PMID- 30013322
OWN - NLM
STAT- MEDLINE
DCOM- 20190116
LR  - 20220331
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 12
DP  - 2018
TI  - Comparisons of therapeutic efficacy and safety of ipilimumab plus GM-CSF versus 
      ipilimumab alone in patients with cancer: a meta-analysis of outcomes.
PG  - 2025-2038
LID - 10.2147/DDDT.S154258 [doi]
AB  - BACKGROUND: Recent clinical studies have shown that initial therapy with combined 
      cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blockade and 
      granulocyte-macrophage colony-stimulating factor (GM-CSF)-based immunotherapies 
      can enhance the antitumor efficacy of this approach. A key unanswered question is 
      whether systemic GM-CSF enhances CTLA-4 blockade. Thus, the objective of this 
      study was taking a meta-analysis of randomized controlled trials to compare the 
      effect of ipilimumab plus GM-CSF versus ipilimumab alone on overall response, 
      overall survival, and progression-free survival, as well as the risk of adverse 
      events (AEs) in patients with cancer. MATERIALS AND METHODS: Searches were made 
      in electronic databases PubMed and Embase, and conference abstracts published by 
      the American Society of Clinical Oncology from 2000 to 2017. Statistical analyses 
      were carried out using either random-effects or fixed-effects models according to 
      the heterogeneity of eligible studies. RESULTS: Six trials comprising of 445 
      patients were included in the meta-analysis. Combination group was superior to 
      the ipilimumab alone in overall response rate, progression-free survival, and 
      overall survival rate (combined relative risk [RR]=1.34, 95% CI: 1.24-1.45, 
      P=0.09; combined hazard ratio [HR]=0.57, 95% CI: 0.32-1.02, P=0.06; combined 
      HR=0.70, 95% CI: 0.60-0.82, P<0.001). Patients with combination therapies had a 
      lower incidence of AEs including high-grade diarrhea (combined RR=0.27, 95% CI: 
      0.11-0.70, P=0.007), nausea (combined RR=0.25, 95% CI: 0.07-0.89, P=0.03), 
      colitis (combined RR=0.34, 95% CI: 0.13-0.86, P=0.02), and fatigue (combined 
      RR=0.91, 95% CI: 0.37-2.2.3, P=0.84) compared to the group having ipilimumab 
      alone. CONCLUSION: These data suggested that the combination of ipilimumab and 
      GM-CSF was associated with a significant improvement in overall survival and 
      lower high-grade toxicities, but there is no difference in overall response rate 
      and progression-free survival among the cancer patients. Therefore, large-scale 
      and well-designed studies are needed to summarize and analyze the data to draw a 
      more convincing conclusion.
FAU - Chen, Peng
AU  - Chen P
AD  - Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, Hubei, 
      430060, People's Republic of China, benhongzh@whu.edu.cn.
FAU - Chen, Fuchao
AU  - Chen F
AD  - Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine, Shiyan, 
      Hubei, 442008, People's Republic of China.
FAU - Zhou, Benhong
AU  - Zhou B
AD  - Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, Hubei, 
      430060, People's Republic of China, benhongzh@whu.edu.cn.
AD  - School of Pharmaceutical Sciences, Wuhan University, Wuhan, Hubei, 430071, 
      People's Republic of China, benhongzh@whu.edu.cn.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20180704
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Ipilimumab)
RN  - 83869-56-1 (Granulocyte-Macrophage Colony-Stimulating Factor)
SB  - IM
MH  - Granulocyte-Macrophage Colony-Stimulating Factor/adverse effects/*therapeutic use
MH  - Humans
MH  - Ipilimumab/adverse effects/*therapeutic use
MH  - Neoplasms/*drug therapy
MH  - Treatment Outcome
PMC - PMC6037403
OTO - NOTNLM
OT  - efficacy
OT  - ipilimumab
OT  - meta-analysis
OT  - safety
OT  - sargramostim
OT  - survival
COIS- Disclosure The authors report no conflicts of interest in this work.
EDAT- 2018/07/18 06:00
MHDA- 2019/01/17 06:00
PMCR- 2018/07/04
CRDT- 2018/07/18 06:00
PHST- 2018/07/18 06:00 [entrez]
PHST- 2018/07/18 06:00 [pubmed]
PHST- 2019/01/17 06:00 [medline]
PHST- 2018/07/04 00:00 [pmc-release]
AID - dddt-12-2025 [pii]
AID - 10.2147/DDDT.S154258 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2018 Jul 4;12:2025-2038. doi: 10.2147/DDDT.S154258. 
      eCollection 2018.