阿特唑单抗、贝伐单抗和铂化疗在宫颈癌中的应用:来自BEATcc的日本人群的结果

IF 3.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Munetaka Takekuma, Shin Nishio, Satoshi Yamaguchi, Mayu Yunokawa, Hiroshi Nishio, Koji Nishino, Akira Kurosaki, Shinichiro Minobe, Guillermo Villacampa, Ana Oaknin, Aikou Okamoto
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引用次数: 0

摘要

目的:本研究分析了在2018年10月至2021年8月的BEATcc试验中,日本妇科肿瘤组在8个部位接受转移性和复发性宫颈癌治疗的56名日本患者中,附加atezolizumab对标准一线含贝伐单抗治疗的疗效。方法:患者随机分为标准组(标准治疗:顺铂50 mg/m²或卡铂5曲线下面积,紫杉醇175 mg/m²,贝伐单抗15 mg/kg)或实验组(标准治疗阿特唑单抗1200 mg)。结果:56例患者中,实验组30例,标准组26例(年龄:53.2±12.9岁对54.7±12.2岁)。实验组的中位无进展生存期为15.8个月(95%可信区间[CI]=10.4-26.1),标准组为11.1个月(8.4-16.5)(风险比[HR]=0.51; 95% CI=0.26-1.01)。实验组的中位总生存期为34.1个月(23.2-38.6),标准组为31.6个月(16.4-36.5)(HR=0.53; 95% CI=0.23-1.21)。实验组客观有效率为86.7%,标准组为84.6%。完全缓解和部分缓解在实验组分别为23.3%和63.3%,在标准组分别为26.9%和57.7%。实验组≥3级不良事件发生率为80.0%,标准组为88.5%。胃肠/泌尿生殖系统瘘发生率在日本患者中较低(1例患者接受atezolizumab),可能是由于更严格的纳入标准。结论:总体而言,加用atezolizumab提高了贝伐单抗和化疗在日本患者中的疗效,可以被认为是日本转移性、持续性或复发性宫颈癌的新的一线治疗选择。试验注册:ClinicalTrials.gov标识符:NCT03556839。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Atezolizumab, bevacizumab, and platinum chemotherapy in cervical cancer: results of Japanese population from BEATcc.

Objective: This study analyzed the efficacy of add-on atezolizumab to standard first-line bevacizumab-containing therapy in 56 Japanese patients with metastatic and recurrent cervical cancer treated across 8 sites under the Japanese Gynecologic Oncology Group between October 2018 and August 2021 in the BEATcc trial.

Methods: Patients were randomized to standard arm (standard therapy: cisplatin 50 mg/m² or carboplatin area under the curve of 5, paclitaxel 175 mg/m², and bevacizumab 15 mg/kg) or experimental arm (standard therapy with atezolizumab 1,200 mg).

Results: Of 56 patients, 30 were in experimental arm vs. 26, standard arm (age: 53.2±12.9 vs. 54.7±12.2 years). Median progression-free survival was 15.8 months (95% confidence interval [CI]=10.4-26.1) in experimental arm vs. 11.1 months (8.4-16.5) in standard arm (hazard ratio [HR]=0.51; 95% CI=0.26-1.01). Median overall survival was 34.1 months (23.2-38.6) in the experimental arm vs. 31.6 months (16.4-36.5), standard arm (HR=0.53; 95% CI=0.23-1.21). Objective response rate was 86.7% in experimental arm vs. 84.6%, standard arm. Complete response and partial response, respectively, were 23.3% and 63.3% in experimental arm and 26.9% and 57.7% in standard arm. Grade ≥3 adverse events occurred in 80.0%, experimental arm and 88.5%, standard arm. Gastrointestinal/genitourinary fistula incidence was lower in Japanese patients (1 patient receiving atezolizumab), likely due to stricter inclusion criteria.

Conclusion: Overall, add-on atezolizumab enhances the efficacy of bevacizumab and chemotherapy in Japanese patients as those in overall BEATcc population and could be considered a new first-line treatment option for metastatic, persistent, or recurrent cervical cancer in Japan.

Trial registration: ClinicalTrials.gov Identifier: NCT03556839.

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来源期刊
Journal of Gynecologic Oncology
Journal of Gynecologic Oncology ONCOLOGY-OBSTETRICS & GYNECOLOGY
CiteScore
6.00
自引率
2.60%
发文量
84
审稿时长
>12 weeks
期刊介绍: The Journal of Gynecologic Oncology (JGO) is an official publication of the Asian Society of Gynecologic Oncology. Abbreviated title is ''J Gynecol Oncol''. It was launched in 1990. The JGO''s aim is to publish the highest quality manuscripts dedicated to the advancement of care of the patients with gynecologic cancer. It is an international peer-reviewed periodical journal that is published bimonthly (January, March, May, July, September, and November). Supplement numbers are at times published. The journal publishes editorials, original and review articles, correspondence, book review, etc.
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