PRELIMINARY results from the MITO 40 study suggest that Niraparib, a maintenance treatment, may offer significant benefits for patients with no residual disease after primary surgery for ovarian cancer. The study, presented by Marilena Di Napoli and colleagues, evaluated the efficacy of Niraparib in patients enrolled in an expanded programme in Italy, which made the treatment available to those with different histologies and no residual disease between 2020 and 2021.
The study focused on 46 patients who had optimal cytoreduction (R0) after primary surgery. Of these, 42 had available data, with a median age of 59 years. Most patients were diagnosed with stage III high-grade serous ovarian cancer and only a small number had BRCA mutations. Treatment duration averaged 33.7 months, and 50% of patients completed the treatment as per the protocol.
The results showed that the median progression-free survival (PFS) was not reached, with progression-free survival rates of 80.9%, 71.4%, and 54.8% at 12, 24, and 36 months, respectively. Disease progression occurred in 20 of patients (47.6%), most during maintenance therapy. Notably, ECOG Performance Status and stage IV disease were significant risk factors for progression.
These preliminary findings indicate that Niraparib is effective in this cohort of mostly BRCA wild-type patients, showing high progression-free survival rates. The study provides promising evidence for the use of Niraparib in patients with no residual disease following surgery, although further analysis is needed.
Helena Bradbury, EMJ
Reference
Di Napoli M et al. PSA-058: Niraparib in patients with no residual disease after primary surgery: preliminary results of the MITO 40 study. Presented at ESGO 2025 Annual Meeting; Feb 20-23; Milan, Italy.
