PMID- 38354746
OWN - NLM
STAT- Publisher
LR  - 20240214
IS  - 1349-7006 (Electronic)
IS  - 1347-9032 (Linking)
DP  - 2024 Feb 14
TI  - Phase I trial of apatinib and paclitaxel+oxaliplatin+5-FU/levoleucovorin for 
      treatment-naive advanced gastric cancer.
LID - 10.1111/cas.16110 [doi]
AB  - Chinese guidelines recommend POF (paclitaxel, oxaliplatin, and 
      5-FU/levoleucovorin) as first-line treatment for advanced gastric cancer (AGC). 
      Apatinib can augment the antitumor effect of paclitaxel, oxaliplatin, or 
      fluorouracil in preclinical studies of AGC. A phase I clinical trial was 
      conducted to evaluate the anticancer activity and maximum tolerated dose (MTD) of 
      apatinib plus POF in treatment-naive patients with AGC and to establish a 
      recommended phase II dose. Participants received escalating doses of daily oral 
      apatinib (250, 375, 500, 625, 750, and 850 mg) plus POF every 2 weeks using a 
      conventional "3 + 3" study design. Among 21 treated patients, one experienced a 
      dose-limiting toxicity (grade 3 skin ulceration at 850 mg). No MTD was reached. 
      Apatinib 750 mg plus POF was recommended for phase II study. The most common 
      grade 3-4 adverse events (AEs) were neutropenia (33.3%), mucositis (14.3%), and 
      hand-foot syndrome (14.3%). Median progression-free and overall survival were 
      10.4 months (95% CI: 6.3, 14.6) and 18.4 months (95% CI: 9.8, 28.2), 
      respectively. Apatinib up to 850 mg coadministered with POF was well tolerated 
      with manageable AEs. The safety and anticancer activity of this regimen warrants 
      its further investigation as first-line treatment for AGC in a larger study.
CI  - (c) 2024 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd 
      on behalf of Japanese Cancer Association.
FAU - Zhao, Shen
AU  - Zhao S
AD  - Department of Gastrointestinal Medical Oncology, Clinical Oncology School of 
      Fujian Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan 
      University Shanghai Cancer Center), Fuzhou, China.
AD  - Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, China.
FAU - Su, LiYu
AU  - Su L
AD  - Department of Gastrointestinal Medical Oncology, Clinical Oncology School of 
      Fujian Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan 
      University Shanghai Cancer Center), Fuzhou, China.
FAU - Huang, Feng
AU  - Huang F
AD  - Department of Gastrointestinal Surgery, Clinical Oncology School of Fujian 
      Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan University 
      Shanghai Cancer Center), Fuzhou, China.
FAU - Zhuo, Changhua
AU  - Zhuo C
AUID- ORCID: 0000-0002-5900-9048
AD  - Department of Gastrointestinal Surgery, Clinical Oncology School of Fujian 
      Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan University 
      Shanghai Cancer Center), Fuzhou, China.
FAU - Ye, Zaisheng
AU  - Ye Z
AD  - Department of Gastrointestinal Surgery, Clinical Oncology School of Fujian 
      Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan University 
      Shanghai Cancer Center), Fuzhou, China.
FAU - Li, Hui
AU  - Li H
AD  - Department of Gastrointestinal Medical Oncology, Clinical Oncology School of 
      Fujian Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan 
      University Shanghai Cancer Center), Fuzhou, China.
FAU - Yin, Yi
AU  - Yin Y
AD  - Department of Gastrointestinal Medical Oncology, Clinical Oncology School of 
      Fujian Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan 
      University Shanghai Cancer Center), Fuzhou, China.
AD  - Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, China.
FAU - Gao, Pengqiang
AU  - Gao P
AD  - Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, 
      China.
FAU - Zhu, Yong
AU  - Zhu Y
AD  - Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, 
      China.
FAU - Lin, Rongbo
AU  - Lin R
AUID- ORCID: 0000-0002-6877-1691
AD  - Department of Gastrointestinal Medical Oncology, Clinical Oncology School of 
      Fujian Medical University, Fujian Cancer Hospital (Fujian Branch of Fudan 
      University Shanghai Cancer Center), Fuzhou, China.
AD  - Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20240214
PL  - England
TA  - Cancer Sci
JT  - Cancer science
JID - 101168776
SB  - IM
OTO - NOTNLM
OT  - apatinib
OT  - clinical trial
OT  - combination chemotherapy
OT  - gastric cancer
OT  - phase 1
OT  - tyrosine protein kinase inhibitors
EDAT- 2024/02/15 00:42
MHDA- 2024/02/15 00:42
CRDT- 2024/02/14 19:03
PHST- 2024/01/23 00:00 [revised]
PHST- 2023/11/15 00:00 [received]
PHST- 2024/01/31 00:00 [accepted]
PHST- 2024/02/15 00:42 [medline]
PHST- 2024/02/15 00:42 [pubmed]
PHST- 2024/02/14 19:03 [entrez]
AID - 10.1111/cas.16110 [doi]
PST - aheadofprint
SO  - Cancer Sci. 2024 Feb 14. doi: 10.1111/cas.16110.