Background: Current guidelines include the use of adjuvant oxaliplatin in clinical stage II or III rectal adenocarcinoma. However, its efficacy is supported by a single phase II trial. We aimed to examine whether oxaliplatin confers survival benefit in this patient population.
Methods: Using the National Cancer Database (2006-2013) we identified 6,868 individuals with clinical stage II or III rectal adenocarcinoma treated with neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy. We used multivariate Cox regression to evaluate survival differences according to treatment intensity and change from clinical to pathological stage.
Results: We demonstrated an association with improved overall survival with the use of doublet adjuvant chemotherapy in pathological stage III rectal adenocarcinoma (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.67-0.92). This association was confirmed in patients with clinical stage III and subsequent pathological stage III disease (HR, 0.69; 95% CI, 0.57-0.83) and was not observed in patients who progressed from clinical stage II to pathological stage III disease. Doublet adjuvant chemotherapy was not associated with improved overall survival in patients with pathological stage 0 or I disease, regardless of their clinical stage.
Conclusion: Adjuvant oxaliplatin following neoadjuvant chemoradiotherapy in rectal adenocarcinoma was confirmed in patients with clinical stage III and subsequent pathological stage III disease. Omission of oxaliplatin can be considered in pathological complete response or pathological stage I disease.
Implications for practice: Current guidelines include the use of oxaliplatin as part of adjuvant chemotherapy (AC) in patients with clinical stage II or III rectal adenocarcinoma (RAC). However, its efficacy is supported only by a single phase II trial. This study found an association with improved overall survival with the use of doublet AC in patients diagnosed with clinical stage III and subsequent pathological stage III, and not in patients with pathological stage 0 or I, regardless of their clinical stage. Therefore, omission of oxaliplatin can be considered in patients with either pathological complete response or pathological stage I RAC, thereby avoiding oxaliplatin-induced neuropathy.
摘要
背景。目前的指南包括在临床 II 或 III 期直肠腺癌中使用奥沙利铂辅助化疗。然而，他的疗效仅由单臂 II 期试验支持。我们的目的是检验奥沙利铂是否对该患者群体的生存有益。
方法。通过国家癌症数据库(2006 ‐ 2013 年)，我们确定了 6 868 名经过新辅助放化疗、手术和辅助化疗治疗的临床 II 期或 III 期直肠腺癌患者。我们使用多变量 Cox 回归分析根据治疗强度和从临床到病理分期的改变来评估的生存期差异。
结果。我们证实了在病理 III 期直肠腺癌中使用双联辅助化疗与总生存率得到改善之间存在关联 [风险比 (HR)，0.78；95% 置信区间 (CI)，0.67‐0.92]。这种关联在临床 III 期和随后的病理 III 期疾病(HR，0.69；95% CI，0.57‐0.83)的患者中得到证实，且并未在从临床 II 期进展至病理 III 期疾病的患者中观察到。无论临床分期如何，双联辅助化疗与病理 0 期或 I 期患者的总体生存率改善均无关。
结论。在临床 III 期和随后的病理 III 期疾病患者中确认了直肠腺癌新辅助放化疗后进行奥沙利铂辅助化疗。在病理性完全缓解或病理性 I 期疾病中可考虑省掉奥沙利铂辅助化疗。
实践意义:目前的指南包括在临床 II 期或 III 期直肠腺癌 (RAC) 患者中使用奥沙利铂作为辅助化疗 (AC) 的一部分。然而，其功效仅由单臂 II 期试验支持。本研究发现，无论其临床分期如何，在被诊断为临床 III 期和随后的病理 III 期的患者中，而不是在病理 0 期或 I 期的患者中，使用双联 AC 与总生存率得到改善存在关联。因此，在病理性完全缓解或病理 I 期 RAC 的患者中可以考虑省掉奥沙利铂，从而避免奥沙利铂诱发的神经病变。
Keywords: Adjuvant; Oxaliplatin; Rectal cancer; Stage II; Stage III.
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