Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study

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.

A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer

“…Patients characteristics at baseline in NIMES‐ROC study were in line with those observed in previous noninterventional studies [15–17], showing that the analyzed real‐life patient population was older (median age: 61 vs. 56 years) and more pretreated (72.5% of patients received at least two prior chemotherapy lines) than patients included in OVA‐301 study [11], where the inclusion criteria allowed only one previous line of treatment (Table 1). Despite the difference in patients' characteristics, the overall data observed in our study are consistent with those observed in the subgroup of platinum‐sensitive patients from the pivotal, randomized phase III OVA‐301 clinical trial [11] and are similar, or even, better than the those observed in previous real‐life studies [15–17]. The primary endpoint of the NIMES‐ROC resulted in a median time for PFS of 9.46 months.…”

“…The median number of cycles of trabectedin plus PLD received per patient in NIMES‐ROC was the same as that reported in the pivotal OVA‐301 trial (median six cycles in OVA‐301) [11] and in real‐life prospective OVA‐YOND observational study conducted in patients with platinum‐sensitive ROC in Germany [17]. Of note, nearly 60% of patients received six or more cycles, suggesting an acceptable safety profile that allowed prolonged treatment, up to 24 cycles in NIMES‐ROC and 21 cycles in OVA‐YOND.…”

“…Such observational studies can provide useful insights of the real‐world safety, efficacy, and management of patients who may be underrepresented in clinical trials because of more restrictive eligibility criteria. In that sense, three previous national studies [15–17] about the real‐life use of trabectedin plus PLD in patients with platinum‐sensitive ROC have reported that this combination confers clinically meaningful long‐term benefit to patients with platinum‐sensitive ROC, comparable to that reported in clinical trials. So far, no prospective, real‐life, pan‐European, noninterventional study with trabectedin plus PLD had been performed.…”

Network Pharmacology, Integrated Bioinformatics, and Molecular Docking Reveals the Anti-Ovarian Cancer Molecular Mechanisms of Cinnamon (Cinnamomum cassia (L.) J. Presl)

“…2 Most OC patients are found to be advanced, and their susceptibility to extensive pelvic and abdominal metastases, multidrug resistance to primary or secondary chemotherapy, and recurrence has led to a high mortality rate, with the 5-year survival rate still hovering at 40%. 3, 4 At present, the treatment of OC is usually a combination of surgery and chemotherapy, 5, 6 but chemical drugs have a certain toxicity and sometimes resistance develops to them, and Chinese medicine has unique advantages in this regard. 7 The vast majority of recurrent OC is incurable and treatment is mostly palliative with the aim of improving symptoms and quality of life, and so prevention of OC recurrence and reversal of platinum resistance are current clinical concerns.…”

Characterization of a DNA Aptamer for Ovarian Cancer Clinical Tissue Recognition and in Vivo Imaging

“…However, their use is controversial due to their lack of sensitivity [5]. Deficiencies in treatment and diagnosis renders the 5 years survival rate remains below 50% [6]. Therefore, more effective molecular probes and therapeutic methods are needed to detect and treat ovarian cancer.…”