旨在确定 III 期 PRIMA/ENGOT-OV26/GOG-3012 研究中接受尼拉帕尼一线维持治疗的晚期卵巢癌患者与长期无进展生存期（≥2 年）相关的特征。 PRIMA 分析中，随机接受尼拉帕尼治疗的患者根据研究者评估的无进展生存期（随机化后<2 年或≥2 年的疾病进展/审查）进行分组。评估预测价值的变量包括东部肿瘤合作组的表现状态、诊断时国际妇产科联合会 (FIGO) 分期、对铂类化疗的临床反应、既往化疗周期数、原发肿瘤位置、体重指数、分类年龄、减灭手术类型、基线目标病灶数量、基线非目标病灶数量、BRCA/同源重组缺陷状态、残留疾病状态以及从化疗结束到随机化的持续时间。使用向后消除法（显着性水平 = 0.15）的 Logistic 回归模型确定了与长期无进展生存期相关的协变量（临床截止日期 2021 年 11 月 17 日）。在随机接受尼拉帕尼治疗的 487 名患者中，152 名 (31%) 患有进展性疾病/随机化后≥2年审查。使用后向消除的多变量逻辑回归模型确定了 BRCA1/2 突变/同源重组缺陷状态 (p<0.0001)、FIGO 分期 (p=0.041)、原发肿瘤位置 (p=0.095) 和基线非目标病变数量 (p =0.0001）与长期无进展生存期相关。在最终模型中，患有 BRCA1 和 BRCA2 突变/同源重组缺陷肿瘤或 BRCA 野生型/未确定/同源重组缺陷肿瘤的患者更有可能实现 ≥2 年无进展生存期（与 BRCA野生型/同源重组熟练/未确定的肿瘤）、FIGO III 期（对比 IV）和 0 或 1 个基线非目标病变（对比 ≥2 个基线非目标病变）。该分析的假设生成结果表明BRCA1/2突变/同源重组缺陷状态、FIGO分期和基线非目标病变数量可以预测接受niraparib一线维持治疗的晚期卵巢癌患者≥2年的无进展生存期。NCT02655016。 © IGCS 和 ESGO 2024。根据 CC BY-NC 允许重复使用。禁止商业再利用。由英国医学杂志出版。

To identify characteristics associated with long-term progression-free survival (≥2 years) in patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in the phase III PRIMA/ENGOT-OV26/GOG-3012 study.In this post hoc analysis of PRIMA, patients randomized to niraparib were grouped based on investigator-assessed progression-free survival (progressive disease/censoring <2 years or ≥2 years after randomization). Variables assessed for predictive value were Eastern Cooperative Oncology Group performance status, International Federation of Gynecology and Obstetrics (FIGO) stage at diagnosis, clinical response to platinum-based chemotherapy, number of prior chemotherapy cycles, primary tumor location, body mass index, categorical age, debulking surgery type, number of baseline target lesions, number of baseline non-target lesions, BRCA/homologous recombination-deficiency status, residual disease status, and duration from end of chemotherapy to randomization. Logistic regression modeling using backward elimination (significance level=0.15) identified covariates associated with long-term progression-free survival (clinical cut-off date November 17, 2021).Of 487 patients randomized to niraparib, 152 (31%) had progressive disease/censoring ≥2 years after randomization. Multivariable logistic regression modeling using backward elimination identified BRCA1/2 mutation/homologous recombination deficiency status (p<0.0001), FIGO stage (p=0.041), primary tumor location (p=0.095), and number of baseline non-target lesions (p=0.0001) to be associated with long-term progression-free survival. Patients significantly more likely to achieve progression-free survival of ≥2 years in the final model were those with BRCA1- and BRCA2-mutated/homologous recombination-deficient tumors or BRCA wild-type/not determined/homologous recombination-deficient tumors (vs BRCA wild-type/homologous recombination-proficient/not determined tumors), FIGO stage III (vs IV), and 0 or 1 baseline non-target lesions (vs ≥2 baseline non-target lesions).The hypothesis-generating results of this analysis suggest that BRCA1/2 mutation/homologous recombination-deficiency status, FIGO stage, and number of baseline non-target lesions may predict progression-free survival of ≥2 years in patients with advanced ovarian cancer receiving niraparib first-line maintenance therapy.NCT02655016.© IGCS and ESGO 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.