新发IV期乳腺癌原发部位的早期局部治疗：一项随机临床试验（EA2108）的结果
Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108).
作者信息
Khan Seema A, Zhao Fengmin, Goldstein Lori J, Cella David, Basik Mark, Golshan Mehra, Julian Thomas B, Pockaj Barbara A, Lee Christine A, Razaq Wajeeha, Sparano Joseph A, Babiera Gildy V, Dy Irene A, Jain Sarika, Silverman Paula, Fisher Carla S, Tevaarwerk Amye J, Wagner Lynne I, Sledge George W
机构信息
Northwestern University, Chicago, IL.
Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA.
出版信息
J Clin Oncol. 2022 Mar 20;40(9):978-987. doi: 10.1200/JCO.21.02006. Epub 2022 Jan 7.
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; = .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% 39.8%; < .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.
目的
在新诊断的乳腺癌患者中，6%或更多的患者存在远处转移。在这种情况下，对于完整原发肿瘤的局部区域治疗被认为可以提高总生存期（OS），但临床试验报告的结果相互矛盾。
方法
患有转移性乳腺癌且原发肿瘤完整的女性接受全身治疗4 - 8个月；如果没有疾病进展，她们被随机分配至对原发部位进行局部区域治疗（按照非转移性疾病的标准进行手术和放疗）或继续全身治疗。主要终点是总生存期；局部区域控制和生活质量是次要终点。该试验设计有85%的把握度检测随机分组患者3年总生存率19.3%的绝对差异。采用分层对数秩检验和Cox比例风险模型比较两组之间的总生存期。使用Gray检验比较局部区域进展的累积发生率。生活质量评估使用标准工具。
结果
在390名入组参与者中，256名被随机分组：131名继续全身治疗，125名接受早期局部区域治疗。未接受早期局部区域治疗的3年总生存率为67.9%，接受早期局部区域治疗的为68.4%（风险比 = 1.11；90%置信区间，0.82至1.52；P = 0.57）。全身治疗组的中位总生存期为53.1个月（95%置信区间，47.9至不可估计），局部区域治疗组为54.9个月（95%置信区间，46.7至不可估计）。随机分配至局部区域治疗的患者局部区域进展较少（3年发生率：16.3%对39.8%；P < 0.001）。两组之间的生活质量指标大体相似。
结论
对患有转移性乳腺癌患者的原发部位进行早期局部区域治疗并不能提高生存率。虽然它与改善局部区域控制相关，但对生活质量没有总体影响。
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