(Prostate Cancer) Is Niraparib Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On February 4, 2022, Dr. Matthew R. Smith and colleagues from Massachusetts General Hospital Cancer Center published results in The Lancet Oncology from the Phase 2 clinical trial (NCT02854436) evaluating the efficacy and safety of oral PARP inhibitor Niraparib monotherapy in previously treated, DNA repair gene-deficient, castration-resistant metastatic prostate cancer patients.
This Phase 2 trial was a multi-center, open-label study administering Niraparib monotherapy to previously treated patients with DNA repair gene defects and castration-resistant metastatic prostate cancer (N=289) until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR).
Of the 289 enrolled patients, 63% (N=182) had received three or more prior lines of therapy. Among the 223 evaluable patients, 142 were BRCA-mutation positive and 81 were BRCA-mutation negative.
Results at median follow-up of 10 months:
In BRCA-mutation positive patients (N=76): Primary endpoint ORR was 34.2%.
Safety:
Most common treatment-related adverse events: nausea (58%, N=169/289), anemia (54%, N=156), vomiting (38%, N=111). Grade 3 or higher adverse events: anemia (33%, N=95), thrombocytopenia (16%, N=47), neutropenia (10%, N=28). Serious adverse events occurred in 46% (N=134/289), including thrombocytopenia (6%, N=17) and anemia (4%, N=13).
Conclusion: Based on the Phase 2 trial results, Dr. Smith and colleagues concluded that Niraparib monotherapy demonstrated meaningful anti-tumor activity with acceptable tolerability in previously treated, DNA repair gene-deficient, castration-resistant metastatic prostate cancer patients.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00757-9/fulltext
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