阿帕替尼联合脂质体多柔比星或紫杉醇对比脂质体多柔比星或紫杉醇单药治疗铂类耐药复发性卵巢癌患者的疗效和安全性。
Efficacy and safety of apatinib combined with liposomal doxorubicin or paclitaxel versus liposomal doxorubicin or paclitaxel monotherapy in patients with recurrent platinum-resistant ovarian cancer.
机构信息
Department of Gynecology, The Second People's Hospital of Liaocheng, Linqing, 252600, China.
Department of Gynecology, The Second Hospital of Liaocheng Affiliated to Shandong First Medical University, Linqing, 252600, China.
出版信息
J Obstet Gynaecol Res. 2023 Jun;49(6):1611-1619. doi: 10.1111/jog.15644. Epub 2023 Mar 29.
AIM
Apatinib is an effective treatment for patients with gynecological cancers. This study aimed to further explore the efficacy and safety of apatinib plus chemotherapy in patients with recurrent platinum-resistant ovarian cancer (PROC).
METHODS
Totally, 105 patients with recurrent PROC receiving apatinib plus chemotherapy (N = 51) and chemotherapy alone (N = 54) were retrospectively enrolled in this cohort study.
RESULTS
Objective response rate (37.3% vs. 14.8%) (p = 0.009) and disease control rate (80.4% vs. 61.1%) (p = 0.030) were increased in the apatinib plus chemotherapy group versus the chemotherapy group. The median (95% confidence interval [CI]) progression-free survival (PFS) and overall survival (OS) were 5.5 (3.4-7.6) and 21.4 (16.2-26.6) months in the apatinib plus chemotherapy group, and they were 3.8 (3.0-4.6) and 14.8 (11.9-17.7) months in the chemotherapy group. Meanwhile, the Kaplan-Meier curves revealed that PFS (p = 0.008) and OS (p = 0.012) were prolonged in the apatinib plus chemotherapy group versus the chemotherapy group. This finding was confirmed by multivariate Cox's proportional regression analyses: enter method (hazard ratio [HR] = 0.515, p = 0.007 for PFS; HR = 0.222, p < 0.001 for OS) and step-forward method (HR = 0.608, p = 0.019 for PFS; HR = 0.346, p = 0.001 for OS). Additionally, the incidence of hypertension was increased in the apatinib plus chemotherapy group versus the chemotherapy group (p = 0.038), while others were not different between the two groups (all p > 0.05). Grades 3 and 4 adverse events were neutropenia, hypertension, leukopenia, hand-foot syndrome, nausea and vomiting, fatigue, thrombocytopenia, and anemia in the apatinib plus chemotherapy group.
CONCLUSION
Apatinib combined with chemotherapy is a superior choice over chemotherapy alone for recurrent PROC management.
目的
阿帕替尼是治疗妇科癌症患者的有效药物。本研究旨在进一步探讨阿帕替尼联合化疗治疗复发性铂耐药卵巢癌（PROC）患者的疗效和安全性。
方法
回顾性纳入了 105 例接受阿帕替尼联合化疗（N=51）和单纯化疗（N=54）的复发性 PROC 患者。
结果
与化疗组相比，阿帕替尼联合化疗组客观缓解率（37.3% vs. 14.8%）（p=0.009）和疾病控制率（80.4% vs. 61.1%）（p=0.030）均提高。阿帕替尼联合化疗组中位（95%置信区间[CI]）无进展生存期（PFS）和总生存期（OS）分别为 5.5（3.4-7.6）和 21.4（16.2-26.6）个月，化疗组分别为 3.8（3.0-4.6）和 14.8（11.9-17.7）个月。同时，Kaplan-Meier 曲线显示阿帕替尼联合化疗组的 PFS（p=0.008）和 OS（p=0.012）均长于化疗组。多因素 Cox 比例回归分析证实了这一结果：进入法（风险比[HR] = 0.515，p=0.007，用于 PFS；HR = 0.222，p<0.001，用于 OS）和逐步前进法（HR = 0.608，p=0.019，用于 PFS；HR = 0.346，p=0.001，用于 OS）。此外，与化疗组相比，阿帕替尼联合化疗组高血压的发生率增加（p=0.038），而其他组间差异无统计学意义（均 p>0.05）。阿帕替尼联合化疗组出现 3 级和 4 级不良反应为中性粒细胞减少、高血压、白细胞减少、手足综合征、恶心呕吐、乏力、血小板减少和贫血。
结论
与单纯化疗相比，阿帕替尼联合化疗是复发性 PROC 治疗的更佳选择。
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