Journal article
Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial.
- Paz-Ares, Luis G. Hospital Universitario 12 de Octubre, CiberOnc, Universidad Complutense and CNIO, Madrid, Spain;
- Trigo Perez, Jose Manuel Hospital Virgen de la Victoria, Málaga, Spain;
- Besse, Benjamin Paris-Sud University, Orsay and Gustave Roussy, Villejuif, France;
- Moreno, Victor START Madrid-FJD, Madrid, Spain;
- Lopez, Rafael University Clinical Hospital and Health Research Institute (IDIS), CIBERONC, Santiago de Compostela University School of Medicine, Santiago De Compostela, Spain;
- Sala, Maria Angeles Hospital Universitario de Basurto, Bilbao, Spain;
- Ponce Aix, Santiago Hospital 12 de Octubre, Madrid, Spain;
- Fernandez, Cristian Marcelo PharmaMar, Colmenar Viejo - Madrid, Spain;
- Siguero, Mariano PharmaMar, Madrid, Spain;
- Kahatt, Carmen Maria PharmaMar, Madrid, Spain;
- Zeaiter, Ali Hassan PharmaMar, Madrid, Spain;
- Zaman, Khalil Breast Center, University Hospital CHUV, Lausanne, Switzerland;
- Boni, Valentina START Madrid-Centro, Madrid, Spain;
- Arrondeau, Jennifer Department of Medical Oncology, Cochin Hospital, Paris Descartes University, AP-HP, CARPEM, Immunomodulatory Therapies Multidisciplinary Study group (CERTIM), Paris, France;
- Martinez Aguillo, Maite Medical Oncology Department, Hospital de Navarra, Irunarrea, Pamplona, Spain;
- Delord, Jean-Pierre Institut Claudius Regaud IUCT-Oncopole, Toulouse, France;
- Awada, Ahmad Institut Jules Bordet, Brussels, Belgium;
- Kristeleit, Rebecca Sophie University College London Hospitals, London, United Kingdom;
- Olmedo Garcia, Maria Eugenia Department of Medical Oncology, Ramon y Cajal University Hospital, Madrid, Spain;
- Subbiah, Vivek The University of Texas MD Anderson Cancer Center, Houston, TX;
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2019, vol. 37, no. 15_suppl, p. 8506-8506
English
8506 Background: Lurbinectedin (L) is a novel anticancer drug that inhibits activated transcription and induces DNA double-strand breaks, leading to apoptosis. Methods: A multicenter phase 2 basket trial assessed the efficacy and safety of L in several cancer types, including small cell lung cancer (SCLC). Primary endpoint was confirmed overall response rate (ORR) by RECIST v.1.1. In the SCLC cohort, a target ORR ≥30% was set. One-hundred and five patients (pts) with ECOG PS 0-2 who had received one prior chemotherapy line were treated with L 3.2 mg/m2 as a 1-hour i.v. infusion on Day 1 q3wk. Results: Median age was 60 years (range, 40-83), 60% were male, ECOG PS 0/1/2 (32%/62%/6%), liver metastasis 41%, history of CNS involvement 3.8%, prior platinum 100%, median chemotherapy-free interval (CTFI): 3.5 (0-16.1) months; prior immunotherapy (IO): 7.6%. Pts received a median of 4 cycles (range, 1-24). Conclusions: L monotherapy is active in second-line SCLC in both resistant and sensitive disease. The acceptable and manageable safety profile is also associated to a convenient treatment administration (Day 1 q3wk). L as second-line treatment in SCLC emerges as a new promising drug for this unmet clinical need. Clinical trial information: NCT02454972. [Table: see text]
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2019.37.15_suppl.8506
- ISSN 0732-183X
- Persistent URL
- https://sonar.ch/global/documents/161656
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