Safety Signals Observed in QUADRA Were Consistent With
Those Found in NOVA1
However, rates of most common adverse reactions observed in QUADRA were different from NOVA, and fatal adverse reactions occurred in 2% of patients, including cardiac arrest. In QUADRA, serious adverse reactions occurred in 43% of patients receiving ZEJULA. Serious adverse reactions in >3% of patients were small intestinal obstruction (7%), vomiting (6%), nausea (5%), and abdominal pain (4%).
Adverse reactions in QUADRA led to:
Dose reduction or interruption, 73%
Most frequently from:
- Thrombocytopenia, 40%
- Anemia, 21%
- Fatigue, 9%
- Nausea, 13%
- Vomiting, 11%
- Neutropenia, 11%
- Abdominal pain, 5%
The approved starting dose for ZEJULA is 300 mg/day (3x100-mg capsules)1
Retrospective post hoc analyses from NOVA identified that baseline body weight <170 lb (77 kg) or baseline platelet count <150,000/uL were predictors of early dose modification, which were further confirmed in QUADRA.2,3
Common lab abnormalities (Grades 1–4) in ≥25% of patients who received ZEJULA in QUADRA included:1
Decreased hemoglobin (83%), increased glucose (66%), decreased platelets (60%), decreased lymphocytes (57%), decreased leukocytes (53%), decreased magnesium (46%), increased alkaline phosphatase (40%), increased gamma glutamyl transferase (40%), increased creatinine (36%), decreased sodium (34%), decreased neutrophils (34%), increased aspartate aminotransferase (29%), and decreased albumin (27%).
References: 1. ZEJULA (niraparib) [package insert]. Waltham, MA: GSK, Inc; October 2019. 2. Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018;29(8):1784-1792. 3. Matulonis UA, Monk BJ, Secord AA, et al. Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer. Presented at: SGO 50th Annual Meeting on Women's Cancer; March 16-19, 2019; Honolulu, HI.