Abstract 73TiP
Background
Ovarian cancer (OC) is the fifth cause of cancer death in women and the deadliest of gynecologic cancers. First-line treatment of newly diagnosed OC includes a combination of surgery and chemotherapy. However, 85% of patients experience recurrence. Prolonging the benefit of first-line platinum with a maintenance therapy is currently the best chance for these patients. PARP inhibitors are essential to improve outcome: Olaparib, Niraparib, and olaparib/bevacizumab are approved with different indications. Niraparib is an highly selective PARP-1 and -2 inhibitor and recent trials showed its activity both in recurrence (NOVA trial) and first diagnosis (PRIMA trial). In the last study, evaluating patients with newly diagnosed advanced OC with residual cancer at primary surgery who had a response to platinum-based chemotherapy, niraparib met the primary endpoint of prolonging progression-free survival (PFS) versus placebo regardless of BRCA mutation or HRD tumor status. A Niraparib Expanded Access Programme (EAP) started in Italy in March 2020 as first-line maintenance treatment option for patients with newly diagnosed advanced OC, before the commercial approval. Until July 2021, 600 patients have been enrolled. This EAP represents an opportunity to evaluate drug efficacy and safety in the real live world. MITO 40 aims to collect retrospectively the data from the patients of the EAP programme that for several characteristics (any residual disease after primary surgery, and histotypes) differs from the population enrolled in PRIMA.
Trial Design
This is a no profit observational retrospective real life multicenter study, the promoter is the NCI Fondazione G. Pascale. The involved centers are part of the MITO group (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies). The primary objective is to observe efficacy of niraparib as maintenance treatment in a real life setting for newly diagnosed ovarian cancer patients within the EAP. The secondary objective is to assess safety and long term clinical outcomes in the same population. Patients retrospectively included in EAP will be followed up prospectively up to 3 years from inclusion in EAP independently of whether they are continuing treatment with niraparib or not.
Legal entity responsible for the study
Fondazione G. Pascale.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.