A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer

Chelariu-Raicu, Anca; Nick, Alpa; Urban, Renata; Gordinier, Mary; Leuschner, Carola; Bavisotto, Linda; Dal Molin, Graziela Zibetti; Whisnant, John K. und Coleman, Robert L. (2021): A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer. In: Gynecologic Oncology, Bd. 160, Nr. 2: S. 418-426

Abstract

Objective. This randomized open-label phase II study evaluated the safety and clinical activity of EP-100 plus weekly paclitaxel in patients with recurrent ovarian cancer expressing positive LHRH receptor. Methods. In a limited run-in dose escalation phase for EP-1 00, six patients were treated with ascending dose levels (13 mg/m2, 20 mg/m2, 30 mg/m2). In the randomized phase, patients received weekly paclitaxel (80 mg/m2 intravenously) plus twice weekly EP-100 (30 mg/m2 intravenously;combination arm) or weekly paclitaxel alone (80 mg/m2 intravenously;paclitaxel arm). The primary study endpoint was overall response rate (ORR). Results. Forty-four patients were then randomized to either the experimental combination arm (n = 23) or the standard of care paclitaxel monotherapy arm (n = 21). The ORR was 35% (95%CI 16%-57%) for the combination arm and 33% (95% CI 15%-57 %) for the paclitaxel arm. An interesting observation from an unplanned analysis was that a subset of patients with target liver lesions showed a greater overall response rate to the combination (69%) compared to paclitaxel alone ( 16%). The frequency of treatment related grade 3-4 adverse events was similar between treatment arms: 48% vs 43% for the combination and paclitaxel arms, respectively. Conclusions. ORR in the EP-100 combination arm was similar to that in the group treated with paclitaxel alone;however, a subset of patients with liver metastases appeared to benefit from the combination. The addition of EP-10 0 did not appear to augment the adverse event profile of paclitaxel and was well tolerated. (c) 2020 ELSEVIER. All rights reserved.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0090-8258
• Sprache: Englisch