Capecitabine-Enhanced Brachytherapy in Locally Advanced Cervical Cancer: A Phase II Non-Randomized Trial on Safety and Efficacy.

IF 1.8 4区医学 Q3 ONCOLOGY

Cancer Investigation Pub Date : 2025-04-01 Epub Date: 2025-04-23 DOI:10.1080/07357907.2025.2493238

Fatemeh Homaei Shandiz, Soudeh Arastouei, Sare Hosseini, Indira Prasad Giri, Seyed Alireza Javadinia, Mahdiye Dayanni, Habibollah Esmaily, Maliheh Hasanzadeh Mofard

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引用次数: 0

Abstract

Aim: To evaluate the safety and efficacy of administering capecitabine concurrent with brachytherapy in advanced-stage cervical cancer.

Methods: Eligible patients with FIGO stage IB2-IVA cervical cancer were enrolled in this phase II non-randomized trial. After external beam chemoradiotherapy (EBRT), patients received capecitabine alongside brachytherapy as radiosensitizer. The primary objective was to assess the tolerability of the combined regimen and its effect on one-year disease-free (DFS) and overall survival rates (OS).

Results: Of the 69 patients completed treatment, 18 were enrolled as intervention group and 51 served as controls. Both groups were matched in terms of comorbidities, stage, and response to EBRT. Overall, concurrent capecitabine administration during brachytherapy was safe. At one-year follow-up, one death was recorded in each group, with recurrence rates of 16.7% in the intervention group and 19.6% in the control group. One-year DFS was 82% (95% CI: 54%-98%) in the intervention group and 87% (95% CI: 72%-94%) in the control group, while one-year OS was 93% (95% CI: 53%-98%) and 97% (95% CI: 85%-99%), respectively (for both p < 0.05).

Conclusion: In conclusion, while capecitabine-augmented brachytherapy was demonstrated to be safe in patients with advanced cervical cancer, its addition did not yield significant improvements in DFS or OS.

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卡培他滨增强近距离治疗局部晚期宫颈癌：安全性和有效性的II期非随机试验。

目的：评价卡培他滨联合近距离放疗治疗晚期宫颈癌的安全性和有效性。方法：FIGO分期IB2-IVA宫颈癌患者入组这项II期非随机试验。在体外放化疗（EBRT）后，患者接受卡培他滨和近距离放疗作为放射增敏剂。主要目的是评估联合方案的耐受性及其对一年无病（DFS）和总生存率（OS）的影响。结果：完成治疗的69例患者中，干预组18例，对照组51例。两组在合并症、分期和对EBRT的反应方面相匹配。总体而言，在近距离治疗期间同时给予卡培他滨是安全的。随访一年，两组各有1例死亡，干预组复发率为16.7%，对照组为19.6%。干预组1年DFS为82% (95% CI: 54%-98%)，对照组1年DFS为87% (95% CI: 72%-94%)，而1年OS分别为93% （95% CI: 53%-98%）和97% (95% CI: 85%-99%)(两组均为p结论：结论：虽然卡培他碱增强近距离放疗在晚期宫颈癌患者中被证明是安全的，但其添加并未显著改善DFS或OS。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Investigation 医学-肿瘤学

CiteScore

3.80

自引率

4.20%

发文量

审稿时长

8.5 months

期刊介绍： Cancer Investigation is one of the most highly regarded and recognized journals in the field of basic and clinical oncology. It is designed to give physicians a comprehensive resource on the current state of progress in the cancer field as well as a broad background of reliable information necessary for effective decision making. In addition to presenting original papers of fundamental significance, it also publishes reviews, essays, specialized presentations of controversies, considerations of new technologies and their applications to specific laboratory problems, discussions of public issues, miniseries on major topics, new and experimental drugs and therapies, and an innovative letters to the editor section. One of the unique features of the journal is its departmentalized editorial sections reporting on more than 30 subject categories covering the broad spectrum of specialized areas that together comprise the field of oncology. Edited by leading physicians and research scientists, these sections make Cancer Investigation the prime resource for clinicians seeking to make sense of the sometimes-overwhelming amount of information available throughout the field. In addition to its peer-reviewed clinical research, the journal also features translational studies that bridge the gap between the laboratory and the clinic.