A systematic review of phase I trials in patients with ovarian cancer

IF 10.5 1区医学 Q1 ONCOLOGY

Cancer treatment reviews Pub Date : 2025-06-26 DOI:10.1016/j.ctrv.2025.102982

Giuliana Pavone , Federica Martorana , Vincenza Ricco , Esteban Andres Ciliberti , Marta Nerone , Cristiana Sessa , Ilaria Colombo

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引用次数: 0

Abstract

Background

Ovarian cancer (OC) is the leading cause of death among gynecological malignancies, with limited treatment options for advanced and platinum-resistant disease. This systematic review analyzes phase I trials to assess recent therapeutic advancements.

Methods

We performed a systematic review of phase I trials in OC, published between 2012 and 2023, retrieving data on trial characteristics and outcomes. Studies were classified according to the tested treatment strategies into chemotherapy-only (CO), chemotherapy + non-chemotherapy agents (CNC) and chemotherapy-free (CF).

Results

78 trials were included, with more than 50 % of them published in the last four years. Overall, chemotherapy and immunotherapy were the most investigated agents. Fourteen trials (17.9 %) evaluated a CO strategy, 42 (53.8 %) a CNC combination and 22 (28.2 %) a CF therapy. Dose-limiting toxicities and toxic deaths were observed in 71 % and 100 % of CO studies, in 45.2 % and 21 % of CNC trials and in 37.4 % and 13.6 % of CF trials, respectively. CNC regimens outperformed the other treatment types in terms of efficacy outcomes, including overall response rate (11.5 % CO; 32.2 % CNC; 25.5 % CF), clinical benefit rate (40 % CO; 62 % CNC; 52 % CF) and median progression free survival (mPFS 5.9 months CO; 6.45 months CNC; 4.85 months CF). Trials enrolling platinum resistant or agnostic patients displayed worse clinical outcomes.

Conclusions

In the last years, there has been an increasing number of phase 1 trials assessing new agents and new combinations in patients with OC. Chemotherapy-free strategies display a more favorable safety profile, while regimens combining CNC agents seem to be more effective compared to CO approaches.

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卵巢癌患者I期临床试验的系统综述

卵巢癌（OC）是妇科恶性肿瘤中导致死亡的主要原因，晚期和铂耐药疾病的治疗选择有限。本系统综述分析了I期试验，以评估最近的治疗进展。方法：我们对2012年至2023年间发表的OC I期试验进行了系统回顾，检索了试验特征和结果的数据。根据测试的治疗策略将研究分为仅化疗（CO），化疗+非化疗药物（CNC）和无化疗（CF）。结果纳入78项试验，其中50%以上发表于最近4年。总体而言，化疗和免疫治疗是研究最多的药物。14项试验（17.9%）评估了CO策略，42项（53.8%）评估了CNC联合治疗，22项（28.2%）评估了CF治疗。剂量限制性毒性和中毒性死亡分别在71%和100%的CO研究、45.2%和21%的CNC试验以及37.4%和13.6%的CF试验中观察到。在疗效结果方面，CNC方案优于其他治疗类型，包括总有效率(11.5% CO；32.2% cnc；25.5% CF)，临床获益率(40% CO；62%数控；52% CF)和中位无进展生存期(mPFS 5.9个月CO；6.45个月CNC；4.85个月CF)。纳入铂耐药或不可知论患者的试验显示出更差的临床结果。在过去的几年中，有越来越多的一期试验评估新的药物和新的联合治疗OC患者。无化疗策略显示出更有利的安全性，而结合CNC药物的方案似乎比CO方法更有效。

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 treatment reviews 医学-肿瘤学

CiteScore

21.40

自引率

0.80%

发文量

109

审稿时长

13 days

期刊介绍： Cancer Treatment Reviews Journal Overview: International journal focused on developments in cancer treatment research Publishes state-of-the-art, authoritative reviews to keep clinicians and researchers informed Regular Sections in Each Issue: Comments on Controversy Tumor Reviews Anti-tumor Treatments New Drugs Complications of Treatment General and Supportive Care Laboratory/Clinic Interface Submission and Editorial System: Online submission and editorial system for Cancer Treatment Reviews