Purpose: The prognosis for patients with refractory softtissue sarcoma (STS) is dismal. Anlotinib has previously shown antitumor activity on STS in preclinical and phase I studies. Patients and Methods: Patients 18 years and older, progressing after anthracycline-based chemotherapy, naive from angiogenesis inhibitors, with at least one measurable lesion according to RECIST 1.1, were enrolled. The main subtypes eligible were undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma (SS), fibrosarcoma (FS), alveolar soft-part sarcoma (ASPS), and clear cell sarcoma (CCS). Participants were treated with anlotinib. The primary endpoint was progression-free rate at 12 weeks (PFR12 weeks). Results: A total of 166 patients were included in the final analysis. Overall, the PFR12 weeks was 68%, and objective response rate was 13% (95% confidence interval, 7.6%-18%). The median progression-free survival (PFS) and overall survival (OS) were 5.6 and 12 months, respectively. The PFR12 weeks, median PFS and OS were: 58%, 4.1 and 11 months for UPS (n = 19); 63%, 5.6 and 13 months for LPS (n = 13); 75%, 11 and 15 months for LMS (n = 26); 75%, 7.7 and 12 months for SS (n = 47); 81%, 5.6 and 12 months for FS (n = 18); 77%, 21 and not reached for ASPS (n = 13); 54%, 11 and 16 months for CCS (n = 7); and 44%, 2.8 and 8.8 months for other sarcoma (n = 23), respectively. The most common clinically significant grade 3 or higher adverse events were hypertension (4.8%), triglyceride elevation (3.6%), and pneumothorax (2.4%). No treatment-related death occurred. Conclusions: Anlotinib showed antitumor activity in several STS entities. The toxicity was manageable. (C) 2018 AACR.
[1]Chinese Acad Med Sci, Natl Canc Ctr, Canc Hosp, POB 2258,17 Panjiayuan Nanli, Beijing 100021, Peoples R China;
[2]Peking Union Med Coll, POB 2258,17 Panjiayuan Nanli, Beijing 100021, Peoples R China;
[3]Peking Univ, Canc Hosp, Beijing, Peoples R China;
[4]Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China;
[5]Sixth Peoples Hosp, Shanghai, Peoples R China;
[6]Liaoning Canc Hosp & Inst, Shenyang, Liaoning, Peoples R China;
[7]Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China;
[8]Minist Educ Beijing, Key Lab Carcinogenesis & Translat Res, Beijing, Peoples R China;
[9]Peking Univ Canc Hosp & Inst, Res Minist Educ Beijing, VIPII Gastrointestinal Canc Div Med Dept, Beijing, Peoples R China;
[10]Bengbu Med Coll, Affiliated Hosp 1, Bengbu, Peoples R China;
[11]Harbin Med Univ, Harbin, Heilongjiang, Peoples R China;
[12]Sun Yat Sen Univ, Ctr Canc, Guangzhou, Guangdong, Peoples R China;
[13]Gansu Prov Canc Hosp, Lanzhou, Peoples R China;
[14]Beijing Union Med Coll Hosp, Beijing, Peoples R China;
[15]Guangxi Med Univ, Affiliated Canc Hosp, Nanning, Peoples R China;
[16]Fujian Med Univ, Affiliated Hosp 1, Fuzhou, Fujian, Peoples R China;
[17]Beijing Jishuitan Hosp, Beijing, Peoples R China;
[18]Fujian Prov Canc Hosp, Fuzhou, Fujian, Peoples R China;
[19]Nanjing Med Univ, Sch Publ Hlth, Nanjing, Jiangsu, Peoples R China
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