| Autor: |
Jimeno A; University of Colorado Cancer Center, Aurora, CO, USA., Sharma MR; The University of Chicago, Chicago, IL, USA., Szyldergemajn S; Pharma Mar, S.A., Colmenar Viejo, Madrid, Spain., Gore L; University of Colorado Cancer Center, Aurora, CO, USA., Geary D; The University of Chicago, Chicago, IL, USA., Diamond JR; University of Colorado Cancer Center, Aurora, CO, USA., Fernandez Teruel C; Pharma Mar, S.A., Colmenar Viejo, Madrid, Spain., Soto Matos-Pita A; Pharma Mar, S.A., Colmenar Viejo, Madrid, Spain., Iglesias JL; Pharma Mar, S.A., Colmenar Viejo, Madrid, Spain., Cullell-Young M; Pharma Mar, S.A., Colmenar Viejo, Madrid, Spain., Ratain MJ; The University of Chicago, Chicago, IL, USA. mratain@medicine.bsd.uchicago.edu. |
| Abstrakt: |
Background Lurbinectedin administered as a 1-h intravenous infusion every 3 weeks induces neutropenia, with the nadir usually occurring during the second week. This phase I study evaluated an alternative lurbinectedin dosing schedule consisting of a 1-h infusion on days 1 and 8 every 3 weeks. Patients and methods Twenty-one patients with advanced cancer received lurbinectedin using a standard cohort dose escalation design. Results Three dose levels of 3, 4, and 5 mg of lurbinectedin were explored. The recommended phase II dose was 5 mg, with 3 of 13 patients having dose-limiting toxicity (DLT), although grade 4 neutropenia occurred in 50% of patients. Other frequent toxicities were mild to moderate nausea and vomiting, fatigue, decreased appetite, stomatitis and asymptomatic creatinine and transaminase increases. No objective responses occurred, but prolonged stable disease was observed in 7 patients, including 3 with soft tissue sarcoma. Conclusion The recommended phase II dose of lurbinectedin is 5 mg, administered as a 1-h infusion on days 1 and 8 every 3 weeks. These data support further testing of this dose and schedule, particularly in soft tissue sarcoma. |
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