van la Parra Raquel F D, de Wilt Johannes H W, Mol Suzanne J J, Mulder Andries H, de Roos Wilfred K, Bosscha Koop
Department of Surgery, Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, The Netherlands.
Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Breast J. 2015 Nov-Dec;21(6):621-6. doi: 10.1111/tbj.12496. Epub 2015 Sep 22.
The Z0011 trial demonstrated no difference in overall survival (OS) and locoregional recurrence in breast cancer patients with a positive sentinel lymph node (SLN) randomized to axillary lymph node dissection (ALND) or no further surgery. The aim of this study was to evaluate locoregional recurrence in a nonrandomized group of SLN positive patients, in whom cALND was not performed, that were retrospectively categorized by the Z0011 eligibility criteria. From two hospital breast cancer databases consisting of 656 consecutive SLN positive breast cancer patients, 88 patients, who did not undergo cALND, were identified. This population was categorized by the Z0011 inclusion criteria (e.g., eligible versus ineligible) and the groups were compared. Thirty-four patients (38.6%) were retrospectively eligible for omitting cALND according to the Z0011 criteria and 54 (61.4%) were not. The median number of SLNs removed in both groups was 1 (range 1-5). The number of positive SLNs did not differ between the groups. Tumor size was slightly larger in the ineligible group (21 mm versus 19 mm) and 76% of patients in the ineligible group underwent a mastectomy. At a median follow-up of 26 months (range 1-84 months), one axillary recurrence was observed in the ineligible group versus 0 in the eligible group. Axillary recurrence was low, even in patients who did not meet the Z0011 inclusion criteria. Future trials that randomize Z0011 ineligible patients are needed to investigate long-term results.
Z0011试验表明，在前哨淋巴结（SLN）阳性的乳腺癌患者中，随机接受腋窝淋巴结清扫术（ALND）或不再进行进一步手术的患者，其总生存期（OS）和局部区域复发率并无差异。本研究的目的是评估一组未进行cALND的非随机SLN阳性患者的局部区域复发情况，这些患者根据Z0011纳入标准进行回顾性分类。从两个医院乳腺癌数据库中筛选出656例连续的SLN阳性乳腺癌患者，其中88例未接受cALND。该人群根据Z0011纳入标准进行分类（例如，符合条件与不符合条件），并对两组进行比较。根据Z0011标准，34例患者（38.6%）回顾性符合省略cALND的条件，54例（61.4%）不符合。两组切除的SLN中位数均为1个（范围1 - 5个）。两组阳性SLN的数量无差异。不符合条件组的肿瘤大小略大（21毫米对19毫米），不符合条件组76%的患者接受了乳房切除术。中位随访26个月（范围1 - 84个月）时，不符合条件组观察到1例腋窝复发，符合条件组为0例。即使在不符合Z0011纳入标准的患者中，腋窝复发率也较低。需要未来的试验将不符合Z0011标准的患者随机分组，以研究长期结果。
