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breast cancer (BC), pembrolizumab alone , 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) 0.92 [0.84, 1.02]< 10%4 studies (4/-)93.9 %lownot evaluable highcrucial-
progression or deaths (PFS) 1.47 [1.29, 1.67]< 132%4 studies (4/-)0.0 %lownot evaluable highimportant-
DCR 0.49 [0.36, 0.68]> 125%2 studies (2/-)0.0 %lownot evaluable highnon important-
objective responses (ORR) 1.11 [0.79, 1.57]> 123%4 studies (4/-)72.6 %lownot evaluable highnon important-

safety endpoints 00

SAE (any grade) 0.99 [0.66, 1.48]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
TRAE (grade 3-4) 0.29 [0.19, 0.43]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.94 [0.37, 2.41]< 10%1 study (1/-)54.8 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 1.05 [0.42, 2.63]< 10%1 study (1/-)45.7 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.94 [0.06, 15.18]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Acute kidney injury TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.94 [0.02, 47.78]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.28 [0.08, 1.01]< 10%1 study (1/-)97.3 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 1.26 [0.28, 5.69]< 10%1 study (1/-)38.1 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 0.94 [0.06, 15.18]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.23 [0.05, 1.10]< 10%1 study (1/-)96.7 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.94 [0.19, 4.72]< 10%1 study (1/-)52.8 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.05 [0.00, 0.79]< 10%1 study (1/-)98.2 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.94 [0.02, 47.78]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 1.91 [0.57, 6.42]< 10%1 study (1/-)14.7 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.90 [0.17, 21.02]< 10%1 study (1/-)30.3 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.09 [0.01, 1.71]< 10%1 study (1/-)94.3 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 5.72 [0.29, 114.60]< 10%1 study (1/-)13.0 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 0.94 [0.02, 47.78]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.12]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) 0.13 [0.02, 1.08]< 10%1 study (1/-)97.0 %NAnot evaluable non important-
Pancytopenia TRAE (grade 3-4) 0.24 [0.01, 5.23]< 10%1 study (1/-)81.7 %NAnot evaluable non important-
Peripheral sensory neuropathy TRAE (grade 3-4) 0.16 [0.01, 3.13]< 10%1 study (1/-)88.5 %NAnot evaluable non important-
Pneumonia TRAE (grade 3-4) 0.24 [0.01, 5.23]< 10%1 study (1/-)81.7 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 5.72 [0.29, 114.60]< 10%1 study (1/-)13.0 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.94 [0.06, 15.18]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Sepsis TRAE (grade 3-4) 0.94 [0.02, 47.78]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Severe skin reaction TRAE (grade 3-4) 1.90 [0.17, 21.02]< 10%1 study (1/-)30.3 %NAnot evaluable non important-
Stomatitis TRAE (grade 3-4) 0.47 [0.02, 14.11]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.94 [0.06, 15.18]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Thyroiditis TRAE (grade 3-4) 0.94 [0.02, 47.78]< 10%1 study (1/-)51.1 %NAnot evaluable non important-
Urticaria TRAE (grade 3-4) 1.89 [0.06, 56.64]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.47 [0.04, 5.22]< 10%1 study (1/-)72.9 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

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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