PMID- 33289956 OWN - NLM STAT- MEDLINE DCOM- 20210618 LR - 20240331 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 26 IP - 4 DP - 2021 Apr TI - A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer. PG - e658-e668 LID - 10.1002/onco.13630 [doi] AB - 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 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. CI - (c) 2020 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press. FAU - Pignata, Sandro AU - Pignata S AUID- ORCID: 0000-0002-8836-2633 AD - Department of Urology and Gynecology, Istituto Nazionale Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)-Fondazione G. Pascale Napoli, Naples, Italy. FAU - Scambia, Giovanni AU - Scambia G AD - Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy. FAU - Villanucci, Alessandro AU - Villanucci A AD - Unita Ospedaliera (UO) Translational Oncology, Department of Oncology, Azienda Ospedaliero Universitaria Careggi Firenze, Florence, Italy. FAU - Naglieri, Emanuele AU - Naglieri E AD - Istituto Oncologico Giovanni Paolo II, Bari, Italy. FAU - Ibarbia, Mikel Arruti AU - Ibarbia MA AD - Hospital de Galdakao, Galdakao, Spain. FAU - Brusa, Federica AU - Brusa F AD - Ospedale Cardinal Massaia, Asti, -Piemonte, Italy. FAU - Bourgeois, Hugues AU - Bourgeois H AD - Centre Jean Bernard-Clinique Victor Hugo, Le Mans, France. FAU - Sorio, Roberto AU - Sorio R AD - Centro di Riferimento Oncologico di Aviano-IRCCS, Aviano, Italy. FAU - Casado, Antonio AU - Casado A AD - Hospital Universitario Clinico San Carlos, Madrid, Spain. FAU - Reichert, Dietmar AU - Reichert D AD - Onkologie Westerstede, Medizinische Studiengesellschaft Nord-West GmbH, Westerstede, Germany. FAU - Dopchie, Catherine AU - Dopchie C AD - Centre Hospitalier Wallonie Picarde site Institut Medico-Chirurgical, Centre Hospitalier Wallonie Picarde, Tournai, Belgium. FAU - De Rivas, Beatriz AU - De Rivas B AD - Medical Affairs, PharmaMar, Madrid, Spain. FAU - de Sande, Luis Miguel AU - de Sande LM AD - Hospital Universitario de Leon, Leon, Spain. LA - eng PT - Clinical Trial, Phase IV PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20210103 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (liposomal doxorubicin) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 80168379AG (Doxorubicin) RN - ID0YZQ2TCP (Trabectedin) SB - IM MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Disease-Free Survival MH - Doxorubicin/adverse effects/analogs & derivatives MH - Europe MH - Female MH - Humans MH - Neoplasm Recurrence, Local/drug therapy MH - *Ovarian Neoplasms/drug therapy MH - Polyethylene Glycols/adverse effects MH - Prospective Studies MH - Trabectedin PMC - PMC8018301 OTO - NOTNLM OT - Noninterventional OT - Ovarian OT - Pegylated liposomal doxorubicin OT - Trabectedin COIS- Disclosures of potential conflicts of interest may be found at the end of this article. EDAT- 2020/12/09 06:00 MHDA- 2021/06/22 06:00 PMCR- 2021/04/01 CRDT- 2020/12/08 12:34 PHST- 2020/10/15 00:00 [received] PHST- 2020/11/25 00:00 [accepted] PHST- 2020/12/09 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/12/08 12:34 [entrez] PHST- 2021/04/01 00:00 [pmc-release] AID - ONCO13630 [pii] AID - 10.1002/onco.13630 [doi] PST - ppublish SO - Oncologist. 2021 Apr;26(4):e658-e668. doi: 10.1002/onco.13630. Epub 2021 Jan 3.