Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.
Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.
Eur Urol. 2019 Apr;75(4):604-611. doi: 10.1016/j.eururo.2018.09.047. Epub 2018 Oct 15.
The extent of lymph node dissection (LND) in bladder cancer (BCa) patients at the time of radical cystectomy may affect oncologic outcome.
To evaluate whether extended versus limited LND prolongs recurrence-free survival (RFS).
DESIGN, SETTING, AND PARTICIPANTS: Prospective, multicenter, phase-III trial patients with locally resectable T1G3 or muscle-invasive urothelial BCa (T2-T4aM0).
Randomization to limited (obturator, and internal and external iliac nodes) versus extended LND (in addition, deep obturator, common iliac, presacral, paracaval, interaortocaval, and para-aortal nodes up to the inferior mesenteric artery).
The primary endpoint was RFS. Secondary endpoints included cancer-specific survival (CSS), overall survival (OS), and complications. The trial was designed to show 15% advantage of 5-yr RFS by extended LND.
In total, 401 patients were randomized from February 2006 to August 2010 (203 limited, 198 extended). The median number of dissected nodes was 19 in the limited and 31 in the extended arm. Extended LND failed to show superiority over limited LND with regard to RFS (5-yr RFS 65% vs 59%; hazard ratio [HR]=0.84 [95% confidence interval 0.58-1.22]; p=0.36), CSS (5-yr CSS 76% vs 65%; HR=0.70; p=0.10), and OS (5-yr OS 59% vs 50%; HR=0.78; p=0.12). Clavien grade ≥3 lymphoceles were more frequently reported in the extended LND group within 90d after surgery. Inclusion of T1G3 tumors may have contributed to the negative study result.
Extended LND failed to show a significant advantage over limited LND in RFS, CSS, and OS. A larger trial is required to determine whether extended compared with limited LND leads to a small, but clinically relevant, survival difference (ClinicalTrials.gov NCT01215071).
In this study, we investigated the outcome in bladder cancer patients undergoing cystectomy based on the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce the rate of tumor recurrence in the expected range.
根治性膀胱切除术时淋巴结清扫（LND）的范围可能会影响肿瘤学结果。
评估广泛与局限性 LND 是否延长无复发生存期（RFS）。
设计、地点和参与者：前瞻性、多中心、III 期试验患者为局部可切除的 T1G3 或肌层浸润性尿路上皮膀胱癌（T2-T4aM0）。
随机分为局限性（闭孔、髂内和髂外淋巴结）与广泛性 LND（此外，深部闭孔、髂总、骶前、腔静脉旁、腹主动脉旁和腹主动脉下淋巴结至肠系膜下动脉）。
主要终点是 RFS。次要终点包括癌症特异性生存（CSS）、总生存（OS）和并发症。该试验旨在显示广泛 LND 可使 5 年 RFS 优势达到 15%。
总共 401 例患者于 2006 年 2 月至 2010 年 8 月随机分组（局限性 203 例，广泛性 198 例）。局限性组和广泛性组的中位数淋巴结清扫数分别为 19 个和 31 个。广泛 LND 在 RFS（5 年 RFS：65%比 59%；风险比[HR]=0.84[95%置信区间 0.58-1.22]；p=0.36）、CSS（5 年 CSS：76%比 65%；HR=0.70；p=0.10）和 OS（5 年 OS：59%比 50%；HR=0.78；p=0.12）方面未显示优于局限性 LND。术后 90d 内，广泛性 LND 组更常报告 Clavien 分级≥3 级的淋巴囊肿。纳入 T1G3 肿瘤可能导致研究结果为阴性。
广泛 LND 在 RFS、CSS 和 OS 方面未显示优于局限性 LND 的显著优势。需要更大规模的试验来确定与局限性 LND 相比，广泛 LND 是否导致生存差异较小但具有临床意义（ClinicalTrials.gov NCT01215071）。
在这项研究中，我们根据淋巴结切除的解剖范围，调查了接受膀胱切除术的膀胱癌患者的预后。我们发现，广泛清除淋巴结并不能在预期范围内降低肿瘤复发率。
