Using PARP Inhibitors Earlier
- Women with BRCA mutations benefit the most from PARP inhibitors
- Regardless of BRCA status, almost all women are eligible to take these drugs after a response to chemo
- PARP inhibitors have very real side effects that should be discussed with your doctor
A new approval by the Food and Drug Administration makes PARP inhibitor therapy available to women earlier in their ovarian cancer treatment. PARP inhibitors work by preventing cancer cells from repairing damaged genetic material, resulting in their death. “That’s really tremendous progress and an incredibly exciting time for ovarian cancer therapeutics,” says Dr. Ramez Eskander, gynecologic oncologist at the University of California, San Diego. Niraparib, the drug that received approval for earlier use, had previously been used to treat women at a later stage of treatment, but the new approval makes the drug available earlier and to more women than before.
Niraparib, like other PARP inhibitors, is given in pill form. Several PARP inhibitors have been approved for the treatment of ovarian cancer over the past several years. “However, we never had a PARP approval in what we call the frontline [initial treatment], when patients are receiving chemotherapy after initial diagnosis,” explains Dr. Eskander. Previous approvals for PARP inhibitors were for treatment after disease recurrence or when cancer returned after initial therapy.
Niraparib was approved for frontline maintenance treatment based on the results of a trial called PRIMA. That study examined whether or not niraparib was an effective maintenance therapy following the completion of initial chemotherapy. The study compared patients who received niraparib after initial chemo versus patients who received a placebo. The researchers wanted to know whether using niraparib as maintenance would lead to a benefit in progression-free survival: a longer time for patients to be alive without evidence of the cancer returning.
“The results were positive, and what we discovered is that not only does niraparib appear to be effective in patients who have a BRCA mutation, but also in a population of patients who have something called homologous recombination deficiency (HRD),” says Dr. Eskander. The cancer cells of patients with HRD have trouble repairing their own DNA, and are especially vulnerable to PARP inhibitor therapy.
The study also showed benefit to patients regardless of whether or not they had a BRCA mutation or HRD. “So the FDA approved niraparib as a maintenance therapy for patients with ovarian cancer who have responded—completely or partially—to their initial chemotherapy with a platinum-based regimen,” says Dr. Eskander. “This is a really exciting approval for us, an opportunity to bring PARPs into the frontline space, which is something that we’ve been waiting for.”
Most recently, the American Society of Clinical Oncology (ASCO) released new guidelines recommending PARP inhibitors be offered to women, with or without genetic mutations, who are newly diagnosed with stage III or IV ovarian cancer and have improved with chemotherapy.
Dr. Amanika Kumar of the Mayo Clinic spoke to SurvivorNet and cautioned that women still need to speak with their doctor to evaluate the benefit of taking a PARP inhibitor to extend life, because there are very real side effects due to the toxicity of the drug. “Patients with HRD (homologous recombination deficiency) have a far better response than those without and those with BRCA mutations even more so. It is on us as clinicians to help patients understand the risks and benefits of treatment. Patients that have no mutation or HRD may choose not to go on maintenance (in fact I recommend they don’t) because there is real toxicity to these meds.”
Learn more about SurvivorNet's rigorous medical review process.
Ramez Eskander, MD, is a board-certified gynecologic oncologist at UCSD. Read More
Using PARP Inhibitors Earlier
- Women with BRCA mutations benefit the most from PARP inhibitors
- Regardless of BRCA status, almost all women are eligible to take these drugs after a response to chemo
- PARP inhibitors have very real side effects that should be discussed with your doctor
A new approval by the Food and Drug Administration makes PARP inhibitor therapy available to women earlier in their ovarian cancer treatment.
PARP inhibitors work by preventing cancer cells from repairing damaged genetic material, resulting in their death. “That’s really tremendous progress and an incredibly exciting time for ovarian cancer therapeutics,” says
Dr. Ramez Eskander, gynecologic oncologist at the University of California, San Diego.
Niraparib, the drug that received approval for earlier use, had previously been used to treat women at a later stage of treatment, but the new approval makes the drug available earlier and to more women than before.
Niraparib, like other PARP inhibitors, is given in pill form. Several PARP inhibitors have been approved for the treatment of ovarian cancer over the past several years. “However, we never had a PARP approval in what we call the frontline [initial treatment], when patients are receiving chemotherapy after initial diagnosis,” explains Dr. Eskander. Previous approvals for PARP inhibitors were for treatment after disease recurrence or when cancer returned after initial therapy.
Read More Niraparib was approved for frontline maintenance treatment based on the results of
a trial called PRIMA. That study examined whether or not niraparib was an effective maintenance therapy following the completion of initial chemotherapy. The study compared patients who received niraparib after initial chemo versus patients who received a placebo. The researchers wanted to know whether using niraparib as maintenance would lead to a benefit in progression-free survival: a longer time for patients to be alive without evidence of the cancer returning.
“The results were positive, and what we discovered is that not only does niraparib appear to be effective in patients who have a BRCA mutation, but also in a population of patients who have something called homologous recombination deficiency (HRD),” says Dr. Eskander. The cancer cells of patients with HRD have trouble repairing their own DNA, and are especially vulnerable to PARP inhibitor therapy.
The study also showed benefit to patients regardless of whether or not they had a BRCA mutation or HRD. “So the FDA approved niraparib as a maintenance therapy for patients with ovarian cancer who have responded—completely or partially—to their initial chemotherapy with a platinum-based regimen,” says Dr. Eskander. “This is a really exciting approval for us, an opportunity to bring PARPs into the frontline space, which is something that we’ve been waiting for.”
Most recently, the American Society of Clinical Oncology (ASCO) released new guidelines recommending PARP inhibitors be offered to women, with or without genetic mutations, who are newly diagnosed with stage III or IV ovarian cancer and have improved with chemotherapy.
Dr. Amanika Kumar of the Mayo Clinic spoke to SurvivorNet and cautioned that women still need to speak with their doctor to evaluate the benefit of taking a PARP inhibitor to extend life, because there are very real side effects due to the toxicity of the drug. “Patients with HRD (homologous recombination deficiency) have a far better response than those without and those with BRCA mutations even more so. It is on us as clinicians to help patients understand the risks and benefits of treatment. Patients that have no mutation or HRD may choose not to go on maintenance (in fact I recommend they don’t) because there is real toxicity to these meds.”
Learn more about SurvivorNet's rigorous medical review process.
Ramez Eskander, MD, is a board-certified gynecologic oncologist at UCSD. Read More
