Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Jpn J Clin Oncol. 2021 Apr 30;51(5):707-712. doi: 10.1093/jjco/hyaa260.
Surgery is recommended for patients with high-risk submucosal invasive rectal cancer (SM-RC) after local resection but affects the quality of life due to stoma placement or impaired anal function; therefore, alternative treatment approaches are needed to prevent local metastasis. The purpose of this study was to assess the short-term safety of adjuvant chemoradiotherapy with capecitabine in patients with high-risk submucosal invasive rectal cancer after local resection.
This single-arm, multicenter, phase II trial included patients undergoing local resection for high-risk submucosal invasive rectal cancer within 12 weeks prior to enrollment. High-risk submucosal invasive rectal cancer was defined as the presence of at least one of the following factors: poor differentiation of adenocarcinoma, submucosal invasion depth > 1 mm, presence of lymphovascular invasion and grade-2 or -3 tumour budding. Protocol treatment comprised 45.0 Gy radiotherapy with conventional fractionation and 1650 mg/m2 capecitabine given twice daily until radiotherapy completion. The primary endpoint was treatment completion rate with an expected rate of 95% and a threshold of 80%.
Twenty-nine patients from six institutions were enrolled between May 2015 and February 2018. One patient was ineligible. Twenty-three patients completed treatment, with a completion rate of 82% (80% confidence interval, 69-91%); the remaining five patients completed treatment with protocol deviation. The median relative dose intensity of capecitabine was 100% (range, 58-100%). Common adverse events included radiation dermatitis (54%), anal pain (39%) and anal mucositis (29%). No grade-3 or higher adverse events were reported.
Adjuvant chemoradiotherapy using capecitabine demonstrated acceptable short-term safety profiles in patients with high-risk submucosal invasive rectal cancer after local resection.
局部切除术后对于高危黏膜下浸润性直肠癌（SM-RC）患者推荐进行手术，但造口或肛门功能受损会影响生活质量；因此，需要替代治疗方法来预防局部转移。本研究旨在评估局部切除术后高危黏膜下浸润性直肠癌患者接受卡培他滨辅助放化疗的短期安全性。
这是一项单臂、多中心、Ⅱ期临床试验，纳入了在入组前 12 周内行局部切除术治疗的高危黏膜下浸润性直肠癌患者。高危黏膜下浸润性直肠癌定义为至少存在以下一种因素：腺癌分化差、黏膜下浸润深度＞1mm、存在脉管侵犯和 2 级或 3 级肿瘤芽生。方案治疗包括常规分割 45.0Gy 放疗和卡培他滨 1650mg/m2，每日两次，直至放疗结束。主要终点为预计 95%、阈值 80%的治疗完成率。
2015 年 5 月至 2018 年 2 月，六家机构共纳入 29 例患者。1 例患者不符合条件。23 例患者完成了治疗，完成率为 82%（80%置信区间，69-91%）；其余 5 例患者违反方案完成了治疗。卡培他滨的中位相对剂量强度为 100%（范围，58-100%）。常见的不良反应包括放射性皮炎（54%）、肛门疼痛（39%）和肛门黏膜炎（29%）。未报告 3 级或更高级别的不良反应。
局部切除术后高危黏膜下浸润性直肠癌患者接受卡培他滨辅助放化疗具有可接受的短期安全性。
