 例临床分期为 II 期或 III 期直肠腺癌患者接受了新辅助放化疗，其中 5606 例（23.0%）患者 pCR。在 pCR 患者中，1401 例（25%）接受了辅助化疗，4205 例（75%）未接受。接受辅助化疗的患者年龄稍小，更有可能有私人保险，更有可能患有临床分期为 III 期疾病，但与未接受辅助化疗的患者相比，在种族、性别、医疗机构类型、Charlson 合并症评分、组织学肿瘤分级、手术类型、住院时间或手术后 30 天再入院率等方面没有显著差异。在调整分析中，与未接受辅助化疗的患者相比，接受辅助化疗的患者在特定时间死亡的风险较低（HR 0.808；95%CI 0.679-0.961；p=0.016）。
支持现有的 NCCN 指南，本研究的结果表明，对于接受新辅助放化疗后 pCR 的 LARC，辅助化疗可提高生存。
