PMID- 34423518
OWN - NLM
STAT- MEDLINE
DCOM- 20211221
LR  - 20211221
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 26
IP  - 12
DP  - 2021 Dec
TI  - Anlotinib Combined with S-1 in Third- or Later-Line Stage IV Non-Small Cell Lung 
      Cancer Treatment: A Phase II Clinical Trial.
PG  - e2130-e2135
LID - 10.1002/onco.13950 [doi]
AB  - LESSONS LEARNED: The combination of anlotinib and S-1 exhibited good antitumor 
      activity in third- or later-line treatment for stage IV non-small cell lung 
      cancer (NSCLC). Combination therapy of anlotinib with S-1 has manageable 
      toxicities in patients with NSCLC. BACKGROUND: This study aimed to evaluate the 
      efficacy and safety of anlotinib combined with S-1 as a third- or later-line 
      treatment for patients with stage IV non-small cell lung cancer (NSCLC). 
      Anlotinib was approved in 2018 by the Chinese Food and Drug Administration (FDA) 
      as a third-line treatment for patients with refractory advanced NSCLC and is 
      under study in the U.S. and Europe. METHODS: Simon's phase II clinical trial 
      design with an alpha error of 5% and a power beta of 80% was used, anticipating a 10% 
      objective response rate (ORR) of anlotinib and a 30% ORR of anlotinib combined 
      with S-1; the required sample size was 29. A total of 29 patients were enrolled 
      in the clinical trial. Patients were treated with anlotinib plus S-1 over a 
      21-day treatment course until disease progression or unacceptable toxic effects. 
      If the efficacy was assessed as stable disease, partial response, or complete 
      response after six cycles, anlotinib was maintained until disease progression or 
      death. The primary endpoint was the objective response rate. Somatic mutations 
      were not required for study enrollment. RESULTS: The median follow-up time was 
      11.1 months. Objective responses were observed in 11 of 29 (37.9%) patients 
      making up the intention-to-treat population, which reached the target primary 
      endpoint of 30% ORR. The median overall and progression-free survival were 16.7 
      and 5.8 months, respectively. The most common grade 3 adverse events (AEs) were 
      gastrointestinal, including nausea, vomiting and diarrhea, fatigue, and 
      hypertension. No grade 4 treatment-related AEs or treatment-related deaths 
      occurred. CONCLUSION: The combination of anlotinib with S-1 in the third- or 
      later-line treatment of stage IV NSCLC shows promising antitumor activity and 
      manageable toxicity in patients with NSCLC; phase III trials will be planned in 
      the future.
CI  - (c) AlphaMed Press; the data published online to support this summary are the 
      property of the authors.
FAU - Xiang, Miao
AU  - Xiang M
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Yang, Xiyue
AU  - Yang X
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Ren, Surong
AU  - Ren S
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Du, Huan
AU  - Du H
AD  - Department of Oncology, Affiliated Hospital of North Sichuan Medical College, Nan 
      Chong, People's Republic of China.
FAU - Geng, Lidan
AU  - Geng L
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Yuan, Li
AU  - Yuan L
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Wen, Yixue
AU  - Wen Y
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Lin, Binwei
AU  - Lin B
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Li, Jie
AU  - Li J
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Zhang, Yu
AU  - Zhang Y
FAU - Feng, Gang
AU  - Feng G
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
FAU - Du, Xiaobo
AU  - Du X
AUID- ORCID: 0000-0001-6348-0636
AD  - Department of Oncology, Mianyang Central Hospital, Mian Yang, People's Republic 
      of China.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20210913
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Indoles)
RN  - 0 (Quinolines)
RN  - 0 (anlotinib)
SB  - IM
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - Combined Modality Therapy
MH  - Humans
MH  - Indoles
MH  - *Lung Neoplasms/drug therapy
MH  - Progression-Free Survival
MH  - Quinolines
MH  - United States
PMC - PMC8649049
OTO - NOTNLM
OT  - Anlotinib
OT  - Non-small cell lung cancer
OT  - S-1
OT  - Third-line treatment
EDAT- 2021/08/24 06:00
MHDA- 2021/12/22 06:00
PMCR- 2021/12/01
CRDT- 2021/08/23 06:55
PHST- 2021/05/07 00:00 [received]
PHST- 2021/08/14 00:00 [accepted]
PHST- 2021/08/24 06:00 [pubmed]
PHST- 2021/12/22 06:00 [medline]
PHST- 2021/08/23 06:55 [entrez]
PHST- 2021/12/01 00:00 [pmc-release]
AID - ONCO13950 [pii]
AID - 10.1002/onco.13950 [doi]
PST - ppublish
SO  - Oncologist. 2021 Dec;26(12):e2130-e2135. doi: 10.1002/onco.13950. Epub 2021 Sep 
      13.