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Journal Title: | OA03.03 Initial Efficacy and Safety Results of Irinotecan Liposome Injection (nal-IRI) in Patients with Small Cell Lung Cancer IASLC 2019 World Conference on Lung Cancer (WCLC). Barcelona Spain. |
Authors: | Paz-Ares Rodriguez, L. Spigel, David R. Chen, Yuanbin Jove, Maria Juan, O. Rich, Patricia Hayes, Theresa M. Calderon, Vanesa Gutierrez Bernabe, R. Navarro, Alejandro Dowlati, Afshin Zhang, Bin Moore, Yan Wang, Tiffany Nazarenko, Natalya Ponce, Santiago Bunn, Paul |
SWH Author: | Hayes, Theresa M. |
Keywords: | Adult Anaemia Antineoplastic Activity Cancer Patient Cancer Survival Clinical Controlled Study Diarrhoea Disease Control Dose Calculation Drug Safety Drug Therapy Febrile Neutropenia Follow Up Human Immunotherapy Male Middle Aged Monotherapy Overall Survival Pharmacokinetics Phase 2 Progression Free Survival Reperfusion Small Cell Lung Cancer Thrombocytopenia Irinotecan Sucrosofate Platinum Conference Abstract |
Issue Date: | 2019 |
Date Accessioned: | 2023-04-12T02:09:46Z |
Date Available: | 2023-04-12T02:09:46Z |
Url: | https://dx.doi.org/10.1016/j.jtho.2019.08.419 |
Description Affiliation: | Hospital Universitario, Madrid/ES Sarah Cannon Research Institute, Nashville, TN/US Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI/US Hospital Duran I Reinals, Institut Català D’Oncologia Hospital Duran I Reinals, Barcelona/ES Hospital Universitari I Politécnic La Fe, Valencia/ES Cancer Treatment Centers of America, Atlanta, AL/US South West Healthcare, Vic, ACT/AU Hospital Regional Universitario de Malaga, Malaga/ES Hospital Universitario Virgen Del Rocio, Seville/ES Hospital Universitari Vall D’Hebron, Barcelona/ES Case Western Reserve University, Cleveland, OH/US Ipsen Bioscience, Boston, MA/US Hospital Universitario 12 de Octubre, Madrid, Spain, Madrid/ES Cancer Center and Department of Medicine, University of Colorado, Denver, AL/US |
Format Startpage: | S211-S212 |
Source Volume: | 14 |
Issue Number: | 10 Supplement |
Database: | Embase |
DOI: | https://dx.doi.org/10.1016/j.jtho.2019.08.419 |
Date: | 2019 |
Abstract: | Background: SCLC accounts for ~15% of lung cancers, with 5-year survival <10%. 50-90% of patients with extensive disease respond to initial treatment; many rapidly relapse due to acquired resistance to front-line platinum-based chemotherapy. Limited treatment options are available for second-line patients. nal-IRI is a liposomal formulation of irinotecan (topoisomerase-1 inhibitor), utilizing intraliposomal stabilization technology to enable high drug load and in-vivo stability. Method(s): RESILIENT (NCT03088813) is a two-part Phase 2/3 study assessing the safety, tolerability, and efficacy of monotherapy nal-IRI in SCLC patients who progressed on/after a front-line platinum regimen: Part 1 includes dose-finding then dose-expansion. Key eligibility criteria included ECOG PS 0-1 and adequate organ function, with prior exposure to immunotherapy allowed. Eligible patients received nal-IRI 70mg/m2 or 85mg/m2 (free-base equivalent) q2w. Primary endpoints were safety and tolerability. Efficacy assessments included objective response rate (ORR), best overall response (BOR), progression-free survival (PFS), and overall survival (OS). Result(s): 30 patients were treated for >=12 weeks in Part 1 (male, 43%; median age, 60.4y; platinum-resistant, 40%) with tumor assessments q6w. During dose-finding, 5 patients received nal-IRI 85mg/m2 (deemed not tolerable: dose-limiting toxicity) and 12 patients received nal-IRI 70mg/m2 (deemed tolerable: selected for dose expansion). At data cut-off** (median follow-up, 4.4mo), 25 patients had received nal-IRI 70mg/m2. Diarrhea was the most common gastrointestinal adverse events (AEs) (Gr3, 20%). Hematologic AEs included neutropenia (Gr3, 8%; Gr4, 8%), anemia (Gr3, 8%), febrile neutropenia (Gr3, 4%), thrombocytopenia (Gr3, 4%; Gr4, 4%). Preliminary efficacy identified 11 patients with partial responses (ORR 44%), BOR (PR+SD) of 72%, and 12-week disease control rate (DCR12wks PR+SD) of 48%. PFS and OS are not yet mature. Conclusion(s): Part 1 demonstrated encouraging anti-tumor activity for nal-IRI 70mg/m2 in patients with SCLC (ORR: 44%, BOR: 72%). nal-IRI 70mg/m2 was generally well tolerated. Future research is warranted to assess nal-IRI in second-line SCLC. [Figure presented] Keywords: Irinotecan Liposome Injection, Monotherapy, small cell lung cancerCopyright © 2019 |
URI: | https://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3737 |
Journal Title: | Journal of Thoracic Oncology |
Type: | Conference Paper |
Conference Name: | IASLC 2019 World Conference on Lung Cancer (WCLC). |
Conference Location: | Barcelona Spain. |
Appears in Collections: | SWH Staff Publications |
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