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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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