PMID- 29372626
OWN - NLM
STAT- MEDLINE
DCOM- 20190513
LR  - 20221207
IS  - 1743-7563 (Electronic)
IS  - 1743-7555 (Linking)
VI  - 14
IP  - 5
DP  - 2018 Oct
TI  - Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with 
      advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data 
      from the ML17032 phase III clinical trial.
PG  - e310-e316
LID - 10.1111/ajco.12832 [doi]
AB  - AIM: To confirm non-inferiority and test potential superiority of 
      capecitabine/cisplatin (XP) over 5-fluorouracil (5-FU)/cisplatin (FP) as 
      first-line treatment for advanced gastric cancer (AGC) in Chinese patients. 
      METHODS: In open-label phase III ML17032 trial, AGC (stage IIIA-IV) patients with 
      or without metastases were randomized 1:1 to receive cisplatin (80 mg/m(2) /day 
      intravenous [IV] day 1) with either capecitabine (1000 mg/m(2) /day oral [PO] 
      twice daily [BID], days 1-14; XP) or 5-FU (800 mg/m(2) /day continuous IV days 
      1-5; FP) every 3 weeks. The primary objective was to confirm the non-inferiority 
      of XP over FP for progression-free survival (PFS). RESULTS: The intent-to-treat 
      (ITT) population included 126 Chinese patients (XP-62, FP-64; 67.5% male, mean 
      age 54.7 years). The primary analysis was performed on the per-protocol (PP) 
      population (105 patients; XP-51, FP-54; 65.7% male). Median PFS in the XP and FP 
      groups was 7.2 and 4.5 months, respectively. The adjusted hazard ratio (HR) for 
      PFS was 0.52 (95% confidence interval [CI]: 0.32-0.83, P = 0.006). Unadjusted HR 
      for PFS in the ITT population was 0.63 (95% CI, 0.42-0.94, P = 0.022). The most 
      frequent drug-related grade 3/4 adverse events (AEs) were neutropenia (XP-20.7%, 
      FP-17.7%) and gastrointestinal disorders (XP-19.0%, FP-19.4%). The overall 
      incidence of grade 3/4 AEs (XP-43.1%, FP-46.8%), serious AEs (XP-1.7%, FP-3.2%), 
      and AEs related to treatment discontinuation (XP-10.3%, FP-16.1%) were 
      comparable. CONCLUSION: XP had a similar safety profile and may demonstrate 
      superiority for PFS compared to FP as first-line treatment of Chinese patients 
      with AGC (NCT02563054).
CI  - (c) 2018 John Wiley & Sons Australia, Ltd.
FAU - Chen, Jia
AU  - Chen J
AD  - Department of Oncology, Jiangsu Cancer Hospital, Jiangsu, China.
FAU - Xiong, Jianping
AU  - Xiong J
AD  - Department of Oncology, The First Affiliated Hospital of Nanchang University, 
      Jiangxi, China.
FAU - Wang, Jiejun
AU  - Wang J
AD  - Department of Oncology, Shanghai Changzheng Hospital, Shanghai, China.
FAU - Zheng, Leizhen
AU  - Zheng L
AD  - Department of Oncology, Xinhua Hospital Affiliated to Shanghai Jiao Tong 
      University School of Medicine, Shanghai, China.
FAU - Gao, YanFei
AU  - Gao Y
AD  - Roche Pharmaceuticals Ltd., Shanghai, China.
FAU - Guan, Zhongzhen
AU  - Guan Z
AD  - Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangdong, 
      China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02563054
GR  - Shanghai Roche Pharmaceuticals Ltd., China/
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180126
PL  - Australia
TA  - Asia Pac J Clin Oncol
JT  - Asia-Pacific journal of clinical oncology
JID - 101241430
RN  - 6804DJ8Z9U (Capecitabine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/secondary
MH  - Adenocarcinoma, Mucinous/*drug therapy/secondary
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Asian People
MH  - Capecitabine/administration & dosage
MH  - Carcinoma, Signet Ring Cell/*drug therapy/secondary
MH  - Cisplatin/administration & dosage
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Stomach Neoplasms/*drug therapy/pathology
MH  - Survival Rate
MH  - Young Adult
OTO - NOTNLM
OT  - 5-fluorouracil
OT  - Chinese
OT  - advanced gastric cancer
OT  - capecitabine
OT  - cisplatin
EDAT- 2018/01/27 06:00
MHDA- 2019/05/14 06:00
CRDT- 2018/01/27 06:00
PHST- 2017/06/15 00:00 [received]
PHST- 2017/11/02 00:00 [accepted]
PHST- 2018/01/27 06:00 [pubmed]
PHST- 2019/05/14 06:00 [medline]
PHST- 2018/01/27 06:00 [entrez]
AID - 10.1111/ajco.12832 [doi]
PST - ppublish
SO  - Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 
      2018 Jan 26.