Please use this identifier to cite or link to this item:
Journal Title: P48.14 RESILIENT Part 2: A phase 3 Study of Liposomal Irinotecan in Patients with Small-Cell Lung Cancer in the Second-Line Setting
2020 World Conference on Lung Cancer. Singapore Singapore.
Authors: Paz-Ares, Luis
Spigel, David R.
Chen, Yuanbin
Jove, Maria
Juan-Vidal, Oscar
Rich, Patricia
Hayes, Theresa
Calderon, Vanesa Gutierrez
Caro, Reyes Bernabe
Mendivil, A. N.
Dowlati, Afshin
Zhang, Bin
Moore, Yan
Wang, Tiffany
Kokhreidze, Jaba
Ponce, Santiago
Bunn, Paul
SWH Author: Hayes, Theresa M.
Keywords: Adult
Antineoplastic Activity
Cancer Patient
Cancer Survival
Central Nervous System
Clinical Trial
Comparative Effectiveness
Conference Abstract
Controlled Study
Drug Efficacy
Drug Formulation
Drug Safety
Drug Therapy
Drug Withdrawal
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Follow Up
Lipid Bilayer
Major Clinical Study
Open Study
Overall Survival
Phase 2 Clinical Trial
Phase 3 Clinical Trial
Preliminary Data
Progression Free Survival
Randomized Controlled Trial
Response Evaluation Criteria in Solid Tumors
Risk Assessment
Sample Size
Small Cell Lung Cancer
DNA Topoisomerase
Endogenous Compound
Issue Date: 2021
Date Accessioned: 2023-04-12T02:09:47Z
Date Available: 2023-04-12T02:09:47Z
Format Startpage: S505
Source Volume: 16
Issue Number: 3 Supplement
Database: Embase
Date: 2021
Abstract: Introduction: Small cell lung cancer (SCLC) accounts for approximately 15% of lung cancers. SCLC is usually sensitive to established first-line therapies, but many patients relapse and develop resistance to platinum-based first-line treatment. Currently, the topoisomerase 1 inhibitor topotecan is the only approved second-line therapy for SCLC in the USA and Europe. Liposomal irinotecan is an intravenous formulation that encapsulates the topoisomerase 1 inhibitor irinotecan in a lipid-bilayer vesicle, leading to prolonged circulation. The safety, tolerability and efficacy of liposomal irinotecan monotherapy in patients with SCLC who progressed with platinum-based first-line therapy is being evaluated in RESILIENT (NCT03088813), a two-part phase 2/3 study. Preliminary data from the dose-ranging part of the study (part 1) indicated that liposomal irinotecan 70 mg/m2 (free base equivalent) administered every 2 weeks was well tolerated and had promising antitumour activity.1 Here, we present the design of RESILIENT part 2, which will assess the efficacy and safety of liposomal irinotecan versus topotecan in the same patient population. References: Paz-Ares L et al. Poster presented at the 2019 American Society of Clinical Oncology conference, May 31-June 4, 2019, Chicago, IL, USA. Method(s): RESILIENT part 2 is a phase 3, open-label study with a planned sample size of 450. Participants are randomized 1:1 to intravenous liposomal irinotecan or intravenous topotecan. Liposomal irinotecan is administered at 70 mg/m2 every 2 weeks and topotecan is administered at 1.5 mg/m2 for 5 consecutive days every 3 weeks. A total of 254 patients have been randomized and received treatment to date (as of August 8, 2020). Tumour assessments are performed using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Response Assessment in Neuro-oncology criteria for CNS lesions. Improvements in symptoms are measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13. Safety assessments include monitoring for adverse events. Overall survival is the primary endpoint of the study. Progression-free survival, objective response rate and proportion of patients reporting symptom improvement are secondary endpoints. Participants will continue study treatment until disease progression, unacceptable toxicity or study withdrawal. Participants will be followed for survival until death or study end, which is when all patients have died, withdrawn consent or are lost to follow-up. Result(s): Conclusion Keywords: liposomal irinotecan, small-cell lung cancer, RESILIENTCopyright © 2021
Journal Title: Journal of Thoracic Oncology
Type: Conference Paper
Conference Name: 2020 World Conference on Lung Cancer.
Conference Location: Singapore.
Appears in Collections:SWH Staff Publications

Files in This Item:
There are no files associated with this item.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Google Media

Google ScholarTM

Who's citing