More than 2 years2 years and 24 days to be exact, without the cancer progressing. With more than half the risk of having a relapse or dying. Good news for women with ovarian cancer, the eighth most common cancer in the world female population, which in Italy has 5,200 new diagnoses per year, especially after the age of 40. ‘Prime’, an independent phase 3 study conducted in China, analyzed the evidence on niraparib, Parp-inhibitor by Gsk, approved in Italy for “the first-line maintenance treatment and in monotherapy for patients with advanced high-grade epithelial ovarian cancer, to the fallopian tubes or primary peritoneal, in complete or partial response after basic chemotherapy of platinum salts “, recalls the company. It is, he stresses, the “first drug of this class indicated as a first-line maintenance treatment for all patients, regardless of the presence of specific mutations”.
In the women who received the drug – it emerges from the study – the progression free survival (Pfs) was equal to 24.8 months, practically tripled compared to the Pfs of women who received placebo (8.3 months). It means a 55% reduction in the chance of the cancer returning or dying, Gsk points out in a note. An important result – we read – to which is added the confirmation of an improvement in the safety profile, in line with what was also detected in the ‘Prima’ study in patients who had received the individualized dose of niraparib: only 6.7 % of women treated with niraparib (5.4% in the placebo arm) permanently discontinued due to adverse events, and this represents the lowest of all Phase 3 studies with all Parp inhibitors in the studies conducted in patients with ovarian cancer.
Prime – details Gsk – is a randomized, double-blind, placebo-controlled phase 3 study. Compared to Prima, the pivotal trial of niraparib, Prime included stage III patients who had no residual disease after primary cytoreductive surgery. In the new study, the authors administered an individualized dose of the drug, based on body weight and platelet count, to improve the safety profile. Enrolled women were of age, with stage III / IV ovarian cancer, who had previously undergone primary or interval cytoreductive surgery, regardless of residual postoperative disease status.
“An important fact – he comments Giorgio Valabrega, Oncology Department of the University of Turin and Scdu Oncologia Ao Mauriziano Umberto I hospital in the Piedmontese capital – is that in all subgroups of patients (with mutations in the Brca genes, with homologous recombination deficiency or without alterations of these genes) a statistically significant benefit was observed in terms of interval progression free. The study then prospectively confirmed the excellent safety profile of niraparib when administered based on patient weight and platelet count prior to initiation of therapy. “
According to Valabrega, however, there is a point that deserves a greater study, confirming the robustness of the data in the Hr proficient population, ie without homologous recombination defect: “To date no technical specifications are available on the test used to define the state of homologous recombination, which may differ from the methods used in the other studies with niraparib. Although it is very likely – he adds – that the two methods identify patients in the same way “.
“In any case – concludes the clinician – Prime definitively confirms that the dosage of niraparib must be individualized for each individual patient, even on the front line, as already partially suggested by the Prima study. In this way it is possible to greatly reduce the side effects. without compromising the effectiveness of the drug in the least. “