Everolimus for the treatment of advanced gastrointestinal or lung nonfunctional neuroendocrine tumors in East Asian patients: a subgroup analysis of the RADIANT-4 study
单位:[1]Department of Gastrointestinal MedicalOncology, University of Texas MD Anderson Cancer Center, Houston,TX, USA[2]Department of MedicalOncology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea[3]Department of Gastroenterology, PekingUnion Medical College Hospital, Beijing,China[4]Department of Hematology and Oncology, Samsung Medical Center,Seoul, South Korea[5]Novartis Oncology,Novartis Pharma AG , Basel, Switzerland[6]Novartis Oncology, Novartis Pharma S.A.S,Rueil-Malmaison, Paris, France[7]Departmentof Gastroenterology, Kyushu UniversityHospital, Fukuoka, Japan[8]Department of Medical Oncology, China-Japan Friendship Hospital, Beijing, China[9]Department of Surgery, Kansai Electric Power Hospital,Osaka, Japan[10]Department of MedicalOncology, Chulalongkorn University and King Chulalongkorn Memorial Hospital,Bangkok, Thailand中山大学附属第二医院[11]Department of Gastrointestinal Medical Oncology,National Cancer Center Hospital, Tsukiji,Chuo-ku, Tokyo, Japan
Background: In RADIANT-4, everolimus showed an improvement of 7.1 months in median progression-free survival (PFS) vs placebo among patients with advanced, well-differentiated, nonfunctional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin. The present analysis focuses on the effect of everolimus on the East Asian-subgroup population of the RADIANT-4 study. Methods: Patients were randomized to receive everolimus 10 mg/day or matching placebo. The primary end point was PFS (central review). Secondary end points were overall response rate, safety, and tolerability. Results: Among 302 patients enrolled in RADIANT-4, 46 were included in the East Asian subgroup (everolimus, n=28; placebo, n=18) analysis. Everolimus was associated with an 82% reduction in the relative risk of disease progression or death (HR 0.18, 95% CI 0.09- 0.38). The median PFS (central review) in this subgroup was 11.2 months with everolimus vs 3.1 months with placebo. Adverse events (AEs) occurred in all 28 patients treated with everolimus and ten patients receiving placebo. The majority of these AEs were grade 1 or 2. Most commonly reported ( >= 30% of incidence) drug-related AEs of any grade included stomatitis (75%, n=21) and rash (43%, n=12) in the everolimus arm. Conclusion: Everolimus demonstrated a clinically meaningful PFS benefit in the East Asian population. The safety findings were consistent with the known safety profile of everolimus. These results support the use of everolimus in the East Asian population with advanced, nonfunctional NETs of GI or lung origin.
第一作者单位:[1]Department of Gastrointestinal MedicalOncology, University of Texas MD Anderson Cancer Center, Houston,TX, USA[*1]Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
通讯作者:
通讯机构:[1]Department of Gastrointestinal MedicalOncology, University of Texas MD Anderson Cancer Center, Houston,TX, USA[*1]Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
推荐引用方式(GB/T 7714):
Yao James C.,Oh Do-Youn,Qian Jiaming,et al.Everolimus for the treatment of advanced gastrointestinal or lung nonfunctional neuroendocrine tumors in East Asian patients: a subgroup analysis of the RADIANT-4 study[J].ONCOTARGETS and THERAPY.2019,12:1717-1728.doi:10.2147/OTT.S182259.
APA:
Yao, James C.,Oh, Do-Youn,Qian, Jiaming,Park, Young Suk,Herbst, Fabian...&Shimada, Yasuhiro.(2019).Everolimus for the treatment of advanced gastrointestinal or lung nonfunctional neuroendocrine tumors in East Asian patients: a subgroup analysis of the RADIANT-4 study.ONCOTARGETS and THERAPY,12,
MLA:
Yao, James C.,et al."Everolimus for the treatment of advanced gastrointestinal or lung nonfunctional neuroendocrine tumors in East Asian patients: a subgroup analysis of the RADIANT-4 study".ONCOTARGETS and THERAPY 12.(2019):1717-1728