["Watch and wait" strategy after neoadjuvant therapy for rectal cancer: status survey of perceptions, attitudes and treatment selection in Chinese surgeons]

Zhonghua Wei Chang Wai Ke Za Zhi. 2019 Jun 25;22(6):550-559. doi: 10.3760/cma.j.issn.1671-0274.2019.06.008.
[Article in Chinese]

Abstract

Objective: To understand the perceptions, attitudes and treatment selection of Chinese surgeons on the "watch and wait" strategy for rectal cancer patients after achieving a clinical complete response (cCR) following neoadjuvant chemoradiotherapy (nCRT). Methods: A cross-sectional survey was used in this study. Selection of subjects: (1) Domestic public grade III A (provincial and prefecture-level) oncology hospitals or general hospitals possessing the radiotherapy department and the diagnosis and treatment qualifications for colorectal cancer. (2) Surgeons of deputy chief physician or above. Using the "Questionnaire Star" online survey platform to create a questionnaire about cognition, attitude and treatment choice of the "watch and wait" strategy after cCR following nCRT for rectal cancer. The questionnaire contained 32 questions, such as the basic information of doctor, the current status of rectal cancer surgery, the management of pathological complete remission (ypCR) after nCRT for rectal cancer, the selection of examination items for diagnosis of cCR, the selection of suitable people undergoing "watch and wait" approach, the nCRT mode for promotion of cCR, the choice of evaluation time point, the willingness to perform "watch and wait" approach and the treatment choice, and the risk and monitoring of "watch and wait" approach. A total of 116 questionnaires were sent to the respondents via WeChat between January 31 and February 19, 2019. Statistical analysis was performed using Fisher's exact test for categorical variables. Results: Forty-eight hospitals including 116 surgeons meeting criteria were enrolled, of whom 77 surgeons filled the questionnaire with a response rate of 66.4%. "Watch and wait" strategy was carried out in 76.6% (59/77) of surgeons. Seventy surgeons (90.9%) were aware of the ypCR rate of rectal cancer after preoperative nCRT and 49 surgeons (63.6%) knew the 3-year disease-free survival of patients with ypCR in their own hospitals. Fifty-five surgeons (71.4%) believed that patients with ypCR undergoing radical surgery met the treatment criteria and were not over-treated. Three most necessary examinations in diagnosing cCR were colonoscopy (96.1%, 74/77), digital rectal examination (DRE) (90.9%,70/77) and DWI-MRI (83.1%, 64/77). Responders preferred to consider a "watch and wait" strategy for patients with baseline characteristics as mrN0 (77.9%, 60/77), mrT2 (68.8%, 53/77) and well-differentiated adenocarcinoma (68.8%, 53/77). Sixty-six surgeons (85.7%) believed that long-term chemoradiotherapy (LCRT) with combination or without combination of induction and/or consolidation of the CapeOX regimen (capecitabine + oxaliplatin) should be the first choice as a neoadjuvant therapy to achieve cCR. Forty-one surgeons (53.2%) believed that a reasonable interval of judging cCR after nCRT should be ≥ 8 weeks. Forty-four surgeons (57.1%) routinely, or in most cases, informed patient the possibility of cCR and proposed to "watch and wait" strategy in the initial diagnosis of patients with non-metastatic rectal cancer. Thirteen surgeons (16.9%) would take the "watch and wait" strategy as the first choice after the patient having cCR. Fifty-two surgeons (67.5%) would be affected by the surgical method, that was to say, "watch and wait" approach would only be recommended to those patients who would achieve cCR and could not preserve the anus or underwent difficult anus-preservation surgery. Sixteen surgeons (20.8%) demonstrated that "watch and wait" strategy would not be recommended to patients with cCR regardless of whether the surgical procedure involved anal sphincter. Eleven surgeons (14.3%) believed that the main risk of "watch and wait" approach came from distant metastasis rather than local recurrence or regrowth. Twenty-nine of surgeons (37.7%) did not understand the difference between "local recurrence" and "local regrowth" during the period of "watch and wait". Twenty-six surgeons (33.8%) thought that the monitoring interval for the first 3 years of "watch and wait" strategy was 3 months, and the follow-up monitoring interval could be 6 months to 5 years. Surgeons from cancer specialist hospitals had higher approval rate, notification rate, and referral rate of "watch and wait" strategy than those from general hospitals. Thirty-one surgeons (42.5%) considered that the difficulty and concern of carrying out "watch and wait" approach in the future was the disease progress leading to medical disputes. Twenty-six surgeons (35.6%) demonstrated that their concern was lack of uniform evaluation standard for cCR. Conclusions: Chinese surgeons seem to have inadequate knowledge of non-operative management for rectal cancer patients achieving cCR after nCRT and show relatively conservative attitudes toward the strategy. Chinese consensus needs to be formed to guide the non-operative management in selected patients. Chinese Watch & Wait Database (CWWD) is also needed to establish and provide more evidence for the use of alternative procedure after a cCR following nCRT.

目的: 了解中国外科医生对于直肠癌新辅助治疗后"等待观察"疗法的认知和态度以及治疗选择现况。 方法: 采用横断面调查研究的方法。研究对象的选择:(1)全国范围内有结直肠癌诊疗资质、并设置有放疗科的公立三级甲等(省级和地市级)肿瘤专科医院或综合医院;(2)目标中心的副主任医师及以上的外科医生。采用"问卷星"网络调查平台创建关于直肠癌新辅助治疗后"等待观察"疗法的认知和态度以及治疗选择调查问卷,问卷内容包含医生基本信息、开展直肠癌手术现况、直肠癌新辅助治疗后病理完全缓解(ypCR)的处理现状、诊断临床完全缓解(cCR)的检查项目选择、"等待观察"适用人群选择、促使达到cCR的新辅助治疗模式和评效时点选择、"等待观察"的实施意愿和治疗选择以及"等待观察"的风险和监测等32个问题,通过微信向调查对象发送问卷链接,2019年1月31日至2月19日,共发出问卷116份。采用Fisher确切概率法进行组间比较。 结果: 共纳入48家医院,在入选医院中筛选116名副主任医师及以上职称的外科医生,共有77名医生填写了本次调查问卷,应答率66.4%。已开展"等待观察"疗法的医生占76.6%(59/77);有90.9%(70/77)的医生知晓本单位直肠癌nCRT后的ypCR率;有63.6%(49/77)的医生知晓本单位ypCR患者的3年无病生存率(DFS);有71.4%(55/77)的外科医生认为,ypCR患者接受根治手术符合诊疗规范,不属于治疗过度。在诊断cCR的必要检查项目中,占前3位的分别为结肠镜(96.1%,74/77)、直肠指诊(90.9%,70/77)和直肠扩散加权成像核磁共振(83.1%,64/77)。关于倾向于实施"等待观察"的基线参考指标,被纳入选择的前3位为mrN(0)(77.9%,60/77)、mrT(2)(68.8%,53/77)和病理高分化腺癌(68.8%,53/77)。有85.7%(66/77)的医生认为,应该首选长程放化疗(LCRT)联合或不联合诱导和(或)巩固CapeOX方案(卡培他滨+奥沙利铂)作为促使达到cCR的新辅助治疗方案。有53.2%(41/77)的医生认为,新辅助放化疗(nCRT)后评判cCR合理的时间间隔应该≥8周、甚至更长。有57.1%(44/77)的医生在非转移性直肠癌患者初诊时,会常规、或在多数情况下向患者告知cCR的可能性和提出选择"等待观察"的建议;有16.9%(13/77)的医生在患者发生cCR后,会把"等待观察"策略作为首选;有67.5%(52/77)的医生其决策会受到手术方式的影响,即会对发生cCR且不能保肛、或保肛有难度的患者,才推荐"等待观察";有20.8%(16/77)的医生表示,无论手术方式是否涉及保肛均不会推荐"等待观察"。有14.3%(11/77)的医生认为,"等待观察"的主要风险来自于远隔转移而不是局部复发或再生;37.7%(29/77)的医生不了解"等待观察"后"局部再生"和"局部复发"的区别。33.8%(26/77)的医生认为,"等待观察"前3年的监测间隔为每3个月,后续监测间隔可为每6个月至5年。肿瘤专科医院外科医生对"等待观察"疗法的认同率、告知率和推荐率高于综合医院外科医生。42.5%(31/73)的医生认为,未来开展"等待观察"疗法的难点和顾虑是"等待观察"后的疾病进展会造成医疗纠纷;35.6%(26/73)的医生认为,其顾虑是目前缺乏cCR的统一评价标准。 结论: 中国外科医生对"等待观察"的认知水平和接受度不高,提示未来需要建立中国"等待观察"登记数据库并开展相应的临床研究,形成国内专家共识以指导"等待观察"疗法在临床中的应用。.

Keywords: "Watch and wait" approach; Clinical complete response; Neoadjuvant chemoradiation; Rectal neoplasms.

MeSH terms

  • Attitude of Health Personnel
  • Chemoradiotherapy, Adjuvant / methods*
  • Cross-Sectional Studies
  • Health Care Surveys
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Neoadjuvant Therapy*
  • Neoplasm Recurrence, Local
  • Rectal Neoplasms / therapy*
  • Surveys and Questionnaires
  • Watchful Waiting / methods*