Department of Oncology, Educational Establishment "Vitebsk State Medical University", Frunze Av., 27, 210009, Vitebsk, Republic of Belarus.
Breast Cancer Res Treat. 2021 Apr;186(2):439-451. doi: 10.1007/s10549-020-06036-z. Epub 2021 Jan 3.
To conduct a prospective randomized controlled study of the optimization of adjuvant therapy in patients with non-metastatic breast cancer, taking into account the presence of circulating tumor cells (CTCs) with an assessment of tumor-specific OS and DFS.
Stage 1 Continuous non-randomized prospective study (n = 102) to study the clinical and prognostic value of CTCs and evaluate the effectiveness of adjuvant systemic therapy in relation to CTC eradication; Stage 2 Prospective randomized controlled study (n = 128) of optimization of adjuvant therapy taking into account CTCs with an assessment of the effectiveness of the standard therapy and an optimized therapy regimen.
Monitoring of CTCs during adjuvant drug treatment has established that a significant decrease in the frequency of CTC identification can be achieved only by sequential administration of anthracyclines and taxanes (paclitaxel) AC-T, which allows reducing CTCs compared to other regimens from 52.6 to 15.8% (p = 0.006). CTC-oriented personalized adjuvant therapy in the experimental group, based on the timely transition from an ineffective adjuvant chemotherapy regimen to taxanes, as well as additional monochemotherapy with gemcitabine can achieve 100% eradication CTCs. In the adjuvant therapy experimental group taking into account CTCs (n = 68), the OS 5-year tumor-specific rate was 90.3 ± 3.8%, (control group 78.7 ± 3.9%, p = 0.036). DFS tumor-specific in the experimental group was 88.0 ± 4.4%, (control group 80.6 ± 3.3%, p = 0.023).
The use of the method of treatment of CTC-oriented personalized adjuvant therapy for non-metastatic breast cancer makes it possible to reliably increase DFS 5-year by 7.4% and OS 5-year by 11.6%.
针对非转移性乳腺癌患者的辅助治疗进行前瞻性随机对照研究，考虑循环肿瘤细胞（CTC）的存在，评估肿瘤特异性总生存期（OS）和无病生存期（DFS）。
第 1 阶段连续非随机前瞻性研究（n=102），研究 CTC 的临床和预后价值，并评估辅助全身治疗与 CTC 清除的有效性；第 2 阶段前瞻性随机对照研究（n=128），考虑 CTC 对辅助治疗进行优化，评估标准治疗和优化治疗方案的有效性。
在辅助药物治疗期间监测 CTC 发现，只有序贯给予蒽环类药物和紫杉烷（紫杉醇）AC-T 才能显著降低 CTC 的检出频率，与其他方案相比，这可以使 CTC 从 52.6%降至 15.8%（p=0.006）。实验组基于从无效辅助化疗方案及时过渡到紫杉烷类药物以及联合使用吉西他滨进行额外的单药化疗的基于 CTC 的个体化辅助治疗，能够实现 CTC 的 100%清除。在考虑 CTC 的辅助治疗实验组（n=68）中，5 年肿瘤特异性 OS 率为 90.3±3.8%（对照组为 78.7±3.9%，p=0.036）。实验组的肿瘤特异性 DFS 为 88.0±4.4%（对照组为 80.6±3.3%，p=0.023）。
对于非转移性乳腺癌，采用基于 CTC 的个体化辅助治疗方法可以可靠地提高 5 年 DFS 7.4%和 OS 5 年 11.6%。
