open access: Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

 Bone marrow suppression or myelotoxicity (adjective myelotoxic) or myelosuppression is the decrease in production of cells responsible for providing immunity (leukocytes), carrying oxygen (erythrocytes), and/or those responsible for normal blood clotting (thrombocytes).
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open access — NEJM
November 7, 2016

Patients
The first patient was enrolled on August 26, 2013. The database for the current analysis was locked on June 20, 2016, and follow-up is ongoing. A total of 553 patients were enrolled in the study at 107 sites in the ENGOT countries, the United States, Canada, and Hungary. Of these patients, 201 received treatment in the gBRCA cohort and 345 in the non-gBRCA cohort (Figure 1Figure 1Enrollment and Outcomes.). At the time of the database lock, 51 patients in the gBRCA cohort and 58 in the non-gBRCA cohort were still receiving niraparib or placebo.
 In conclusion, the duration of progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer was significantly longer in the niraparib group than in the placebo group, regardless of the presence or absence of gBRCA mutations or HRD status. The treatment-associated myelotoxicity required dose modifications or delays but was not associated with a long-term increase in mortality or morbidity.


....Overall, the niraparib side-effect profile was consistent with that in previous studies, and adverse events were managed with appropriate dose modifications and delays. Although grade 3 or 4 hematologic abnormalities were common, the low incidence of discontinuation because of such events (9.3%) (Table S4 in the Supplementary Appendix) and the absence of cumulative thrombocytopenia show the effectiveness of dose modifications. Notably, patient-reported outcomes were similar in the niraparib group and the placebo group, indicating that niraparib did not adversely affect the patients’ quality of life over the course of treatment.

In conclusion, the duration of progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer was significantly longer in the niraparib group than in the placebo group, regardless of the presence or absence of gBRCA mutations or HRD status. The treatment-associated myelotoxicity required dose modifications or delays but was not associated with a long-term increase in mortality or morbidity.