PDF(Pubmed)
Abstract：
UNASSIGNED: Pre-clinical studies showed the anti-tumor mechanisms of PARP inhibitors (PARPi) and platinum have some crossover and overlap in the DNA damage repair pathway, patients who respond to platinum-based chemotherapy are also more likely to be sensitive to PARPi. This real-world study mainly aimed to evaluate whether TRAE (treatment-related adverse event) between platinum based chemotherapy (PBC) and niraparib are also associated.
UNASSIGNED: Patients received niraparib as maintenance treatment or salvage therapy for advanced ovarian cancer at the First Affiliated Hospital of Gannan Medical University from January 2020 to August 2023 were included. Survival data of niraparib treatment and adverse events occurred during the last platinum-based chemotherapy cycle before starting niraparib treatment and during niraparib treatment are documented. Fisher\'s exact test were used for correlation analysis.
UNASSIGNED: 1. 40 patients treated with niraparib were included in the analysis, including 31 patients treated with niraparib for 1st-line maintenance therapy, 6 patients for PSR (platinum-sensitive recurrence) maintenance therapy, and 3 patients for salvage therapy. The overall median follow-up time was 15.0 months (ranged from 2.2 months to 32.1 months). 2. Overall grade≥3 TRAE (40% vs 70%, p=0.012) including anemia (20% vs 45%, p=0.041) and neutrophil count decreased (17.5% vs 57.5%, p<0.001) was significantly lower during niraparib treatment compared to during chemotherapy. 3. Any grade TRAE (75% vs 100%, p=0.002) including white blood cell count decreased (47.5% vs 87.5%, p<0.001), red blood cell count decreased (57.5% vs 92.5%, p<0.001), anemia (55% vs 87.5%, p<0.001) and neutrophil count decreased (35% vs 85%, p<0.001) were also significantly lower in niraparib treatment group compared with chemotherapy group. No new safety signals were identified.
UNASSIGNED: 1. In this real-world practice, we observed that patients with advanced ovarian cancer who experienced any grade and grade ≥3 TRAE during chemotherapy were well tolerated when treated with niraparib, particularly the incidence of any grade and grade ≥3 anemia, and neutrophil count decreased during niraparib treatment were significantly lower compared with that during chemotherapy. 2. For patients with ovarian cancer who have experienced grade ≥3 hematological adverse reactions during prior platinum-based chemotherapy, greater attention should be paid to the monitoring and management of hematological adverse reactions during subsequent treatment with niraparib.
UNASSIGNED: Patients received niraparib as maintenance treatment or salvage therapy for advanced ovarian cancer at the First Affiliated Hospital of Gannan Medical University from January 2020 to August 2023 were included. Survival data of niraparib treatment and adverse events occurred during the last platinum-based chemotherapy cycle before starting niraparib treatment and during niraparib treatment are documented. Fisher\'s exact test were used for correlation analysis.
UNASSIGNED: 1. 40 patients treated with niraparib were included in the analysis, including 31 patients treated with niraparib for 1st-line maintenance therapy, 6 patients for PSR (platinum-sensitive recurrence) maintenance therapy, and 3 patients for salvage therapy. The overall median follow-up time was 15.0 months (ranged from 2.2 months to 32.1 months). 2. Overall grade≥3 TRAE (40% vs 70%, p=0.012) including anemia (20% vs 45%, p=0.041) and neutrophil count decreased (17.5% vs 57.5%, p<0.001) was significantly lower during niraparib treatment compared to during chemotherapy. 3. Any grade TRAE (75% vs 100%, p=0.002) including white blood cell count decreased (47.5% vs 87.5%, p<0.001), red blood cell count decreased (57.5% vs 92.5%, p<0.001), anemia (55% vs 87.5%, p<0.001) and neutrophil count decreased (35% vs 85%, p<0.001) were also significantly lower in niraparib treatment group compared with chemotherapy group. No new safety signals were identified.
UNASSIGNED: 1. In this real-world practice, we observed that patients with advanced ovarian cancer who experienced any grade and grade ≥3 TRAE during chemotherapy were well tolerated when treated with niraparib, particularly the incidence of any grade and grade ≥3 anemia, and neutrophil count decreased during niraparib treatment were significantly lower compared with that during chemotherapy. 2. For patients with ovarian cancer who have experienced grade ≥3 hematological adverse reactions during prior platinum-based chemotherapy, greater attention should be paid to the monitoring and management of hematological adverse reactions during subsequent treatment with niraparib.
摘要：
■临床前研究表明，PARP抑制剂（PARPi）和铂的抗肿瘤机制在DNA损伤修复途径中存在一些交叉和重叠，对铂类化疗有反应的患者也更可能对PARPi敏感.这项真实世界的研究主要旨在评估铂类化疗（PBC）和尼拉帕尼之间的TRAE（治疗相关不良事件）是否也相关。
■纳入2020年1月至2023年8月在赣南医科大学第一附属医院接受尼拉帕尼维持治疗或挽救治疗晚期卵巢癌的患者。记录了尼拉帕尼治疗的生存数据和在开始尼拉帕尼治疗之前的最后一个基于铂的化疗周期期间发生的不良事件。相关分析采用Fisher精确检验。
■1.40例接受尼拉帕尼治疗的患者被纳入分析，包括31例接受尼拉帕尼一线维持治疗的患者，6例PSR（铂敏感复发）维持治疗，和3名患者进行抢救治疗。中位随访时间为15.0个月(2.2个月至32.1个月)。2.总体等级≥3TRAE(40%vs70%，p=0.012），包括贫血（20%vs45%，p=0.041）和中性粒细胞计数减少（17.5%vs57.5%，与化疗期间相比，在尼拉帕尼治疗期间p<0.001）显着降低。3.任何等级的TRAE（75%对100%，p=0.002)包括白细胞计数下降(47.5%vs87.5%,p<0.001)，红细胞计数下降（57.5%vs92.5%，p<0.001)，贫血（55%vs87.5%，p<0.001）和中性粒细胞计数降低（35%对85%，与化疗组相比，尼拉帕尼治疗组的p<0.001）也显着降低。没有发现新的安全信号。
■1.在现实世界的实践中，我们观察到，在化疗期间出现任何级别和≥3级TRAE的晚期卵巢癌患者在接受尼拉帕尼治疗时耐受性良好，特别是任何等级和≥3级贫血的发生率，尼拉帕尼治疗期间中性粒细胞计数下降明显低于化疗期间。2.对于在铂类化疗期间出现≥3级血液学不良反应的卵巢癌患者，在随后使用尼拉帕尼治疗期间，应更加重视血液学不良反应的监测和管理。
■纳入2020年1月至2023年8月在赣南医科大学第一附属医院接受尼拉帕尼维持治疗或挽救治疗晚期卵巢癌的患者。记录了尼拉帕尼治疗的生存数据和在开始尼拉帕尼治疗之前的最后一个基于铂的化疗周期期间发生的不良事件。相关分析采用Fisher精确检验。
■1.40例接受尼拉帕尼治疗的患者被纳入分析，包括31例接受尼拉帕尼一线维持治疗的患者，6例PSR（铂敏感复发）维持治疗，和3名患者进行抢救治疗。中位随访时间为15.0个月(2.2个月至32.1个月)。2.总体等级≥3TRAE(40%vs70%，p=0.012），包括贫血（20%vs45%，p=0.041）和中性粒细胞计数减少（17.5%vs57.5%，与化疗期间相比，在尼拉帕尼治疗期间p<0.001）显着降低。3.任何等级的TRAE（75%对100%，p=0.002)包括白细胞计数下降(47.5%vs87.5%,p<0.001)，红细胞计数下降（57.5%vs92.5%，p<0.001)，贫血（55%vs87.5%，p<0.001）和中性粒细胞计数降低（35%对85%，与化疗组相比，尼拉帕尼治疗组的p<0.001）也显着降低。没有发现新的安全信号。
■1.在现实世界的实践中，我们观察到，在化疗期间出现任何级别和≥3级TRAE的晚期卵巢癌患者在接受尼拉帕尼治疗时耐受性良好，特别是任何等级和≥3级贫血的发生率，尼拉帕尼治疗期间中性粒细胞计数下降明显低于化疗期间。2.对于在铂类化疗期间出现≥3级血液学不良反应的卵巢癌患者，在随后使用尼拉帕尼治疗期间，应更加重视血液学不良反应的监测和管理。
