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Journal Title: MO01.39 Liposomal Irinotecan in Adults with Small Cell Lung Cancer who Progressed on Platinum-Based Therapy: Subgroup Analyses by Platinum Sensitivity
2020 North America Conference on Lung Cancer. Virtual, Online.
Authors: Spigel, David R.
Paz-Ares, Luis G.
Chen, Yuanbin
Jove, Maria
Juan-Vidal, Oscar
Rich, Patricia
Hayes, Theresa
Calderon, Vanesa Gutierrez
Caro, Reyes Bernabe
Navarro, Alejandro
Dowlati, Afshin
Zhang, Bin
Moore, Yan
Wang, Tiffany
Nazarenko, Natalya
Kokhreidze, Jaba
Ponce, Santiago
Bunn, Paul
SWH Author: Hayes, Theresa M.
Keywords: Adult
Adverse Drug Reaction
Antineoplastic Activity
Cancer Patient
Cancer Resistance
Cancer Survival
Clinical Article
Clinical Trial
Conference Abstract
Controlled Study
Disease Assessment
Disease Control
Dose Calculation
Drug Safety
Drug Therapy
Follow Up
Middle Aged
Overall Response Rate
Overall Survival
Phase 2 Clinical Trial
Preliminary Data
Progression Free Survival
Randomized Controlled Trial
Response Evaluation Criteria in Solid Tumors
Side Effect
Small Cell Lung Cancer
Issue Date: 2021
Date Accessioned: 2023-04-12T02:09:45Z
Date Available: 2023-04-12T02:09:45Z
Format Startpage: S32
Source Volume: 16
Issue Number: 1 Supplement
Database: Embase
Date: 2021
Abstract: Background: Most patients with extensive small cell lung cancer (SCLC) develop drug resistance to platinum-based first-line therapy or discontinue for other reasons, and second-line therapies are limited. RESILIENT ( identifier NCT03088813) is a two-part phase 2/3 study assessing the safety, tolerability and efficacy of second-line liposomal irinotecan monotherapy in adults with SCLC who progressed with platinum-based first-line therapy. Preliminary data from RESILIENT part 1 (cut off May 8 2019; >= 12 weeks follow-up) showed that liposomal irinotecan 70 mg/m2 free 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 patients). 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 years, with an Eastern Cooperative Oncology Group performance status score of 0/1 and adequate organ function; a single line of prior immunotherapy was permitted. Participants received liposomal irinotecan 70 mg/m2 or 85 mg/m2 free base every 2 weeks, with disease assessments every 6 weeks (Response Evaluation Criteria in Solid Tumors v1.1). Analyses were undertaken for the dose-finding phase recommended dose in subgroups of platinum-resistant/platinum-sensitive patients (with/without disease progression within 90 days from completion of first-line therapy). Result(s): During dose finding, 5 patients received liposomal irinotecan 85 mg/m2 (deemed not tolerable owing to dose-limiting toxicity) and 12 received 70 mg/m2 (deemed tolerable; recommended dose for dose-expansion phase in which 13 additional patients were included). Analyses included all 25 patients receiving the recommended dose (mean exposure, 13.95 weeks [median 14.86; standard deviation 7.222]). In the platinum-sensitive subgroup (33.3% men; median age 62.0 years), ORR was 53.3% (8/15 patients) and 12-week disease control rate (DCR12wks) was 60% (9/15 patients); in the platinum-resistant subgroup (50.0% men, median age 58.0 years) both ORR and DCR12wks were 30% (3/10 patients). Overall survival 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 first-line therapy before receiving second-line liposomal irinotecan 70 mg/m2 in this phase 2 study. RESILIENT part 2, an ongoing, phase 3, randomized controlled trial versus topotecan, will provide further data.Copyright © 2020
Journal Title: Journal of Thoracic Oncology
Type: Conference Paper
Conference Name: 2020 North America Conference on Lung Cancer.
Conference Location: Virtual, Online.
Appears in Collections:SWH Staff Publications

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