Dataset Information

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

ABSTRACT: The 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.Eligible 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.Seventy-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.Trabectedin 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.

SUBMITTER: Runnebaum IB

PROVIDER: S-EPMC5948298 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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

Runnebaum Ingo B IB Reichert Dietmar D Ringsdorf Uta U Kuther Markus M Hesse Tobias T Sehouli Jalid J Wimberger Pauline P

Journal of cancer research and clinical oncology 20180406 6

<h4>Purpose</h4>The OVA-YOND study is the first prospective, non-interventional trial designed to evaluate trabectedin (1.1 mg/m<sup>2</sup>) plus PLD (30 mg/m<sup>2</sup>) in patients with platinum-sensitive recurrent ovarian cancer (ROC), given according to the marketing authorization in real-life clinical practice across Germany.<h4>Methods</h4>Eligible patients were adults with platinum-sensitive ROC, pretreated with ≥ 1 platinum-containing regimen/s. The primary endpoint was to assess safet ...[more]

PMID: 29623421

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Project description:PurposeThe noninterventional, prospective NIMES-ROC phase IV study (NCT02825420) evaluated trabectedin plus pegylated liposomal doxorubicin (PLD) in real-life clinical practice.Patients and methodsEligible participants included adults with platinum-sensitive recurrent ovarian cancer (PS-ROC) who had received one or more cycles of trabectedin/PLD before inclusion according to the marketing authorization. The primary endpoint was progression-free survival (PFS) according to investigator criteria.ResultsTwo hundred eighteen patients from five European countries were evaluated, 72.5% of whom were pretreated with at least two prior chemotherapy lines and received a median of six cycles of trabectedin/PLD (range: 1-24). Median PFS was 9.46 months (95% confidence interval [CI], 7.9-10.9), and median overall survival (OS) was 23.56 months (95% CI, 18.1-34.1). Patients not pretreated with an antiangiogenic drug obtained larger median PFS (p < .007) and OS (p < .048), largely owning to differences between the two populations. Twenty-four patients (11.0%) had a complete response, and 57 patients (26.1%) achieved a partial response for an objective response rate (ORR) of 37.2%. Fifty-nine patients (27.1%) had disease stabilization for a disease control rate of 64.2%. No statistically significant difference in PFS, OS, or ORR was observed by BRCA1/2 status and platinum sensitivity. Most common grade 3/4 adverse events (AEs) were neutropenia (30.3%), anemia (6.4%), thrombocytopenia (5.5%), and asthenia (5.0%). No deaths attributed to treatment-related AEs or unexpected AEs occurred.ConclusionThe combination of trabectedin/PLD represents a clinically meaningful and safe option for patients with PS-ROC regardless of prior treatment with an antiangiogenic drug, being comparable with previously observed outcomes in selected and less pretreated patients from clinical trials.Implications for practiceThis noninterventional, prospective study, conducted in 57 reference sites across Europe, consistently confirmed that trabectedin plus pegylated liposomal doxorubicin (PLD) in routine clinical practice represents a clinically meaningful and safe option for women with platinum-sensitive recurrent ovarian cancer. Although the study population represented a heterogeneous, older, and more pretreated population than those in prospective clinical trials, the combination of trabectedin plus PLD induced comparable clinical benefits, with a similar and manageable safety profile. Overall, these findings show that trabectedin in combination with PLD maintains antitumor activity when administered to heavily pretreated patients in real-life clinical practice.

Project description:BackgroundIn recent years, pegylated liposomal doxorubicin (PLD) has been widely used to improve the survival of patients with ovarian cancer; however, it is unclear whether the combinational use of PLD with other drugs is more effective. Therefore, this meta-analysis aimed to confirm the efficacy and safety of trabectedin, combined with PLD, in the treatment of recurrent ovarian cancer.MethodsData corresponding to all eligible clinical trials as of May 15, 2022, was retrieved using several electronic retrieval databases including PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), ClinicalTrials.gov, Excerpta Medica Database (EMBASE) and Cochrane Library clinical controlled trials (CENTRAL). Comprehensive hazard ratios (HRs), risk ratios (RRs), and 95% confidence intervals (CIs) were calculated using the Review Manager software 5.4 (RevMan 5.4).ResultsFrom two phase III randomized controlled trials, 1248 patients with recurrent ovarian cancer were included in this meta-analysis. Results of meta-analysis revealed that trabectedin, combined with PLD chemotherapy, significantly improved overall survival (OS) in patients with BReast CAncer gene (BRCA)-associated recurrence (HR, 0.49; 95% CI, [0.33-0.73]; P = 0.0004) and platinum-sensitive recurrence whose platinum-free interval (PFI) was 6-12 months (HR, 0.66; 95% CI, [0.52-0.84]; P = 0.0005). In addition, compared with PLD alone, combination therapy significantly improved the progression-free survival (PFS) in patients with recurrent ovarian cancer (HR, 0.86; 95% CI, [0.74-0.99]; P = 0.03). Combination therapy also significantly improved PFS in patients with BRCA-associated recurrence (HR, 0.58; 95% CI, [0.40-0.58]; P = 0.004), and platinum-sensitive recurrence (HR, 0.73; 95% CI, [0.56-0.95]; P = 0.02). Trabectedin combined with PLD was more prone to grade 3-4 toxic side effects than PLD alone (P < 0.05); however, fatal adverse events related to non-toxic side effects occurred.ConclusionTrabectedin combined with PLD significantly improves OS and PFS in patients with BRCA-associated and platinum-sensitive recurrent ovarian cancers. The potential use of trabectedin combined with PLD should be selected according to the PFI and BRCA mutation status of patients.

Dataset Information

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

Publications

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

Similar Datasets

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