The first standard treatment for advanced ovarian cancer patients is platinum-based chemotherapy. If the patient responds to this chemotherapy, she will continue to receive it to the maximum that can be given because of cumulative toxicity in the body and not until the disease worsens. This means that an advanced ovarian cancer patient can receive treatment, respond to it, and then discontinue it. The patient is then enters a period of follow-up only where she does not receive treatment and usually ends when the disease progresses. This period is called “maintenance phase”.
A drug called “Niraprib”, commercial name “Zejula®”, was approved for the treatment of cancer patients with ovarian cancer whose tumor expresses a BRCA mutation and are BRCA carriers. This group of patients accounts for only about 15% of all ovarian cancer patients and the standard maintenance treatment in the remaining 85% of patients is “no treatment”.
Niraparib is taken orally once a day and belongs to the “PARP inhibitor” family.
About PRIMA study –
PRIMA is Phase 3 study designed to evaluate niraparib versus placebo in first-line platinum responsive Stage III or IV ovarian cancer patients without filtering by BRCA status. The study assesses the efficacy of niraparib as maintenance treatment, as measured by the length of time until the disease progresses, also called PFS and compared it with the group of patients who received placebo.
The results have been announced and are positive, demonstrating significant improvements in the length of time until the disease progresses (PFS) regardless of their BRCA status. The detailed results will be published in a near oncology meeting.
In addition to these findings the results for the safety and tolerability of Zejula was consistent with previous clinical trials.
There is no doubt that the patients who participated in the study earned the opportunity to gain treatment during the maintenance stage with the most advanced biological drug in the world. This treatment worked, was successful and they received it long before the drug will officially be approved by the world health authorities and reimbursed.
The best management for any patient with cancer is receiving the most innovative cancer drugs in advanced stages of development. There, the hope and chances to live longer go far beyond the standard protocols.
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