摘要
目的回顾分析西安交大一附院上皮性卵巢癌患者一线化疗中的实际平均卡铂剂量,按照Calvert公式反推出曲线下面积(area under the curve,AUC),比较AUC剂量的差异对中国人群的疗效和安全性影响。方法纳入2012年1月1日至2022年1月1日之间在西安交大一附院首次接受紫杉醇+卡铂3周疗方案一线化疗的患者。根据AUC中位数,将患者分为高剂量和低剂量组,比较其客观缓解率(overall response rate,ORR)、疾病控制率(disease control rate,DCR)、无进展生存期(progression free survival,PFS)和总生存期(overall survival,OS),以及不良事件(adverse events,AEs)的发生率。结果共纳入153例患者,卡铂AUC的中位数为3.981(2.314~5.446)。AUC≥5的患者只有10.46%(16/153)。77例患者AUC<4,76例患者AUC≥4,两组患者基线特性无统计学差异(P>0.05)。两组的ORR分别为59.74%和57.89%,DCR分别为87.01%和85.53%;中位PFS分别为14、15.5个月,中位OS分别为50、55个月。上述结局指标在组间均无统计学差异(P>0.05)。血液学AEs中血红蛋白、中性粒细胞和血小板减少在组间有统计学差异;恶心呕吐、腹泻便秘、1-2级发热在组间有统计学差异(P<0.05)。此外,剂量限制性毒性(dose limiting toxicity,DLT)指标包括4级血小板减少和发热性中性粒细胞减少,在高剂量组发生率显著升高(P<0.05)。结论与国外指南推荐的卡铂AUC 5-6比较,我院卵巢癌一线化疗实际卡铂给药剂量普遍不足。低剂量组和高剂量组患者疗效没有统计学差异,但是鉴于高剂量组部分AEs发生风险增加、DLT风险增加,不建议盲目增加卡铂AUC剂量。
Objective To retrospectively analyze the average carboplatin dosage and calculate the area under the curve(AUC)using the Calvert formula in first-line chemotherapy in patients with epithelial ovarian cancer in The First Affiliated Hospital of Xi’an Jiaotong University so as to evaluate the effect of the AUC difference in the Chinese population on therapeutic efficacy and safety.Methods We enrolled patients who underwent first-line chemotherapy with paclitaxel and carboplatin 3-week regimen in our hospital from January 1,2012 to January 1,2022.According to the median of AUC,the patients were divided into high-dose group and low-dose group.The overall response rate(ORR),disease control rate(DCR),progression free survival(PFS),overall survival(OS),and the incidence of adverse events(AEs)were compared.Results A total of 153 patients were enrolled in this study and the median AUC of carboplatin was 3.981(range 2.314-5.446).Only 10.46%patients(16/153)had an AUC above 5.There were 77 patients with the AUC<4.There were 76 patients with AUC≥4.No significant difference was observed in baseline characteristics between the two groups(P>0.05).The ORR in the low-dose group and the high-dose group was 59.74%and 57.89%,respectively,and the DCR was 87.01%and 85.53%,respectively.The median PFS of the two groups was 14 and 15.5 months,respectively,and the median OS was 50 and 55 months,respectively.None of the above outcomes were statistically different between the two groups(P>0.05).The two groups showed significant differences in the incidence of anemia,neutropenia,and thrombocytopenia(P<0.05).The incidence of nausea and vomiting,grade 1-2 diarrhea or constipation,and grade 1-2 fever showed significant differences(P<0.05).In addition,the incidence of dose limiting toxicity(DLT),including grade 4 thrombocytopenia and febrile neutropenia(FN),was significantly increased in the highdose group(P<0.05).Conclusion Compared with the recommended AUC 5-6 of carboplatin abroad,the actual carboplatin dosage in the first-line chemotherapy for patients with epithelial ovarian cancer was generally insufficient in our hospital.There was no difference in therapeutic efficacy between the patients with AUC<4 and AUC≥4.However,considering the increased risk of some AEs and DLT in the high-dose group,it is not recommended to increase the carboplatin AUC blindly.
作者
景卫
汪蕾
韩露
李敏
周雪
郭苗
李奇灵
JING Wei;WANG Lei;HAN Lu;LI Min;ZHOU Xue;GUO Miao;LI Qiling(Department of Obstetrics and Gynecology,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061;Department of Gynecologic Oncology,Shaanxi Provincial Tumor Hospital,Xi’an 710061,China)
出处
《西安交通大学学报(医学版)》
CAS
CSCD
北大核心
2023年第2期243-250,共8页
Journal of Xi’an Jiaotong University(Medical Sciences)
基金
陕西省自然科学基础研究计划(No.2017ZDJC-11)。
关键词
卡铂
上皮性卵巢癌
AUC
一线化疗
疗效
不良事件
剂量限制性毒性
carboplatin
epithelial ovarian cancer
AUC
first-line chemotherapy
therapeutic efficacy
adverse event
dose limiting toxicity