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奥拉帕利致卵巢癌患者恶心呕吐的时间趋势分析及危险因素:一项前瞻性研究

Time-Trend Analysis and Risk Factors for Niraparib-Induced Nausea and Vomiting in Ovarian Cancer: A Prospective Study.

作者信息

Jeong Young Wook, Kim Dongkyu Eugene, Kim Ji Hyun, Kim Se Ik, Ha Hyeong In, Park Sang-Yoon, Lim Myong Cheol

机构信息

Center for Gynecologic Cancer, National Cancer Center, Goyang, Korea.

Department of Biochemistry, Western University of Ontario, London, Ontario, Canada.

出版信息

Cancer Res Treat. 2025 Jul;57(3):865-872. doi: 10.4143/crt.2024.899. Epub 2024 Nov 4.

DOI:10.4143/crt.2024.899
PMID:39512063
Abstract

PURPOSE

Nausea and vomiting are major non-hematological adverse events associated with niraparib maintenance therapy. This study aimed to investigate the time-trend patterns of niraparib-induced nausea and vomiting (NINV) and the associated risk factors in patients with ovarian cancer.

MATERIALS AND METHODS

In this prospective study, we enrolled patients with stage III-IV epithelial ovarian cancer who received niraparib as frontline maintenance therapy. The clinicopathological characteristics and time-trend patterns of patients with NINV were collected through in-person surveys and electronic medical records from the National Cancer Center.

RESULTS

Of 53 patients, 50 (94.3%) were diagnosed with high-grade serous ovarian carcinoma. BRCA mutations and homologous recombination deficiency (HRD) were identifi ed in 23 (43.4%) and 32 (60.4%) patients, respectively. Thirty-one patients (58.5%) had NINV. Time-trend analyses revealed that the fi rst peak intensity of NINV was reached at 3 h post-dose, and the second peak intensity was reached at 11 hour post-dose. NINV signifi cantly decreased from week 1 to weeks 8 and 12. In multivariate analyses of risk factors for NINV, HRD-positive tumors (p < 0.001) and prior experience of chemotherapy-induced nausea and vomiting (p=0.004) were associated with the occurrence of NINV.

CONCLUSION

Pre-emptive treatment with antiemetics is required to manage early-phase NINV during niraparib maintenance therapy in patients with risk factors. Additional larger studies are needed to confi rm these fi ndings and to develop optimal preventive strategies for NINV.

摘要

目的

恶心和呕吐是与尼拉帕利维持治疗相关的主要非血液学不良事件。本研究旨在调查尼拉帕利引起的恶心和呕吐(NINV)的时间趋势模式以及卵巢癌患者中的相关危险因素。

材料和方法

在这项前瞻性研究中,我们纳入了接受尼拉帕利作为一线维持治疗的III-IV期上皮性卵巢癌患者。通过亲自调查和国家癌症中心的电子病历收集了NINV患者的临床病理特征和时间趋势模式。

结果

53例患者中,50例(94.3%)被诊断为高级别浆液性卵巢癌。分别在23例(43.4%)和32例(60.4%)患者中检测到BRCA突变和同源重组缺陷(HRD)。31例患者(58.5%)出现NINV。时间趋势分析显示,NINV的第一个峰值强度在给药后3小时达到,第二个峰值强度在给药后11小时达到。从第1周到第8周和第12周,NINV显著下降。在NINV危险因素的多因素分析中,HRD阳性肿瘤(p<0.001)和既往化疗引起的恶心和呕吐经历(p=0.004)与NINV的发生相关。

结论

对于有危险因素的患者,在尼拉帕利维持治疗期间需要采取预防性使用止吐药的措施来管理早期NINV。需要更多更大规模的研究来证实这些发现,并制定针对NINV的最佳预防策略。

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