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metastatic/advanced mGC or mGEJC, avelumab based treatment , meta-analysis of study results

Outcome Relative effect 95%CI LoD Trt. better when I2 k (RCT/OBS) Bayesian probability Overall ROB Publication bias Degree of certainty Endpoint importance Published MA

efficacy endpoints 00

deaths (OS) 1.00 [0.83, 1.20]< 135%2 studies (2/-)52.0 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 1.34 [0.81, 2.20]< 191%2 studies (2/-)12.6 %some concernnot evaluable moderateimportant-
DCR 0.49 [0.30, 0.81]> 164%2 studies (2/-)0.3 %some concernnot evaluable moderatenon important-
objective responses (ORR) 0.83 [0.52, 1.33]> 10%2 studies (2/-)21.9 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 1.25 [0.67, 2.33]< 10%1 study (1/-)24.1 %NAnot evaluable non important-
AE (grade 3-4) 0.98 [0.68, 1.40]< 10%1 study (1/-)55.1 %NAnot evaluable non important-
AE leading to death (grade 5) 1.22 [0.57, 2.59]< 10%1 study (1/-)30.3 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.43 [0.28, 0.64]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
SAE (any grade) 1.26 [0.86, 1.83]< 10%1 study (1/-)11.9 %NAnot evaluable non important-
STRAE (any grade) 0.79 [0.42, 1.50]< 10%1 study (1/-)76.3 %NAnot evaluable non important-
TRAE (any grade) 0.40 [0.29, 0.55]< 112%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.27 [0.19, 0.39]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 0.48 [0.04, 5.36]< 10%2 studies (2/-)72.1 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (any grade) 0.42 [0.18, 0.98]< 158%2 studies (2/-)97.8 %some concernnot evaluable moderatenon important-

TRAE (grade 3-4) endpoints 00

Alopecia TRAE (grade 3-4) 0.96 [0.02, 48.74]< 10%1 study (1/-)50.8 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.04 [0.00, 0.71]< 10%1 study (1/-)98.5 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.19 [0.02, 1.63]< 10%1 study (1/-)93.4 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.12 [0.01, 2.25]< 10%1 study (1/-)92.0 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.16 [0.02, 1.31]< 10%1 study (1/-)95.6 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.48 [0.04, 5.32]< 10%1 study (1/-)72.4 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.08 [0.00, 1.40]< 10%1 study (1/-)95.7 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 1.29 [0.28, 5.84]< 10%1 study (1/-)37.1 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.72 [0.16, 3.25]< 10%1 study (1/-)66.7 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 0.48 [0.04, 5.32]< 10%1 study (1/-)72.4 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 1.93 [0.06, 57.86]< 10%1 study (1/-)35.5 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.24 [0.01, 5.32]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.02 [0.00, 0.30]< 10%1 study (1/-)99.7 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.24 [0.01, 5.32]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.07 [0.00, 1.17]< 10%1 study (1/-)96.6 %NAnot evaluable non important-

LoD: level of statistical demonstration: Statistically conclusive: statistically significant with a strict control of overall risk of type 1 error (statistically demonstrated), does not take into account the risk of bias; suggested: nominally statistically significant but without a strict control of overall risk of type 1 error; inconclusive: not nominally statistically significant; safety concerns;
Bayesian probability: Bayesian posterior probability of treatment effect (computed with a noninformative prior); ROB: risk of bias; k: number of studies; published MA: number of published meta-analysis on the same topic; degree of certainty adapted from GRADE. Trt. better when: indicates when the relative treatment effect shows that the studied treatment is better than control.



 

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