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urothelial cancer (UC) - bladder cancer (BC), atezolizumab plus SoC , 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) 0.83 [0.69, 1.00]< 10%1 study (1/-)97.5 %NAnot evaluable crucial-
progression or deaths (PFS) 0.82 [0.70, 0.96]< 10%1 study (1/-)99.3 %NAnot evaluable important-
CRR 1.96 [1.21, 3.17]> 10%1 study (1/-)99.7 %NAnot evaluable non important-
DOR 0.70 [0.46, 1.08]< 10%1 study (1/-)94.7 %NAnot evaluable non important-
objective responses (ORR) 1.15 [0.88, 1.51]> 10%1 study (1/-)84.7 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 2.34 [0.43, 12.83]< 10%1 study (1/-)16.5 %NAnot evaluable non important-
AE (grade 3-4) 0.92 [0.63, 1.34]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
AE leading to death (grade 5) 1.27 [0.70, 2.27]< 10%1 study (1/-)21.6 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.05 [0.79, 1.40]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
SAE (any grade) 1.11 [0.85, 1.46]< 10%1 study (1/-)21.9 %NAnot evaluable non important-
STRAE (any grade) 1.33 [0.99, 1.80]< 10%1 study (1/-)3.0 %NAnot evaluable non important-
TRAE (any grade) 1.04 [0.53, 2.03]< 10%1 study (1/-)45.3 %NAnot evaluable non important-
TRAE (grade 3-4) 1.02 [0.72, 1.43]< 10%1 study (1/-)46.4 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.96 [0.60, 6.40]< 10%1 study (1/-)13.4 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Anaemia TRAE (grade 3-4) 1.11 [0.67, 1.84]< 10%1 study (1/-)34.7 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 2.00 [0.82, 4.92]< 10%1 study (1/-)6.5 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 2.59 [0.27, 25.03]< 10%1 study (1/-)20.7 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 2.61 [0.70, 9.73]< 10%1 study (1/-)7.6 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 1.73 [0.31, 9.49]< 10%1 study (1/-)26.5 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 2.01 [1.12, 3.62]< 10%1 study (1/-)1.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.72 [0.06, 51.51]< 10%1 study (1/-)37.9 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.86 [0.02, 43.49]< 10%1 study (1/-)52.9 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 1.11 [0.55, 2.26]< 10%1 study (1/-)38.6 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 1.08 [0.82, 1.42]< 10%1 study (1/-)29.8 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 1.43 [0.81, 2.50]< 10%1 study (1/-)10.8 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.66 [0.37, 1.17]< 10%1 study (1/-)92.1 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 1.76 [0.81, 3.80]< 10%1 study (1/-)7.7 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 2.22 [1.05, 4.68]< 10%1 study (1/-)1.8 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.74 [0.44, 1.24]< 10%1 study (1/-)87.3 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.54 [0.23, 1.27]< 10%1 study (1/-)92.0 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 1.38 [1.03, 1.84]< 10%1 study (1/-)1.5 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 1.25 [0.89, 1.76]< 10%1 study (1/-)10.1 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.86 [0.37, 2.00]< 10%1 study (1/-)63.9 %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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