当前位置：
X-MOL 学术
›
JAMA Surg.
›
论文详情
Our official English website, www.x-mol.net, welcomes your
feedback! (Note: you will need to create a separate account there.)
Long-term Oncological and Functional Outcomes of Chemoradiotherapy Followed by Organ-Sparing Transanal Endoscopic Microsurgery for Distal Rectal Cancer: The CARTS Study.
JAMA Surgery ( IF 15.7 ) Pub Date : 2019-01-01 , DOI: 10.1001/jamasurg.2018.3752 Rutger C H Stijns 1 , Eelco J R de Graaf 2 , Cornelis J A Punt 3 , Iris D Nagtegaal 4 , Joost J M E Nuyttens 5 , Esther van Meerten 6 , Pieter J Tanis 7 , Ignace H J T de Hingh 8 , George P van der Schelling 9 , Yair Acherman 10 , Jeroen W A Leijtens 11 , Andreas J A Bremers 1 , Geerard L Beets 12 , Christiaan Hoff 13 , Cornelis Verhoef 14 , Corrie A M Marijnen 15 , Johannes H W de Wilt 1 ,
JAMA Surgery ( IF 15.7 ) Pub Date : 2019-01-01 , DOI: 10.1001/jamasurg.2018.3752 Rutger C H Stijns 1 , Eelco J R de Graaf 2 , Cornelis J A Punt 3 , Iris D Nagtegaal 4 , Joost J M E Nuyttens 5 , Esther van Meerten 6 , Pieter J Tanis 7 , Ignace H J T de Hingh 8 , George P van der Schelling 9 , Yair Acherman 10 , Jeroen W A Leijtens 11 , Andreas J A Bremers 1 , Geerard L Beets 12 , Christiaan Hoff 13 , Cornelis Verhoef 14 , Corrie A M Marijnen 15 , Johannes H W de Wilt 1 ,
Affiliation
|
Importance
Treatment of rectal cancer is shifting toward organ preservation aiming to reduce surgery-related morbidity. Short-term outcomes of organ-preserving strategies are promising, but long-term outcomes are scarce in the literature.
Objective
To explore long-term oncological outcomes and health-related quality of life (HRQL) in patients with cT1-3N0M0 rectal cancer who underwent neoadjuvant chemoradiotherapy (CRT) followed by transanal endoscopic microsurgery (TEM).
Design, Setting, and Participants
In this multicenter phase II feasibility study, patients with cT1-3N0M0 rectal cancer admitted to referral centers for rectal cancer throughout the Netherlands between February 2011 and September 2012 were prospectively included. These patients were to be treated with neoadjuvant CRT followed by TEM in case of good response. An intensive follow-up scheme was used to detect local recurrences and/or distant metastases. Data from validated HRQL questionnaires and low anterior resection syndrome questionnaires were collected. Data were analyzed from February 2011 to April 2017.
Main Outcomes and Measures
The primary study outcome of the study was the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL.
Results
Of the 55 included patients, 30 (55%) were male, and the mean (SD) age was 64 (39-82) years. Patients were followed up for a median (interquartile range) period of 53 (39-57) months. Two patients (4%) died during CRT, 1 (2%) stopped CRT, and 1 (2%) was lost to follow-up. Following CRT, 47 patients (85%) underwent TEM, of whom 35 (74%) were successfully treated with local excision alone. Total mesorectal excision was performed in 16 patients (4 with inadequate responses, 8 with completion after TEM, and 4 with salvage for local recurrence). The actuarial 5-year local recurrence rate was 7.7%, with 5-year disease-free and overall survival rates of 81.6% and 82.8%, respectively. Health-related quality of life during follow-up was equal to baseline, with improved emotional well-being in patients treated with local excision (mean score at baseline, 72.0; 95% CI, 67.1-80.1; mean score at follow-up, 86.9; 95% CI, 79.2-94.7; P = .001). Major, minor, and no low anterior resection syndrome was experienced in 50%, 28%, and 22%, respectively, of patients with successful organ preservation.
Conclusions and Relevance
In early-stage rectal cancer (cT1-3N0M0), CRT enables organ preservation with additional TEM surgery in approximately two-thirds of patients with good long-term oncological outcome and HRQL. This multimodality treatment triggers a certain degree of bowel dysfunction, and one-third of patients still undergo radical surgery and are overtreated by CRT.
中文翻译：
化学放射疗法的长期肿瘤学和功能结果，然后进行保留器官的经肛门内窥镜显微手术治疗远处直肠癌：CARTS研究。
重要性直肠癌的治疗正朝着器官保存的方向发展，旨在减少与手术相关的发病率。器官保存策略的短期结果是有希望的，但是长期结果在文献中很少。目的探讨接受新辅助放化疗（CRT），经肛门内镜显微手术（TEM）的cT1-3N0M0直肠癌患者的长期肿瘤学结局和与健康相关的生活质量（HRQL）。设计，背景和参与者在这项多中心II期可行性研究中，前瞻性纳入了2011年2月至2012年9月间进入荷兰整个直肠癌转诊中心的cT1-3N0M0直肠癌患者。如果反应良好，这些患者将接受新辅助CRT治疗，然后进行TEM治疗。强化随访方案用于检测局部复发和/或远处转移。收集来自经过验证的HRQL问卷和低位前切除综合征问卷的数据。分析了2011年2月至2017年4月的数据。主要结果和措施这项研究的主要研究结果是通过TEM进行的ypT0-1标本数量。次要结果参数是局部复发和HRQL。结果在55名患者中，男性（30％（55％））的平均年龄（SD）为64岁（39-82）。对患者进行了53（39-57）个月的中位（四分位间距）随访。CRT期间有2例患者（4％）死亡，停止CRT的患者1例（2％），随访失败的患者1例（2％）。CRT后，有47例患者（85％）接受了TEM，其中35例（74％）仅通过局部切除术就得到了成功的治疗。16例患者进行了全直肠系膜切除术（4例反应不充分，8例在TEM后完成，4例因局部复发而行抢救）。五年期精算局部复发率为7.7％，五年无病率和总生存率分别为81.6％和82.8％。随访期间与健康相关的生活质量与基线相当，局部切除治疗的患者的情绪健康得到改善（基线时的平均评分为72.0； 95％CI为67.1-80.1；随访时的平均评分为86.9； 95％CI，79.2-94.7； P = .001）。成功完成器官保留的患者分别有50％，28％和22％经历了大，小和无低位的前切除综合征。结论和相关性在早期直肠癌（cT1-3N0M0）中，CRT可使大约三分之二具有良好长期肿瘤学结局和HRQL的患者接受额外的TEM手术进行器官保存。这种多模式治疗会引发一定程度的肠功能障碍，三分之一的患者仍需接受根治性手术，并且接受了CRT的过度治疗。
更新日期：2019-01-17
中文翻译：
化学放射疗法的长期肿瘤学和功能结果，然后进行保留器官的经肛门内窥镜显微手术治疗远处直肠癌：CARTS研究。
重要性直肠癌的治疗正朝着器官保存的方向发展，旨在减少与手术相关的发病率。器官保存策略的短期结果是有希望的，但是长期结果在文献中很少。目的探讨接受新辅助放化疗（CRT），经肛门内镜显微手术（TEM）的cT1-3N0M0直肠癌患者的长期肿瘤学结局和与健康相关的生活质量（HRQL）。设计，背景和参与者在这项多中心II期可行性研究中，前瞻性纳入了2011年2月至2012年9月间进入荷兰整个直肠癌转诊中心的cT1-3N0M0直肠癌患者。如果反应良好，这些患者将接受新辅助CRT治疗，然后进行TEM治疗。强化随访方案用于检测局部复发和/或远处转移。收集来自经过验证的HRQL问卷和低位前切除综合征问卷的数据。分析了2011年2月至2017年4月的数据。主要结果和措施这项研究的主要研究结果是通过TEM进行的ypT0-1标本数量。次要结果参数是局部复发和HRQL。结果在55名患者中，男性（30％（55％））的平均年龄（SD）为64岁（39-82）。对患者进行了53（39-57）个月的中位（四分位间距）随访。CRT期间有2例患者（4％）死亡，停止CRT的患者1例（2％），随访失败的患者1例（2％）。CRT后，有47例患者（85％）接受了TEM，其中35例（74％）仅通过局部切除术就得到了成功的治疗。16例患者进行了全直肠系膜切除术（4例反应不充分，8例在TEM后完成，4例因局部复发而行抢救）。五年期精算局部复发率为7.7％，五年无病率和总生存率分别为81.6％和82.8％。随访期间与健康相关的生活质量与基线相当，局部切除治疗的患者的情绪健康得到改善（基线时的平均评分为72.0； 95％CI为67.1-80.1；随访时的平均评分为86.9； 95％CI，79.2-94.7； P = .001）。成功完成器官保留的患者分别有50％，28％和22％经历了大，小和无低位的前切除综合征。结论和相关性在早期直肠癌（cT1-3N0M0）中，CRT可使大约三分之二具有良好长期肿瘤学结局和HRQL的患者接受额外的TEM手术进行器官保存。这种多模式治疗会引发一定程度的肠功能障碍，三分之一的患者仍需接受根治性手术，并且接受了CRT的过度治疗。
京公网安备 11010802027423号