patient subgroup...
Age < 65y (younger) Age > 65y Asian type ECOG 0 ECOG 1
Top evidence (RCT only, high risk of bias excluded)
Best available evidence (possibly low or very low)
All RCTs
All studies (RCT+OBS)
mBC - TNBC - L1 - all population, pembrolizumab based treatment versus chemotherapy, 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) 0.89 [0.76, 1.05]< 1 0% 1 study (1/-) 92.1 % NA not evaluable crucial - progression or deaths (PFS) 0.82 [0.69, 0.97]< 1 0% 1 study (1/-) 99.0 % NA not evaluable important - objective responses (ORR) 0.24 [0.17, 0.33]> 1 0% 1 study (1/-) 0.0 % NA not evaluable non important - safety endpoints 00 AE (any grade) 1.25 [0.41, 3.87]< 1 0% 1 study (1/-) 34.7 % NA not evaluable non important - AE (grade 3-4) 1.26 [0.91, 1.76]< 1 0% 1 study (1/-) 8.4 % NA not evaluable non important - TRAE (any grade) 1.35 [0.68, 2.70]< 1 0% 1 study (1/-) 19.7 % NA not evaluable non important - TRAE (grade 3-4) 1.06 [0.78, 1.44]< 1 0% 1 study (1/-) 35.8 % NA not evaluable non important - TRAE leading to death (grade 5) 2.00 [0.09, 44.58]< 1 0% 1 study (1/-) 33.2 % NA not evaluable non important - TRAE (grade 3-4) endpoints 00 Alopecia TRAE (grade 3-4) 0.83 [0.20, 3.51]< 1 0% 1 study (1/-) 59.9 % NA not evaluable non important - Anaemia TRAE (grade 3-4) 1.15 [0.77, 1.71]< 1 0% 1 study (1/-) 25.2 % NA not evaluable non important - Colitis TRAE (grade 3-4) 2.00 [0.09, 44.58]< 1 0% 1 study (1/-) 33.2 % NA not evaluable non important - Fatigue TRAE (grade 3-4) 1.15 [0.47, 2.82]< 1 0% 1 study (1/-) 38.3 % NA not evaluable non important - Hyperthyroidism TRAE (grade 3-4) 1.00 [0.03, 29.90]< 1 0% 1 study (1/-) 50.0 % NA not evaluable non important - Hypothyroidism TRAE (grade 3-4) 2.00 [0.09, 44.58]< 1 0% 1 study (1/-) 33.2 % NA not evaluable non important - Increased ALT TRAE (grade 3-4) 1.29 [0.67, 2.48]< 1 0% 1 study (1/-) 22.7 % NA not evaluable non important - Leucopenia TRAE (grade 3-4) 0.83 [0.58, 1.19]< 1 0% 1 study (1/-) 84.3 % NA not evaluable non important - Nausea TRAE (grade 3-4) 1.13 [0.34, 3.69]< 1 0% 1 study (1/-) 42.2 % NA not evaluable non important - Neutropenia TRAE (grade 3-4) 0.99 [0.73, 1.36]< 1 0% 1 study (1/-) 52.1 % NA not evaluable non important - Pneumonitis TRAE (grade 3-4) 6.05 [0.34, 108.78]< 1 0% 1 study (1/-) 11.3 % NA not evaluable non important - Severe skin reaction TRAE (grade 3-4) 10.16 [0.59, 174.64]< 1 0% 1 study (1/-) 5.7 % NA not 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.