Jensen Maj-Britt, Balslev Eva, Knoop Ann Søegaard, Tuxen Malgorzata K, Højris Inger, Jakobsen Erik H, Cold Søren, Danø Hella, Glavicic Vesna, Kenholm Julia, Ejlertsen Bent
Danish Breast Cancer Cooperative Group, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark.
Department of Pathology, Herlev and Gentofte Hospital, Copenhagen, Denmark.
J Clin Oncol. 2025 Feb;43(4):373-380. doi: 10.1200/JCO.24.00836. Epub 2024 Oct 23.
The primary analysis of the DBCG 07-READ trial reported in 2017 provided evidence of no overall benefit from adjuvant anthracyclines in patients with early normal breast cancer in disease-free survival (DFS), distant disease-free survival (DDFS), or overall survival (OS). We performed a protocol-scheduled analysis of DDFS, DFS, and OS on the basis of 10-year follow-up. Full details on incident heart failure (HF) and second cancers were presented. Patients in the intention-to-treat population assigned to epirubicin and cyclophosphamide followed by docetaxel (EC-D) had longer DDFS (adjusted hazard ratio [HR], 0.79 [95% CI, 0.64 to 0.98]; = .03) and DFS (HR, 0.83 [95% CI, 0.69 to 0.99]; = .04) than patients assigned to docetaxel and cyclophosphamide (DC). There was no statistically significant difference in mortality rates. The 10-year cumulative risk of HF was 2.1% (95% CI, 1.4 to 3.3) with EC-D and 1.1% (95% CI, 0.6 to 2.0) with DC (HR, 2.12 [95% CI, 1.03 to 4.35]; = .04). In conclusion, anthracycline followed by docetaxel improved outcome compared with DC in patients with normal early breast cancer, and no clinical value of testing was shown. The risk of HF was doubled in patients receiving anthracycline; however, overall, the risk of HF was low.
2017年报道的丹麦乳腺癌协作组（DBCG）07-READ试验的初步分析表明，辅助性蒽环类药物对早期正常乳腺癌患者的无病生存期（DFS）、远处无病生存期（DDFS）或总生存期（OS）均无总体益处。我们基于10年随访对DDFS、DFS和OS进行了方案规定的分析。报告了新发心力衰竭（HF）和第二原发性癌症的全部详细情况。在意向性治疗人群中，接受表柔比星和环磷酰胺序贯多西他赛（EC-D）治疗的患者比接受多西他赛和环磷酰胺（DC）治疗的患者有更长的DDFS（校正风险比[HR]，0.79[95%CI，0.64至0.98]；P = 0.03）和DFS（HR，0.83[95%CI，0.69至0.99]；P = 0.04）。死亡率无统计学显著差异。EC-D组HF的10年累积风险为2.1%（95%CI，1.4至3.3），DC组为1.1%（95%CI，0.6至2.0）（HR，2.12[95%CI，1.03至4.35]；P = 0.04）。总之，对于早期正常乳腺癌患者，蒽环类药物序贯多西他赛与DC相比改善了结局，且未显示出基因检测的临床价值。接受蒽环类药物治疗的患者HF风险增加一倍；然而，总体而言，HF风险较低。
