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卡铂联合三氧化二砷与卡铂联合多西他赛治疗局部晚期宫颈癌的随机、开放标签、II期临床研究

Carboplatin combined with arsenic trioxide versus carboplatin combined with docetaxel treatment for LACC: A randomized, open-label, phase II clinical study.

作者信息

Li Sijin, Zhang Yawen, Li Haiying, He Zeyang, Li An, Yan Jiao, Li Daocheng

机构信息

Medical Department of Obstetrics and Gynecology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510000, Guangdong, China.

Gynecology, Baiyun Branch of the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.

出版信息

Open Med (Wars). 2024 Dec 12;19(1):20241106. doi: 10.1515/med-2024-1106. eCollection 2024.

Abstract

PURPOSE

This study compared the efficacy and safety of carboplatin combined with arsenic trioxide versus carboplatin combined with docetaxel in treating locally advanced cervical cancer (LACC).

METHODS

A total of 48 patients were enrolled between January 2019 and December 2022 and randomly assigned to the experimental group (carboplatin + arsenic trioxide, = 24) or control group (carboplatin + docetaxel, = 24). The clinical efficacy, adverse reactions, and serological markers were analyzed.

RESULTS

There was no significant difference in baseline characteristics or total effective rates between the two groups (72.22% vs 68.42%, > 0.05). Both groups showed significant reductions in serum squamous cell carcinoma antigen levels after chemotherapy ( < 0.05), but no significant difference was observed between groups (6.00 ± 11.36 ng/mL vs 8.42 ± 12.17 ng/mL, > 0.05). Additionally, there was no significant difference in the incidence of adverse reactions ( > 0.05).

CONCLUSION

Arsenic trioxide combined with carboplatin as a preoperative neoadjuvant chemotherapy for LACC is not worse than docetaxel combined with carboplatin in terms of short-term efficacy and safety during the treatment of LACC.

摘要

目的

本研究比较了卡铂联合三氧化二砷与卡铂联合多西他赛治疗局部晚期宫颈癌(LACC)的疗效和安全性。

方法

2019年1月至2022年12月共纳入48例患者,随机分为实验组(卡铂+三氧化二砷,n = 24)和对照组(卡铂+多西他赛,n = 24)。分析临床疗效、不良反应和血清学标志物。

结果

两组患者的基线特征或总有效率无显著差异(72.22%对68.42%,P>0.05)。化疗后两组患者血清鳞状细胞癌抗原水平均显著降低(P<0.05),但组间无显著差异(6.00±11.36 ng/mL对8.42±12.17 ng/mL,P>0.05)。此外,不良反应发生率无显著差异(P>0.05)。

结论

在LACC治疗期间的短期疗效和安全性方面,三氧化二砷联合卡铂作为LACC的术前新辅助化疗并不比多西他赛联合卡铂差。

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