PMID- 31096532
OWN - NLM
STAT- MEDLINE
DCOM- 20190529
LR  - 20210112
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 98
IP  - 20
DP  - 2019 May
TI  - Risk of dermatologic and mucosal adverse events associated with PD-1/PD-L1 
      inhibitors in cancer patients: A meta-analysis of randomized controlled trials.
PG  - e15731
LID - 10.1097/MD.0000000000015731 [doi]
LID - e15731
AB  - BACKGROUND: Programmed death 1 protein (PD-1) and programmed death-ligand 1 
      (PD-L1) inhibitors are promising cancer immunotherapy. Their dermatologic safety 
      profiles are still poorly understood. The purpose of this article is to evaluate 
      the incidence of selected dermatologic and mucosal adverse effects (AEs) and 
      determine the risk of developing these adverse events associated with PD-1/PD-L1 
      inhibitors, compared with chemotherapy or ipilimumab. METHODS: PubMed was 
      searched for eligible studies (up to February 21, 2019). Only phase II and phase 
      III randomized controlled trials (RCTs) compared with chemotherapy or ipilimumab 
      monotherapy were included in this meta-analysis. RESULTS: A total 11,465 patients 
      from 18 clinical trials were included in this meta-analysis. Rash and pruritus 
      were the most frequently reported dermatologic AE, with incidence 11.8% and 12.2% 
      respectively. Compared with patients receiving chemotherapy, PD-1/PD-L1 inhibitor 
      treated patients had higher risk of developing rash (RR = 1.84), pruritus 
      (RR = 3.74) and vitiligo (RR = 9.54), and also lower risk in developing mucosal 
      inflammation (RR = 0.26), stomatitis (RR = 0.26), and alopecia (RR = 0.03). 
      Additionally, anti-PD1/PD-L1 drugs had similar risk of developing rash and lower 
      risk of inducing pruritus compared to ipilimumab. In the subgroup analysis, PD-L1 
      inhibitor demonstrated better safety than PD-1 inhibitor in developing rash, with 
      RR = 1.38 and RR = 2.11, respectively. CONCLUSION: Our meta-analysis concluded 
      that anti PD-1/PD-L1 drugs have different dermatological and mucosal safety 
      profile compared to conventional therapy, and differences of dermatological 
      toxicity between PD-1 and PD-L1 inhibitor warrant further investigation.
FAU - Yang, Wenwei
AU  - Yang W
AD  - Department of Clinical Medicine, Queen Mary College of Nanchang University, 
      Nanchang, Jiangxi.
FAU - Li, Shuquan
AU  - Li S
AD  - Department of Clinical Medicine, Queen Mary College of Nanchang University, 
      Nanchang, Jiangxi.
FAU - Yang, Qingrui
AU  - Yang Q
AD  - Department of Rheumatology and Immunology, Shandong University Affiliated 
      Provincial Hospital, Jinan, Shandong, China.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (Ipilimumab)
RN  - 0 (Programmed Cell Death 1 Receptor)
SB  - IM
MH  - Alopecia/chemically induced
MH  - Antineoplastic Agents, Immunological/*adverse effects
MH  - B7-H1 Antigen/*antagonists & inhibitors
MH  - Drug Therapy
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Exanthema/chemically induced
MH  - Humans
MH  - Incidence
MH  - Ipilimumab/*adverse effects
MH  - Mucositis/chemically induced
MH  - Programmed Cell Death 1 Receptor/*antagonists & inhibitors
MH  - Pruritus/chemically induced
MH  - Randomized Controlled Trials as Topic
MH  - Stomatitis/chemically induced
MH  - Vitiligo/chemically induced
PMC - PMC6531085
COIS- This study received no support in the form of equipment, drugs, grants, or 
      funding. Authors declare that there are no conflicts of interest with regard to 
      this study.
EDAT- 2019/05/18 06:00
MHDA- 2019/05/30 06:00
PMCR- 2019/05/17
CRDT- 2019/05/18 06:00
PHST- 2019/05/18 06:00 [entrez]
PHST- 2019/05/18 06:00 [pubmed]
PHST- 2019/05/30 06:00 [medline]
PHST- 2019/05/17 00:00 [pmc-release]
AID - 00005792-201905170-00103 [pii]
AID - MD-D-19-02396 [pii]
AID - 10.1097/MD.0000000000015731 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2019 May;98(20):e15731. doi: 10.1097/MD.0000000000015731.