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Journal Title: RESILIENT part I, an open-label, safety run-in of liposomal irinotecan in adults with small cell lung cancer (SCLC) who have progressed with platinum-based first-line (1L) therapy: Subgroup analyses by platinum sensitivity
2020 Annual Meeting of the American Society of Clinical Oncology, ASCO 2020. Chicago, IL United States.
Authors: Spigel, David R.
Paz-Ares, Luis G.
Chen, Yuanbin
Jove, Maria
Juan-Vidal, Oscar
Rich, Patricia
Hayes, Theresa M.
Calderon, Vanesa Gutierrez
Caro, Reyes Bernabe
Navarro, Alejandro
Dowlati, Afshin
Zhang, Bin
Moore, Yan
Wang, Haofei Tiffany
Kokhreidze, Jaba
Nazarenko, Natalya
Aix, Santiago Ponce
Bunn, Paul
SWH Author: Hayes, Theresa M.
Keywords: Adult
Antineoplastic Activity
Cancer Patient
Cancer Resistance
Cancer Survival
Clinical Article
Clinical Trial
Conference Abstract
Controlled Study
Disease Control
Dose Calculation
Drug Safety
Drug Therapy
Drug Tolerability
ECOG Performance Status
Follow Up
Middle Aged
Overall Response Rate
Phase 2 Clinical Trial
Preliminary Data
Progression Free Survival
Randomized Controlled Trial
Response Evaluation Criteria in Solid Tumors
Small Cell Lung Cancer
Issue Date: 2020
Date Accessioned: 2023-04-12T02:09:55Z
Date Available: 2023-04-12T02:09:55Z
Description Affiliation: arah Cannon Research Institute, Nashville, TN; Hospital Universitario 12 de Octubre, Madrid, Spain; Cancer and Hematology Centers of Western Michigan, Grand Rapids, MI; Institut Català d’Oncologia, Barcelona, Spain; Hospital Universitario y Politécnico La Fe, Valencia, Spain; Cancer Treatment Centers of America, Atalanta, GA; South West Healthcare, Warrnambool, VIC, Australia; Hospital Regional Universitario de Málaga, Málaga, Spain; Hospital Universitario Virgen Del Rocio, Seville, Spain; Hospital Universitari Vall d'Hebron, Barcelona, Spain; Case Western Reserve University, Cleveland, OH; Ipsen Bioscience, Boston, MA; Hospital Universitario 12 De Octubre, Madrid, Spain; University of Colorado, Denver, CO
Source Volume: 38
Issue Number: 15
Database: Embase
DOI: 10.1200/JCO.2020.38.15-suppl.9069
Date: 2020
Abstract: Background: Most patients with extensive SCLC develop drug resistance to platinum-based 1L therapy or discontinue for other reasons, and second-line (2L) therapies are limited. RESILIENT (NCT03088813) is a two-part phase 2/3 study assessing the safety, tolerability and efficacy of 2L liposomal irinotecan monotherapy in adults with SCLC who progressed with platinum-based 1L therapy. Preliminary data from RESILIENT part 1 (cut-off May 8 2019; >= 12 weeks follow-up) showed that liposomal irinotecan 70 mg/m2free base every 2 weeks was generally well tolerated and had encouraging antitumor activity (Paz-Ares et al. WCLC 2019 OA03.03). Objective response rate (ORR; secondary endpoint) was 44% (11/25). Here we report efficacy analyses in post hoc subgroups by platinum sensitivity. Method(s): RESILIENT part 1 was an open-label, single-arm study comprising dose-finding and dose-expansion phases. Eligible patients were aged >= 18 y, with an ECOG performance status score of 0/1 and adequate organ function; a single line of prior immunotherapy was allowed. Participants received liposomal irinotecan 70 mg/m2or 85 mg/m2free base every 2 weeks, with tumor assessments every 6 weeks (RECIST v1.1). Analyses were undertaken for the dose-finding phase recommended dose (RD) in subgroups of platinum-resistant/sensitive patients (with/without progression within 90 days from completion of 1L therapy). Result(s): During dose finding, 5 patients received liposomal irinotecan 85 mg/m2(deemed not tolerable; dose-limiting toxicity) and 12 received 70 mg/m2(deemed tolerable; RD for dose-expansion phase in which 13 more patients were included). Analyses included all 25 patients receiving the RD (mean exposure, 13.95 weeks [median 14.86; SD 7.222]). In the platinum-sensitive subgroup (33.3% men; median age 62.0 y) ORR was 53.3% (8/15) and 12-week disease control rate (DCR12wks) was 60% (9/15); in the platinum-resistant subgroup (50% men, median age 58.0 y) both ORR and DCR12wks were 30% (3/10). Overall and progression-free survival (secondary endpoints) are not yet mature. Conclusion(s): ORR and DCR12wks were numerically higher in platinum-sensitive than in platinum-resistant patients with SCLC who had progressed with platinum-based 1L therapy before receiving 2L liposomal irinotecan 70 mg/m2in this phase 2 study. RESILIENT part 2, an ongoing, phase 3, randomized controlled trial vs topotecan, will provide further data.
Journal Title: Journal of Clinical Oncology
Type: Conference Paper
Conference Name: 2020 Annual Meeting of the American Society of Clinical Oncology, ASCO 2020.
Conference Location: Chicago, IL United States.
Appears in Collections:SWH Staff Publications

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