Veliparib伴随一线化疗并作为卵巢癌维持治疗：最终总生存期和疾病相关症状结果

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2025-06-17 DOI:10.1016/j.ejca.2025.115587

Robert L. Coleman , Gini F. Fleming , Mark F. Brady , Elizabeth M. Swisher , Karina D. Steffensen , Michael Friedlander , Aikou Okamoto , Kathleen N. Moore , Charles A. Leath III , David Cella , Zhaowen Sun , Shilpen Patel , Zequn Tang , Christine K. Ratajczak , Carol Aghajanian , Michael A. Bookman

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引用次数: 0

摘要

在VELIA试验中，与单独卡铂+紫杉醇诱导治疗相比，在标准的一线铂基化疗中加入veliparib并继续作为维持治疗可显着延长中位无进展生存期（PFS）(23.5个月vs 17.3个月；P <； 0.001)。我们现在从患者报告的试验结果中报告最终总生存期（OS）和最新的安全性和疾病相关症状（DRS）。方法：这项随机、安慰剂对照、双盲、多中心、3期研究纳入了初始诊断为III/IV期高级别浆液性卵巢癌的成年女性，她们接受了原发性或间隔期细胞减少手术。患者以1:1:1的比例随机分为化疗+维利帕尼后维利帕尼维持（维利帕尼全程），化疗+维利帕尼后安慰剂维持（仅维利帕尼联合），或化疗+安慰剂后安慰剂维持（安慰剂全程）。PFS为主要终点；OS和DRS为次要终点。结果在意向治疗人群（N = 1140）中，veliparib全药组的中位OS为59.2个月（95 %可信区间：52.1,68.2），veliparib单药组的中位OS为58.0（50.6,64.1）个月，安慰剂全药组的中位OS为57.8（52.3,63.8）个月。总体各组之间或brca缺陷组和同源重组缺陷组的OS结果无显著差异。在较长的随访期间没有发现新的安全性信号，DRS分析表明，当veliparib加入化疗或用于维持时，总体上没有显著的额外症状相关负担。结论：本研究未发现在铂基化疗中加入veliparib并继续作为维持治疗的OS或DRS益处，尽管在PFS中观察到比单独化疗有益处。

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Veliparib concomitant with first-line chemotherapy and as maintenance therapy in ovarian cancer: Final overall survival and disease-related symptoms results

Introduction

In the VELIA trial, the addition of veliparib to standard first-line platinum-based chemotherapy and continued as maintenance resulted in significantly longer median progression-free survival (PFS) compared with carboplatin plus paclitaxel induction therapy alone (23.5 vs 17.3 months; p < 0.001) in patients with ovarian cancer. We now report final overall survival (OS) and updated safety and disease-related symptoms (DRS) from patient-reported outcomes of the trial.

Methods

This randomized, placebo-controlled, double-blind, multicenter, phase 3 study enrolled adult women with an initial diagnosis of stage III/IV high-grade serous ovarian cancer undergoing primary or interval cytoreductive surgery. Patients were randomized 1:1:1 to chemotherapy plus veliparib followed by veliparib maintenance (veliparib-throughout), chemotherapy plus veliparib followed by placebo maintenance (veliparib-combination-only), or chemotherapy plus placebo followed by placebo maintenance (placebo-throughout). PFS was the primary endpoint; OS and DRS were secondary endpoints.

Results

In the intention-to-treat population (N = 1140), median OS was 59.2 months (95 % confidence interval: 52.1, 68.2) for the veliparib-throughout group, 58.0 (50.6, 64.1) months for veliparib-combination-only, and 57.8 (52.3, 63.8) months for placebo-throughout. OS outcomes were not significantly different between arms overall or in the BRCA-deficient and homologous recombination-deficient cohorts. No new safety signals were identified during the longer follow-up period and DRS analyses indicated there was no significant additional symptom-related burden overall when veliparib was added to chemotherapy or used for maintenance.

Conclusion

No OS or DRS benefit of addition of veliparib to platinum-based chemotherapy and continued as maintenance therapy was detected in this study, despite an observed benefit over chemotherapy alone in PFS.

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.