直肠癌保括约肌手术与腹会阴联合切除术的比较疗效：美国国立外科辅助乳腺和肠道项目随机试验R-04中的患者报告结局
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.
作者信息
Russell Marcia M, Ganz Patricia A, Lopa Samia, Yothers Greg, Ko Clifford Y, Arora Amit, Atkins James N, Bahary Nathan, Soori Gamini S, Robertson John M, Eakle Janice, Marchello Benjamin T, Wozniak Timothy F, Beart Robert W, Wolmark Norman
机构信息
*National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations and Biostatistical Centers, Pittsburgh, PA †David Geffen School of Medicine at UCLA, VA Greater Los Angeles Healthcare System, Los Angeles, CA ‡UCLA Schools of Medicine & Public Health and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA §University of Pittsburgh Graduate School of Public Health Department of Biostatistics, Pittsburgh, PA ∥UCLA, Los Angeles, CA ¶Kaiser Permanente Oncology Clinical Trials, Northern California, Vallejo, CA **Southeast Cancer Control Consortium CCOP, Goldsboro, NC ††University of Pittsburgh Medical Center, Pittsburgh, PA ‡‡Missouri Valley Cancer Consortium CCOP, Omaha, NE §§Beaumont Hospital System, Royal Oak, MI ∥∥Florida Cancer Specialists, Sarasota, FL ¶¶Montana Cancer Consortium, Billings, MT ***Helen F. Graham Cancer Center, Newark, DE †††Glendale Memorial Hospital and Health Center, Glendale, CA ‡‡‡Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA.
出版信息
Ann Surg. 2015 Jan;261(1):144-8. doi: 10.1097/SLA.0000000000000594.
OBJECTIVE
National Surgical Adjuvant Breast and Bowel Project (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).
METHODS
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 nonrandomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, sex, stage, intended surgery, and randomly assigned chemoradiotherapy.
RESULTS
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 1 year. For the EORTC QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P = 0.0005) at 1 year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P = 0.02) at 1 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 1 year (26.9 vs 21.5, P = 0.03). SSS patients reported worse gastrointestinal 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).
CONCLUSIONS
Symptoms and functional problems were detected at 1 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.
目的
美国国家外科辅助乳腺和肠道项目（NSABP）R-04是一项针对可切除的II-III期直肠癌患者的新辅助放化疗随机对照试验。我们假设接受腹会阴联合切除术（APR）的患者生活质量比接受保肛手术（SSS）的患者差。
方法
为了获得患者报告的结局（PROs），我们在基线和术后1年使用了两个症状量表：癌症治疗功能评估-结直肠癌量表（FACT-C）和欧洲癌症研究与治疗组织结直肠癌患者生活质量问卷模块（EORTC QLQ-CR38）。评分按非随机分配的确定性手术（APR与SSS）进行分层。分析对基线评分和分层因素进行了控制：年龄、性别、分期、预期手术以及随机分配的放化疗。
结果
在1608例随机分配的患者中，987例有用于计划分析的数据；62%接受了SSS；38%接受了APR。FACT-C总分和子量表评分在术后1年时，不同手术方式之间无统计学差异。对于EORTC QLQ-CR38功能量表，APR患者在术后1年报告的身体形象比SSS患者差（70.3对77.0，P = 0.0005）。接受APR的男性在术后1年报告的性快感比接受SSS的男性差（43.7对54.7，P = 0.02）。对于EORTC QLQ-CR38症状量表评分，APR患者在术后1年报告的排尿症状比SSS组差（26.9对21.5，P = 0.03）。SSS患者报告的胃肠道症状比APR患者差（18.9对15.2，P < 0.0001），体重减轻情况也是如此（10.１对6.0，P = 0.0０2）。
结论
EORTC QLQ-CR38在术后1年检测到了症状和功能问题，反映出接受APR的患者与接受SSS的患者症状特征不同。这些PROs提供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。
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