Calvary Mater Newcastle Hospital, Newcastle, NSW, Australia.
Breast Cancer Trials Ltd., Newcastle, NSW, Australia.
Breast Cancer Res Treat. 2019 Jul;176(2):357-365. doi: 10.1007/s10549-019-05187-y. Epub 2019 Apr 26.
The separate impacts of dose and dose intensity of chemotherapy for metastatic breast cancer remain uncertain. The primary objective of this trial was to compare a short, high-dose, intensive course of epirubicin and cyclophosphamide (EC) with a longer conventional dose regimen delivering the same total dose of chemotherapy.
This open label trial randomised 235 women with metastatic breast cancer to receive either high-dose epirubicin 150 mg/m and cyclophosphamide 1500 mg/m with filgrastim support every 3 weeks for 3 cycles (HDEC) or standard dose epirubicin 75 mg/m and cyclophosphamide 750 mg/m every 3 weeks for 6 cycles (SDEC). Primary outcomes were time to progression, overall survival and quality of life.
In 118 patients allocated HDEC 90% of the planned dose was delivered, compared to 96% in the 117 participants allocated SDEC. There were no significant differences in the time to disease progression (5.7 vs. 5.8 months, P = 0.19) or overall survival (14.5 vs. 16.5 months, P = 0.29) between HDEC and SDEC, respectively. Patients on HDEC reported worse quality of life during therapy, but scores improved after completion to approximate those reported by patients allocated SDEC. Objective tumour response was recorded in 33 (28%) on HDEC and 42 patients (36%) on SDEC. HDEC produced more haematologic toxicity.
For women with metastatic breast cancer, disease progression, survival or quality of life were no better with high-dose intensity compared to standard dose EC chemotherapy. Australian Clinical Trials Registry registration number ACTRN12605000478617.
转移性乳腺癌化疗的剂量和剂量强度的单独影响仍不确定。本试验的主要目的是比较短程、高剂量、强化的表柔比星和环磷酰胺（EC）方案与更长时间的常规剂量方案，以提供相同的总化疗剂量。
这项开放标签试验将 235 名转移性乳腺癌患者随机分为两组，一组接受高剂量表柔比星 150mg/m2 和环磷酰胺 1500mg/m2，并用粒细胞集落刺激因子支持，每 3 周为一个周期，共 3 个周期（HDEC）；另一组接受标准剂量表柔比星 75mg/m2 和环磷酰胺 750mg/m2，每 3 周为一个周期，共 6 个周期（SDEC）。主要结局是无进展生存期、总生存期和生活质量。
在接受 HDEC 治疗的 118 名患者中，90%的计划剂量得到了给药，而在接受 SDEC 治疗的 117 名患者中，这一比例为 96%。两组之间疾病进展时间（5.7 与 5.8 个月，P=0.19）或总生存期（14.5 与 16.5 个月，P=0.29）均无显著差异。HDEC 组患者在治疗期间的生活质量较差，但在治疗结束后有所改善，接近接受 SDEC 治疗的患者的报告。HDEC 组有 33 例（28%）和 SDEC 组有 42 例（36%）患者有客观肿瘤反应。HDEC 方案引起更多的血液学毒性。
对于转移性乳腺癌患者，与标准剂量 EC 化疗相比，高剂量强度并未改善疾病进展、生存或生活质量。澳大利亚临床试验注册中心注册号 ACTRN12605000478617。
