阳和汤加红景天联合紫杉醇对晚期TNBC患者的疗效影响

Effects of Yang He Decoction Associated with Paclitaxel in Advanced Triple Negative Breast Cancer

目的:观察阳和汤加红景天联合紫杉醇治疗对TNBC患者的生存影响及不良反应。方法:初次复发的TNBC患者50名随机分为治疗组(A组,25人)和对照组(B组,25人)。A组每个周期服用阳和汤加红景天方每天1剂,一共服用10天,加紫杉醇175mg/m^2,Q21化疗,直至疾病进展或无法耐受;B组紫杉醇175mg/m^2,Q21化疗,直至疾病进展或无法耐受。每两个周期评估疾病控制率(DCR),随访比较两组生存情况并观察药物不良反应。结果:第2周期时A组DCR稍优于B组(44%VS 32%);第4周期时A组DCR显著优于B组(64%VS 36%,P<0.05);第6周期时A组DCR显著优于B组(76%VS 40%,P<0.05)。A组平均疾病无进展生存期(PFS)为5.53个月[95%可信区间(Confidence Interval,CI):4.33~8.12],优于B组的3.67个月(95%CI为3.24~3.89)(P<0.01)。患者未出现严重药物不良反应。结论:阳和汤加红景天联合紫杉醇治疗晚期TNBC优于紫杉醇单药化疗,疗效更好,耐受性更好,副作用更小。

Objectives To evaluate the clinical efficacy of Yang He decoction associated with Paclitaxel in advanced triple negative breast cancer. Methods Fifty TNBC patients achieved partial response or disease stabilization following last chemotherapy were divided into treatment group(group A, n=25) and control group(group B, n=25) according to patients' own opinions. In group A, Yang He Decoction was oral administrated at one dose, twice one day, additional Paclitaxel at the dose of 175 mg/m^2, Q21. In group B, Paclitaxel at the dose of 175 mg/m^2 Q21, disease progression or intolerance. The disease control rate(DCR) was evaluated every two cycles, and the survival and adverse drug reactions were observed. Mean progression free survival(PFS) were evaluated by Kaplan-Meier method. Results Group A showed a little favorable DCR compared with group B(44% VS 32%) in 2 cycles, group A showed a big favorable DCR compared with group B(64% VS36%) in 4 cycles, Group A showed a bigger favorable DCR compared with group B(76% VS 40%) in 6 cycles. Mean PFS in group A was 5.53 months(95%CI: 4.33～8.12) vs 3.67 months(95% CI: 3.24～3.89) in group B(P<0.01)respectively. The major adverse effects were mild and tolerable. Conclusions Yang He Decoction associated with Paclitaxel is superior to Paclitaxel mono-therapy in treatment of advanced TNBC, because of better tolerance and less side effects.