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贝伐珠单抗治疗晚期或复发性 Müllerian 癌的真实世界疗效和安全性:单机构经验。

Real-world Efficacy and Safety of Bevacizumab for Advanced or Recurrent Müllerian Cancer: A Single-institutional Experience.

机构信息

Department of Obstetrics and Gynecology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan;

Department of Obstetrics and Gynecology, Osaka City University Graduate School of Medicine, Osaka, Japan.

出版信息

Anticancer Res. 2023 Jul;43(7):3097-3105. doi: 10.21873/anticanres.16481.

Abstract

BACKGROUND/AIM: The efficacy and safety of bevacizumab for ovarian cancer have been reported in randomized phase III clinical trials. It is important to gather experience and data in a real-world setting. The objective of the present study was to evaluate the efficacy and safety of bevacizumab for patients with ovarian cancer in a real-world setting.

PATIENTS AND METHODS

For front-line settings, patients with FIGO stage III-IV ovarian cancer treated using bevacizumab and chemotherapy after debulking surgery (Chemo + Bev group, n=79), in addition to those treated with only chemotherapy after debulking surgery (Chemo group; n=66), at our institute were reviewed retrospectively. For recurrent settings, patients with recurrent ovarian cancers treated with bevacizumab and any chemotherapy were reviewed retrospectively (n=65).

RESULTS

In the front-line setting, the disease-free survival was significantly longer in the Chemo + Bev group compared with that in the Chemo group (p=0.021). Hypertension and proteinuria were found to be statistically more frequent in the Chemo + Bev group compared with that in the Chemo group (p=0.002 and p=0.004). In the recurrent setting, in platinum-sensitive patients, the response rate (RR) and the disease control ratio (DCR) were 78.4 and 94.1%, respectively. In platinum-resistant patients, the RR and the DCR were 28.6 and 57.1% respectively. The median progression-free survival was 18.3 and 7.1 months for platinum-sensitive recurrence and platinum-resistant recurrence, respectively. The major ≥ grade 3 adverse event was neutropenia.

CONCLUSION

The present study provided encouraging real-world evidence of the efficacy and safety of bevacizumab for ovarian cancer in real-world.

摘要

背景/目的:贝伐珠单抗治疗卵巢癌的疗效和安全性已在随机 III 期临床试验中得到证实。在真实世界环境中积累经验和数据非常重要。本研究的目的是评估贝伐珠单抗治疗卵巢癌患者的疗效和安全性。

患者和方法

对于一线治疗,回顾性分析了我院接受贝伐珠单抗联合化疗(Chemo + Bev 组,n=79)和单纯化疗(Chemo 组,n=66)减瘤术后的 FIGO 分期 III-IV 期卵巢癌患者的疗效。对于复发性疾病,回顾性分析了接受贝伐珠单抗联合任何化疗治疗的复发性卵巢癌患者(n=65)。

结果

一线治疗中,Chemo + Bev 组的无疾病生存时间明显长于 Chemo 组(p=0.021)。Chemo + Bev 组高血压和蛋白尿的发生率明显高于 Chemo 组(p=0.002 和 p=0.004)。在复发性疾病中,在铂敏感患者中,缓解率(RR)和疾病控制率(DCR)分别为 78.4%和 94.1%。在铂耐药患者中,RR 和 DCR 分别为 28.6%和 57.1%。铂敏感复发和铂耐药复发的中位无进展生存期分别为 18.3 个月和 7.1 个月。≥3 级主要不良事件为中性粒细胞减少症。

结论

本研究提供了令人鼓舞的真实世界证据,证实了贝伐珠单抗治疗卵巢癌的疗效和安全性。

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