Background <p>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&#xa0;years.</p> Methods <p>Women aged ≥ 50&#xa0;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&#xa0;years), B (65–74&#xa0;years), and C (≥ 75&#xa0;years). The primary outcome was progression-free survival. The secondary outcomes were toxicity and dose reduction.</p> Results <p>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 (<i>p</i> = 0.001), residual tumor (<i>p</i> = 0.01) and Eastern Cooperative Oncology Group (ECOG) &gt; 1 (<i>p</i> = 0.01) in group C. Most patients started niraparib at 200&#xa0;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 (<i>p</i> = 0.08). In patients ≥ 75&#xa0;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&#xa0;months (95%CI: 2.0–25.0) for group A, 29&#xa0;months (95%CI: 11.0–52.0) for group B, and 16&#xa0;months (95%CI: 1.0–31.0) for group C (<i>p</i> = 0.78).</p> Conclusions <p>Our findings suggest that niraparib is safe and well-tolerated in aged ≥ 75&#xa0;years. Concerns about toxicity should not preclude the enrollment of elderly patients in treatment regiments.</p>

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Real-life observational study on niraparib in older patients with primary tubo-ovarian cancer: a focus on safety and efficacy

  • Adriana Ionelia Apostol,
  • Matteo Bruno,
  • Carolina Maria Sassu,
  • Serena Maria Boccia,
  • Laura Vertechy,
  • Giorgia Russo,
  • Ilary Ruscito,
  • Filippo Maria Capomacchia,
  • Giovanni Scambia,
  • Anna Fagotti,
  • Claudia Marchetti

摘要

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.