Retrospective observational study of patients treated with niraparib in an individual patient access program in Norway.
Poly (ADP-ribose) polymerase (PARP) inhibitors have emerged as new treatment options in ovarian cancer. While there is now also evidence for the efficacy in the first line setting, they were initially studied in recurrent disease both as maintenance after chemotherapy but also as treatment on its own. The NOVA study was conducted in the maintenance setting of patients with recurrent high-grade serous ovarian-, tube or peritoneal cancer who had responded to platinum-based chemotherapy. In 2017 Tesaro opened an individual patient access program in Norway, and in July 2017 the first Norwegian patient was enrolled. We performed a retrospective observational study of patients treated with niraparib in the individual patient access program in Norway. The objective of the study is to provide preliminary efficacy and safety data in a rather unselected population of non-gBRCA patients with recurrent ovarian-, tube-, or peritoneal cancer.
Study Type
OBSERVATIONAL
Enrollment
106
Niraparib provided through the patient access program
Oslo University Hospital (OUH)
Oslo, Norway
Time to first subsequent treatment
Date of start of niraparib to start date of subsequent treatment
Time frame: Through study completion, an average of 15 months
Time to progression
Date of start niraparib to date of investigator assessed progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18.5 months
Time to progression assesed by CA-125
Date of start niraparib to date of 2xUNL CA-125
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18.5 months
Type of subsequent chemotherapy if applicable
Type of subsequent chemotherapy
Time frame: Through study completion, an average of 15 months
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
Response to subsequent chemotherapy (investigator assessed, measured as ORR and CBR
Time frame: Through study completion, an average of 15 months
Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
Proportion of patients with at least one grade 3 and 4 hematologic and non-hematologic toxicity
Time frame: Through study completion, an average of 15 months
Frequency of dose interruptions
Frequency of dose interruptions
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Through study completion, an average of 15 months
Frequency of dose reductions
Frequency of dose reductions
Time frame: Through study completion, an average of 15 months
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
Reasons for discontinuation (i.e. toxicity, progressive disease, patient preferences, other)
Time frame: Through study completion, an average of 15 months
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Compare progression-free survival data in groups by CA 125 at baseline (normalized vs not normalized)
Time frame: Through study completion, an average of 15 months