PMID- 33178765
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220418
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 8
IP  - 19
DP  - 2020 Oct
TI  - Apatinib combined with paclitaxel-based chemotherapy in patients with 
      taxane-resistant advanced gastric cancer: a single-arm exploratory study.
PG  - 1233
LID - 10.21037/atm-20-5841 [doi]
LID - 1233
AB  - BACKGROUND: Apatinib combined with chemotherapy might be effective and safe for 
      the management of advanced gastric cancer, but the available data are limited. To 
      investigate the efficacy and safety of apatinib in combination with paclitaxel 
      (PTX) alone or POF (PTX, oxaliplatin, and 5-fluorouracil) in patients with 
      taxane-resistant advanced gastric cancer. METHODS: Patients with taxane-resistant 
      advanced gastric cancer were enrolled in the single-center, open-labeled, 
      single-arm, exploratory study (ClinicalTrials.gov #NCT02697838). Apatinib was 
      administered at 850 mg po in combination with weekly PTX or the POF regimen. The 
      primary endpoint was the objective response rate (ORR). The secondary endpoints 
      included disease control rate (DCR), progression-free survival (PFS), overall 
      survival (OS), the time to tumor progression (TTP), and safety. RESULTS: Twenty 
      participants were recruited from 08/2016 to 01/2018. The duration of the study 
      treatment was 2.07 (0.03-16.2) months. The median follow-up was 24.8 (0.3-26.0) 
      months. The reasons for termination of treatment were disease progression (n=6), 
      adverse events (AEs) (n=5), and patients' will (n=9). The ORR was 11.1% (95% CI: 
      1.4-34.7%) and the DCR was 77.8% (95% CI: 52.4-93.6%). The median PFS was 3.5 
      (95% CI: 1.9-5.1) months, the median OS was 4.7 (95% CI: 2.0-7.3) months, and the 
      median TTP was 4.2 (95% CI: 0.562-7.838) months. All 20 (100%) patients had AEs, 
      17 (85%) had apatinib treatment-emergent AEs (TEAEs), and 18 (90%) had 
      chemotherapy TEAEs. The main grade 3-4 TEAEs were neutropenia, leukopenia, 
      hypertension, and anemia. CONCLUSIONS: This preliminary study suggests that 
      apatinib combined with PTX or POF might be effective and tolerable in patients 
      with chemotherapy-refractory gastric cancer. Studies are necessary to confirm the 
      results. TRIAL REGISTRATION: ClinicalTrials.gov #NCT02697838.
CI  - 2020 Annals of Translational Medicine. All rights reserved.
FAU - Zhao, Shen
AU  - Zhao S
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
AD  - Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, Fujian, China.
FAU - Fan, Nanfeng
AU  - Fan N
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Li, Hui
AU  - Li H
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Liu, Jie
AU  - Liu J
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Huang, Feng
AU  - Huang F
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Chen, Yigui
AU  - Chen Y
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Zhou, Min
AU  - Zhou M
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Yu, Jiaqing
AU  - Yu J
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
FAU - Lin, Rongbo
AU  - Lin R
AD  - Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, 
      Fujian, China.
AD  - Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
AD  - Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, Fujian, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02697838
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC7607108
OTO - NOTNLM
OT  - Apatinib
OT  - advanced stage
OT  - drug resistance
OT  - gastric cancer
OT  - paclitaxel (PTX)
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at http://dx.doi.org/10.21037/atm-20-5841). Dr. Lin reports 
      grants from the Fujian Provincial Health Technology Project, grants from Natural 
      Science Foundation of Fujian Province, grants from Beijing Xisike Clinical 
      Oncology Research Foundation, during the conduct of the study; Dr. Zhao reports 
      grants from Natural Science Foundation of Fujian Province, during the conduct of 
      the study. The other authors have no conflicts of interest to declare.
EDAT- 2020/11/13 06:00
MHDA- 2020/11/13 06:01
PMCR- 2020/10/01
CRDT- 2020/11/12 05:45
PHST- 2020/11/12 05:45 [entrez]
PHST- 2020/11/13 06:00 [pubmed]
PHST- 2020/11/13 06:01 [medline]
PHST- 2020/10/01 00:00 [pmc-release]
AID - atm-08-19-1233 [pii]
AID - 10.21037/atm-20-5841 [doi]
PST - ppublish
SO  - Ann Transl Med. 2020 Oct;8(19):1233. doi: 10.21037/atm-20-5841.