“Few Options Exist for Treatment of Patients With Small-Cell lung Cáncer (SCLC) After Failure of First-Line Therapy. Lurbinectedin is a Selective Inhibitor of Oncogenic Transcription. In this Phase 2 Study, we Evaluated the Efficacy and Safety of Lurbinectedin in Patients with SCLC After Failure of Platinum-based Chemotherapy,” the Researchers Wrote.
The Trial included adult patients from 26 hospitals in the U.S. and six countries in Europe with a pathologically proven SCLC diagnosis. Eligibility criteria included Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease using the Response Criteria in Solid Tumors (RECIST) version 1.1, no brain metastasis, and adequate organ function. All patients were treated only with one prior line of chemotherapy at least three weeks prior to the start of the study. Every three weeks, patients received 3.2 mg/m2 lurbinectedin intravenously for one hour until disease progression or unacceptable toxicity. The main outcome was patients with an overall (complete or partial) response, which was evaluated by investigator assessment.
Final Analysis included 105 Lurbinectedin-treated patients who were followed for a median 17.1 months. Per investigator assessment, overall response was achieved by 37 patients (35.2%; 95% confidence interval [CI], 26.2% to 45.2%). Hematological abnormalities were the most commonly cited grade 3 to 4 adverse events (AEs), in particular Anemia (9%), Leucopenia (29%), neutropenia (46%), and Thrombocytopenia (7%). Eleven patients (10%) presented serious treatment-related AEs, primarily Neutropenia (5%) Febrile Neutropenia (5%). There were no Treatment-related Deaths.
Lurbinectedin Was Active as Second-Line Therapy for SCLC in Terms of Overall Response and Had an Acceptable and Manageable Safety Profile.
