PMID- 27813059
OWN - NLM
STAT- MEDLINE
DCOM- 20170623
LR  - 20220409
IS  - 1097-0215 (Electronic)
IS  - 0020-7136 (Linking)
VI  - 140
IP  - 4
DP  - 2017 Feb 15
TI  - Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 
      27 prospective clinical trials.
PG  - 948-958
LID - 10.1002/ijc.30501 [doi]
AB  - Immune checkpoint inhibition therapy has benefited people and shown powerful 
      anti-tumor activity during the past several years. Nivolumab, a fully human IgG4 
      monoclonal antibody against PD-1, is a widely studied immune checkpoint inhibitor 
      for the treatment of cancers. To assess the safety and efficacy of nivolumab, 27 
      clinical trials on nivolumab were analyzed. Results showed that the summary risks 
      of all grade adverse effects (AEs) and grade >/=3 AEs were 0.65 and 0.12. The rate 
      of nivolumab-related death was 0.25%. The most common any grade AEs were fatigue 
      (25.1%), rush (13.0%), pruritus (12.5%), diarrhea (12.1%), nausea (11.8%) and 
      asthenia (10.4%). The most common grade >/=3 AEs were hypophosphatemia (only 2.3%) 
      and lymphopenia (only 2.1%). The pooled objective response rate (ORR), 6-month 
      progression-free survival (PFS) rate and 1-year overall survival (OS) rate were 
      0.26, 0.40 and 0.52, respectively. The odds ratio of ORR between PD-L1 positive 
      and negative was 2.34 (95% CI 1.77-3.10, p < 0.0001). The odds ratios of ORR, 
      6-month PFS rate and 1-year OS rate between nivolumab and chemotherapeutics were 
      2.77 (95% CI 1.69-4.56, p < 0.0001), 1.97 (95% CI 1.02-3.81, p = 0.04) and 1.87 
      (95% CI 1.46-2.40, p <0.0001), respectively. In conclusion, nivolumab has durable 
      outcomes with tolerable AEs and drug-related deaths in cancer patients. Nivolumab 
      monotherapy has better treatment response compared with chemotherapy, whereas 
      chemotherapeutics have significantly higher risk of adverse effects than 
      nivolumab.
CI  - (c) 2016 UICC.
FAU - Tie, Yan
AU  - Tie Y
AD  - State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, West 
      China Medical School Sichuan University, Chengdu, China.
AD  - Collaborative Innovation Center of Biotherapy, West China Hospital, West China 
      Medical School Sichuan University, Chengdu, China.
FAU - Ma, Xuelei
AU  - Ma X
AD  - State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, West 
      China Medical School Sichuan University, Chengdu, China.
AD  - Collaborative Innovation Center of Biotherapy, West China Hospital, West China 
      Medical School Sichuan University, Chengdu, China.
FAU - Zhu, Chenjing
AU  - Zhu C
AD  - West China Medical School, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Mao, Ye
AU  - Mao Y
AD  - State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, West 
      China Medical School Sichuan University, Chengdu, China.
AD  - Collaborative Innovation Center of Biotherapy, West China Hospital, West China 
      Medical School Sichuan University, Chengdu, China.
FAU - Shen, Kai
AU  - Shen K
AD  - West China Medical School, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Wei, Xiawei
AU  - Wei X
AD  - Department of Gerontology, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Chen, Yan
AU  - Chen Y
AD  - Department of Gerontology, West China Hospital, Sichuan University, Chengdu, 
      China.
FAU - Zheng, Heng
AU  - Zheng H
AD  - Department of Gynaecology, West China Second Hospital, Sichuan University, 
      Chengdu, China.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20161116
PL  - United States
TA  - Int J Cancer
JT  - International journal of cancer
JID - 0042124
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Neoplasm Proteins)
RN  - 0 (PDCD1 protein, human)
RN  - 0 (Programmed Cell Death 1 Receptor)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
MH  - Clinical Trials as Topic/*statistics & numerical data
MH  - Disease-Free Survival
MH  - Drug Eruptions/etiology
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - Hematologic Diseases/chemically induced
MH  - Humans
MH  - Hypophosphatemia/chemically induced
MH  - *Molecular Targeted Therapy/adverse effects
MH  - Neoplasm Proteins/antagonists & inhibitors
MH  - Neoplasms/*drug therapy
MH  - Nivolumab
MH  - Programmed Cell Death 1 Receptor/antagonists & inhibitors
MH  - Prospective Studies
OTO - NOTNLM
OT  - efficacy
OT  - meta-analysis
OT  - nivolumab
OT  - safety
EDAT- 2016/11/05 06:00
MHDA- 2017/06/24 06:00
CRDT- 2016/11/05 06:00
PHST- 2016/07/23 00:00 [received]
PHST- 2016/10/27 00:00 [accepted]
PHST- 2016/11/05 06:00 [pubmed]
PHST- 2017/06/24 06:00 [medline]
PHST- 2016/11/05 06:00 [entrez]
AID - 10.1002/ijc.30501 [doi]
PST - ppublish
SO  - Int J Cancer. 2017 Feb 15;140(4):948-958. doi: 10.1002/ijc.30501. Epub 2016 Nov 
      16.