尼拉帕尼和安洛替尼治疗铂耐药卵巢癌患者的不良事件管理:来自II期多中心ANNIE研究的最新进展

IF 2.8 3区 医学 Q1 Pharmacology, Toxicology and Pharmaceutics
Therapeutics and Clinical Risk Management Pub Date : 2025-07-21 eCollection Date: 2025-01-01 DOI:10.2147/TCRM.S526755
Ting Deng, Lei Yan, Jing Li, Guochen Liu, Aijun Yin, Yanling Feng, Min Zheng, Chuyao Zhang, He Huang, Qidan Huang, An Lin, Jie Jiang, Beihua Kong, Jihong Liu
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引用次数: 0

摘要

背景:ANNIE研究的初步分析表明,尼拉帕尼-安洛替尼联合治疗铂耐药复发性卵巢癌(PROC)具有良好的抗肿瘤活性。我们报告最新的总生存期(OS)和安全性数据,以及来自ANNIE研究的关键治疗突发不良事件(TEAE)的管理。方法:在多中心、单臂、2期ANNIE研究中,入组患者每天口服一次尼拉帕尼200 mg或300 mg(基线体重导向),安洛替尼10 mg(方案修改前12 mg),每21天周期的第1-14天。安全管理涉及一个由专科医生组成的多学科小组,他们对主要合并症和teae进行监测和干预。结果:40例患者入组。中位随访19.0个月后,更新的中位OS为18.2个月(95%置信区间:12.1-不可评估)。最常见的teae是高血压(n=22, 55%)、白细胞减少(n=18, 45%)、手足综合征(n=17, 43%)、血小板减少(n=15, 38%)、中性粒细胞减少(n=14, 35%)和高甘油三酯血症(n=12, 30%)。高血压和心血管事件大多通过使用受体阻滞剂进行早期干预来控制。高甘油三酯血症主要使用阿托伐他汀和辛伐他汀治疗。血液学毒性与先前的研究一致,没有发生严重的血液学事件。对方案进行修改以减少手足综合征的发生率,对有明显症状的患者局部使用糖皮质激素和非甾体类抗炎药。结论:更新的OS分析显示,尼拉帕尼-安洛替尼对PROC患者持续的长期疗效。安全性数据反映了令人满意的耐受性和不良事件管理,支持多学科疾病管理团队参与卵巢癌护理。临床试验注册:NCT04376073。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse Event Management in Patients with Platinum-Resistant Ovarian Cancer Treated with Niraparib and Anlotinib: Updates from the Phase II, Multi-Center ANNIE Study.

Background: The primary analysis of the ANNIE study demonstrated promising anti-tumor activity of the niraparib-anlotinib combination in platinum-resistant recurrent ovarian cancer (PROC). We report updated overall survival (OS) and safety data and the management of key treatment-emergent adverse event (TEAE) from the ANNIE study.

Methods: In the multi-center, single-arm, Phase 2 ANNIE study, enrolled patients received oral niraparib 200 mg or 300 mg (baseline bodyweight-directed) once daily and anlotinib 10 mg (12 mg before protocol amendment) once daily on days 1-14 of each 21-day cycle. Safety management involved a multidisciplinary team comprising specialist physicians, who performed monitoring and intervention for key comorbidities and TEAEs.

Results: Forty patients were enrolled. After a median follow-up of 19.0 months, the updated median OS was 18.2 months (95% confidence interval: 12.1-not evaluable). The most common TEAEs were hypertension (n=22, 55%), leukopenia (n=18, 45%), hand-foot syndrome (n=17, 43%), thrombocytopenia (n=15, 38%), neutropenia (n=14, 35%), and hypertriglyceridemia (n=12, 30%). Hypertension and cardiovascular events were mostly managed by early interventions using beta-blockers. Hypertriglyceridemia was mostly managed using atorvastatin and simvastatin. Hematological toxicities were consistent with prior studies and no severe hematologic events occurred. Protocol amendment was implemented to reduce the incidence of hand-foot syndrome, while topical glucocorticoids and non-steroidal anti-inflammatory drugs were used in patients with apparent symptoms.

Conclusion: The updated OS analysis showed sustained long-term efficacy of niraparib-anlotinib in PROC patients. The safety data reflected satisfactory tolerability and adverse event management, supporting the involvement of a multidisciplinary disease management team in ovarian cancer care.

Clinical trial registration: NCT04376073.

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来源期刊
Therapeutics and Clinical Risk Management
Therapeutics and Clinical Risk Management HEALTH CARE SCIENCES & SERVICES-
CiteScore
5.30
自引率
3.60%
发文量
139
审稿时长
16 weeks
期刊介绍: Therapeutics and Clinical Risk Management is an international, peer-reviewed journal of clinical therapeutics and risk management, focusing on concise rapid reporting of clinical studies in all therapeutic areas, outcomes, safety, and programs for the effective, safe, and sustained use of medicines, therapeutic and surgical interventions in all clinical areas. The journal welcomes submissions covering original research, clinical and epidemiological studies, reviews, guidelines, expert opinion and commentary. The journal will consider case reports but only if they make a valuable and original contribution to the literature. As of 18th March 2019, Therapeutics and Clinical Risk Management will no longer consider meta-analyses for publication. The journal does not accept study protocols, animal-based or cell line-based studies.
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