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Poster Display session 1

3157 - Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203)


28 Sep 2019


Poster Display session 1


Tumour Site



Yihebali Chi


Annals of Oncology (2019) 30 (suppl_5): v683-v709. 10.1093/annonc/mdz283


Y. Chi1, Y. Yao2, Z. Fang3, S. Wang4, G. Huang5, Q. Cai6, G. Shang7, G. Wang8, G. Qu9, Q. Wu10, Y. Jiang11, J. Song12, J. Chen13, X. Zhu14, Z. Cai15, C. Bai16, Y. Lu17, Z. Yu18, J. Shen19, J. Cai20

Author affiliations

  • 1 Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 2 Medical Oncology, Affiliated Sixth People’s Hospital, Shanghai Jiaotong University, shanghai/CN
  • 3 Orthopedics & Soft Tissue Department, Peking University Cancer Hospital, 100142 - Beijing/CN
  • 4 Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou/CN
  • 5 Orthopedics & Soft Tissue Department, Hunan Cancer Hospital, changsha/CN
  • 6 Department Of Bone And Soft Tissue, Henan Cancer Hospital, Zhengzhou/CN
  • 7 Orthopedics & Soft Tissue Department, Liaoning Cancer Hospital and Institute, shenyang/CN
  • 8 Orthopedics & Soft Tissue Department, Tianjin Medical University Cancer Institute & Hospital, Tianjin/CN
  • 9 Orthopedic Surgery, Harbin Medical University Cancer Hospital, Harbin/CN
  • 10 Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu/CN
  • 11 Department Of Medical Oncology, Cancer Center, State Key Laboratory Of Biotherapy, West China Hospital, Sichuan University, 610041 - Chengdu/CN
  • 12 Orthopedics & Soft Tissue Department, Gansu Provincial Cancer Hospital, Lanzhou/CN
  • 13 Cancer Center, Wuhan Union Hospital, Wuhan/CN
  • 14 Department Of Orthopedics, Arthrosis & Sports Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou/CN
  • 15 Department Of Orthopedics, The First People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai/CN
  • 16 Medical Oncology, Peking Union Medical College Hospital/ Chinese Academy of Medical Sciences, Beijing/CN
  • 17 Department Of Breast And Bone Soft Tissue Tumors, Guangxi Medical University Affiliated Tumor Hospital, Nanning/CN
  • 18 Orthopedics Department, Jiangxi Cancer Hospital, Nanchang/CN
  • 19 Department Of Bone Tumor, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou/CN
  • 20 Department Of Hepatobiliary Surgery, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 100021 - Beijing/CN


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Abstract 3157


Leiomyosarcoma (LMS) is one of the most common pathologic subtypes of soft tissue sarcoma (STS) with limited treatment options. An earlier analysis in ALTER0203 showed efficacy and safety of anlotinib in overall subtype of STS. Here we report subgroup analysis of the patients with Leiomyosarcoma in ALTER0203.


Key inclusion criteria: aged from 18 to 70, confirmed histological diagnosis of advanced LMS, angiogenesis inhibitor naive, progressing after anthracycline-contained chemotherapy, measurable disease (RECIST 1.1), ECOG performance status (PS) 1-2. Anlotinib 12 mg per day 2 weeks on and 1 week off or placebo was given after 2:1 randomization. Primary endpoint: progression-free survival (PFS). Secondary endpoints: overall response rate (ORR), disease control rate (DCR) and so on.


41 eligible LMS patients, 9 males (21.95%), median age 49 (range 28-66), received either anlotinib (n = 27) or placebo (n = 14). The median PFS was 1.43 months for placebo and 5.83 months for anlotinib (P<0.0001). CR or PR was not observed for both placebo and anlotinib. SD was 2/14 for placebo versus 16/27 for anlotinib (P = 0.01). The most common adverse events (AEs) were hypertension, elevated TSH, hypertriglyceridaemia. The most common grade 3 or higher AEs were hypertension, gamma glutamyl transferase elevation, hyponatremia.Table:


EfficacyAlotinib (n = 27)Placebo (n = 14)P-value
mPFS (mos)5.831.43< 0.0001
ORR, n(%)0(0%)0(0%)N/A
DCR, n(%)16(59.26%)2(14.29%)0.01
The most common AEs, n(%)
Hypertension20(74.07%)1(7.14%)< 0.0001
TSH elevation19(70.37%)0(0%)< 0.0001
Grade≥3 AEs, n(%)
Hypertension5(18.52%)0(0%)< 0.0001
Gamma glutamyl transferase elevation2(7.41%)1(7.14%)1.0


Anlotinib not only improves PFS and DCR significantly, but also presents good safety in patients with LMS, which suggests that anlotinib could be an option for LMS patients.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.


Chia Tai Tianqing Pharmaceutical Group Co., Ltd.


All authors have declared no conflicts of interest.

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