Results from a Phase I Trial.
Presented Saturday, June 2, 2018
Ahmad Awada, Philippe Georges Aftimos, Emiliano Calvo, Valentina Boni, Victor Moreno, Bernard Doger, Xarles Erik Luepke, Katrin Zaragoza, Mariano Siguero, Carmen Maria Kahatt, Arturo Soto-Matos, Tamara Sauri, Josep Tabernero; Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; START Madrid, Madrid, Spain; START Madrid CIOCC, Hospital HM... View More
PM1183 (lurbinectedin, Zepsyre) is a new anticancer drug that blocks transcription, induces DNA double-strand breaks, and modulates the tumor microenvironment. Single-agent PM1183 has antitumor activity in various solid tumors, including metastatic breast cancer (MBC), and pre-clinical synergism/additivity with fluoropyrimidines. A phase I trial determined the recommended dose (RD) for the oral fluoropyrimidine capecitabine (XEL) as 1650mg/m2 BID Day (D) 1 to D14 plus PM1183 2.2 mg/m2 D1, every 3 weeks. Here we present results of the MBC patients (pts) treated in this trial.
MBC pts with adequate organ function and < 3 prior chemotherapy lines for advanced disease were treated with PM1183+XEL until disease progression, or unacceptable toxicity. Stable asymptomatic brain metastases were allowed.
A total of 28 female MBC pts were treated between April 2013 and September 2016; 15 at RD. At cut-off, 5 pts (3 at RD) were still on treatment. Baseline characteristics and efficacy data are shown in Table 1. At RD, hematological toxicities consisted of neutropenia [40% grade (G) 3; 7% G4] and anemia (13% G3). No febrile neutropenia was observed. Non-hematological toxicities were generally mild to moderate, including nausea, fatigue, palmar-plantar erythrodysesthesia syndrome, diarrhea, and decreased appetite. All AEs were reversible and manageable with dose reductions, omissions and/or delays. Main dose-limiting toxicities (DLTs) at maximum tolerated dose were hematological.
The PM1183+XEL combination showed encouraging clinical activity in MB. Further development is warranted in this indication.
*.- La Combinación PM1183 + XELODA ha Mostrado una Actividad Clínica Alentadora en Cáncer de Mama Metastásico .
*.- El Desarrollo Adicional está Garantizado en esta Indicación .
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