Patients with advanced, newly diagnosed ovarian cancer will be able to be treated with a PARP inhibitor (niraparib) from January 2022, regardless of the presence of mutations in the BRCA1 and BRCA2 genes. It is a modern drug that extends the remission period of the disease. Both patients and doctors were waiting for this decision.
In Poland, about 3700 women develop ovarian cancer each year, and about 2600 die. It is one of the most difficult cancers in women to treat, in 70 percent. cases diagnosed in advanced stages, as it does not give specific symptoms for a long time. Surgery is the mainstay of treatment for advanced ovarian cancer. – U 70-80 percent patients in advanced clinical stages, it is not possible to remove all tumor foci. The patients receive chemotherapy, after which the vast majority have remission. After some time, however, the cancer returns. The breakthrough in the treatment were PARP inhibitors: drugs which allow the remission period to be extended – says prof. Mariusz Bidziński, national consultant in the field of oncological gynecology.
So far, only one PARP inhibitor has been reimbursed in Poland: olaparib, only for patients with mutations in the BRCA1 and BRCA2 genes. From January 2022, niraparib: the second PARP inhibitor, will also be reimbursed for all ovarian cancer patients who have responded to platinum-based chemotherapy, regardless of whether they have a mutation in the BRCA1, BRCA2 genes or not. Thanks to this, access to therapy will gain approx. 70%. patients who do not have mutations in the BRCA1, 2 genes, so so far have not had a chance for modern remission maintenance treatment. – Patients who did not have a confirmed mutation in the BRCA1, 2 genes could not receive PARP inhibitors so far and felt somewhat disadvantaged, especially since the use of niraparib clearly improves the treatment results. Clinical trials show that the drug significantly prolongs the time until the next relapse of the disease; these are significant periods – emphasizes prof. Mariusz Bidziński.
In clinical trials (NOVA, PRIMA), niraparib was administered to patients with mutations in the BRCA1 and BRCA2 genes as well as other abnormalities in the DNA repair pathway, and to patients who had no genetic mutations detected.
– In each of the subgroups, benefits were obtained from the use of niraparib in the form of extended time to progression, time free from disease symptoms, although the greatest benefits were achieved by patients with BRCA1 and BRCA2 mutations – adds Prof. Anita Chudecka-Głaz, head of the Department of Surgical Gynecology and Gynecological Oncology of Adults and Girls of the Independent Public Clinical Hospital No. 2 PUM in Szczecin.
Who is the reimbursement of a new drug for?
From January 2022, niraparib will be available to patients with ovarian cancer, regardless of the presence of mutations in the BRCA1, BRCA2 genes. The drug will be reimbursed in the first-line treatment for patients with newly diagnosed, advanced ovarian cancer. – It is a drug for stage XNUMX ovarian cancer patients with macroscopic residual disease after surgery, stage XNUMX or stage XNUMX or stage XNUMX patients receiving neoadjuvant chemotherapy with platinum analogues. It is also a low-differentiated neoplasm, as ovarian cancers with high cellular differentiation are treated differently. Most women with advanced ovarian cancer will meet these criteria, adds Prof. Anita Chudecka-Głaz.
In advanced ovarian cancer, optimal surgery is essential: if all neoplastic lesions are removed, the risk of relapse is low. – Unfortunately, in 70-80 percent. cases, it is not possible to remove all changes. Then the use of PARP inhibitors can bring very significant benefits – emphasizes prof. Bidziński.
The reimbursement of niraparib is in line with the results of the PRIMA clinical trial, which means that the drug will be administered to patients with newly diagnosed ovarian cancer. – First-line treatment, implemented at the earliest possible stage, is the most effective, the most effective – adds prof. Chudecka-Głaz.
The drug will be reimbursed from January 2022; its actual availability to patients will depend on the contract signed by the hospital with the National Health Fund. – We expect that some hospitals that have so far conducted the program of treating advanced ovarian cancer will sign contracts in January and the drug will be available to patients – adds Prof. Bidziński.
A good decision of the Ministry of Health
The quick decision of the Ministry of Health to reimburse niraparib pleases both experts and patients. – We waited for this decision, as the community of gynecologists oncologists we are very pleased that it was made. Thanks to it, many women will have a chance for a long time without symptoms of the disease – says prof. Chudecka-Głaz.
It is also important that PARP inhibitors are drugs that are very convenient to use. They are taken orally, and they do not have many side effects. – It is very modern, one could say “intelligent” drugs; in contrast to chemotherapy, which by damaging cancer cells, “incidentally” damages healthy cells and systems, which sometimes causes severe side effects. PARP inhibitors work at the molecular level, therefore they do not cause serious side effects – emphasizes prof. Włodzimierz Sawicki, president of the Polish Society of Oncological Gynecology. Women can return to normal family, social and often professional activities. This is extremely important because, although ovarian cancer is most often diagnosed at the perimenopausal age, much younger women, aged 20–30, also suffer from the disease.
– We are happy to have niraparib on the reimbursement list. As an organization representing patients primarily with ovarian cancer, we are convinced that this will allow for the maintenance and extension of the remission period in a much larger number of patients with ovarian cancer. Niraparib, unlike other PARP inhibitors, can also be used by patients who do not have mutations in the BRCA1 and BRCA2 genes. Many of them asked about the possibility of such treatment – says Barbara Górska, president of the “Blue Butterfly” Association, who herself has been suffering from advanced ovarian cancer for many years and is an example that thanks to modern treatment one can live with this disease for many years. – As the Polish Cancer Patient Coalition, we have been fighting for many years for the optimal treatment of patients with all types of cancer, including ovarian cancer. We are very glad that thanks to this bold decision of the Ministry of Health, Poland has joined the group of countries where all women, regardless of their genetic mutation status, get a chance for modern and optimal treatment, as the results of clinical trials show that such treatment is effective – adds Krystyna Wechmann, president of the Polish Cancer Patient Coalition.
The patients emphasize that the most important issue today is that the knowledge about the possibility of using PARP inhibitors, regardless of the status in the BRCA1 and BRCA2 genes, reaches the doctors and that the possibilities of using modern drugs are followed by the earliest diagnosis and good organization of treatment. It is also the main postulate of the Polish Society of Oncological Gynecology and a national consultant in the field of oncological gynecology. – The key is that the patient from the very beginning is led in a specialized center and operated by a team experienced in performing such surgeries. There is ample evidence that it translates into years of life – says prof. Bidziński. He announces that in January, work will begin on the preparation of an ovarian cancer register, and throughout 2022, work will continue on the creation of Ovarian Cancer Units, i.e. centers for comprehensive diagnosis and treatment of ovarian cancer. – There are currently 59 centers accredited by the European Society of Gynecology in Europe
Oncology; three in Poland (in Gdynia, Białystok and Warsaw). I think that they should be considered first as Ovarian Cancer Units, but there should definitely be more of them – emphasizes prof. Bidziński.
Thanks to early diagnosis, good treatment organization and the possibility of using modern drugs, ovarian cancer has a chance to become a chronic disease that can be lived with for many years.
- You can buy genetic mail-order testing for breast and ovarian cancer at Medonet Market
Authorized press material prepared by the Journalist for Health Association in connection with the introduction in Poland of the reimbursement of PARP inhibitors treatment for patients with ovarian cancer, regardless of the presence of mutations in the BRCA1 and BRCA2 genes. January 2022.