PMID- 37329569
OWN - NLM
STAT- MEDLINE
DCOM- 20231216
LR  - 20231226
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 28
IP  - 12
DP  - 2023 Dec 11
TI  - Anlotinib Combined With Toripalimab as First-Line Therapy for Unresectable 
      Hepatocellular Carcinoma: A Prospective, Multicenter, Phase II Study.
PG  - e1239-e1247
LID - 10.1093/oncolo/oyad169 [doi]
AB  - BACKGROUND: For patients with unresectable hepatocellular carcinoma (HCC), the 
      first-line therapeutic options are still relatively limited, and treatment 
      outcomes remain poor. We aimed to assess the efficacy and safety of anlotinib 
      combined with toripalimab as first-line therapy for unresectable HCC. METHODS: In 
      this single-arm, multicenter, phase II study (ALTER-H-003), patients with 
      advanced HCC without previous systemic anticancer therapy were recruited. 
      Eligible patients were given anlotinib (12 mg on days 1-14) combined with 
      toripalimab (240 mg on day 1) in a 3-week cycle. The primary endpoint was the 
      objective response rate (ORR) by immune-related Response Evaluation Criteria in 
      Solid Tumours (irRECIST)/RECIST v1.1 and modified RECIST (mRECIST). Secondary 
      endpoints included disease control rate (DCR), duration of response (DoR), 
      progression-free survival (PFS), overall survival (OS), and safety. RESULTS: 
      Between January 2020 and Jul 2021, 31 eligible patients were treated and included 
      in the full analysis set. At data cutoff (January 10, 2023), the ORR was 29.0% 
      (95% CI: 12.1%-46.0%) by irRECIST/RECIST v1.1, and 32.3% (95% CI: 14.8%-49.7%) by 
      mRECIST criteria, respectively. Confirmed DCR and median DoR by irRECIST/RECIST 
      v1.1 and mRECIST criteria were 77.4 % (95% CI: 61.8%-93.0%) and not reached 
      (range: 3.0-22.5+ months), respectively. Median PFS was 11.0 months (95% CI: 
      3.4-18.5 months) and median OS was 18.2 months (95% CI: 15.8-20.5 months). Of the 
      31 patients assessed for adverse events (AEs), the most common grade >/= 3 
      treatment-related AEs were hand-foot syndrome (9.7%, 3/31), hypertension (9.7%, 
      3/31), arthralgia (9.7%, 3/31), abnormal liver function (6.5%, 2/31), and 
      decreased neutrophil counts (6.5%, 2/31). CONCLUSIONS: Anlotinib combined with 
      toripalimab showed promising efficacy and manageable safety in Chinese patients 
      with unresectable HCC in the first-line setting. This combination therapy may 
      offer a potential new therapeutic approach for patients with unresectable HCC.
CI  - (c) The Author(s) 2023. Published by Oxford University Press.
FAU - Zhang, Cheng-Sheng
AU  - Zhang CS
AD  - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical 
      University, Haikou, People's Republic of China.
FAU - Zeng, Zhi-Ming
AU  - Zeng ZM
AD  - Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical 
      University, Nanning, People's Republic of China.
FAU - Zhuo, Man-Yun
AU  - Zhuo MY
AD  - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical 
      University, Haikou, People's Republic of China.
FAU - Luo, Jing-Ru
AU  - Luo JR
AD  - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical 
      University, Haikou, People's Republic of China.
FAU - Zhuang, Xiao-Hong
AU  - Zhuang XH
AD  - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical 
      University, Haikou, People's Republic of China.
FAU - Xu, Jun-Nv
AU  - Xu JN
AD  - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical 
      University, Haikou, People's Republic of China.
FAU - Zeng, Jie
AU  - Zeng J
AD  - Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical 
      University, Nanning, People's Republic of China.
FAU - Ma, Jie
AU  - Ma J
AD  - Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical 
      University, Nanning, People's Republic of China.
FAU - Lin, Hai-Feng
AU  - Lin HF
AD  - Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical 
      University, Haikou, People's Republic of China.
LA  - eng
GR  - 820QN403/Natural Science Foundation of Hainan Province/
GR  - Hnky2022-34/Scientific Research Project of Higher Education in Hainan Province/
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (anlotinib)
RN  - 8JXN261VVA (toripalimab)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Hepatocellular/drug therapy
MH  - Prospective Studies
MH  - *Liver Neoplasms/drug therapy
PMC - PMC10712726
OTO - NOTNLM
OT  - anlotinib
OT  - first-line treatment
OT  - hepatocellular carcinoma
OT  - toripalimab
COIS- The authors indicated no financial relationships.
EDAT- 2023/06/17 19:16
MHDA- 2023/12/17 09:45
PMCR- 2023/06/17
CRDT- 2023/06/17 15:36
PHST- 2023/03/01 00:00 [received]
PHST- 2023/05/01 00:00 [accepted]
PHST- 2023/12/17 09:45 [medline]
PHST- 2023/06/17 19:16 [pubmed]
PHST- 2023/06/17 15:36 [entrez]
PHST- 2023/06/17 00:00 [pmc-release]
AID - 7200007 [pii]
AID - oyad169 [pii]
AID - 10.1093/oncolo/oyad169 [doi]
PST - ppublish
SO  - Oncologist. 2023 Dec 11;28(12):e1239-e1247. doi: 10.1093/oncolo/oyad169.