PMID- 36808337
OWN - NLM
STAT- MEDLINE
DCOM- 20230228
LR  - 20230502
IS  - 2284-0729 (Electronic)
IS  - 1128-3602 (Linking)
VI  - 27
IP  - 3
DP  - 2023 Feb
TI  - Comparative clinical outcomes and predictive biomarkers of sintilimab 
      combinations vs. single therapy in cancer: a systematic review and meta-analysis 
      of randomized controlled trials.
PG  - 911-923
LID - 31184 [pii]
LID - 10.26355/eurrev_202302_31184 [doi]
AB  - OBJECTIVE: This study aimed to compare the efficacy and safety between sintilimab 
      combinations and single treatment in cancer patients, as well as identify 
      biomarkers for selection of patients who might benefit from the combination 
      treatments. MATERIALS AND METHODS: A search of randomized clinical trials (RCTs) 
      comparing sintilimab combinations vs. single treatment in different tumors 
      according to the PRISMA guidelines was performed. Selected endpoints included 
      completion response rate (CR), objective response rate (ORR), disease control 
      rate (DCR), overall survival (OS), progression-free survival (PFS), major adverse 
      effects (AEs), immune-related adverse events (irAEs). Subgroup analyses based on 
      different combination regimens, tumor type and basic biomarkers were included. 
      RESULTS: Results reported from 11 RCTs involving 2,248 patients were included in 
      this analysis. Pooled results indicated that both sintilimab plus chemotherapy 
      and sintilimab plus targeted therapy significantly improved CR [RR=2.44, 95% CI 
      (1.14, 5.20), p=0.021; RR=2.91, 95% CI (1.29, 6.57), p=0.010], ORR [RR=1.34, 95% 
      CI (1.13, 1.59), p=0.001; RR=1.70, 95% CI (1.13, 2.56), p=0.011], PFS [HR=0.56, 
      95% CI (0.43, 0.69), p<0.001; HR=0.56, 95% CI (0.49, 0.64), p<0.001] and OS 
      [HR=0.59, 95% CI (0.48, 0.70), p<0.001]. Subgroup analyses suggested that the 
      sintilimab-chemotherapy group exhibited a superior PFS benefit than the 
      chemotherapy alone group regardless of age, gender, EGOS PS, PD-L1 expression, 
      smoking status, and clinical stage. There were no significant statistical 
      differences in the incidence of any grade and grade 3 or worse AEs between the 
      two groups [RR=1.00, 95% CI (0.91, 1.10), p=0.991; RR=1.06, 95% CI (0.94, 1.20), 
      p=0.352]. While the incidence of any grade irAEs was higher with sintilimab plus 
      chemotherapy as compared to chemotherapy alone (RR=1.24, 95% CI (1.01, 1.54), 
      p=0.044), but no significant difference was found for grade 3 or worse irAEs 
      (RR=1.11, 95% CI (0.60, 2.03), p=0.741). CONCLUSIONS: Sintilimab combinations 
      brought benefits to a greater number of patients at the cost of a mild increase 
      of irAEs. PD-L1 expression may not be used as a predictive biomarker, composite 
      biomarkers consisting of PD-L1 and MHC class II expression are worth to be 
      explored to enlarge the patient population that benefits from sintilimab 
      combinations.
FAU - Li, J
AU  - Li J
AD  - Pharmaceutical Department, Hubei Cancer Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China. 104076762@qq.com.
FAU - Zang, X-Y
AU  - Zang XY
FAU - Dai, Z
AU  - Dai Z
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - Italy
TA  - Eur Rev Med Pharmacol Sci
JT  - European review for medical and pharmacological sciences
JID - 9717360
RN  - 0 (B7-H1 Antigen)
RN  - 0 (Biomarkers)
RN  - 8FU7FQ8UPK (sintilimab)
SB  - IM
MH  - Humans
MH  - B7-H1 Antigen
MH  - Biomarkers
MH  - *Lung Neoplasms/pathology
MH  - *Neoplasms
MH  - Randomized Controlled Trials as Topic
EDAT- 2023/02/23 06:00
MHDA- 2023/02/25 06:00
CRDT- 2023/02/22 12:47
PHST- 2023/02/22 12:47 [entrez]
PHST- 2023/02/23 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
AID - 31184 [pii]
AID - 10.26355/eurrev_202302_31184 [doi]
PST - ppublish
SO  - Eur Rev Med Pharmacol Sci. 2023 Feb;27(3):911-923. doi: 
      10.26355/eurrev_202302_31184.