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400038 重庆, 陆军军医大学(第三军医大学)第一附属医院呼吸与危重症医学科
[ 周向东,E-mail:xiangdongzhou@126.com ZHOU Xiangdong E-mail: xiangdongzhou@126.com
收稿:2020-11-04,
修回:2021-01-16,
纸质出版:2021-04-15
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胡雪婷, 王康, 罗虎, 等. 晚期肺腺癌患者维持治疗中EGFR-TKI联合贝伐珠单抗的回顾性分析[J]. 第三军医大学学报, 2021,43(7):648-654.
Xueting HU, Kang WANG, Hu LUO, et al. EGFR-TKI plus bevacizumab as maintenance therapy for advanced lung adenocarcinoma: a retrospective study of 192 cases[J]. Journal of Third Military Medical University, 2021, 43(7): 648-654.
胡雪婷, 王康, 罗虎, 等. 晚期肺腺癌患者维持治疗中EGFR-TKI联合贝伐珠单抗的回顾性分析[J]. 第三军医大学学报, 2021,43(7):648-654. DOI: 10.16016/j.1000-5404.202011035.
Xueting HU, Kang WANG, Hu LUO, et al. EGFR-TKI plus bevacizumab as maintenance therapy for advanced lung adenocarcinoma: a retrospective study of 192 cases[J]. Journal of Third Military Medical University, 2021, 43(7): 648-654. DOI: 10.16016/j.1000-5404.202011035.
目的
2
对比分析EGFR突变阳性的晚期肺腺癌患者经EGFR-TKI治疗达疾病稳定后联合贝伐珠单抗维持治疗与EGFR-TKI单药治疗的疗效与安全性。
方法
2
收集2013-2019年就诊于本院的192例晚期肺腺癌患者,其中联合组30例,单药组162例。联合组患者经一线EGFR-TKI诱导治疗后联合贝伐珠单抗维持治疗,单药组患者经一线EGFR-TKI治疗直至疾病进展。运用1∶1倾向性评分匹配共匹配29对患者。对比两组患者的总无进展生存期(progression-free survival,PFS1)、进入稳定期后的无进展生存期(PFS2)、持续缓解时间(duration of response,DoR)、客观缓解率(objective response rate,ORR)、肿瘤大小变化及安全性等。
结果
2
疗效方面:联合组较单药组中位PFS1、PFS2均明显延长,且差异有统计性意义,两组PFS1分别为17.3、11.5个月(
HR
=0.401
P
=0.001),PFS2分别为6.0、3.9个月(
HR
=0.527
P
=0.023);联合组及单药组中位DoR分别为12.2、8.6个月,差异有统计学意义(
HR
=0.503
P
=0.037);两组ORR分别为79.3%、72.4%,差异无统计学意义,但联合组较单药组肿瘤距基线缩小的程度更大。安全性方面:两组均无治疗相关死亡事件发生;两组常见的不良反应为皮肤及黏膜损害(55%
vs
62%)、肝功损害(55%
vs
45%)、肾功能损害(17%
vs
7%)、高血压(10%
vs
0);两组3/4级不良事件发生率分别为14%、7%,差异无统计学意义。
结论
2
EGFR-TKI联合贝伐珠单抗维持治疗的疗效优于EGFR-TKI单药治疗,且毒副作用无明显升高。
Objective
2
To compare the efficacy and safety of EGFR-TKI plus bevacizumab as maintenance therapy with EGFR-TKI alone for EGFR-mutated advanced lung adenocarcinoma.
Methods
2
Clinical data of 192 patients with advanced lung adenocarcinoma admitted in our hospital from 2013 to 2019 were collected and retrospectively analyzed. Thirty of them received combination therapy (EGFR-TKI plus bevacizumab as maintenance therapy)
and the other 162 monotherapy (continuous treatment with EGFR-TKI until disease progression). Then 29 pairs of patients were matched by propensity score matching at a ratio of 1∶1. Overall progression-free survival (PFS1)
PFS after reaching stable disease (PFS2)
duration of response (DoR)
objective response rate (ORR)
tumor size changes and safety profiles were compared between the 2 groups.
Results
2
The combination group had significantly longer median PFS1 (17.3
vs
11.5 months
HR
=0.401
P
=0.001) and PFS2 (6.0
vs
3.9 months
HR
=0.527
P
=0.023)
and also statistically longer median DoR (12.2
vs
8.6 months
HR
=0.503
P
=0.037) when compared with the monotherapy group.The ORR was 79.3% and 72.4%
respectively
with no statistical difference but the reduction in target tumor lesion size was greater in the combination group. No treatment-associated death occurred in both groups. Common advance events were skin and mucous damage (55%
vs
62%)
hepatic function damage (55%
vs
45%)
renal function damage (17%
vs
7%) and hypertension (10%
vs
0). The rate of grade 3 or worse adverse events were 14% versus 7% in the 2 groups (
P
>
0.05).
Conclusion
2
EGFR-TKI plus bevacizumab is superior to EGFR-TKI monotherapy with more effective maintenance therapy and tolerable toxicity.
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