PMID- 34012920
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220423
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 11
DP  - 2021
TI  - Efficacy and Safety of Apatinib Treatment for Advanced Cholangiocarcinoma After 
      Failed Gemcitabine-Based Chemotherapy: An Open-Label Phase II Prospective Study.
PG  - 659217
LID - 10.3389/fonc.2021.659217 [doi]
LID - 659217
AB  - PURPOSE: As a novel small-molecule vascular endothelial growth factor receptor-2 
      tyrosine kinase inhibitor (VEGFR2-TKI), Methylsulfonic apatinib (apatinib) 
      exhibits a specific antitumor effect in various solid tumors via inhibition of 
      angiogenesis. The present study was performed to evaluate the clinical efficacy 
      and safety of apatinib in the treatment of advanced cholangiocarcinoma after 
      failed gemcitabine-based chemotherapy. PATIENTS AND METHODS: This was a 
      prospective open-label phase II trial (NCT03521219). A total of 32 patients, in 
      whom gemcitabine-based first-line chemotherapy for advanced intrahepatic 
      cholangiocarcinoma had failed, were consecutively enrolled in a prospective, 
      open, exploratory, and single-center clinical trial from November 2017 to 
      November 2018. They were treated with apatinib mesylate second-line monotherapy 
      (orally, 500 mg per day for a cycle of 28 days) until progressive disease or 
      unacceptable toxicity. Using Response Evaluation Criteria in Solid Tumor version 
      1.1 (RECIST 1.1) and the Common Terminology Criteria for Adverse Events version 
      4.0 (NCI-CTCAE 4.0), the efficacy and adverse were evaluated, respectively. 
      Kaplan-Meier method was used for survival analysis. RESULTS: Twenty-six patients 
      were enrolled in full analysis set. At the end of follow-up, two patients were 
      lost to follow-up, 24 of 26 patients in FAS were included in efficacy analyses. 
      For the efficacy analysis set, the objective response rate (ORR) was 20.8% [95% 
      confidence interval (CI): 9.24-40.47%] and the disease control rate (DCR) was 
      62.5% (95% CI: 112.86-387.14 days). One patient (4%) showed complete response 
      (CR), 4 patients (17%) showed partial response (PR), 10 patients (41.7%) stable 
      disease (SD), and 9 patients (37.5%) had progressive disease (PD). Meanwhile, 
      apatinib therapy achieved the median progression-free survival PFS was 95 days 
      (95% CI: 79.70-154.34 days), and the median OS was 250 days (95% CI: 
      112.86-387.14 days). Furthermore, univariate analysis revealed that age and 
      tumor's anatomic location significantly affected PFS (P < 0.05). The most common 
      clinically adverse events (AEs) included myelosuppression (69.2%), hypertension 
      (57.7%), proteinuria (46.2%). The AEs were mild, mainly in grade 1 or 2, and no 
      toxicity-induced death occurred. CONCLUSION: Apatinib monotherapy is an effective 
      and promising regimen for treating patients with advanced cholangiocarcinoma who 
      experienced failure of gemcitabine-based chemotherapy.
CI  - Copyright (c) 2021 Zhang, Gong, Pang, Hou and He.
FAU - Zhang, Ge
AU  - Zhang G
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - Gong, Shuai
AU  - Gong S
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - Pang, Lina
AU  - Pang L
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - Hou, Lixia
AU  - Hou L
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - He, Wei
AU  - He W
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20210503
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC8126718
OTO - NOTNLM
OT  - *advanced cholangiocarcinoma
OT  - *angiogenesis
OT  - *apatinib
OT  - *efficacy
OT  - *prospective study
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- 2021/05/21 06:00
MHDA- 2021/05/21 06:01
PMCR- 2021/01/01
CRDT- 2021/05/20 06:45
PHST- 2021/01/27 00:00 [received]
PHST- 2021/04/12 00:00 [accepted]
PHST- 2021/05/20 06:45 [entrez]
PHST- 2021/05/21 06:00 [pubmed]
PHST- 2021/05/21 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2021.659217 [doi]
PST - epublish
SO  - Front Oncol. 2021 May 3;11:659217. doi: 10.3389/fonc.2021.659217. eCollection 
      2021.