A Prospective Multicenter Phase II Study on the Feasibility and Efficacy of S-1 and Oxaliplatin Neoadjuvant Chemotherapy for Locally Advanced Rectal Cancer
A Prospective Multicenter Phase II Study on the Feasibility and Efficacy of S-1 and Oxaliplatin Neoadjuvant Chemotherapy for Locally Advanced Rectal Cancer
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DOI：
10.1097/dcr.0000000000001927
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发表时间：
2022-05-01
影响因子：
3.9
通讯作者：
Hakamada, Kenichi
中科院分区：
文献类型：
--
作者：
Sakamoto, Yoshiyuki;Morohashi, Hajime;Hakamada, Kenichi
背景：新辅助放化疗和全直肠系膜切除构成了多个指南中直肠癌的护理标准。然而，新辅助放化疗并没有表现出明显的生存获益，反而导致了不良事件的增加。相反，新辅助化疗有望预防放疗引起的不良事件，但这种治疗方法仍存在争议。 目的：本研究的目的是评估 S-1 和奥沙利铂新辅助化疗联合全直肠系膜切除术治疗可切除局部晚期直肠癌的可行性和疗效。设计：该研究是一项前瞻性、单组 II 期试验。背景：该研究在多个机构进行。患者：58 名患者纳入可切除的局部晚期直肠癌患者。干预：术前给予三个周期的 S-1 和奥沙利铂。 S-1 每天口服 80 mg/m(2)，连续 14 天，然后休息 7 天。第一天以每天 130 mg/m(2) 的剂量静脉注射奥沙利铂。 1个周期的持续时间被认为是21天。新辅助化疗后行全直肠系膜切除联合双侧淋巴结清扫。 主要观察指标：本研究旨在检测S-1联合奥沙利铂新辅助化疗的可行性和疗效。结果：S-1联合奥沙利铂新辅助化疗3个疗程完成率为94.8%（55/58）。停药的原因是血小板减少症（3.4%）和肝损伤（1.7%）。新辅助化疗最常见的严重（≥ 3 级）不良反应是血小板减少症（3.4%）。没有严重的不良临床症状。结果，52 名患者中有 51 名 (98.1%) 实现了 R0 切除。 10 名患者 (19.2%) 出现病理完全缓解。 局限性：这是一项单臂、非随机 II 期研究。 结论：S-1 和奥沙利铂新辅助化疗与全直肠系膜切除相结合是可切除局部晚期直肠癌的一种可行且有前景的治疗选择。请参阅视频摘要：http://linksiww.com/DCR/B555。
BACKGROUND: Neoadjuvant chemoradiotherapy and total mesorectal excision compose the standard of care for rectal cancer in multiple guidelines. However, neoadjuvant chemoradiotherapy has not exhibited clear survival benefits but rather has led to an increase in adverse events. Conversely, neoadjuvant chemotherapy is expected to prevent adverse events caused by radiation, yet this treatment is still controversial.OBJECTIVE: The purpose of this study was to evaluate the feasibility and efficacy of S-1 and oxaliplatin neoadjuvant chemotherapy together with total mesorectal excision for resectable locally advanced rectal cancer.DESIGN: The study was a prospective, single-arm phase II trial.SETTINGS: The study was conducted at multiple institutions.PATIENTS: Fifty-eight patients with resectable locally advanced rectal cancer were enrolled.INTERVENTION: Three cycles of S-1 and oxaliplatin were administered before surgery. S-1 was administered orally at 80 mg/m(2) per day for 14 consecutive days, followed by a 7-day resting period. Oxaliplatin was given intravenously on the first day at a dose of 130 mg/m(2) per day. The duration of 1 cycle was considered to be 21 days. Total mesorectal excision with bilateral lymph node dissection was carried out after neoadjuvant chemotherapy.MAIN OUTCOME MEASURES: The study was designed to detect the feasibility and efficacy of S-1 and oxaliplatin as neoadjuvant chemotherapy.RESULTS: The completion rate of 3 courses of S-1 and oxaliplatin as neoadjuvant chemotherapy was 94.8% (55/58). The reasons for discontinuation were thrombocytopenia (3.4%) and liver injury (1.7%). The most common severe (grade >= 3) adverse effect of neoadjuvant chemotherapy was thrombocytopenia (3.4%). There were no severe adverse clinical symptoms. Consequently, R0 resection was achieved in 51 (98.1%) of 52 patients. Pathologic complete response occurred in 10 patients (19.2%).LIMITATIONS: This was a single-arm, nonrandomized phase II study.CONCLUSIONS: The combination of S-1 and oxaliplatin neoadjuvant chemotherapy and total mesorectal excision is a feasible and promising treatment option for resectable locally advanced rectal cancer. See Video Abstract at http://linksiww.com/DCR/B555.