Please use this identifier to cite or link to this item: https://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3481
Journal Title: RESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer
Authors: Spigel, David R.
Paz-Ares, Luis
Moore, Yan
Zhang, Bin
Dowlati, Afshin
Navarro, Alejandro
Caro, Reyes Bernabe
Calderon, Vanesa Gutierrez
Hayes, Theresa M.
Rich, Patricia
Juan-Vidal, Oscar
Jove, Maria
Chen, Yuanbin
Bunn, Paul A.
Ponce, Santiago
Kokhreidze, Jaba
Yao, Xiaopan
SWH Author: Hayes, Theresa M.
Keywords: Liposomal Irinotecan
Chemotherapy
Small Cell Lung Cancer
Platinum-resistant Disease
Subsequent Therapy
Aged
Disease Progression
Diarrhoea
Irinotecan
Human
Lung Neoplasms
Liposomes
Neutropenia
Middle Aged
Small Cell Lung Carcinoma
Issue Date: May-2022
Date Accessioned: 2023-03-17T04:57:10Z
Date Available: 2023-03-17T04:57:10Z
Accession Number: 35195913
Url: https://www.ncbi.nlm.nih.gov/pubmed/35195913
Description Affiliation: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.
Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit & Universidad Complutense, Madrid, Spain.
Institut Catala d'Oncologia, Hospital Duran i Reinals, Barcelona, Spain.
Cancer & Hematology Centers of Western Michigan, Grand Rapids, Missouri.
Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Hospital Universitario Virgen del Rocio, Seville, Spain.
Cancer Treatment Centers of America, Atlanta, Georgia.
Hospital Universitari i Politecnic La Fe, Valencia, Spain.
Hospital Regional Universitario de Malaga, Malaga, Spain.
South West Healthcare, Warrnambool, Victoria, Australia.
University of Colorado Cancer Center, Aurora, Colorado.
Ipsen Biopharmaceuticals Inc, Cambridge, Massachusetts.
Case Western Reserve University, Cleveland, Ohio.
Format Startpage: 1801-1811
Source Volume: 128
Issue Number: 9
Database: Medline
Notes: eng
Clinical Trial, Phase II
Research Support, Non-U.S. Gov't
2022/02/24
Cancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23.
DOI: 10.1002/cncr.34123
Date: NLM
May 1
Abstract: BACKGROUND: RESILIENT (NCT03088813) is a phase 2/3 study assessing the safety, tolerability, and efficacy of liposomal irinotecan monotherapy in patients with small cell lung cancer and disease progression on/after first-line platinum-based therapy. Here, we present results from RESILIENT part 1. METHODS: This open-label, single-arm, safety run-in evaluation with dose-exploration and dose-expansion phases included patients >/=18 years old with Eastern Cooperative Oncology Group performance status of 0/1; those with asymptomatic central nervous system metastases were eligible. The primary objectives were to evaluate safety and tolerability and recommend a dose for further development. Efficacy end points were objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). RESULTS: During dose exploration, 5 patients received intravenous liposomal irinotecan at 85 mg/m(2) (deemed not tolerable; dose-limiting toxicity) and 12 patients received 70 mg/m(2) (deemed tolerable). During dose expansion, 13 additional patients received intravenous liposomal irinotecan at 70 mg/m(2) . Of these 25 patients (median age [range], 59.0 [48.0-73.0] years, 92.0% with metastatic disease), 10 experienced grade >/=3 treatment-related treatment-emergent adverse events (TEAEs), most commonly diarrhea (20.0%) and neutropenia (16.0%), and 3 had serious treatment-related TEAEs, of whom 2 died. ORR was 44.0% (95% confidence interval [CI]: 24.40-65.07; 1 complete response, 10 partial responses) and median (95% CI) PFS and OS were 3.98 (1.45-4.24) months and 8.08 (5.16-9.82) months, respectively. CONCLUSION: Overall, no new safety signals were identified with liposomal irinotecan, and antitumor activity was promising. RESILIENT part 2, a randomized, controlled, phase 3 study of liposomal irinotecan versus topotecan, is ongoing. LAY SUMMARY: Small cell lung cancer (SCLC) is an aggressive disease with few treatment options after platinum-based therapy. Administering 1 option, irinotecan, as a "liposomal" formulation, may extend drug exposure and improve outcomes. The RESILIENT part 1 trial assessed the safety and efficacy of liposomal irinotecan in 25 adults with SCLC after disease progression despite platinum-based therapy. No new safety concerns were reported. The most common moderate-to-severe side effects were diarrhea (20% of patients) and neutropenia (16%). Tumors responded to treatment in 44% of patients. Average survival was 8.08 months, and time to disease progression was 3.98 months. Liposomal irinotecan trials are ongoing.
URI: https://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3481
Journal Title: Cancer
Type: Journal Article
Appears in Collections:SWH Staff Publications

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