Department of Surgery, University of Pittsburgh Medical Center, Magee-Womens Hospital, Pittsburgh, PA.
Istanbul University Istanbul School of Medicine, Istanbul, Turkey.
J Am Coll Surg. 2021 Dec;233(6):742-751.e5. doi: 10.1016/j.jamcollsurg.2021.08.686. Epub 2021 Sep 13.
The aim of this randomized clinical trial was to evaluate the overall survival (OS) data of patients diagnosed with de novo stage IV breast cancer (BC) who received locoregional treatment (LRT) over a 10-year follow-up.
The MF07-01 is a 1:1 multicenter, randomized clinical trial comparing the LRT with systemic therapy (ST), where ST was given to all patients either immediately after randomization or after surgical resection of the intact primary tumor.
A total of 278 patients were randomized and 265 patients were in the final analysis. At 10-year follow-up, survivals were 19% (95% CI 13%-28%) and 5% (95% CI 2%-12%) in the LRT group and ST group, respectively. Median survival was 46 months for the LRT group and 35 months for the ST group, and hazard of death was 29% lower in the LRT group compared with the ST group (hazard ratio [HR] 0.71; 95% CI 0.59-0.86; p = 0.0003).
Patients with a diagnosis of de novo stage IV BC who underwent LRT followed by ST had a 14% higher chance of OS by the end of the 10-year follow-up compared with the patients who received only ST. The longer study follow-up revealed that LRT should be presented to patients when discussing treatment options.
本随机临床试验的目的是评估在 10 年随访期间接受局部区域治疗（LRT）的初诊 IV 期乳腺癌（BC）患者的总生存（OS）数据。
MF07-01 是一项 1:1 的多中心随机临床试验，比较了 LRT 与系统治疗（ST），所有患者均在随机分组后或完整原发肿瘤切除后立即接受 ST。
共有 278 名患者被随机分组，265 名患者进行了最终分析。在 10 年随访时，LRT 组和 ST 组的生存率分别为 19%（95%CI 13%-28%）和 5%（95%CI 2%-12%）。LRT 组的中位生存时间为 46 个月，ST 组为 35 个月，LRT 组的死亡风险比 ST 组低 29%（风险比 [HR] 0.71；95%CI 0.59-0.86；p=0.0003）。
初诊 IV 期 BC 患者接受 LRT 后再行 ST 的 OS 比仅接受 ST 的患者在 10 年随访结束时提高了 14%。更长的研究随访时间表明，在讨论治疗方案时，应向患者提供 LRT。
