多柔比星脂质体联合贝伐珠单抗治疗铂类耐药型复发性卵巢癌的临床疗效和安全性观察

Observation of clinical efficacy and safety of doxorubicin liposome combined with bevacizumab in the treatment of platinum-resistant recurrent ovarian cancer

摘要:

目的 观察多柔比星脂质体联合贝伐珠单抗治疗铂类耐药型复发性卵巢癌患者的临床疗效及安全性。方法 选取我院2017年1月—2018年12月收治的76例铂类耐药型复发性卵巢癌患者，采用随机数字分组法分为对照组和观察组，每组38例。对照组患者给予多西他赛联合贝伐珠单抗化疗6个周期，观察组患者给予多柔比星脂质体联合贝伐珠单抗化疗6个周期。比较两组患者的临床疗效，药物不良反应，血清人附睾蛋白4（HE4）、糖类抗原125（CA125）水平变化，以及中位生存期（mOS）和中位无疾病进展生存期（mPFS）。结果 治疗后，观察组患者疾病控制率（DCR）、客观有效率（ORR）分别为76.32%、57.89%，高于对照组的52.63%、31.58%（P<0.05）。观察组患者血清HE4、CA125水平均低于对照组（P<0.05）。对照组患者恶心呕吐、白细胞减少、乏力等药物不良反应发生率高于观察组（P<0.05），但观察组心脏毒性发生率高于对照组（P<0.05）。两组患者血小板减少、肝肾功能损伤、高血压等不良反应发生率相比较，差异无统计学意义（P>0.05）。观察组患者mOS、mPFS较对照组明显延长，差异具有统计学意义（P<0.05）。结论 多柔比星脂质体联合贝伐珠单抗在铂类耐药型复发性卵巢癌患者中疗效值得肯定，安全性好。

Abstract:

Objective To study the clinical efficacy and safety of doxorubicin liposome combined with bevacizumab in patients with platinum-resistant recurrent ovarian cancer.Methods Seventy-six patients with platinum-resistant recurrent ovarian cancer admitted in our hospital between January 2017 and December 2018 were selected in this study. Patients were divided into the control group and the observation group by random number grouping method, 38 cases in each group. The patients in the control group were given docetaxel combined with bevacizumab chemotherapy for 6 cycles, and those in the observation group were given doxorubicin liposome combined with bevacizumab chemotherapy for 6 cycles. Compare the clinical effects, incidence of adverse drug reactions, changes of serum levels of human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125), median survival (mOS) and median progression-free survival (mPFS) between the two groups.Results After treatment, the disease control rate (DCR) and objective response rate (ORR) of patients in observation group were respectively 76.32% and 57.89%, but they were respectively 52.63% and 31.58% in the control group. Both DCR and ORR were higher in the observation group than in the control group (P<0.05). The serum levels of HE4 and CA125 in the observation group were respectively lower than in the control group after treatment. The incidence of adverse drug reactions such as nausea and vomiting, leukopenia, and fatigue were lower in the observation group than in the control group (P<0.05), but the incidence of cardiotoxicity in the observation group was higher than in the control group (P<0.05). The incidence of adverse reactions such as thrombocytopenia, liver and kidney function damage, hypertension had no statistical differences between the two groups (P>0.05). The mOS and mPFS of the observation group were respectively longer than those of the control group (P<0.05).Conclusion The efficacy of doxorubicin liposome combined with bevacizumab is worthy of recognition for patients with platinum-resistant recurrent ovarian cancer, with good safety.