Abstract 1290
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.
Resources from the same session
2860 - Prognostic value of metabolic response assessed by 18FDG-PET after induction chemotherapy and after chemoradiotherapy (CRT) in localized esophageal squamous cell carcinoma (ESCC) patients (pts) receiving definite CRT (dCRT)
Presenter: Yeonghak Bang
Session: Poster Display session 2
Resources:
Abstract
3881 - Comprehensive genomic profiling of early-stage esophageal squamous cell carcinoma
Presenter: Jing Zuo
Session: Poster Display session 2
Resources:
Abstract
3944 - A novel nomogram and risk classification system predicting radiation pneumonitis in patients with esophageal cancer receiving radiotherapy
Presenter: Lu Wang
Session: Poster Display session 2
Resources:
Abstract
1956 - Drinking alcohol, smoking, multiple dysplastic lesions and the risk of field cancerization of squamous cell carcinoma in the esophagus and head and neck region
Presenter: Chikatoshi Katada
Session: Poster Display session 2
Resources:
Abstract
2144 - Neoadjuvant chemotherapy can eliminate the negative impact of postoperative infectious complications on recurrence in patients with esophageal cancer
Presenter: Kazuki Kano
Session: Poster Display session 2
Resources:
Abstract
2403 - Comparison of chemoradiotherapy (CRT) followed by consolidation with cisplatin and 5-fluorouracil (CF) versus definitive CRT with carboplatin and paclitaxel (CP) in esophageal cancer
Presenter: Marcelle Cesca
Session: Poster Display session 2
Resources:
Abstract
3247 - Paclitaxel in Combination with Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous cell Carcinoma: A Phase II Clinical Trial
Presenter: Yuhong Li
Session: Poster Display session 2
Resources:
Abstract
4293 - Prognosis of esophageal squamous cell carcinoma based on local immunity evaluation
Presenter: Elena Zlatnik
Session: Poster Display session 2
Resources:
Abstract
5419 - Impact of Sarcopenia and adiposity in survival of metastatic esophageal cancer (MEC)
Presenter: Aline Fares
Session: Poster Display session 2
Resources:
Abstract
2083 - PALAESTRA - A phase II trial with short-course radiotherapy followed by chemotherapy as palliative treatment in esophageal adenocarcinoma
Presenter: David Borg
Session: Poster Display session 2
Resources:
Abstract