Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04.
Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04.
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DOI：
10.1097/sla.0000000000000594
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发表时间：
2015-01
影响因子：
9
通讯作者：
Wolmark N
中科院分区：
文献类型：
--
作者：
Russell MM;Ganz PA;Lopa S;Yothers G;Ko CY;Arora A;Atkins JN;Bahary N;Soori GS;Robertson JM;Eakle J;Marchello BT;Wozniak TF;Beart RW Jr;Wolmark N
NSABP R-04是一项在可切除的II-III期直肠癌患者中进行新辅助放化疗的随机对照试验。我们假设接受腹会阴切除术（APR）的患者的生活质量比接受保留括约肌手术（SSS）的患者差。为了获得患者报告的结局（PRO），我们在基线和术后1年使用了两种症状量表：癌症治疗功能评估-结直肠（FACT-C）和欧洲癌症研究和治疗组织结直肠癌患者生活质量问卷（EORTC QLQ-CR 38）模块。根据非随机分配的确定性手术（APR vs SSS）对评分进行分层。分析控制了基线评分和分层因素：年龄、性别、分期、预期手术和随机分配的放化疗。在随机分配的1，608例患者中，987例有计划分析的数据; 62%接受SSS; 38%接受APR。1年时不同手术的FACT-C总分和子量表评分无统计学差异。对于EORTC-QLQ-CR 38功能量表，APR患者在1年时报告的身体形象（70.3 vs 77.0，P=0.0005）比SSS患者差。接受APR的男性在一年时报告的性享受比接受SSS的男性更差（43.7 vs 54.7，P=0.02）。对于EORTC-QLQ-CR 38症状量表评分，1年时APR患者报告的排尿症状比SSS组更差（26.9 vs 21.5，P=0.03）。SSS患者报告的胃肠道症状比APR患者严重（18.9 vs 15.2，P<0.0001），体重减轻（10.1 vs 6.0，P=0.002）。EORTC-QLQ-CR 38在1年时检测到症状和功能问题，反映了接受APR的患者与接受SSS的患者的不同症状特征。来自这些PRO的信息可能有助于为预期进行直肠癌手术的患者提供咨询。
NSABP R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II–III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS). To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by non-randomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, gender, stage, intended surgery, and randomly assigned chemoradiotherapy. Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at one year. For the EORTC-QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P=0.0005) at one year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P=0.02) at one year than did those undergoing SSS. For the EORTC-QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at one year (26.9 vs 21.5, P=0.03). SSS patients reported worse GI tract symptoms than did the APR patients (18.9 vs 15.2, P<0.0001), as well as weight loss (10.1 vs 6.0, P=0.002). Symptoms and functional problems were detected at one year by EORTC-QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer.