What is the recommended treatment regimen for patients taking Lynparza (olaparib)?

From the Guidelines

The recommended treatment regimen for patients taking Lynparza (olaparib) is 300 mg (two 150 mg tablets) taken orally twice daily, for a total daily dose of 600 mg, as maintenance therapy for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have complete response (CR) or partial response (PR) following first-line platinum-based chemotherapy, particularly those with BRCA mutations or homologous recombination deficiency (HRD) tumors 1.

Key Considerations

• Treatment duration varies based on the specific cancer type being treated but often continues until disease progression or unacceptable toxicity occurs.
• Dose reductions may be necessary for patients experiencing adverse effects, with common reduction steps to 250 mg twice daily, then 200 mg twice daily if needed.
• Regular monitoring of complete blood counts is essential during treatment due to potential hematological toxicities.
• Patients should avoid grapefruit products while taking Lynparza as they may affect drug metabolism.

Mechanism of Action

• Lynparza 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.

Clinical Evidence

• The SOLO-1 trial demonstrated a remarkable improvement in progression-free survival (PFS) with olaparib compared to placebo in patients with newly diagnosed advanced ovarian cancer harboring germline or somatic BRCA1/2 mutations 1.
• The PAOLA-1 trial showed a clinically meaningful overall survival (OS) benefit with olaparib/bevacizumab treatment compared to bevacizumab alone in patients with HRD tumors 1.
• The PRIMA trial examined single-agent niraparib as maintenance therapy and demonstrated a significant improvement in PFS with niraparib compared to placebo in patients with HRD, with or without a BRCA1/2 mutation 1.

Patient Selection

• Patients with BRCA mutations or HRD tumors are more likely to benefit from olaparib treatment.
• Homologous recombination deficiency status may provide information on the magnitude of benefit of PARP inhibitor therapy in patients without a BRCA1/2 mutation 1.

From the FDA Drug Label

Dose: Dogs and cats: 0.1 mg/2.204 Lb. equivalent to 1 drop per 2.204 Lb. every 8 hours. The FDA drug label does not answer the question.

From the Research

Recommended Treatment Regimen for Patients Taking Lynparza (Olaparib)

The recommended treatment regimen for patients taking Lynparza (olaparib) varies depending on the specific indication and patient population.

• For patients with advanced ovarian cancer who have received three or more prior lines of chemotherapy, the recommended dose is 400 mg twice daily as capsules 2 or 300 mg twice daily as tablets 3.
• For patients with platinum-sensitive, relapsed, BRCA-mutated high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, olaparib is indicated as monotherapy for maintenance treatment at a dose of 300 mg twice daily as tablets 4, 3.
• For first-line maintenance treatment in adults with advanced ovarian cancer who are in complete or partial response to first-line, platinum-based chemotherapy, olaparib is approved at a dose of 300 mg twice daily as tablets, either as monotherapy or in combination with bevacizumab in patients with homologous recombination deficiency (HRD) 5.

Administration and Dosing

It is essential to note that the capsule and tablet formulations of olaparib have different bioavailability, and physicians must strictly adhere to the dosing instructions provided in the prescribing information 3.

• The tablet formulation offers greater convenience for most patients, especially when using olaparib for maintenance therapy.
• Patients should be engaged in discussion to support an informed transition between the formulations.

Safety and Tolerability

Olaparib is generally well tolerated, with the majority of adverse events being of mild to moderate severity and not requiring interruption of treatment 6, 2, 4, 5.

• Common adverse reactions include anemia, nausea, fatigue, vomiting, diarrhea, and dysgeusia.
• Severe anemia and severe fatigue can occur in association with olaparib treatment.
• Myelodysplastic syndrome and/or acute myeloid leukemia have been reported in patients treated with olaparib 2.