1290 - Niraparib initial dose and its’ management in patients with recurrent high-grade serous ovarian cancer.

Background

Niraparib, a PARP inhibitor, is indicated as maintenance therapy in patients with relapsed, platinum sensitive high-grade serous ovarian cancer. The initial dose, especially after presentation of RADAR Analysis remains a subject of discussion. The aim of our study was to evaluate the initial dose management.

Methods

All subsequent patients who started niraparib maintenance therapy were eligible to be included in this analysis. We collected weight of patient, the initial dose and its modifications within the therapy period.

Results

We identified 72 patients between May 2017 and January 2019. Twenty patients began the therapy prior and 52 after to RADAR Analysis presentation. The mean weight of all patients was 64.9kg and in mentioned subgroups 61.4kg and 66.2kg respectively. The median dose in all patients was 200mg and in patients who started prior and after RADAR data publication 300mg and 200mg respectively. The mean dose in those groups 300mg and 217.3mg respectively. The dose reduction was necessary in 90% (18 pts.) and 28.8% (17 pts.) within first 3 therapy cycles in patients who started prior and after RADAR Analysis publication respectively.

Conclusions

To our knowledge, it is the first analysis on niraparib initial dose management. The dose adjustment according RADAR analysis data resulted in more frequent 200mg application from the beginning of the therapy. Moreover, significantly less patients needed dose adjustment in the first three months of the therapy. The initial dose reduction seems to be a reasonable and well tolerated option in patients who are going to start niraparib maintenance therapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

J.P. Grabowski: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Clovis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Tesaro; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Riemser. E.I. Braicu: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Clovis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Roche; Honoraria (self): Incyte; Honoraria (institution), Advisory / Consultancy: CRA International; Honoraria (self), Advisory / Consultancy: Seattle Genetics. J. Sehouli: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Clovis; Advisory / Consultancy: Lilly; Advisory / Consultancy: Johnson and Johnson; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Tesaro; Advisory / Consultancy: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Research grant / Funding (institution): Bayer; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): PharmaMar; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Honoraria (institution): Teva; Honoraria (self): Olympus. All other authors have declared no conflicts of interest.