PMID- 35282086
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220315
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 10
IP  - 2
DP  - 2022 Jan
TI  - Apatinib plus 5-fluorouracil as a third or subsequent-line treatment option for 
      metastatic colorectal cancer: a phase-II, single-arm, prospective study.
PG  - 100
LID - 10.21037/atm-22-77 [doi]
LID - 100
AB  - BACKGROUND: For metastatic colorectal cancer (mCRC) patients for whom at least 2 
      lines of previous standard therapies have failed, the prognosis is often 
      unfavorable due to very limited subsequent treatment options. We sought to 
      explore the efficacy of apatinib, an oral small-molecule vascular endothelial 
      growth factor receptor-2 inhibitor, plus 5-fluorouracil (5-FU) as a third- or 
      subsequent-line treatment for mCRC. METHODS: In this phase-II, single-arm, 
      prospective study, the eligible patients had been histologically confirmed to 
      have adenocarcinoma of the colon or rectum for which at least 2 previous regimens 
      of standard therapies had failed. All the patients were treated with a daily dose 
      of 250 mg of apatinib, in combination with capecitabine, Tegafur Gimeracil 
      Oteracil Potassium Capsule (S-1), or 5-FU, until disease progression, 
      unacceptable toxicity, or consent withdrawal. RESULTS: From June 2017 to April 
      2018, 16 patients were enrolled in this study. Among them, 4 achieved partial 
      response, 7 had stable disease, and 5 had progression disease, resulting in an 
      objective response rate of 25.00% [95% confidence interval (CI): 7.27-52.38%], 
      and a disease control rate of 68.75% (95% CI: 41.34-88.98%). The median 
      progression-free survival (PFS) was 4.83 months (95% CI: 2.17-8.90 months), and 
      the median overall survival (OS) was 9.10 months (95% CI: 5.59-15.18 months). The 
      common treatment-related adverse events (AEs) were hand-foot syndrome (56.25%), 
      hypertension (37.50%), proteinuria (37.50%), gingival bleeding (18.75%) and 
      abdominal pain (18.75%). Grade 3 AEs, including hand-foot syndrome (18.75%), 
      hypertension (12.50%), and proteinuria (12.50%), were observed in 7 patients. 
      CONCLUSIONS: The combination regimen of apatinib plus 5-FU had encouraging 
      anti-tumor efficacy, and is a feasible third- or subsequent-line treatment option 
      for mCRC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03210064.
CI  - 2022 Annals of Translational Medicine. All rights reserved.
FAU - Chen, Runzhi
AU  - Chen R
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Yang, Liu
AU  - Yang L
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Hu, Sheng
AU  - Hu S
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Yin, Zhusheng
AU  - Yin Z
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Nie, Yanli
AU  - Nie Y
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Xu, Hongli
AU  - Xu H
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Zhong, Yi
AU  - Zhong Y
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Zhu, Yuze
AU  - Zhu Y
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Liang, Xinjun
AU  - Liang X
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Xu, Huiting
AU  - Xu H
AD  - Department of Medical Oncology, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03210064
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC8848367
OTO - NOTNLM
OT  - 5-fluorouracil (5-FU)
OT  - Cancer
OT  - apatinib
OT  - third-line treatment
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at 
      https://atm.amegroups.com/article/view/10.21037/atm-22-77/coif). All authors 
      report that the study protocol was supported by the Jiangsu Hengrui 
      Pharmaceutical Group Co., Ltd. The authors have no other conflicts of interest to 
      declare.
EDAT- 2022/03/15 06:00
MHDA- 2022/03/15 06:01
PMCR- 2022/01/01
CRDT- 2022/03/14 05:30
PHST- 2021/12/22 00:00 [received]
PHST- 2022/01/20 00:00 [accepted]
PHST- 2022/03/14 05:30 [entrez]
PHST- 2022/03/15 06:00 [pubmed]
PHST- 2022/03/15 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - atm-10-02-100 [pii]
AID - 10.21037/atm-22-77 [doi]
PST - ppublish
SO  - Ann Transl Med. 2022 Jan;10(2):100. doi: 10.21037/atm-22-77.