Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.
Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.
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DOI：
10.1097/sla.0000000000003002
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发表时间：
2019-04
影响因子：
9
通讯作者：
Nelson H
中科院分区：
文献类型：
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作者：
Fleshman J;Branda ME;Sargent DJ;Boller AM;George VV;Abbas MA;Peters WR Jr;Maun DC;Chang GJ;Herline A;Fichera A;Mutch MG;Wexner SD;Whiteford MH;Marks J;Birnbaum E;Margolin DA;Larson DW;Marcello PW;Posner MC;Read TE;Monson JRT;Wren SM;Pisters PWT;Nelson H
目的探讨直肠癌患者行开腹或腹腔镜手术治疗后的无病生存率（DFS）和复发率。这项随机临床试验（ACOSOG（Alliance）Z6051）于2008-2013年进行，比较了接受新辅助放化疗的患者中肛门边缘12 cm内（T1-3，N 0 -2，M0）II/III期直肠癌的开腹和开腹切除术。使用开放器械进行直肠解剖（包括混合手助腹腔镜）或在气腹下使用腹腔镜器械切除直肠和直肠系膜。2年DFS和复发是Z6051的次要终点。DFS和复发没有把握度，正在评估优效性。在第3、6、9、12个月和此后每6个月使用癌胚抗原、体格检查、计算机断层扫描和结肠镜检查确定复发。486例患者被随机分配至CABG（243例）或OPEN（243例），其中462例符合分析条件（CABG =240例，OPEN=222例）。中位随访时间为47.9个月。2年DFS为79.5%（95%CI，74.4-84.9），OPEN为83.2%（95%CI，78.3-88.3）。局部和区域复发率分别为4.6%和4.5%。远处复发率分别为14.6%和16.7%。DFS受不成功切除的影响（HR 1.87，95% CI，1.21-2.91）：（不完整标本的复合（HR 1.65，95% CI，0.85-3.18）;阳性环周切除边缘（HR 2.31，95% CI，1.40-3.79）;阳性远端边缘（HR 2.53，95% CI，1.30-3.77）。根据DFS和复发的结局，腹腔镜辅助直肠癌切除术与开腹直肠癌切除术无显著差异。报告了2008-2013年期间进行的一项多中心非劣效性随机临床试验（ACOSOG（Alliance）Z6051）的无病生存期次要终点，该试验比较了II/III期直肠癌行低位前切除术和开腹腹会阴根治性切除术。切除术后2年的无病生存率与腹腔镜或开放技术治疗的直肠切除术相似。
To determine the disease free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. This randomized clinical trial (ACOSOG (Alliance) Z6051), performed between 2008–2013, compared LAP and OPEN resection of Stage II/III rectal cancer, within 12 cm of the anal verge (T1–3, N0–2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2 year DFS and recurrence were secondary endpoints of Z6051. The DFS and recurrence were not powered and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12 and every 6 months thereafter using carcinoembryonic antigen, physical exam, computed tomography and colonoscopy. 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP=240 and OPEN=222). Median follow up is 47.9 months. 2 year DFS was LAP 79.5% (95%CI, 74.4–84.9) and OPEN 83.2% (95% CI, 78.3–88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN. DFS was impacted by unsuccessful resection (HR 1.87, 95% CI, 1.21–2.91): (composite of incomplete specimen (HR 1.65, 95% CI, 0.85–3.18); positive circumferential resection margins (HR 2.31, 95% CI, 1.40–3.79); positive distal margin (HR 2.53, 95% CI, 1.30–3.77). Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence. Reporting of the secondary endpoint of the disease free survival of a multi-center non-inferiority randomized clinical trial (ACOSOG (Alliance) Z6051) performed between 2008–2013 comparing LAP and OPEN low anterior and abdominoperineal radical resection for Stage II/III rectal cancer. Disease free survival two years after resection was found to be similar for patients treated with laparoscopic or open techniques for proctectomy.