Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Cancer Med. 2023 Jun;12(12):13352-13360. doi: 10.1002/cam4.6034. Epub 2023 May 8.
BACKGROUND: Standard treatment of locally advanced rectal cancer (LARC) was neoadjuvant chemoradiotherapy (CRT), followed by total mesorectal excision (TME). Total neoadjuvant treatment (TNT), a new concept, attempts to deliver both systemic chemotherapy and neoadjuvant CRT prior to surgery. Patients treated with neoadjuvant chemotherapy were more likely to show higher tumor regression. The objective of this trial was to increase complete clinical rate (cCR) for LARC patients by optimizing tumor response, using TNT regimen as compared to conventional chemoradiotherapy. TESS, a prospective, open-label, multicenter, single-arm, phase 2 study, is underway. METHODS: Main inclusion criteria include cT3-4aNany or cT1-4aN+ rectal adenocarcinoma aged 18-70y; Eastern Cooperative Oncology Group (ECOG) performance 0-1; location ≤5 cm from anal verge. Ninety-eight patients will receive 2 cycles of neoadjuvant chemotherapy Capeox (capecitabine + oxaliplatin) before, during, and after radiotherapy 50Gy/25 fractions, before TME (or other treatment decisions, such as Watch and Wait strategy) and adjuvant chemotherapy capecitabine 2 cycles. Primary endpoint is the cCR rate. Secondary endpoints include ratio of sphincter preservation strategy; pathological complete response rate and tumor regression grade distribution; local recurrence or metastasis; disease-free survival; locoregional recurrence-free survival; acute toxicity; surgical complications; long-term anal function; late toxicity; adverse effect, ECOG standard score, and quality of life. Adverse events are graded per Common Terminology Criteria for Adverse Events V5.0. Acute toxicity will be monitored during antitumor treatment, and late toxicity will be monitored for 3 years from the end of the first course of antitumor treatment. DISCUSSION: The TESS trial aims to explore a new TNT strategy, which is expected to increase the rate of cCR and sphincter preservation rate. This study will provide new options and evidence for a new sandwich TNT strategy in patients with distal LARC.
背景：局部晚期直肠癌（LARC）的标准治疗方法是新辅助放化疗（CRT），然后进行全直肠系膜切除术（TME）。全新的概念——全新辅助治疗（TNT），尝试在手术前同时给予全身化疗和新辅助 CRT。接受新辅助化疗的患者更有可能表现出更高的肿瘤消退。本试验的目的是通过优化肿瘤反应，使用 TNT 方案与常规放化疗相比，提高 LARC 患者的完全临床缓解率（cCR）。TESS 是一项正在进行的前瞻性、开放标签、多中心、单臂、2 期研究。
方法：主要纳入标准包括 cT3-4aNany 或 cT1-4aN+直肠腺癌，年龄 18-70 岁；东部肿瘤协作组（ECOG）表现 0-1；肿瘤位置距肛门缘≤5cm。98 例患者将在放疗 50Gy/25 次时，在接受新辅助化疗 Capeox（卡培他滨+奥沙利铂）之前、期间和之后，在 TME（或其他治疗决策，如观察等待策略）和辅助化疗卡培他滨 2 个周期前接受治疗。主要终点是 cCR 率。次要终点包括保肛策略的比例；病理完全缓解率和肿瘤消退分级分布；局部复发或转移；无病生存率；局部无复发生存率；急性毒性；手术并发症；长期肛门功能；迟发性毒性；不良事件；ECOG 标准评分和生活质量。根据常见不良事件术语标准 V5.0 对不良事件进行分级。在抗肿瘤治疗期间监测急性毒性，从抗肿瘤治疗第一疗程结束后 3 年监测迟发性毒性。
讨论：TESS 试验旨在探索一种新的 TNT 策略，预计将提高 cCR 率和保肛率。本研究将为远端 LARC 患者提供一种新的三明治 TNT 策略的新选择和证据。
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