Department of Oncology, Sheba Medical Center, Tel-Hashomer, Israel
Tel-Aviv University, Tel-Aviv, Israel.
Oncologist. 2019 Aug;24(8):e671-e676. doi: 10.1634/theoncologist.2018-0333. Epub 2019 Jan 29.
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.
背景：目前的指南包括在临床 II 期或 III 期直肠腺癌中使用辅助奥沙利铂。然而，其疗效仅得到一项 II 期试验的支持。我们旨在研究奥沙利铂是否能为这一患者群体带来生存获益。
方法：我们利用国家癌症数据库（2006-2013 年），确定了 6868 例接受新辅助放化疗、手术和辅助化疗的临床 II 期或 III 期直肠腺癌患者。我们使用多变量 Cox 回归来评估根据治疗强度和临床至病理分期变化的生存差异。
结果：我们发现，在病理 III 期直肠腺癌患者中，使用双联辅助化疗与总体生存改善相关（风险比 [HR]，0.78；95%置信区间 [CI]，0.67-0.92）。这一关联在临床 III 期且随后病理 III 期疾病的患者中得到了证实（HR，0.69；95% CI，0.57-0.83），而在从临床 II 期进展至病理 III 期疾病的患者中并未观察到。双联辅助化疗与病理 0 期或 I 期疾病患者的总体生存改善无关，无论其临床分期如何。
结论：在新辅助放化疗后，奥沙利铂在直肠腺癌患者的临床 III 期和随后的病理 III 期疾病中得到了证实。在病理完全缓解或病理 I 期疾病中，可以考虑不使用奥沙利铂。
临床意义：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，其疗效仅得到一项 II 期试验的支持。本研究发现，在诊断为临床 III 期且随后为病理 III 期的患者中，使用双联 AC 与总体生存改善相关，而在病理 0 期或 I 期患者中则没有，无论其临床分期如何。因此，在病理完全缓解或病理 I 期 RAC 患者中可以考虑不使用奥沙利铂，从而避免奥沙利铂引起的周围神经病变。
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