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Anlotinib Monotherapy for Refractory Metastatic Colorectal Cancer: A Double-Blinded, Placebo-Controlled, Randomized Phase III Trial (ALTER0703).

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机构： [a]Departments 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, People’s Republic of China [b]Departments of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China [c]Department of Medical Oncology, Jiangsu Province Hospital, Nanjing, People’s Republic of China [d]Department of Digestive Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China [e]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, People’s Republic of China [f]Department of Gastrointestinal Oncology, Liaoning Cancer Hospital & Institute, Shenyang, People’s Republic of China [g]Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan, People’s Republic of China [h]Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, People’s Republic of China [i]Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University, Hangzhou, People’s Republic of China [j]Department of Medical Oncology, Tangdu Hospital, Air Force Medical University, Xi'an, People’s Republic of China [k]Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, People’s Republic of China [l]Department of Gastrointestinal Oncology, 307 Hospital of PLA, Academy of Military Medical Sciences, Beijing, People’s Republic of China [m]Department of Medical Oncology, Jilin Cancer Hospital, Changchun, People’s Republic of China [n]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, People’s Republic of China [o]Department of Oncology, the Second Xiangya Hospital, Central South University, Changsha, People’s Republic of China. [p]Department of Abdominal Oncology, Fujian Cancer Hospital, Fuzhou, People’s Republic of China [q]Department of Oncology, The Second Hospital of Anhui Medical University, Hefei, People’s Republic of China [r]Department of Oncology, Henan Cancer Hospital, Zhengzhou, People’s Republic of China [s]Department of Surgical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, People’s Republic of China [t]Department of Medical Oncology, Nantong Tumor Hospital, Nantong, People’s Republic of China [u]Department of Medical Oncology, Jiangxi Cancer Hospital, Nanchang, People’s Republic of China [v]Department of Digestive Internal Medicine, The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, People’s Republic of China. [w]Department of Medical oncology, Chongqing Cancer Hospital, Chongqing, People’s Republic of China. [x]Department of Medical Oncology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, People’s Republic of China [y]Department of integrated Chinese and Western Medicine, Shaanxi Provincial Cancer Hospital, Xi’an, People’s Republic of China [z]Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-.sen University, Guangzhou, People’s Republic of China [aa]Department of Gastrointestinal Surgery, Gansu Provincial Cancer Hospital, Lanzhou, People’s Republic of China [bb]Department of Medical Oncology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, People’s Republic of China [cc]First Department of Medical Oncology, Yunnan Cancer Hospital, Kunming, People’s Republic of China [dd]Department of Medical Oncology, Forth Hospital of Hebei Medical University, Hebei, People’s Republic of China [ee]Department of Medical Oncology, Liuzhou Worker’s Hospital, Liuzhou, People’s Republic of China. [ff]Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China [gg]Department of Medical Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China [hh]Department of Medical Oncology, Qinghai Provincial People’s Hospital, Xining, People’s Republic of China Disclosures of potential conflicts of interest may be found at the end of this article.

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关键词： Colorectal cancer Metastatic Anlotinib Survival Progression-free survival Adverse events

摘要：

Treatment options for refractory metastatic colorectal cancer (mCRC) were limited. Anlotinib is a novel multitarget tyrosine kinase inhibitor. ALTER0703 study was conducted to assess efficacy and safety of anlotinib for patients with refractory mCRC.This was a multicenter, double-blinded, placebo-controlled, randomized phase III trial involving 33 hospitals in China. Patients had taken at least two lines of therapies were 2:1 randomized to receive oral anlotinib (12 mg/day; days 1-14; 21 days per cycle) or placebo, plus best supportive care. Randomization was stratified by previous VEGF-targeting treatments and time from diagnosis to metastases. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL), and safety.A total of 419 patients (anlotinib: 282; placebo: 137) were treated from December 2014 to August 2016. The median PFS was improved in anlotinib group (4.1 months; 95% confidence interval [CI], 3.4-4.5) over placebo group (1.5 months; 95% CI, 1.4-1.5), with a hazard ratio (HR) of 0.34 (95% CI, 0.27-0.43; p < .0001). However, median OS was similar between two groups (8.6 months; 95% CI, 7.8-9.7 vs. 7.2 months; 95% CI, 6.2-8.8; HR, 1.02; p = .870). Improvements of ORR and DCR were observed in anlotinib over placebo. The most common grade ≥ 3 anlotinib related adverse events were hypertension (20.92%), increased γ-GT (7.09%), and hand-foot skin reaction (6.38%).Anlotinib was tolerated in Chinese patients with refractory mCRC. Although OS did not reach significant difference, anlotinib still provided clinical benefits by substantially prolonged PFS in these patients.In this randomized clinical trial that included 419 patients with refractory metastatic colorectal cancer, substantial prolonged in progression-free survival was noted in patients who received anlotinib compared with those given placebo. Improvements on objective response rate and disease control rate was also observed in anlotinib group. However, overall survival was similar between the two groups. In a word, in third-line or above treatment of Chinese patients with refractory metastatic colorectal cancer, anlotinib provided clinical benefit by significantly prolonged progression-free survival.© 2021 AlphaMed Press.

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出版当年[2021]版：

大类 | 2 区医学

小类 | 3 区肿瘤学

最新[2023]版：

大类 | 2 区

医学

小类 | 2 区肿瘤学

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出版当年[2020]版：

Q2 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY

影响因子： 4.8 最新[2023版] 5.3 最新五年平均 5.55 出版当年[2020版] 6.458 出版当年五年平均 5.025 出版前一年[2019版] 5.837 出版后一年[2021版]

第一作者：

第一作者机构： [a]Departments 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, People’s Republic of China

通讯作者：

通讯机构： [b]Departments of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China [*1]Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, People’s Republic of China.

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Anlotinib Monotherapy for Refractory Metastatic Colorectal Cancer: A Double-Blinded, Placebo-Controlled, Randomized Phase III Trial (ALTER0703).

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