Publications by authors named "E I Braicu"
Article Synopsis
- The study compared the combination of lenvatinib and pembrolizumab (len + pembro) with traditional chemotherapy for advanced or recurrent endometrial cancer (aEC) in patients who had not previously been treated.
- Results showed that while len + pembro did not statistically outperform chemotherapy in terms of progression-free survival (PFS) or overall survival (OS), it offered similar outcomes, indicating noninferiority.
- The trial involved 842 patients and found median PFS and OS were comparable between the two treatment groups, suggesting len + pembro could be an effective alternative to chemotherapy for this cancer type.
Purpose: Niraparib is a poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor approved for the maintenance treatment of advanced ovarian cancer (OC). Niraparib was originally approved in recurrent OC at a fixed starting dose (FSD) of 300 mg once daily (QD). This analysis characterized the population pharmacokinetics (PK) of niraparib and evaluated the relationships between exposure, efficacy, and safety to support clinical use of an individualized dosing strategy, in which the starting dose of niraparib was adjusted based on patient characteristics to improve the benefit-risk profile.
View Article and Find Full Text PDFArticle Synopsis
- The study aimed to assess the safety and tolerability of an individualized starting dose (ISD) of niraparib in patients with newly diagnosed advanced ovarian cancer who responded to platinum-based chemotherapy.
- An analysis of treatment-emergent adverse events (TEAEs) revealed that common side effects occurred early, with hematologic TEAEs resolving in over 89% of patients within a median duration of about 2 weeks.
- Overall, the niraparib ISD was found to be well tolerated, indicating the importance of close monitoring after starting treatment and helping set patient expectations regarding safety.
Objective: To identify characteristics associated with long-term progression-free survival (≥2 years) in patients with advanced ovarian cancer treated with niraparib first-line maintenance therapy in the phase III PRIMA/ENGOT-OV26/GOG-3012 study.
Methods: In this post hoc analysis of PRIMA, patients randomized to niraparib were grouped based on investigator-assessed progression-free survival (progressive disease/censoring <2 years or ≥2 years after randomization). Variables assessed for predictive value were Eastern Cooperative Oncology Group performance status, International Federation of Gynecology and Obstetrics (FIGO) stage at diagnosis, clinical response to platinum-based chemotherapy, number of prior chemotherapy cycles, primary tumor location, body mass index, categorical age, debulking surgery type, number of baseline target lesions, number of baseline non-target lesions, /homologous recombination-deficiency status, residual disease status, and duration from end of chemotherapy to randomization.