Abstract
PurposeThe OVA-YOND study is the first prospective, non-interventional trial designed to evaluate trabectedin (1.1 mg/m2) plus PLD (30 mg/m2) in patients with platinum-sensitive recurrent ovarian cancer (ROC), given according to the marketing authorization in real-life clinical practice across Germany.MethodsEligible patients were adults with platinum-sensitive ROC, pretreated with ≥ 1 platinum-containing regimen/s. The primary endpoint was to assess safety/tolerability of the combination.ResultsSeventy-seven patients with platinum-sensitive relapse from 31 sites were evaluated. Patients received a median of 6 cycles (range 1–21) with 39 patients (50.6%) receiving ≥ 6 cycles. Median treatment duration was 4.2 months (range 0.7–18.8), mostly on an outpatient basis (88.3% of patients). Most common grade 3/4 trabectedin-related adverse events (AEs) were leukopenia (18.2%), neutropenia (15.6%), thrombocytopenia (9.1%), alanine (7.8%) and aspartate aminotransferase (6.5%) increase, and nausea/vomiting (5.2% each). Neutropenia (18.2%), leukopenia (15.6%), thrombocytopenia (10.4%), and nausea/vomiting (5.2% each) were the most frequent grade 3/4 PLD-related AEs. No deaths attributed to drug-related AEs or unexpected AEs occurred. Five patients (6.5%) had a complete response and 19 patients (24.7%) achieved a partial response for an objective response rate of 31.2% with median response duration of 6.25 months. Sixteen patients (20.8%) had disease stabilization for a disease control rate of 51.9%. Median progression-free survival was 6.3 months and median overall survival was 16.4 months.ConclusionTrabectedin plus PLD confer clinically meaningful benefit to pre-treated patients with platinum-sensitive ROC, being comparable to those previously observed in selected populations from clinical trials and with a manageable safety profile.
Highlights
Ovarian cancer is an acronym for a group of different cancers that are derived from different, often non-ovarian tissues, resulting in the different cancer histotypes with diverse molecular heterogeneity, genetic instability and mutagenicity (Bast et al 2009; The Cancer Genome Atlas Research Network 2011; Vaughan et al 2011)
For patients suffering from platinum-induced toxicities or hypersensitivity, patients who had received more than one platinum-based chemotherapy or patients with partially platinum-sensitive disease who can benefit from a delay in platinum re-treatment (Poveda et al 2014) the combination of trabectedin plus pegylated liposomal doxorubicin (PLD) represents an alternative in treating patients with platinum-sensitive relapse
The time to progression (TTP), progression-free survival (PFS) and overall survival (OS) analyses were defined as the time interval from the first administration of trabectedin plus PLD to the earliest date of disease progression for TTP, or until the earliest date of disease progression or death, regardless of cause for PFS, whereas OS was defined as the time between the start of trabectedin plus PLD and patient death from any cause
Summary
Ovarian cancer is an acronym for a group of different cancers that are derived from different, often non-ovarian tissues, resulting in the different cancer histotypes with diverse molecular heterogeneity, genetic instability and mutagenicity (Bast et al 2009; The Cancer Genome Atlas Research Network 2011; Vaughan et al 2011). Following the initial approval of trabectedin in 2007, being the first ever marine-derived antineoplastic drug approved (Demetri et al 2009), based on the results from a phase III randomized OVA-301 study (ClinicalTrials.gov Identifier: NCT00113607), which compared pegylated liposomal doxorubicin (PLD) alone with the combination of PLD and trabectedin in patients with ROC, in 2009 trabectedin plus PLD obtained the second marketing authorization for the treatment of patients with platinum-sensitive ROC (Monk et al 2010). According with the recent survey carried out in Italy about the real-world management of trabectedin plus PLD in patients with platinum-sensitive ROC, currently, among the non-platinum/non-taxane treatments, this combination is the most frequently adopted regimen in such patients (Ferrandina et al 2017). For patients suffering from platinum-induced toxicities or hypersensitivity, patients who had received more than one platinum-based chemotherapy or patients with partially platinum-sensitive disease who can benefit from a delay in platinum re-treatment (Poveda et al 2014) the combination of trabectedin plus PLD represents an alternative in treating patients with platinum-sensitive relapse
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