International journal of clinical oncology · 2025
Real-life observational study on niraparib in older patients with primary tubo-ovarian cancer: a focus on safety and efficacy.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Apostol Adriana Ionelia, Bruno Matteo, Sassu Carolina Maria, Boccia Serena Maria, Vertechy Laura, Russo Giorgia, Ruscito Ilary, Capomacchia Filippo Maria, Scambia Giovanni, Fagotti Anna, Marchetti Claudia
Аннотация
BACKGROUND: Niraparib is approved for maintenance treatment of tubo-ovarian cancer patients, but data on older patients are limited. This retrospective study evaluated its safety and efficacy in primary advanced tubo-ovarian cancer, focusing on patients ≥ 75 years.
METHODS: Women aged ≥ 50 years diagnosed with primary high-grade serous tubo-ovarian cancer, treated with niraparib between 2019-2023, were enrolled. Patients were stratified into three groups: A (50-64 years), B (65-74 years), and C (≥ 75 years). The primary outcome was progression-free survival. The secondary outcomes were toxicity and dose reduction.
RESULTS: 127 patients were identified: 62 (48.8%) group A, 26 (20.5%) group B, and 39 (30.7%) group C. Baseline characteristics were comparable across groups, excluding a higher proportion of interval cytoreductive surgeries (p = 0.001), residual tumor (p = 0.01) and Eastern Cooperative Oncology Group (ECOG) > 1 (p = 0.01) in group C. Most patients started niraparib at 200 mg/day with dose reductions primarily occurred within fourth cycle. Dose reductions were observed in 77.4%, 69.2% and 56.4% of patients in groups A, B, and C, respectively (p = 0.08). In patients ≥ 75 years, 26 (66.7%) discontinued treatment due to disease progression (48.7%) or toxicity (17.9%). There were no significant differences in common or grade ≥ 3 adverse events between groups. Progression-free survival was 12 months (95%CI: 2.0-25.0) for group A, 29 months (95%CI: 11.0-52.0) for group B, and 16 months (95%CI: 1.0-31.0) for group C (p = 0.78).
CONCLUSIONS: Our findings suggest that niraparib is safe and well-tolerated in aged ≥ 75 years. Concerns about toxicity should not preclude the enrollment of elderly patients in treatment regiments.
METHODS: Women aged ≥ 50 years diagnosed with primary high-grade serous tubo-ovarian cancer, treated with niraparib between 2019-2023, were enrolled. Patients were stratified into three groups: A (50-64 years), B (65-74 years), and C (≥ 75 years). The primary outcome was progression-free survival. The secondary outcomes were toxicity and dose reduction.
RESULTS: 127 patients were identified: 62 (48.8%) group A, 26 (20.5%) group B, and 39 (30.7%) group C. Baseline characteristics were comparable across groups, excluding a higher proportion of interval cytoreductive surgeries (p = 0.001), residual tumor (p = 0.01) and Eastern Cooperative Oncology Group (ECOG) > 1 (p = 0.01) in group C. Most patients started niraparib at 200 mg/day with dose reductions primarily occurred within fourth cycle. Dose reductions were observed in 77.4%, 69.2% and 56.4% of patients in groups A, B, and C, respectively (p = 0.08). In patients ≥ 75 years, 26 (66.7%) discontinued treatment due to disease progression (48.7%) or toxicity (17.9%). There were no significant differences in common or grade ≥ 3 adverse events between groups. Progression-free survival was 12 months (95%CI: 2.0-25.0) for group A, 29 months (95%CI: 11.0-52.0) for group B, and 16 months (95%CI: 1.0-31.0) for group C (p = 0.78).
CONCLUSIONS: Our findings suggest that niraparib is safe and well-tolerated in aged ≥ 75 years. Concerns about toxicity should not preclude the enrollment of elderly patients in treatment regiments.