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• W4385296543 abstract "Background Lurbinectedin was approved by FDA and other Health Regulatory Agencies for treating adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Safety profile at approved dose (3.2 mg/m2 every three weeks) was acceptable and manageable in 105 adult SCLC patients from a phase II basket trial. This study analyzes safety data from several solid tumors treated at the lurbinectedin approved dose. Methods Data were pooled from 554 patients: 335 from all nine tumor-specific cohorts of the phase II basket trial, and 219 from a randomized phase III trial (CORAIL) in platinum-resistant ovarian cancer. Events and laboratory abnormalities were graded using NCI-CTCAE v.4. Results Most common tumors were ovarian (n=219, 40%), SCLC (n=105, 19%) and endometrial (n=73, 13%). Transient hematological laboratory abnormalities were the most frequent grade ≥3 events: neutropenia (41%), leukopenia (30%), anemia (17%) and thrombocytopenia (10%). Most common treatment-emergent non-hematological events (any grade) were transient transaminase increases (alanine aminotransferase [66%], aspartate aminotransferase [53%]), fatigue (63%), nausea (57%), constipation (32%), vomiting (30%), and decreased appetite (25%). Dose reductions were mostly due to hematological toxicities, but most patients (79%) remained on full lurbinectedin dose. Serious events mostly consisted of hematological disorders. Eighteen treatment discontinuations (3%) and seven deaths (1%) were due to treatment-related events. Conclusions This analysis confirms a manageable safety profile for lurbinectedin in patients with advanced solid tumors. Findings are consistent with those reported in patients with relapsed SCLC, Ewing sarcoma, germline BRCA1/2 metastatic breast cancer, neuroendocrine tumors, and ovarian cancer. Trial code ClinicalTrials.gov identifier: NCT02454972 and NCT02421588." @default.
• W4385296543 created "2023-07-28" @default.
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• W4385296543 date "2023-10-01" @default.
• W4385296543 modified "2023-10-17" @default.
• W4385296543 title "Pooled Safety Analysis of Single-agent Lurbinectedin in Patients with Advanced Solid Tumors" @default.
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• W4385296543 doi "https://doi.org/10.1016/j.ejca.2023.113259" @default.
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