Understanding Dose Modification

In an exploratory analysis

Body Weight and Baseline Platelet Count Were Significant Predictors of Patients Most Likely to Require Early Dose Modification1

In patients with at least one of these baseline characteristics1:

  • There was a higher incidence of grade 3-4 thrombocytopenia, compared with patients whose weight was ≥170 lbs, and who had a platelet count ≥150,000/μL (35% vs 12%)

  • As a result of dose interruptions and reductions, the average dose during the first 2 months was approximately 200 mg
  • 17% remained on a dose of 300 mg at month 4

An exploratory analysis confirmed that dose modification did not compromise treatment efficacy.2

 

References: 1. Lord R, Mirza MR, Woelber L, et al. Safety and dose modification for patients with low body weight recieving niraparib in the ENGOT-OV16/NOVA phase III trial. Presented at: SGO Annual Meeting on Women's Cancer; March 24-27, 2018. New Orleans. Abstract 20. 2. Wang J, Zhang Z-Y, Mansoor R, et al. The exposure-reponse relationship of niraparib patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Poster presented at: Annual Congress of the European Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. Poster 933PD.

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