Please use this identifier to cite or link to this item: https://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3481
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dc.contributor.authorSpigel, David R.-
dc.contributor.authorPaz-Ares, Luis-
dc.contributor.authorMoore, Yan-
dc.contributor.authorZhang, Bin-
dc.contributor.authorDowlati, Afshin-
dc.contributor.authorNavarro, Alejandro-
dc.contributor.authorCaro, Reyes Bernabe-
dc.contributor.authorCalderon, Vanesa Gutierrez-
dc.contributor.authorHayes, Theresa M.-
dc.contributor.authorRich, Patricia-
dc.contributor.authorJuan-Vidal, Oscar-
dc.contributor.authorJove, Maria-
dc.contributor.authorChen, Yuanbin-
dc.contributor.authorBunn, Paul A.-
dc.contributor.authorPonce, Santiago-
dc.contributor.authorKokhreidze, Jaba-
dc.contributor.authorYao, Xiaopan-
dc.date.accessioned2023-03-17T04:57:10Z-
dc.date.available2023-03-17T04:57:10Z-
dc.date.issued2022-05-
dc.identifier.urihttps://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3481-
dc.description.abstractBACKGROUND: 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.isversionof20220223-
dc.subjectLiposomal Irinotecan-
dc.subjectChemotherapy-
dc.subjectSmall Cell Lung Cancer-
dc.subjectPlatinum-resistant Disease-
dc.subjectSubsequent Therapy-
dc.subjectAged-
dc.subjectDisease Progression-
dc.subjectDiarrhoea-
dc.subjectIrinotecan-
dc.subjectHuman-
dc.subjectLung Neoplasms-
dc.subjectLiposomes-
dc.subjectNeutropenia-
dc.subjectMiddle Aged-
dc.subjectSmall Cell Lung Carcinoma-
dc.titleRESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer-
dc.typeJournal Article-
dc.identifier.journaltitleCancer-
dc.accession.number35195913-
dc.identifier.urlhttps://www.ncbi.nlm.nih.gov/pubmed/35195913-
dc.description.affiliationSarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.-
dc.description.affiliationHospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit & Universidad Complutense, Madrid, Spain.-
dc.description.affiliationInstitut Catala d'Oncologia, Hospital Duran i Reinals, Barcelona, Spain.-
dc.description.affiliationCancer & Hematology Centers of Western Michigan, Grand Rapids, Missouri.-
dc.description.affiliationHospital Universitari Vall d'Hebron, Barcelona, Spain.-
dc.description.affiliationHospital Universitario Virgen del Rocio, Seville, Spain.-
dc.description.affiliationCancer Treatment Centers of America, Atlanta, Georgia.-
dc.description.affiliationHospital Universitari i Politecnic La Fe, Valencia, Spain.-
dc.description.affiliationHospital Regional Universitario de Malaga, Malaga, Spain.-
dc.description.affiliationSouth West Healthcare, Warrnambool, Victoria, Australia.-
dc.description.affiliationUniversity of Colorado Cancer Center, Aurora, Colorado.-
dc.description.affiliationIpsen Biopharmaceuticals Inc, Cambridge, Massachusetts.-
dc.description.affiliationCase Western Reserve University, Cleveland, Ohio.-
dc.format.startpage1801-1811-
dc.source.volume128-
local.issue.number9-
dc.identifier.databaseMedline-
dc.identifier.noteseng-
dc.identifier.notesClinical Trial, Phase II-
dc.identifier.notesResearch Support, Non-U.S. Gov't-
dc.identifier.notes2022/02/24-
dc.identifier.notesCancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23.-
dc.identifier.importdoi10.1002/cncr.34123-
dc.identifier.dateNLM-
dc.identifier.dateMay 1-
dc.contributor.swhauthorHayes, Theresa M.-
Appears in Collections:SWH Staff Publications

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