Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)
Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)
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DOI：
10.1200/jco.21.02006
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发表时间：
2022-03-20
影响因子：
45.3
通讯作者：
Sledge, George W.
中科院分区：
文献类型：
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作者：
Khan, Seema A.;Zhao, Fengmin;Sledge, George W.
目的：6%或更多的新诊断乳腺癌患者存在远处转移。在这种情况下，对完整原发肿瘤的局部治疗被假设可以提高总生存率（OS），但临床试验报告的结果相互矛盾。方法：患有转移性乳腺癌和原发肿瘤完整的女性接受4-8个月的全身治疗；如果没有疾病进展，他们被随机分配到原发部位的局部治疗（非转移性疾病的手术和放疗标准）或持续的全身治疗。主要终点为OS；局部区域控制和生活质量是次要终点。在随机分配的患者中，试验设计提供85%的能力来检测3年OS率的绝对差异为19.3%。采用分层对数秩检验和Cox比例风险模型比较各组间OS。局部区域进展的累积发生率采用Gray检验进行比较。生活质量评估使用标准仪器。结果入组的390名参与者中，256名随机分配：131名接受持续全身治疗，125名接受早期局部治疗。未接受早期局部治疗的3年OS为67.9%，接受早期局部治疗的为68.4%（风险比= 1.11;90% CI, 0.82 ~ 1.52; P = 0.57）。系统治疗组的中位OS为53.1个月（95% CI， 47.9至不可估计），局部局部治疗组的中位OS为54.9个月（95% CI， 46.7至不可估计）。随机分配到局部治疗组的局部区域进展较少（3年发生率：16.3% vs 39.8%; P < 0.001）。两组的生活质量指标基本相似。结论早期对原发部位进行局部治疗并不能提高转移性乳腺癌患者的生存率。虽然它与改善局部区域控制有关，但对生活质量没有总体影响。(c)美国临床肿瘤学会2022
PURPOSE Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results.METHODS Women presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments.RESULTS Of 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio = 1.11; 90% CI, 0.82 to 1.52; P = .57). The median OS was 53.1 months (95% CI, 47.9 to not estimable) in the systemic therapy arm and 54.9 months (95% CI, 46.7 to not estimable) in the locoregional therapy arm. Locoregional progression was less frequent in those randomly assigned to locoregional therapy (3-year rate: 16.3% v 39.8%; P < .001). Quality-of-life measures were largely similar between arms.CONCLUSION Early locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life. (c) 2022 by American Society of Clinical Oncology