Montagna Emilia, Bagnardi Vincenzo, Cancello Giuseppe, Sangalli Claudia, Pagan Eleonora, Iorfida Monica, Mazza Manuelita, Mazzarol Giovanni, Dellapasqua Silvia, Munzone Elisabetta, Goldhirsch Aaron, Colleoni Marco
Division of Medical Senology, European Institute of Oncology, Milan, Italy.
Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Breast Care (Basel). 2018 Jul;13(3):177-181. doi: 10.1159/000487630. Epub 2018 Apr 26.
Few data are available on the benefit of metronomic cyclophosphamide, capecitabine, and vinorelbine as first-line therapy in patients with metastatic triple-negative breast cancer.
This phase II study assessed the safety and efficacy of metronomic oral chemotherapy with vinorelbine 40 mg orally 3 times a week, cyclophosphamide 50 mg daily, and capecitabine 500 mg 3 times a day (VEX regimen) in untreated metastatic triple-negative breast cancer patients. The biopsy of the metastatic site had to be triple-negative, independent of the hormone receptor expression of the primary tumor. The primary endpoint was time to progression (TTP). Secondary endpoints included assessment of safety and clinical benefit (objective response rate plus stable disease rate at ≥24 weeks).
25 patients were included, and 22 were evaluable for both efficacy and toxicities (median age, 66 years). Median TTP was 6.4 months (95% confidence interval 3.6-12.6). The most common grade 1-2 toxicities were nausea, diarrhea, leuko-/neutropenia, and reversible liver enzyme alteration. Grade 3 events included hand and foot syndrome (9%).
The VEX regimen demonstrated activity and was relatively well tolerated when given as first-line therapy in selected metastatic breast cancer patients with triple-negative disease.
关于节拍性环磷酰胺、卡培他滨和长春瑞滨作为转移性三阴性乳腺癌患者一线治疗的获益情况，可用数据较少。
这项II期研究评估了节拍性口服化疗方案（长春瑞滨40mg口服，每周3次；环磷酰胺50mg每日；卡培他滨500mg，每日3次，即VEX方案）在未经治疗的转移性三阴性乳腺癌患者中的安全性和疗效。转移部位活检结果必须为三阴性，且与原发肿瘤的激素受体表达无关。主要终点为疾病进展时间（TTP）。次要终点包括安全性评估和临床获益（客观缓解率加≥24周时的疾病稳定率）。
纳入25例患者，其中22例可评估疗效和毒性（中位年龄66岁）。中位TTP为6.4个月（95%置信区间3.6 - 12.6）。最常见的1 - 2级毒性反应为恶心、腹泻、白细胞/中性粒细胞减少以及可逆性肝酶改变。3级事件包括手足综合征（9%）。
在选定的转移性三阴性乳腺癌患者中，VEX方案作为一线治疗显示出活性且耐受性相对良好。
