Archives of gynecology and obstetrics · 2026
Between research and introduction to clinical routine-Experience with niraparib from the compassionate use program in Germany (NOGGO Register Analysis).
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Grabowski Jacek P, Welz Julia, Heublein Sabine, Krajewska Maja, Boer Jolijn D, Kraus Fabian, Arndt Tjadina, Moosmann Nicolas, Heinrich Bernhard, Engler Tobias, Agabejli Saida, Ugur Mustafa Celalettin, Witteler Ralf, Albrecht Oliver, Müller-Huesmann Harald, Oskay-Özcelik Gülten, Hettwer Cristina, Kaiser Sabrina, Braicu Elena, Sehouli Jalid
Аннотация
PURPOSE: Ovarian cancer (OC) is frequently diagnosed at a late, advanced stage, resulting in poor survival outcomes. PARP inhibitors like niraparib have shown significant efficacy in high-grade OC, particularly in tumors with homologous recombination deficiency, including BRCA mutations. This study aimed to evaluate dose modifications, safety, tolerability, and the impact on quality of life associated with niraparib in real-world clinical practice.
METHODS: This non-interventional, register-based study included patients with platinum-sensitive recurrent OC who received niraparib as part of the compassionate-use program (CUP) in Germany. Clinical baseline characteristics, treatment data, adverse events (AEs), and quality-of-life measures were collected both prospectively and retrospectively across 14 centers. Data analysis was performed using descriptive statistical methods.
RESULTS: Overall, 68 female patients were enrolled in the CUP register. Most patients had good performance status, with no significant comorbidities or concomitant medications. The most frequently reported AEs associated with niraparib were thrombocytopenia, fatigue, and nausea. Approximately half of patients required dose adjustments. AEs were less common in patients with normal physical examination findings, better ECOG performance status, and absence of comorbidities. Prior use of PARP inhibitors or previous treatment-related side effects increased the likelihood of AEs during niraparib therapy. The median treatment duration was 182 days, with disease progression being the most common reason for discontinuation.
CONCLUSION: Niraparib treatment within the German CUP demonstrated favorable safety and tolerability profiles, supporting its effectiveness in a real-world setting for patients with recurrent OC. These findings are consistent with results from clinical trials, further reinforcing the role of niraparib in this patient population.
METHODS: This non-interventional, register-based study included patients with platinum-sensitive recurrent OC who received niraparib as part of the compassionate-use program (CUP) in Germany. Clinical baseline characteristics, treatment data, adverse events (AEs), and quality-of-life measures were collected both prospectively and retrospectively across 14 centers. Data analysis was performed using descriptive statistical methods.
RESULTS: Overall, 68 female patients were enrolled in the CUP register. Most patients had good performance status, with no significant comorbidities or concomitant medications. The most frequently reported AEs associated with niraparib were thrombocytopenia, fatigue, and nausea. Approximately half of patients required dose adjustments. AEs were less common in patients with normal physical examination findings, better ECOG performance status, and absence of comorbidities. Prior use of PARP inhibitors or previous treatment-related side effects increased the likelihood of AEs during niraparib therapy. The median treatment duration was 182 days, with disease progression being the most common reason for discontinuation.
CONCLUSION: Niraparib treatment within the German CUP demonstrated favorable safety and tolerability profiles, supporting its effectiveness in a real-world setting for patients with recurrent OC. These findings are consistent with results from clinical trials, further reinforcing the role of niraparib in this patient population.