{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T21:07:57Z","timestamp":1774127277219,"version":"3.50.1"},"reference-count":43,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T00:00:00Z","timestamp":1645574400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013733","name":"Ipsen Biopharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013733","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>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\u2010line platinum\u2010based therapy. Here, we present results from RESILIENT part 1.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This open\u2010label, single\u2010arm, safety run\u2010in evaluation with dose\u2010exploration and dose\u2010expansion phases included patients \u226518\u00a0years 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\u2010free survival (PFS), and overall survival (OS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During dose exploration, 5 patients received intravenous liposomal irinotecan at 85\u00a0mg\/m<jats:sup>2<\/jats:sup> (deemed not tolerable; dose\u2010limiting toxicity) and 12 patients received 70\u00a0mg\/m<jats:sup>2<\/jats:sup> (deemed tolerable). During dose expansion, 13 additional patients received intravenous liposomal irinotecan at 70\u00a0mg\/m<jats:sup>2<\/jats:sup>. Of these 25 patients (median age [range], 59.0 [48.0\u201073.0] years, 92.0% with metastatic disease), 10 experienced grade \u22653 treatment\u2010related treatment\u2010emergent adverse events (TEAEs), most commonly diarrhea (20.0%) and neutropenia (16.0%), and 3 had serious treatment\u2010related TEAEs, of whom 2 died. ORR was 44.0% (95% confidence interval [CI]: 24.40\u201065.07; 1 complete response, 10 partial responses) and median (95% CI) PFS and OS were 3.98 (1.45\u20104.24) months and 8.08 (5.16\u20109.82) months, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Lay Summary<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n\n<jats:list-item><jats:p>Small cell lung cancer (SCLC) is an aggressive disease with few treatment options after platinum\u2010based therapy.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Administering 1 option, irinotecan, as a \u201cliposomal\u201d formulation, may extend drug exposure and improve outcomes.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>The RESILIENT part 1 trial assessed the safety and efficacy of liposomal irinotecan in 25 adults with SCLC after disease progression despite platinum\u2010based therapy.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>No new safety concerns were reported.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>The most common moderate\u2010to\u2010severe side effects were diarrhea (20% of patients) and neutropenia (16%).<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Tumors responded to treatment in 44% of patients.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Average survival was 8.08 months, and time to disease progression was 3.98 months.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Liposomal irinotecan trials are ongoing.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.34123","type":"journal-article","created":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T10:33:44Z","timestamp":1645612424000},"page":"1801-1811","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["RESILIENT part 1: a phase 2 dose\u2010exploration and dose\u2010expansion study of second\u2010line liposomal irinotecan in adults with small cell lung cancer"],"prefix":"10.1002","volume":"128","author":[{"given":"Luis","family":"Paz\u2010Ares","sequence":"first","affiliation":[{"name":"Hospital Universitario 12 de Octubre, H12O\u2010CNIO Lung Cancer Clinical Research Unit &amp; 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