Lynn Patricio B, Renfro Lindsay A, Carrero Xiomara W, Shi Qian, Strombom Paul L, Chow Oliver, Garcia-Aguilar Julio
1 Colorectal Service, Memorial Sloan Kettering Cancer Center, New York, New York 2 Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
Dis Colon Rectum. 2017 May;60(5):459-468. doi: 10.1097/DCR.0000000000000758.
Little is known about anorectal function and quality of life after chemoradiation followed by local excision, which is an alternative to total mesorectal excision for selected patients with early rectal cancer.
The purpose of this study was to prospectively assess anorectal function and health-related quality of life of patients with T2N0 rectal cancer who were treated with an alternative approach.
This was a prospective, phase II trial.
The study was multicentric (American College of Surgeons Oncology Group trial Z6041).
Patients with stage cT2N0 rectal adenocarcinomas were treated with an oxaliplatin/capecitabine-based chemoradiation regimen followed by local excision.
Anorectal function and quality of life were assessed at enrollment and 1 year postoperatively with the Fecal Incontinence Severity Index, Fecal Incontinence Quality of Life scale, and Functional Assessment of Cancer Therapy-Colorectal Questionnaire. Results were compared, and multivariable analysis was performed to identify predictors of outcome.
Seventy-one patients (98%) were evaluated at enrollment and 66 (92%) at 1 year. Compared with baseline, no significant differences were found on Fecal Incontinence Severity Index scores at 1 year. Fecal Incontinence Quality of Life results were significantly worse in the lifestyle (p < 0.001), coping/behavior (p < 0.001), and embarrassment (p = 0.002) domains. There were no differences in the Functional Assessment of Cancer Therapy overall score, but the physical well-being subscale was significantly worse and emotional well-being was improved after surgery. Treatment with the original chemoradiation regimen predicted worse depression/self-perception and embarrassment scores in the Fecal Incontinence Quality of Life, and male sex was predictive of worse scores in the Functional Assessment of Cancer Therapy overall score and trial outcome index.
Small sample size, relatively short follow-up, and absence of information before cancer diagnosis were study limitations.
Chemoradiation followed by local excision had minimal impact on anorectal function 1 year after surgery. Overall quality of life remained stable, with mixed effects on different subscales. This information should be used to counsel patients about expected outcomes.
对于接受放化疗后行局部切除术后的肛门直肠功能和生活质量，人们了解甚少，对于部分早期直肠癌患者而言，局部切除是全直肠系膜切除的替代方案。
本研究旨在前瞻性评估采用替代方法治疗的T2N0期直肠癌患者的肛门直肠功能及与健康相关的生活质量。
这是一项前瞻性II期试验。
该研究为多中心研究（美国外科医师学会肿瘤学组试验Z6041）。
cT2N0期直肠腺癌患者接受以奥沙利铂/卡培他滨为基础的放化疗方案，随后进行局部切除。
在入组时及术后1年，采用大便失禁严重程度指数、大便失禁生活质量量表及癌症治疗功能评估-结直肠问卷评估肛门直肠功能和生活质量。对结果进行比较，并进行多变量分析以确定预后预测因素。
71例患者（98%）在入组时接受评估，66例（92%）在1年时接受评估。与基线相比，1年时大便失禁严重程度指数评分无显著差异。大便失禁生活质量结果在生活方式（p < 0.001）、应对/行为（p < 0.001）和尴尬（p = 0.002）领域显著更差。癌症治疗功能评估总体评分无差异，但术后身体幸福感子量表显著更差，情绪幸福感得到改善。采用原放化疗方案治疗可预测大便失禁生活质量中抑郁/自我认知和尴尬评分更差，男性则预测癌症治疗功能评估总体评分和试验结果指数更差。
样本量小、随访时间相对较短以及缺乏癌症诊断前的信息是本研究的局限性。
放化疗后行局部切除术后1年对肛门直肠功能影响极小。总体生活质量保持稳定，对不同子量表有混合影响。该信息应用于向患者咨询预期结果。
