辅助化疗与新辅助化疗和切除术后病理完全缓解的直肠癌患者总生存的关系。
Association of Adjuvant Chemotherapy With Overall Survival in Patients With Rectal Cancer and Pathologic Complete Response Following Neoadjuvant Chemotherapy and Resection.
机构信息
Department of Surgery, University of Texas Southwestern Medical Center, Dallas.
Department of Veterans Affairs North Texas Health Care System, Dallas.
出版信息
JAMA Oncol. 2018 Jul 1;4(7):938-943. doi: 10.1001/jamaoncol.2018.0231.
IMPORTANCE
Adjuvant chemotherapy (AC) in patients with rectal cancer with pathologic complete response following neoadjuvant chemoradiotherapy (nCRT) and resection is recommended by treatment guidelines. However, its role in this setting is equivocal because data supporting benefits are lacking.
OBJECTIVE
To compare the overall survival (OS) between AC and postoperative observation (OB) in patients with rectal cancer with pathologic complete response following nCRT and resection.
DESIGN, SETTING, AND PARTICIPANTS: We identified a cohort of patients with rectal cancer and a complete pathological response (ypT0N0) after nCRT in the National Cancer Database between 2006 and 2012. Patients who received AC were compared with OB patients by propensity score matching. Overall survival was compared using the stratified log-rank test and stratified Cox regression model. The outcomes after AC vs OB were also evaluated in patient subgroups. The data analysis was completed in June 2017.
EXPOSURES
Adjuvant chemotherapy and OB.
MAIN OUTCOMES AND MEASURES
Overall survival.
RESULTS
We identified 2764 patients (mean [SD] age, 60.0 [12.3] years; 40% female) with clinical stage II or III resected adenocarcinoma of the rectum who had received nCRT and were complete responders (ypT0N0M0). Of this cohort, 741 patients in the AC group were matched by propensity score to 741 patients who underwent OB. The AC cohort had better OS compared with the OB cohort (hazard ratio, 0.50; 95% CI, 0.32-0.79). The 1-, 3-, and 5-year OS rates were 99.7%, 97.1%, and 94.7% for the AC group and 99.2%, 93.6%, and 88.4% for the OB group (P = .005). In subgroup analysis, patients with clinical stage T3/T4 and node-positive disease benefited most from AC (hazard ratio, 0.47; 95% CI, 0.25-0.91).
CONCLUSIONS AND RELEVANCE
Adjuvant chemotherapy was associated with improved OS in patients with pathologic complete response after nCRT for resected locally advanced rectal cancer. This study supports the use of AC in this setting where there is currently paucity of data.
重要性
对于接受新辅助放化疗（nCRT）和切除术后病理完全缓解的直肠患者，治疗指南推荐辅助化疗（AC）。然而，在这种情况下，它的作用是有争议的，因为缺乏支持获益的数据。
目的
比较接受 nCRT 和切除术后病理完全缓解的直肠患者接受 AC 与术后观察（OB）的总生存率（OS）。
设计、设置和参与者：我们在 2006 年至 2012 年期间，在国家癌症数据库中确定了一个接受 nCRT 后完全病理缓解（ypT0N0）的直肠患者队列。通过倾向评分匹配，将接受 AC 的患者与 OB 患者进行比较。使用分层对数秩检验和分层 Cox 回归模型比较总生存率。还在患者亚组中评估了 AC 后与 OB 后的结果。数据分析于 2017 年 6 月完成。
暴露
辅助化疗和 OB。
主要结果和测量
总生存率。
结果
我们确定了 2764 例接受 nCRT 并完全缓解（ypT0N0M0）的临床分期 II 或 III 期直肠腺癌切除患者（平均[SD]年龄，60.0[12.3]岁；40%为女性）。在此队列中，AC 组的 741 例患者通过倾向评分与 741 例接受 OB 的患者相匹配。与 OB 组相比，AC 组的 OS 更好（风险比，0.50；95%CI，0.32-0.79）。AC 组的 1、3 和 5 年 OS 率分别为 99.7%、97.1%和 94.7%，OB 组分别为 99.2%、93.6%和 88.4%（P=0.005）。在亚组分析中，临床分期 T3/T4 和淋巴结阳性疾病患者从 AC 中获益最大（风险比，0.47；95%CI，0.25-0.91）。
结论和相关性
在接受 nCRT 治疗的局部晚期直肠患者中，病理完全缓解后接受辅助化疗与 OS 改善相关。本研究支持在目前数据匮乏的情况下在这种情况下使用 AC。
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