Revolution Parp inhibitors, Gsk drug available for advanced ovarian cancer

There is no screening and the symptoms are often nonspecific: abdominal swelling, pelvic pain, frequent urination, loss of appetite. For this reason, recognizing an ovarian cancer in the initial phase is not easy and prevention and information play a fundamental role. The advent of Parp inhibitors in recent years has changed the therapeutic paradigm of ovarian cancer and consequently the prospects and quality of life of patients. A small revolution that today marks a further step forward. Niraparib, the Parp inhibitor of Gsk, has also been approved in Italy for the first-line maintenance treatment in monotherapy for patients with advanced high-grade epithelial ovarian cancer (Figo stage III and IV), fallopian tubes or primary peritoneal cancer , in complete or partial response after platinum-based chemotherapy. The fundamental novelty – explains Gsk – is that it is the first drug of this class to be indicated as a first-line maintenance treatment for all patients, regardless of their mutational status. With the green light of the regulatory authority, it will therefore not only be patients with mutated Brca ovarian cancer – about one in four of those at an advanced stage – who will benefit from niraparib, but also patients without the Brca mutation. Furthermore, in the case of mutated Brca patients, the availability of niraparib offers the oncologist the opportunity to choose the most appropriate Parp inhibitor based on the characteristics of each individual patient. In support of the new indication of niraparib there are the results of the Prima study, which demonstrated – continues Gsk – in the context of first-line maintenance a clinically and statistically significant benefit in terms of time free from relapse, both in mutated BRCA patients (60 %), than in those without the mutation (57%). In the overall population, niraparib reduced the risk of progression or death by 38% compared to placebo. These findings are particularly important as 80% of patients relapse after chemotherapy. “The additional advantage for patients – explains Domenica Lorusso, associate professor of gynecology and obstetrics at the Catholic University of the Sacred Heart in Rome and head of clinical research at the Gemelli Irccs Polyclinic Foundation, at a press conference today in Rome – consists in oral single-administration home, which is well reconciled with the return to a life as close to normal as possible at the end of chemotherapy. Today – continues Lorusso – it is no longer acceptable for a patient with newly diagnosed ovarian cancer to not receive any maintenance therapy at the end of the chemotherapy”. Ovarian cancer is the eighth most common malignancy in women worldwide. In Italy it is estimated that there are 5,200 new diagnoses every year, the majority of which are made in women over 40 years of age. The indication of the experts and of the same guidelines is to carry out the Brca test already at the time of diagnosis, because the result of the test has both a therapeutic implication and a prognostic value: patients with the Brca mutation have a better prognosis and respond better in general to specific treatments. Carrying out the test also has a preventive value, since women with the mutation have a greater risk of developing other cancers as well. “Even in the presence of Parp inhibitors such as niraparib that can be prescribed regardless of the Brca mutation, because they have shown efficacy in all patients, the test for Brc must be performed in all women with ovarian cancer already at the diagnosis of the disease”, Lorusso strongly emphasizes. Once the mutation has been identified, the investigation can be extended to other women in the family and prevention or risk reduction strategies can be implemented, such as the removal of the fallopian tubes and ovaries (in the future probably only of the tube), when the woman has completed her fertile life. It is estimated that in Italy there are about 150,000 people with mutations in the Brca1 and Brca2 genes.