دورية أكاديمية
Progression-free survival and safety at 3.5 years of follow-up : results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer
| العنوان: | Progression-free survival and safety at 3.5 years of follow-up : results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer |
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| المؤلفون: | Gonzalez-Martin, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C., Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andres, Moore, Richard G., Vulsteke, Christof, O'Cearbhaill, Roisin E., Malinowska, Izabela A., Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R., Monk, Bradley J. |
| المصدر: | 0959-8049 ; European journal of cancer |
| سنة النشر: | 2023 |
| المجموعة: | IRUA - Institutional Repository van de Universiteit Antwerpen |
| مصطلحات موضوعية: | Human medicine |
| الوصف: | Purpose: To report updated long-term efficacy and safety from the double-blind, placebo-controlled, phase 3 PRIMA/ENGOT-OV26/GOG-3012 study (NCT02655016).Methods: Patients with newly diagnosed advanced ovarian cancer with complete or partial response (CR or PR) to first-line platinum-based chemotherapy received niraparib or placebo once daily (2:1 ratio). Stratification factors were best response to first-line chemotherapy re-gimen (CR/PR), receipt of neoadjuvant chemotherapy (yes/no), and homologous re-combination deficiency (HRD) status (deficient [HRd]/proficient [HRp] or not determined). Updated (ad hoc) progression-free survival (PFS) data (as of November 17, 2021) by in-vestigator assessment (INV) are reported. Results: In 733 randomised patients (niraparib, 487; placebo, 246), median PFS follow-up was 3.5 years. Median INV-PFS was 24.5 versus 11.2 months (hazard ratio, 0.52; 95% confidence interval [CI], 0.40-0.68) in the HRd population and 13.8 versus 8.2 months (ha-zard ratio, 0.66; 95% CI, 0.56-0.79) in the overall population for niraparib and placebo, respectively. In the HRp population, median INV-PFS was 8.4 versus 5.4 months (hazard ratio, 0.65; 95% CI, 0.49-0.87), respectively.Results were concordant with the primary analysis. Niraparib-treated patients were more likely to be free of progression or death at 4 years than placebo-treated patients (HRd, 38% versus 17%; overall, 24% versus 14%). The most common grade & GE; 3 treatment-emergent adverse events in niraparib patients were thrombocytopenia (39.7%), anaemia (31.6%), and neutropenia (21.3%). Myelodysplastic syndromes/acute myeloid leukaemia incidence rate (1.2%) was the same for niraparib-and placebo-treated patients. Overall survival remained immature.Conclusions: Niraparib maintained clinically significant improvements in PFS with 3.5 years of follow-up in patients with newly diagnosed advanced ovarian cancer at high risk of pro-gression irrespective of HRD status. No new safety signals were identified.& COPY; 2023 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/isi/001045038900001 |
| الإتاحة: | https://doi.org/10.1016/J.EJCA.2023.04.024Test https://hdl.handle.net/10067/1984740151162165141Test https://repository.uantwerpen.be/docstore/d:irua:19074Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.14F28221 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |