多灶性同侧乳腺癌患者保乳治疗后的局部复发：ACOSOG Z11102（Alliance）研究结果。
Local Recurrence After Breast-Conserving Therapy in Patients With Multiple Ipsilateral Breast Cancer: Results From ACOSOG Z11102 (Alliance).
机构信息
Mayo Clinic, Rochester, MN.
Dartmouth Hitchcock Medical Center, Dartmouth College-Norris Cotton Cancer Center, Lebanon, NH.
出版信息
J Clin Oncol. 2023 Jun 10;41(17):3184-3193. doi: 10.1200/JCO.22.02553. Epub 2023 Mar 28.
PURPOSE
Breast-conserving therapy (BCT) is the preferred treatment for unifocal breast cancer (BC). The oncologic safety of BCT for multiple ipsilateral breast cancer (MIBC) has not been demonstrated in a prospective study. ACOSOG Z11102 (Alliance) is a phase II, single-arm, prospective trial designed to evaluate oncologic outcomes in patients undergoing BCT for MIBC.
PATIENTS AND METHODS
Women age 40 years and older with two to three foci of biopsy-proven cN0-1 BC were eligible. Patients underwent lumpectomies with negative margins followed by whole breast radiation with boost to all lumpectomy beds. The primary end point was cumulative incidence of local recurrence (LR) at 5 years with an a priori rate of clinical acceptability of <8%.
RESULTS
Among 270 women enrolled between November 2012 and August 2016, there were 204 eligible patients who underwent protocol-directed BCT. The median age was 61 years (range, 40-87 years). At a median follow-up of 66.4 months (range, 1.3-90.6 months), six patients developed LR for an estimated 5-year cumulative incidence of LR of 3.1% (95% CI, 1.3 to 6.4). Patient age, number of sites of preoperative biopsy-proven BC, estrogen receptor status and human epidermal growth factor receptor 2 status, and pathologic T and N categories were not associated with LR risk. Exploratory analysis showed that the 5-year LR rate in patients without preoperative magnetic resonance imaging (MRI; n = 15) was 22.6% compared with 1.7% in patients with a preoperative MRI (n = 189; = .002).
CONCLUSION
The Z11102 clinical trial demonstrates that breast-conserving surgery with adjuvant radiation that includes lumpectomy site boosts yields an acceptably low 5-year LR rate for MIBC. This evidence supports BCT as a reasonable surgical option for women with two to three ipsilateral foci, particularly among patients with disease evaluated with preoperative breast MRI.
目的
保乳治疗（BCT）是单侧乳腺癌（BC）的首选治疗方法。多灶性同侧乳腺癌（MIBC）的 BCT 肿瘤学安全性尚未在前瞻性研究中得到证实。ACOSOG Z11102（联盟）是一项 II 期、单臂、前瞻性试验，旨在评估 MIBC 患者接受 BCT 的肿瘤学结果。
患者和方法
年龄≥40 岁、有 2-3 个活检证实的 cN0-1BC 病灶的女性符合条件。患者接受了保乳切除术，切缘阴性，然后对所有保乳术床进行全乳放疗和加量放疗。主要终点是 5 年累积局部复发（LR）率，事先设定的临床可接受率<8%。
结果
在 2012 年 11 月至 2016 年 8 月期间入组的 270 名女性中，有 204 名符合条件的患者接受了方案指导的 BCT。中位年龄为 61 岁（范围，40-87 岁）。中位随访 66.4 个月（范围，1.3-90.6 个月）时，有 6 名患者发生 LR，估计 5 年 LR 累积发生率为 3.1%（95%CI，1.3-6.4）。患者年龄、术前活检证实 BC 部位数、雌激素受体状态和人表皮生长因子受体 2 状态以及病理 T 和 N 分期与 LR 风险无关。探索性分析显示，未行术前磁共振成像（MRI）检查的患者（n=15）5 年 LR 率为 22.6%，而行术前 MRI 检查的患者（n=189）5 年 LR 率为 1.7%（P=0.002）。
结论
Z11102 临床试验表明，保乳手术联合辅助放疗，包括保乳术部位加量放疗，可使 MIBC 的 5 年 LR 率保持在可接受的低水平。这一证据支持 BCT 作为 2-3 个同侧病灶女性的合理手术选择，尤其是在接受术前乳腺 MRI 评估的患者中。
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