Department of Breast and Endocrine Surgery, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.
Department of Breast Surgery, Osaka General Medical Center, Osaka, Japan.
Int J Clin Oncol. 2018 Oct;23(5):860-866. doi: 10.1007/s10147-018-1297-0. Epub 2018 May 22.
In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent loco-regional outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Japanese patients with breast cancer.
Patients meeting the Z0011 inclusion criteria and providing consent to receive no additional ALND were prospectively enrolled at the Osaka International Cancer Institute from April 2012 to December 2016. Cumulative incidence of loco-regional recurrence was estimated and compared to that of the Z0011 study.
Among a total of 881 patients who underwent breast-conserving surgery, 189 fulfilling the Z0011 criteria were enrolled and eligible for the subsequent analysis. Adjuvant chemotherapy was given to 113 (59.8%) patients, adjuvant hormone therapy to 170 (89.9%), and whole breast irradiation to 183 (96.8%). The frequency of tumors with positive lymphovascular invasion (p < 0.0001) and macrometastases in SLNs (p < 0.0001) were significantly higher in our study than in the Z0011 study. At the median follow-up of 36 months (range 10-64 months), only 2 of 189 patients (1.1%) experienced loco-regional recurrence. The 5-year cumulative rate of loco-regional recurrences was 1.3% (95% CI 0-3.1%), and the 3-year distant DFS rate was 96.8% (95% CI 94.0-99.6%).
Our prospective study showed that it is feasible to apply the Z0011 strategy to Japanese patients with clinically node-negative breast cancer undergoing breast-conserving surgery with planned whole breast irradiation.
在接受保乳手术且前哨淋巴结（SLN）阳性的患者中，ACOSOG Z0011 试验表明，单独接受 SLN 解剖（SLND）和接受腋窝淋巴结清扫（ALND）的患者具有等效的局部区域治疗效果。我们开展了一项前瞻性单臂研究，以确认 Z0011 标准对日本乳腺癌患者的适用性。
2012 年 4 月至 2016 年 12 月，大阪国际癌症研究所前瞻性入组符合 Z0011 纳入标准且同意不接受额外 ALND 的患者。估计并比较局部区域复发的累积发生率与 Z0011 研究的结果。
在总共 881 例接受保乳手术的患者中，有 189 例符合 Z0011 标准，符合随后分析的条件。113 例（59.8%）患者接受了辅助化疗，170 例（89.9%）接受了辅助激素治疗，183 例（96.8%）接受了全乳放疗。在我们的研究中，肿瘤有阳性淋巴管血管侵犯（p<0.0001）和 SLN 中存在大转移灶（p<0.0001）的比例显著高于 Z0011 研究。在中位随访 36 个月（10-64 个月）时，仅 189 例患者中有 2 例（1.1%）出现局部区域复发。局部区域复发的 5 年累积率为 1.3%（95%CI 0-3.1%），3 年远处无病生存率为 96.8%（95%CI 94.0-99.6%）。
我们的前瞻性研究表明，对于接受计划全乳放疗的临床淋巴结阴性乳腺癌保乳手术患者，应用 Z0011 策略是可行的。
