RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer.

Autor:	Spigel DR; Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN., Dowlati A; University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, OH., Chen Y; Cancer and Hematology Centers of Western Michigan, Grand Rapids, MI., Navarro A; Hospital Universitario Vall d'Hebron and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain., Yang JC; National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan., Stojanovic G; Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia., Jove M; Institut Català d'Oncologia Hospital Duran i Reynals, Barcelona, Spain., Rich P; Southeastern Regional Medical Center, Newnan, GA., Andric ZG; University Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia., Wu YL; Guangdong Lung Cancer Institute, Guangzhou, China., Rudin CM; Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, NY., Chen H; Ipsen, Cambridge, MA., Zhang L; Ipsen, Cambridge, MA., Yeung S; Ipsen, Cambridge, MA., Benzaghou F; Ipsen, Cambridge, MA., Paz-Ares L; Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain., Bunn PA; University of Colorado School of Medicine, Aurora, CO.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Jul 01; Vol. 42 (19), pp. 2317-2326. Date of Electronic Publication: 2024 Apr 22.
DOI:	10.1200/JCO.23.02110
Abstrakt:	Purpose: The phase III RESILIENT trial compared second-line liposomal irinotecan with topotecan in patients with small cell lung cancer (SCLC). Patients and Methods: 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 2 every 2 weeks in a 6-week cycle) or IV topotecan (1.5 mg/m 2 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). Results: 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]; P = .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 P = .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. Conclusion: 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.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu