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mHCC - 1st line (L1), immune chekpoint inhibitors versus sorafenib, 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) 0.71 [0.58, 0.85]< 164%4 studies (4/-)100.0 %lownot evaluable highcrucial-
deaths (OS) (extension) 0.81 [0.73, 0.91]< 10%2 studies (2/-)100.0 %lownot evaluable highimportant-
progression or deaths (PFS) 0.80 [0.63, 1.02]< 181%3 studies (3/-)96.1 %some concernnot evaluable moderateimportant-
objective responses (ORR) 2.57 [1.79, 3.69]> 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 0.90 [0.38, 2.16]< 162%3 studies (3/-)59.1 %lownot evaluable highnon important-
AE (grade 3-4) 1.34 [0.71, 2.53]< 190%3 studies (3/-)18.3 %lownot evaluable highnon important-
AE leading to death (grade 5) 1.03 [0.66, 1.61]< 10%3 studies (3/-)44.8 %lownot evaluable highnon important-
AE leading to treatment discontinuation (any grade) 1.41 [0.69, 2.86]< 180%3 studies (3/-)17.3 %lownot evaluable highnon important-
SAE (any grade) 1.38 [0.92, 2.07]< 10%1 study (1/-)6.1 %NAnot evaluable non important-
STRAE (grade 3-4) 0.30 [0.22, 0.41]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.53 [0.28, 1.00]< 10%1 study (1/-)97.5 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 0.47 [0.12, 1.90]< 10%1 study (1/-)85.6 %NAnot evaluable non important-
Acute kidney injury AE (grade 3-4) 0.16 [0.02, 1.51]< 10%1 study (1/-)94.5 %NAnot evaluable non important-
Alopecia AE (grade 3-4) 0.47 [0.01, 23.97]< 10%1 study (1/-)64.3 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 1.07 [0.32, 3.53]< 10%1 study (1/-)45.7 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.12 [0.01, 1.05]< 10%1 study (1/-)97.2 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.47 [0.01, 23.97]< 10%1 study (1/-)64.3 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.24 [0.01, 7.07]< 10%1 study (1/-)79.4 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.31 [0.09, 1.11]< 10%1 study (1/-)96.4 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.34 [0.12, 1.01]< 10%1 study (1/-)97.4 %NAnot evaluable non important-
Dyspepsia AE (grade 3-4) 0.12 [0.01, 2.61]< 10%1 study (1/-)90.9 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.63 [0.14, 2.84]< 10%1 study (1/-)72.7 %NAnot evaluable non important-
Epistaxis AE (grade 3-4) 0.24 [0.01, 7.07]< 10%1 study (1/-)79.4 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.75 [0.24, 2.34]< 10%1 study (1/-)68.8 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 1.29 [0.73, 2.28]< 10%1 study (1/-)18.8 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 1.39 [0.61, 3.18]< 10%1 study (1/-)21.8 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 2.91 [0.64, 13.19]< 10%1 study (1/-)8.3 %NAnot evaluable non important-
Infusion-related reaction AE (grade 3-4) 7.75 [0.44, 135.83]< 10%1 study (1/-)8.3 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.47 [0.03, 7.61]< 10%1 study (1/-)70.0 %NAnot evaluable non important-
Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4) 0.02 [0.00, 0.28]< 10%1 study (1/-)99.7 %NAnot evaluable non important-
Proteinuria AE (grade 3-4) 4.86 [0.62, 38.30]< 10%1 study (1/-)6.8 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 0.47 [0.01, 23.97]< 10%1 study (1/-)64.3 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.95 [0.17, 5.23]< 10%1 study (1/-)52.4 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.06 [0.00, 1.10]< 10%1 study (1/-)97.0 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.95 [0.23, 3.84]< 10%1 study (1/-)53.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.95 [0.09, 10.54]< 10%1 study (1/-)51.7 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 0.24 [0.01, 7.07]< 10%1 study (1/-)79.4 %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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