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DC Field | Value | Language |
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dc.contributor.author | Spigel, David R. | - |
dc.contributor.author | Paz-Ares, Luis | - |
dc.contributor.author | Moore, Yan | - |
dc.contributor.author | Zhang, Bin | - |
dc.contributor.author | Dowlati, Afshin | - |
dc.contributor.author | Navarro, Alejandro | - |
dc.contributor.author | Caro, Reyes Bernabe | - |
dc.contributor.author | Calderon, Vanesa Gutierrez | - |
dc.contributor.author | Hayes, Theresa M. | - |
dc.contributor.author | Rich, Patricia | - |
dc.contributor.author | Juan-Vidal, Oscar | - |
dc.contributor.author | Jove, Maria | - |
dc.contributor.author | Chen, Yuanbin | - |
dc.contributor.author | Bunn, Paul A. | - |
dc.contributor.author | Ponce, Santiago | - |
dc.contributor.author | Kokhreidze, Jaba | - |
dc.contributor.author | Yao, Xiaopan | - |
dc.date.accessioned | 2023-03-17T04:57:10Z | - |
dc.date.available | 2023-03-17T04:57:10Z | - |
dc.date.issued | 2022-05 | - |
dc.identifier.uri | https://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3481 | - |
dc.description.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. | - |
dc.relation.isversionof | 20220223 | - |
dc.subject | Liposomal Irinotecan | - |
dc.subject | Chemotherapy | - |
dc.subject | Small Cell Lung Cancer | - |
dc.subject | Platinum-resistant Disease | - |
dc.subject | Subsequent Therapy | - |
dc.subject | Aged | - |
dc.subject | Disease Progression | - |
dc.subject | Diarrhoea | - |
dc.subject | Irinotecan | - |
dc.subject | Human | - |
dc.subject | Lung Neoplasms | - |
dc.subject | Liposomes | - |
dc.subject | Neutropenia | - |
dc.subject | Middle Aged | - |
dc.subject | Small Cell Lung Carcinoma | - |
dc.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 | - |
dc.type | Journal Article | - |
dc.identifier.journaltitle | Cancer | - |
dc.accession.number | 35195913 | - |
dc.identifier.url | https://www.ncbi.nlm.nih.gov/pubmed/35195913 | - |
dc.description.affiliation | Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee. | - |
dc.description.affiliation | Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit & Universidad Complutense, Madrid, Spain. | - |
dc.description.affiliation | Institut Catala d'Oncologia, Hospital Duran i Reinals, Barcelona, Spain. | - |
dc.description.affiliation | Cancer & Hematology Centers of Western Michigan, Grand Rapids, Missouri. | - |
dc.description.affiliation | Hospital Universitari Vall d'Hebron, Barcelona, Spain. | - |
dc.description.affiliation | Hospital Universitario Virgen del Rocio, Seville, Spain. | - |
dc.description.affiliation | Cancer Treatment Centers of America, Atlanta, Georgia. | - |
dc.description.affiliation | Hospital Universitari i Politecnic La Fe, Valencia, Spain. | - |
dc.description.affiliation | Hospital Regional Universitario de Malaga, Malaga, Spain. | - |
dc.description.affiliation | South West Healthcare, Warrnambool, Victoria, Australia. | - |
dc.description.affiliation | University of Colorado Cancer Center, Aurora, Colorado. | - |
dc.description.affiliation | Ipsen Biopharmaceuticals Inc, Cambridge, Massachusetts. | - |
dc.description.affiliation | Case Western Reserve University, Cleveland, Ohio. | - |
dc.format.startpage | 1801-1811 | - |
dc.source.volume | 128 | - |
local.issue.number | 9 | - |
dc.identifier.database | Medline | - |
dc.identifier.notes | eng | - |
dc.identifier.notes | Clinical Trial, Phase II | - |
dc.identifier.notes | Research Support, Non-U.S. Gov't | - |
dc.identifier.notes | 2022/02/24 | - |
dc.identifier.notes | Cancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23. | - |
dc.identifier.importdoi | 10.1002/cncr.34123 | - |
dc.identifier.date | NLM | - |
dc.identifier.date | May 1 | - |
dc.contributor.swhauthor | Hayes, Theresa M. | - |
Appears in Collections: | SWH Staff Publications |
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