Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: Results from the PRIMA/ENGOT‐OV26/GOG‐3012 trial

• Published in: Cancer 2023-06, Vol.129 (12), p.1846-1855
• Main Authors: Mirza, Mansoor R., González‐Martín, Antonio, Graybill, Whitney S., O’Malley, David M., Gaba, Lydia, Stephanie Yap, Oi Wah, Guerra, Eva M., Rose, Peter G., Baurain, Jean‐François, Ghamande, Sharad A., Denys, Hannelore, Prendergast, Emily, Pisano, Carmela, Follana, Philippe, Baumann, Klaus, Calvert, Paula M., Korach, Jacob, Li, Yong, Malinowska, Izabela A., Gupta, Divya, Monk, Bradley J.
• Format: Article
• Language: English
• Subjects: Body Weight; Cancer; Carcinoma, Ovarian Epithelial - drug therapy; Chemotherapy; Dosage; Effectiveness; Female; Homologous recombination; Humans; Indazoles; individualized starting dose; niraparib; Oncology; Ovarian cancer; Ovarian Neoplasms - drug therapy; Placebos; Platelets; Platinum; Poly(ADP-ribose) Polymerase Inhibitors - therapeutic use; poly(ADP‐ribose) polymerase inhibitors/adverse effects; Prospective Studies; Safety
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.34706

Background The PRIMA/ENGOT‐OV26/GOG‐3012 (NCT02655016) trial was amended to prospectively evaluate the safety and efficacy of an individualized starting dose (ISD) regimen of niraparib for first‐line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. Methods In the phase 3 PRIMA trial, patients with newly diagnosed advanced ovarian cancer with a complete/partial response to first‐line platinum‐based chemotherapy (N = 733) were initially treated with a fixed starting dose (FSD) regimen of 300 mg once daily. Subsequently, the protocol was amended so newly enrolled patients received an ISD: 200 mg once daily in patients with baseline body weight