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metastatic-recurrent HNSCC (mHNSCC), pembrolizumab alone versus HER inhibitor, 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 [0.70, 0.99]< 10%1 study (1/-)98.2 %NAnot evaluable crucial-
deaths (OS) (extension) 0.74 [0.61, 0.90]< 10%1 study (1/-)99.9 %NAnot evaluable important-
progression or deaths (PFS) 1.34 [1.13, 1.59]< 10%1 study (1/-)0.0 %NAnot evaluable important-
objective responses (ORR) 0.36 [0.25, 0.53]> 10%1 study (1/-)0.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.31 [0.22, 0.44]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE leading to death (grade 5) 0.84 [0.48, 1.48]< 10%1 study (1/-)72.6 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 0.36 [0.23, 0.55]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 0.05 [0.02, 0.09]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.09 [0.06, 0.13]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.35 [0.09, 1.34]< 10%1 study (1/-)93.6 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.92 [0.06, 57.35]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.04 [0.01, 0.16]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.16 [0.02, 1.31]< 10%1 study (1/-)95.6 %NAnot evaluable non important-
Blood and lymphatic system disorders TRAE (grade 3-4) 0.02 [0.01, 0.07]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Blood creatinine increased TRAE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.96 [0.13, 6.84]< 10%1 study (1/-)51.8 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.12 [0.01, 0.94]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.19 [0.02, 1.62]< 10%1 study (1/-)93.4 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 5.79 [0.29, 116.06]< 10%1 study (1/-)12.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.25 [0.07, 0.92]< 10%1 study (1/-)98.1 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 0.07 [0.02, 0.23]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
General disorders and administration site conditions TRAE (grade 3-4) 0.19 [0.08, 0.46]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 3.85 [0.17, 85.65]< 10%1 study (1/-)20.0 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.92 [0.06, 57.35]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 1.92 [0.06, 57.35]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.31 [0.06, 1.57]< 10%1 study (1/-)92.0 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.03 [0.00, 0.47]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Metabolism and nutrition disorders TRAE (grade 3-4) 0.26 [0.14, 0.49]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.13 [0.03, 0.58]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
Myocarditis TRAE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.48 [0.02, 14.29]< 10%1 study (1/-)66.3 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.03 [0.00, 0.47]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 3.85 [0.17, 85.65]< 10%1 study (1/-)20.0 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.11]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pancreatitis TRAE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 2.42 [0.46, 12.55]< 10%1 study (1/-)14.8 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.11 [0.02, 0.47]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 0.29 [0.11, 0.73]< 10%1 study (1/-)99.6 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.05 [0.00, 0.80]< 10%1 study (1/-)98.2 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.04 [0.00, 0.27]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.09 [0.01, 1.73]< 10%1 study (1/-)94.2 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.96 [0.06, 15.37]< 10%1 study (1/-)51.2 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 0.19 [0.02, 1.62]< 10%1 study (1/-)93.4 %NAnot evaluable non important-
Acute kidney injury AE (grade 3-4) 1.93 [0.35, 10.60]< 10%1 study (1/-)22.7 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.24 [0.13, 0.44]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.31 [0.08, 1.16]< 10%1 study (1/-)95.8 %NAnot evaluable non important-
Blood and lymphatic system disorders AE (grade 3-4) 0.10 [0.06, 0.18]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.28 [0.08, 1.03]< 10%1 study (1/-)97.2 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.23 [0.05, 1.11]< 10%1 study (1/-)96.6 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 2.26 [0.58, 8.83]< 10%1 study (1/-)12.1 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.60 [0.26, 1.42]< 10%1 study (1/-)87.7 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 0.03 [0.00, 0.47]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Gastrointestinal disorders AE (grade 3-4) 0.33 [0.20, 0.56]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
General disorders and administration site conditions AE (grade 3-4) 0.42 [0.23, 0.75]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 7.74 [0.41, 147.13]< 10%1 study (1/-)8.9 %NAnot evaluable non important-
Hypothyroidism AE (grade 3-4) 0.96 [0.02, 48.37]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 0.38 [0.07, 1.97]< 10%1 study (1/-)87.5 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.03 [0.00, 0.47]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Metabolism and nutrition disorders AE (grade 3-4) 0.51 [0.33, 0.77]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Mucosal inflammation AE (grade 3-4) 0.25 [0.08, 0.75]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.03 [0.00, 0.44]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Nervous system disorders AE (grade 3-4) 0.40 [0.18, 0.85]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.01 [0.00, 0.09]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pneumonitis AE (grade 3-4) 0.80 [0.41, 1.56]< 10%1 study (1/-)74.1 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.11 [0.02, 0.47]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Renal and urinary disorders AE (grade 3-4) 1.15 [0.35, 3.81]< 10%1 study (1/-)40.9 %NAnot evaluable non important-
Respiratory, thoracic and mediastinal disorders AE (grade 3-4) 2.17 [1.12, 4.18]< 10%1 study (1/-)1.1 %NAnot evaluable non important-
Sepsis AE (grade 3-4) 2.91 [0.58, 14.53]< 10%1 study (1/-)9.7 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders AE (grade 3-4) 1.61 [0.58, 4.50]< 10%1 study (1/-)18.0 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 0.05 [0.00, 0.80]< 10%1 study (1/-)98.2 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.03 [0.00, 0.25]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Vascular disorders AE (grade 3-4) 0.76 [0.35, 1.64]< 10%1 study (1/-)76.0 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.12 [0.01, 0.94]< 10%1 study (1/-)97.8 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 2.26 [0.58, 8.83]< 10%1 study (1/-)12.1 %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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