Ni Jing, Cheng Xianzhong, Zhou Rui, Zhao Qian, Xu Xia, Guo Wenwen, Gu Hongyuan, Chen Chen, Chen Xiaoxiang
Department of Gynecologic Oncology, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Department of Chemotherapy, The Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Front Oncol. 2021 Sep 6;11:724620. doi: 10.3389/fonc.2021.724620. eCollection 2021.
PARP inhibitor (PARPi) is an important progress in ovarian cancer treatment. The available evidence suggests that BRCA mutation and homologous recombination deficiency (HRD) are effective biological markers for PARPi. Here we investigated the relationship between adverse events (AEs) and efficacy of PARPi in ovarian cancer patients.
Seventy-eight patients with ovarian cancer patients underwent Olaparib and Niraparib from July 2018 to July 2020 were analyzed. AEs were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Chi-square test or fisher exact tests was performed to observe the association between categorical variables. Logistic regression analysis was conducted to investigate the independent variables for disease control response (DCR). Progression-free survival (PFS) was compared between AEs variables by log-rank test.
Patients with AEs in the first one week had a higher DCR compared with those after one week (86.11% 60.98%, p=0.013). Patients with serious AEs (SAEs) had a significantly higher DCR (81.40% 60.60%, p=0.045). There were associations between anemia and DCR in both occurrence (79.63% 56.52%, p=0.037) and grade (100% 73.17%, p=0.048). The median PFS of patients with hematological toxicity was longer than that of patients with no-hematological toxicity (30 20 weeks, p=0.047). Patients with hematological toxicity within four weeks had prolonged median PFS than those with hematological toxicity after four weeks (40 22 weeks, p=0.003).
The early presence of AEs and SAEs in hematological toxicity of PARPi were related to the antitumor efficacy, which might be a valid and easily measurable clinical marker in ovarian cancer patients.
聚（ADP - 核糖）聚合酶抑制剂（PARPi）是卵巢癌治疗的一项重要进展。现有证据表明，BRCA突变和同源重组缺陷（HRD）是PARPi有效的生物学标志物。在此，我们研究了卵巢癌患者中不良事件（AE）与PARPi疗效之间的关系。
分析了2018年7月至2020年7月期间接受奥拉帕利和尼拉帕利治疗的78例卵巢癌患者。不良事件通过美国国立癌症研究所不良事件通用术语标准（NCI CTCAE）v5.0进行评估。采用卡方检验或Fisher精确检验观察分类变量之间的关联。进行逻辑回归分析以研究疾病控制反应（DCR）的独立变量。通过对数秩检验比较不良事件变量之间的无进展生存期（PFS）。
第一周出现不良事件的患者与一周后出现不良事件的患者相比，疾病控制率更高（86.11%对60.98%，p = 0.013）。出现严重不良事件（SAE）的患者疾病控制率显著更高（81.40%对60.60%，p = 0.045）。贫血在发生率（79.63%对56.52%，p = 0.037）和分级（100%对73.17%，p = 0.048）方面与疾病控制率均存在关联。血液学毒性患者的中位无进展生存期长于无血液学毒性的患者（3个月对2个月，p = 0.047）。四周内出现血液学毒性的患者中位无进展生存期长于四周后出现血液学毒性的患者（4个月对2.2个月，p = 0.003）。
PARPi血液学毒性中不良事件和严重不良事件的早期出现与抗肿瘤疗效相关，这可能是卵巢癌患者中一个有效且易于测量的临床标志物。
