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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Tuesday, March 23, 2021
Patients with platinum-sensitive recurrent ovarian cancer who were treated with individualized doses of niraparib had a significantly reduced risk of disease progression or death and longer progression-free survival compared with those given placeboes, according to recent research conducted by Xiaohua Wu, MD, PhD, of the Fudan University Shanghai Cancer Center, China, and colleagues. These findings, which are based on the phase III, double- blind, placebo-controlled NORA trial of 265 Chinese adults with this type of ovarian cancer, were published in the Annals of Oncology.
“This is the first trial of PARP inhibitor maintenance therapy for ovarian cancer conducted in an Asian patient population and will support a change in clinical practice,” the study authors concluded. “Individualized niraparib dosing is effective and safe and should be considered standard practice in this setting.”
Of 265 patients who were randomly assigned to receive niraparib, there was a 68% reduction in the risk of disease progression or death (P = .0001). Median progression-free survival was also longer with niraparib at 18.3 months versus 5.4 months for patients given a placebo. The longer progression-free survival did not appear to be dependent on BRCA mutation status. Patients given niraparib also had significantly longer median chemotherapy-free interval (18.5 vs. 9.7 months; P = .0001) and time to first subsequent treatment (16.7 vs. 7.7 months; P = .0001).
In terms of toxicity, however, more patients given niraparib experienced grade ≥ 3 treatment-emergent adverse events compared with those given placeboes (50.8% vs. 19.3%). In addition, 11.3% of patients treated with niraparib experienced grade ≥ 3 platelet count decrease or thrombocytopenia.
The investigators acknowledged several limitations of their study. First, patients were not tested for homologous recombination deficiency. Second, individualized dosing was done solely after a change in protocol, and not all patients were randomly assigned during that scheme. Third, the researchers did not collect quality-of-life data.
Disclosure: For full disclosures of the study authors, visit annalsofoncology.org.
