PMID- 34796105
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220428
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 11
DP  - 2021
TI  - Anlotinib in Chinese Patients With Recurrent Advanced Cervical Cancer: A 
      Prospective Single-Arm, Open-Label Phase II Trial.
PG  - 720343
LID - 10.3389/fonc.2021.720343 [doi]
LID - 720343
AB  - OBJECTIVE: This phase II, single-arm, prospective study aimed to evaluate the 
      efficacy and safety of anlotinib in Chinese patients with recurrent or metastatic 
      cervical cancer (CC). METHODS: Patients with histologically proven recurrent or 
      metastatic advanced CC were enrolled at Fudan University Shanghai Cancer Center. 
      Patients received 12 mg of oral anlotinib daily before breakfast for 2 weeks of 
      each 3-week (21 days) cycle separated by a 1-week interval. Anlotinib was 
      administered orally until disease progression, patient withdrawal, intolerant 
      toxicity, or death. The primary endpoint was the objective response rate (ORR) 
      according to the Response Evaluation Criteria in Solid Tumors, and the secondary 
      endpoints included the disease control rate (DCR), progression-free survival 
      (PFS), overall survival (OS), and safety. RESULTS: Between September 2018 and 
      November 2019, 41 patients were recruited. The median age was 53 years old. The 
      histological results revealed that 82.9% of the recruited patients had squamous 
      cell carcinoma, 14.6% had adenocarcinoma, and 2.4% had other types. At the data 
      cutoff date, six patients were still being treated, and 35 patients had 
      discontinued treatment. Forty (40/41, 97.5%) patients were evaluated for 
      treatment response. The median PFS and OS was 3.2 and 9.9 months, respectively, 
      in patients who received anlotinib treatment. The ORR was 24.4%. In addition, 
      34.2% (14/41) of patients were confirmed to have stable disease, and 39.0% 
      (16/41) of patients were confirmed to have progressive disease. The DCR was 
      58.5%. Ten patients (10/41) had a confirmed response during the follow-up period. 
      Most adverse events (AEs) were grade 1 or 2. High-grade AEs (grade 3) included 
      urinary leukocyte positivity (9.8%), hematuria (4.9%), and hypertension (2.4%). 
      CONCLUSION: This is the first study to evaluate the efficacy and safety of 
      anlotinib in Chinese patients with recurrent or metastatic CC. Anlotinib produced 
      durable clinical responses with manageable safety in these patients.
CI  - Copyright (c) 2021 Zhu, Song, Zheng, Xia, Chen, Ke and Wu.
FAU - Zhu, Jun
AU  - Zhu J
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Song, Chunyan
AU  - Song C
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
FAU - Zheng, Zhong
AU  - Zheng Z
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Xia, Lingfang
AU  - Xia L
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Chen, Yanqiong
AU  - Chen Y
AD  - Department of Radiology, Fudan University Shanghai Cancer Center, Shanghai, 
      China.
FAU - Ke, Guihao
AU  - Ke G
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Wu, Xiaohua
AU  - Wu X
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20211102
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC8593387
OTO - NOTNLM
OT  - VEGF inhibitor
OT  - anlotinib
OT  - cervical cancer
OT  - monotherapy therapy
OT  - recurrent advanced cervical cancer
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2021/11/20 06:00
MHDA- 2021/11/20 06:01
PMCR- 2021/01/01
CRDT- 2021/11/19 06:58
PHST- 2021/06/08 00:00 [received]
PHST- 2021/10/18 00:00 [accepted]
PHST- 2021/11/19 06:58 [entrez]
PHST- 2021/11/20 06:00 [pubmed]
PHST- 2021/11/20 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2021.720343 [doi]
PST - epublish
SO  - Front Oncol. 2021 Nov 2;11:720343. doi: 10.3389/fonc.2021.720343. eCollection 
      2021.