PMID- 38483309
OWN - NLM
STAT- Publisher
LR  - 20240314
IS  - 1557-3265 (Electronic)
IS  - 1078-0432 (Linking)
DP  - 2024 Mar 14
TI  - First-Line Anlotinib Treatment for Soft Tissue Sarcoma in Chemotherapy-Ineligible 
      Patients: An Open-label, Single-arm, Phase 2 Clinical Trial.
LID - 10.1158/1078-0432.CCR-23-3983 [doi]
AB  - PURPOSE: Standard treatment for patients with unresectable locally advanced or 
      metastatic soft-tissue sarcoma (LA/M STS) is chemotherapy based on 
      anthracyclines, but patient tolerance of chemotherapy is limited. The present 
      trial (NCT03792542) investigated the use of anlotinib as first-line treatment for 
      patients with advanced STS, in particular liposarcoma (LPS). PATIENTS AND 
      METHODS: Eligible patients were previously untreated, pathologically confirmed, 
      unresectable LA/M STS cases. Anlotinib was given orally at a dose of 12 mg once 
      daily from day 1 to day 14 every 3 weeks until disease progression or intolerable 
      adverse events (AEs) occurred. The primary endpoint was progression-free survival 
      (PFS) and the secondary endpoints overall survival (OS), the objective response 
      rate and the disease control rate (DCR). The safety profile was also evaluated. 
      RESULTS: Forty patients were enrolled from April 2019 to Jun 2022 and are 
      included in the intention-to-treat analysis. The median PFS was 6.83 months [95% 
      confidence interval (CI): 4.17-8.71] and the median OS 27.40 months (95% CI: 
      16.43-not evaluable); 1 patient reached partial response and 26 attained stable 
      disease, with a DCR of 67.5% (27/40). Median PFS and OS times for LPS patients 
      were 8.71 and 16.23 months, respectively. Ten (25.0%) patients had 
      treatment-related AEs >/= grade 3, with in particular a higher incidence of 
      hypertension (15.0%) and proteinuria (7.5%). CONCLUSIONS: The findings suggest a 
      potential benefit in employing front-line anlotinib to treat patients with STS, 
      who are not eligible for cytotoxic chemotherapy. Of note, the clinical outcomes 
      for the LPS subgroup of patients were encouraging.
FAU - Li, Tao
AU  - Li T
AUID- ORCID: 0000-0002-5924-0522
AD  - Institute of Cancer and Basic Medicine, Chinese Academy of Sciences, Cancer 
      Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer 
      Hospital, Hangzhou, Zhejiang, China.
FAU - Dong, Ying
AU  - Dong Y
AUID- ORCID: 0009-0004-1656-6348
AD  - The Second Affiliated Hospital, College of Medicine, Zhejiang University, 
      Hangzhou, China.
FAU - Wei, Yongzhong
AU  - Wei Y
AUID- ORCID: 0009-0007-0402-5204
AD  - Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical 
      University, Nanjing, Jiangsu, China.
FAU - Wang, Shoufeng
AU  - Wang S
AUID- ORCID: 0000-0002-3805-6048
AD  - Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University 
      Medical School, Nanjing, China.
FAU - Liu, Yunxia
AU  - Liu Y
AUID- ORCID: 0000-0003-2486-384X
AD  - Hangzhou Third People's Hospital, Hangzhou, Zhejiang, China.
FAU - Chen, Jia
AU  - Chen J
AUID- ORCID: 0009-0002-1224-534X
AD  - Jiangsu Cancer Hospital, Nanjing, Jiangsu, China.
FAU - Xiong, Wenhua
AU  - Xiong W
AUID- ORCID: 0009-0003-4973-0709
AD  - Ningbo Second Hospital, Ningbo, Zhejiang, China.
FAU - Lin, Nong
AU  - Lin N
AUID- ORCID: 0000-0003-4939-113X
AD  - The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 
      Zhejiang, China.
FAU - Huang, Xin
AU  - Huang X
AUID- ORCID: 0000-0002-6247-1946
AD  - The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 
      Zhejiang, China.
FAU - Liu, Meng
AU  - Liu M
AUID- ORCID: 0009-0008-7893-5099
AD  - The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 
      Zhejiang, China.
FAU - Yan, Xiaobo
AU  - Yan X
AUID- ORCID: 0000-0001-8509-869X
AD  - The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 
      Zhejiang, China.
FAU - Ye, Zhaoming
AU  - Ye Z
AUID- ORCID: 0000-0001-5951-5840
AD  - The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 
      Zhejiang, China.
FAU - Li, Binghao
AU  - Li B
AUID- ORCID: 0009-0008-7394-616X
AD  - The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 
      Zhejiang, China.
LA  - eng
PT  - Journal Article
DEP - 20240314
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
SB  - IM
EDAT- 2024/03/14 12:49
MHDA- 2024/03/14 12:49
CRDT- 2024/03/14 10:53
PHST- 2024/03/12 00:00 [accepted]
PHST- 2023/12/22 00:00 [received]
PHST- 2024/02/21 00:00 [revised]
PHST- 2024/03/14 12:49 [medline]
PHST- 2024/03/14 12:49 [pubmed]
PHST- 2024/03/14 10:53 [entrez]
AID - 735153 [pii]
AID - 10.1158/1078-0432.CCR-23-3983 [doi]
PST - aheadofprint
SO  - Clin Cancer Res. 2024 Mar 14. doi: 10.1158/1078-0432.CCR-23-3983.