What is the recommended use and dosage of Zejula (niraparib) for ovarian cancer treatment?

From the Guidelines

Zejula (niraparib) is recommended for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, with a standard dosage of 300 mg taken orally once daily. The dosage may need to be adjusted based on patient weight and platelet count, with a starting dose of 200 mg daily recommended for patients weighing less than 77 kg or with platelet counts below 150,000/μL to reduce the risk of thrombocytopenia, as indicated in the QUADRA study 1.

Key Considerations

• Zejula should be continued until disease progression or unacceptable toxicity occurs, with dose modifications necessary based on adverse reactions, and potential reductions to 200 mg and then to 100 mg if needed, as suggested by the PRIMA trial 1.
• Common side effects include thrombocytopenia, anemia, neutropenia, fatigue, and hypertension, requiring regular blood count monitoring during treatment, as reported in the NOVA trial 1.
• Zejula works by inhibiting poly(ADP-ribose) polymerase (PARP) enzymes, which prevents cancer cells from repairing their damaged DNA, ultimately leading to cancer cell death, particularly in tumors with BRCA mutations or homologous recombination deficiency, as explained in the ARIEL3 study 1.

Patient Selection

• Patients with germline or somatic pathogenic or likely pathogenic variants in BRCA1 or BRCA2 genes should be treated with olaparib, as recommended by the SOLO1 trial 1.
• The addition of olaparib to bevacizumab may be offered to patients with stage III-IV EOC with g/sBRCA1/2 and/or genomic instability and a partial or complete response to chemotherapy plus bevacizumab combination, as suggested by the PAOLA-1 study 1.
• Maintenance therapy with single-agent PARPi may be offered for patients with EOC who have not received a PARPi and have responded to platinum-based therapy regardless of BRCA mutation status, as indicated by the VELIA trial 1.

Monitoring and Management

• Regular monitoring of blood counts and management of adverse reactions are crucial to minimize the risk of thrombocytopenia and other side effects, as emphasized in the QUADRA study 1.
• Dose adjustments and potential reductions should be made based on individual patient response and tolerance, as suggested by the PRIMA trial 1.

From the Research

Zejula (Niraparib) for Ovarian Cancer Treatment

• Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor approved for the maintenance treatment of recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in complete or partial response to platinum-based chemotherapy 2, 3.
• The recommended use of Zejula is for maintenance therapy in adults with advanced ovarian cancer who have responded to platinum-based chemotherapy, regardless of homologous-recombination deficiency status 4.

Dosage and Administration

• The dosage of Zejula is based on a weight- and platelet count-based individualized regimen, which has been shown to improve hematological tolerability 4.
• Common adverse reactions with Zejula include thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension 3.

Efficacy and Safety

• Zejula has been shown to significantly prolong progression-free survival (PFS) in patients with recurrent, platinum-sensitive, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer, regardless of BRCA mutation or homologous recombination deficiency (HRD) status 2, 3.
• The safety profile of Zejula is manageable, with most adverse events being hematologic abnormalities, which can be managed with dose interruption or modification 2, 4.