دورية أكاديمية
A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer
| العنوان: | A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer |
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| المؤلفون: | Pignata, Sandro, Scambia, Giovanni, Villanucci, Alessandro, Naglieri, Emanuele, Ibarbia, Mikel Arruti, Brusa, Federica, Bourgeois, Hugues, Sorio, Roberto, Casado, Antonio, Reichert, Dietmar, Dopchie, Catherine, De Rivas, Beatriz, Sande, Luis Miguel |
| المصدر: | The Oncologist ; volume 26, issue 4, page e658-e668 ; ISSN 1083-7159 1549-490X |
| بيانات النشر: | Oxford University Press (OUP) |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | Purpose The noninterventional, prospective NIMES-ROC phase IV study (NCT02825420) evaluated trabectedin plus pegylated liposomal doxorubicin (PLD) in real-life clinical practice. Patients and Methods Eligible 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. Results Two 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. Conclusion The 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 Practice This noninterventional, prospective study, conducted in 57 reference sites across Europe, consistently ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1002/onco.13630 |
| الإتاحة: | https://doi.org/10.1002/onco.13630Test https://academic.oup.com/oncolo/article-pdf/26/4/e658/41923356/oncolo_26_4_e658.pdfTest |
| حقوق: | http://creativecommons.org/licenses/by-nc-nd/4.0Test/ |
| رقم الانضمام: | edsbas.DCC22FE0 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/onco.13630 |
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