Spigel, David RDavid RSpigelDowlati, AfshinAfshinDowlatiChen, YuanbinYuanbinChenNavarro, AlejandroAlejandroNavarroCHIH-HSIN YANGStojanovic, GoranGoranStojanovicJove, MariaMariaJoveRich, PatriciaPatriciaRichAndric, Zoran GZoran GAndricWu, Yi-LongYi-LongWuRudin, Charles MCharles MRudinChen, HuanyuHuanyuChenZhang, LiLiZhangYeung, StanleyStanleyYeungBenzaghou, FawziFawziBenzaghouPaz-Ares, LuisLuisPaz-AresBunn, Paul APaul ABunn2024-09-232024-09-232024-07-01https://scholars.lib.ntu.edu.tw/handle/123456789/721496The phase III RESILIENT trial compared second-line liposomal irinotecan with topotecan in patients with small cell lung cancer (SCLC).Patients with SCLC and progression on or after first-line platinum-based chemotherapy were randomly assigned (1:1) to intravenous (IV) liposomal irinotecan (70 mg/m every 2 weeks in a 6-week cycle) or IV topotecan (1.5 mg/m daily for 5 consecutive days, every 3 weeks in a 6-week cycle). The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS) and objective response rate (ORR).Among 461 randomly assigned patients, 229 received liposomal irinotecan and 232 received topotecan. The median follow-up was 18.4 months. The median OS was 7.9 months with liposomal irinotecan versus 8.3 months with topotecan (hazard ratio [HR], 1.11 [95% CI, 0.90 to 1.37]; = .31). The median PFS per blinded independent central review (BICR) was 4.0 months with liposomal irinotecan and 3.3 months with topotecan (HR, 0.96 [95% CI, 0.77 to 1.20]; nominal = .71); ORR per BICR was 44.1% (95% CI, 37.6 to 50.8) and 21.6% (16.4 to 27.4), respectively. Overall, 42.0% and 83.4% of patients receiving liposomal irinotecan and topotecan, respectively, experienced grade ≥3 related treatment-emergent adverse events (TEAEs). The most common grade ≥3 related TEAEs were diarrhea (13.7%), neutropenia (8.0%), and decreased neutrophil count (4.4%) with liposomal irinotecan and neutropenia (51.6%), anemia (30.9%), and leukopenia (29.1%) with topotecan.Liposomal irinotecan and topotecan demonstrated similar median OS and PFS in patients with relapsed SCLC. Although the primary end point of OS was not met, liposomal irinotecan demonstrated a higher ORR than topotecan. The safety profile of liposomal irinotecan was consistent with its known safety profile; no new safety concerns emerged.en[SDGs]SDG3journal article10.1200/JCO.23.0211038648575