Yihebali Chi1, Guangqian Ji2,3, Jing Zhang4, Haijian Tang2,3, Yang Yang2,3, Wei Liu2,3, Nan Wang2,3, Chunhui Gao2,3, Yongkun Sun2, Jinwan Wang2. 1. Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. yihebalichi@hotmail.com. 2. Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. 3. Department of Medical Oncology, Sanhuan Cancer Hospital, Chaoyang District, Beijing, China. 4. Department of Medical Oncology, The First Affiliated Hospital of Hebei North University, Zhangjiakou, 075000, China.
Abstract
BACKGROUND: For advanced tumors that lack specific oncogenic alteration and are resistant to chemotherapy, anti-angiogenesis therapy or immunotherapy or a combination of the two are the most important treatments. Anlotinib is a newly developed oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis. This was an open-label, single-arm, phase 2 study to validate the efficacy and safety of anlotinib in patients with various cancer types. METHODS: Patients with advanced malignancy who have failed previous therapies or lack effective treatment choices received daily oral administration of 12 mg anlotinib on days 1-14 every 3 weeks until disease progression, intolerable toxicity or physician decision. The primary endpoint was objective response rate (ORR). RESULTS: A total of 93 eligible patients with 26 different cancer types were enrolled. The overall ORR was 21.5%. The median PFS was 5.7 months and median OS was 12.0 months. The most common treatment-related AE of all grades and of grade 3 was both hypertriglyceridemia at an incidence of 40.9% and 5.4%, respectively. CONCLUSIONS: Anlotinib exhibits objective efficacy and safety in advanced malignancy and might be a possible treatment option for many types of cancer patients who have failed prior treatment and with no optimal therapy regimen.
BACKGROUND: For advanced tumors that lack specific oncogenic alteration and are resistant to chemotherapy, anti-angiogenesis therapy or immunotherapy or a combination of the two are the most important treatments. Anlotinib is a newly developed oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis. This was an open-label, single-arm, phase 2 study to validate the efficacy and safety of anlotinib in patients with various cancer types. METHODS:Patients with advanced malignancy who have failed previous therapies or lack effective treatment choices received daily oral administration of 12 mg anlotinib on days 1-14 every 3 weeks until disease progression, intolerable toxicity or physician decision. The primary endpoint was objective response rate (ORR). RESULTS: A total of 93 eligible patients with 26 different cancer types were enrolled. The overall ORR was 21.5%. The median PFS was 5.7 months and median OS was 12.0 months. The most common treatment-related AE of all grades and of grade 3 was both hypertriglyceridemia at an incidence of 40.9% and 5.4%, respectively. CONCLUSIONS:Anlotinib exhibits objective efficacy and safety in advanced malignancy and might be a possible treatment option for many types of cancerpatients who have failed prior treatment and with no optimal therapy regimen.
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Authors: Robert J Motzer; Paul B Robbins; Thomas Powles; Laurence Albiges; John B Haanen; James Larkin; Xinmeng Jasmine Mu; Keith A Ching; Motohide Uemura; Sumanta K Pal; Boris Alekseev; Gwenaelle Gravis; Matthew T Campbell; Konstantin Penkov; Jae Lyun Lee; Subramanian Hariharan; Xiao Wang; Weidong Zhang; Jing Wang; Aleksander Chudnovsky; Alessandra di Pietro; Amber C Donahue; Toni K Choueiri Journal: Nat Med Date: 2020-09-07 Impact factor: 53.440