PMID- 35381739
OWN - NLM
STAT- MEDLINE
DCOM- 20220407
LR  - 20220407
IS  - 1998-4138 (Electronic)
IS  - 1998-4138 (Linking)
VI  - 17
IP  - 7
DP  - 2021 Dec
TI  - The efficacy and safety of combined ipilimumab and nivolumab versus ipilimumab in 
      patients with Stage III/IV unresectable melanoma: A systematic review and 
      meta-analysis.
PG  - 1679-1688
LID - 10.4103/jcrt.jcrt_1669_21 [doi]
AB  - BACKGROUND: In this meta-analysis, we compared the clinical efficacy and safety 
      of ipilimumab/nivolumab combination therapy with those of ipilimumab monotherapy 
      for stage III/IV unresectable melanoma. MATERIALS AND METHODS: A search for 
      randomized controlled trials (RCTs) reported by relevant studies conducted up to 
      May 2021 was performed in the PubMed, Cochrane Library, Embase, CNKI, Wanfang, 
      and VIP databases. Literature screening, data extraction, and quality evaluation 
      were conducted independently by two researchers. The target parameters were 
      complete response (CR), partial response (PR), objective response rate (ORR), 
      time to progression (TTP), overall survival (OS), adverse events (AEs), and AEs 
      in each organ system. RESULTS: Ten articles reporting the results of three RCTs, 
      including 790 subjects, were evaluated. In the pooled results, the CR (risk ratio 
      [RR] = 4.48, 95% confidence interval [CI] [2.73, 7.33]), PR (RR = 2.82, 95% CI 
      [2.09, 3.81]), and ORR (RR=3.31, 95%CI[2.60, 4.20]) were statistically different 
      between the two treatment groups. The CR, PR, and ORR in the combination therapy 
      group were 22.00% (90/409), 36.43% (149/409), and 58.44% (239/409), respectively, 
      versus 4.97% (18/362), 12.98% (47/362), and 17.96% (65/362), respectively, in the 
      monotherapy group. There were significant differences in TTP and OS between the 
      two groups (TTP: hazard ratio [HR] = 0.41, 95% CI [0.35, 0.49]; OS: HR = 0.55, 
      95% CI [0.45, 0.67]). PFS and OS were longer in the combination therapy group 
      than in the monotherapy group. The incidence of treatment-related AEs (TRAEs) and 
      AEs leading to death (RR = 1.00, 95% CI [0.97, 1.02]; RR = 2.28, 95% CI [0.54, 
      9.55], respectively) was not significantly different, but the incidence of Grade 
      3-4 AEs and AEs leading to discontinuation was higher in the combination therapy 
      group than in the monotherapy group (RR = 1.81, 95% CI [1.15, 2.86]); RR = 2.66, 
      95% CI [2.02, 3.52], respectively). CONCLUSIONS: Ipilimumab/nivolumab combination 
      therapy was more effective than ipilimumab monotherapy for patients with stage 
      III/IV unresectable melanoma. Although the incidence of TRAEs did not differ 
      between the two groups, the severity of cases (Grade 3-4 AEs and AEs leading to 
      discontinuation) was lower in the monotherapy group than in the combination 
      therapy group. Additional high-quality studies are needed to verify the efficacy 
      and safety of this drug combination, determine the optimal dosage, and explore 
      additional potential drug combinations.
FAU - Zhu, Yuqing
AU  - Zhu Y
AD  - The First Clinical Medical College of Zhejiang Chinese Medical University, Hang 
      Zhou, Zhejiang Province, China.
FAU - Cheng, Hui
AU  - Cheng H
AD  - The Second Clinical Medical College of Zhejiang Chinese Medical University, Hang 
      Zhou, Zhejiang Province, China.
FAU - Zhong, Minhong
AU  - Zhong M
AD  - The First Clinical Medical College of Zhejiang Chinese Medical University, Hang 
      Zhou, Zhejiang Province, China.
FAU - Hu, Yijie
AU  - Hu Y
AD  - The First Clinical Medical College of Zhejiang Chinese Medical University, Hang 
      Zhou, Zhejiang Province, China.
FAU - Li, Qiushuang
AU  - Li Q
AD  - Department of Clinical Evaluation Center, The First Affiliated Hospital of 
      Zhejiang Chinese Medical University, Hang Zhou, Zhejiang Province, China.
FAU - Gao, Xiangfu
AU  - Gao X
AD  - Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese 
      Medical University, Hang Zhou, Zhejiang Province, China.
FAU - Liu, Shan
AU  - Liu S
AD  - Department of Clinical Evaluation Center, The First Affiliated Hospital of 
      Zhejiang Chinese Medical University, Hang Zhou, Zhejiang Province, China.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - India
TA  - J Cancer Res Ther
JT  - Journal of cancer research and therapeutics
JID - 101249598
RN  - 0 (Ipilimumab)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Humans
MH  - Ipilimumab/adverse effects
MH  - *Melanoma
MH  - Nivolumab/adverse effects
MH  - *Skin Neoplasms/drug therapy
OTO - NOTNLM
OT  - Ipilimumab
OT  - melanoma
OT  - meta-analysis
OT  - nivolumab
OT  - systematic evaluation
COIS- None
EDAT- 2022/04/07 06:00
MHDA- 2022/04/08 06:00
CRDT- 2022/04/06 02:59
PHST- 2022/04/06 02:59 [entrez]
PHST- 2022/04/07 06:00 [pubmed]
PHST- 2022/04/08 06:00 [medline]
AID - JCanResTher_2021_17_7_1679_339231 [pii]
AID - 10.4103/jcrt.jcrt_1669_21 [doi]
PST - ppublish
SO  - J Cancer Res Ther. 2021 Dec;17(7):1679-1688. doi: 10.4103/jcrt.jcrt_1669_21.