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breast cancer - HER2-positive, 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) 0.84 [0.74, 0.94]< 160%13 studies (13/-)99.8 %some concernlow moderatecrucial-
deaths (OS) (extension) 0.76 [0.68, 0.83]< 10%5 studies (5/-)100.0 %some concernnot evaluable moderateimportant-
iDFS 0.67 [0.50, 0.90]< 10%1 study (1/-)99.6 %NAnot evaluable important-
PFS (extension) 0.69 [0.59, 0.81]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.74 [0.66, 0.84]< 163%10 studies (10/-)100.0 %some concernlow moderateimportant-
RFS/DFS 0.79 [0.68, 0.91]< 130%3 studies (3/-)99.9 %some concernnot evaluable moderateimportant-
DOR 0.50 [0.34, 0.73]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
events or deaths (EFS) 0.83 [0.57, 1.21]< 10%2 studies (2/-)83.4 %some concernnot evaluable moderatenon important-
events or deaths (EFS) (extended) 0.89 [0.66, 1.22]< 10%2 studies (2/-)76.3 %some concernnot evaluable moderatenon important-
objective responses (ORR) 1.74 [1.16, 2.59]> 180%8 studies (8/-)99.7 %some concernnot evaluable moderatenon important-
pCR 1.24 [0.65, 2.38]> 182%3 studies (3/-)74.2 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (grade 3-4) 1.39 [0.96, 2.02]< 10%1 study (1/-)4.1 %NAnot evaluable non important-
AE leading to death (grade 5) 8.09 [0.43, 153.93]< 10%1 study (1/-)8.4 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.29 [0.88, 1.90]< 10%3 studies (3/-)9.6 %lownot evaluable highnon important-
SAE (any grade) 1.57 [0.95, 2.61]< 10%1 study (1/-)4.0 %NAnot evaluable non important-
STRAE (any grade) 1.48 [0.85, 2.59]< 10%1 study (1/-)8.3 %NAnot evaluable non important-
TRAE (grade 3-4) 1.23 [0.85, 1.78]< 10%1 study (1/-)13.7 %NAnot evaluable non important-
TRAE leading to death (grade 5) 4.01 [0.18, 89.40]< 10%1 study (1/-)19.3 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Anaemia AE (grade 3-4) 0.74 [0.36, 1.54]< 10%2 studies (2/-)78.8 %some concernnot evaluable moderatenon important-
Asthenia AE (grade 3-4) 0.89 [0.29, 2.72]< 15%2 studies (2/-)58.0 %some concernnot evaluable moderatenon important-
Back pain AE (grade 3-4) 0.98 [0.02, 50.38]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Constipation AE (grade 3-4) 1.00 [0.17, 5.83]< 10%2 studies (2/-)49.9 %some concernnot evaluable moderatenon important-
Decreased appetite AE (grade 3-4) 0.99 [0.14, 7.14]< 10%2 studies (2/-)50.3 %some concernnot evaluable moderatenon important-
Diarrhoea AE (grade 3-4) 1.58 [0.65, 3.83]< 116%2 studies (2/-)15.4 %some concernnot evaluable moderatenon important-
Fatigue AE (grade 3-4) 1.53 [0.67, 3.46]< 10%2 studies (2/-)15.6 %some concernnot evaluable moderatenon important-
Headache AE (grade 3-4) 0.99 [0.06, 16.02]< 10%2 studies (2/-)50.2 %some concernnot evaluable moderatenon important-
Nausea AE (grade 3-4) 1.20 [0.27, 5.40]< 19%2 studies (2/-)40.5 %some concernnot evaluable moderatenon important-
Palmar–plantar erythrodysesthesia syndrome AE (grade 3-4) 0.98 [0.29, 3.27]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.75 [0.09, 6.50]< 10%2 studies (2/-)60.1 %some concernnot evaluable moderatenon important-
Rash AE (grade 3-4) 0.48 [0.02, 14.79]< 10%1 study (1/-)65.9 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 1.55 [0.16, 15.45]< 10%2 studies (2/-)35.5 %some concernnot evaluable moderatenon important-
Vomiting AE (grade 3-4) 0.60 [0.14, 2.57]< 10%2 studies (2/-)75.4 %some concernnot evaluable moderatenon important-
Weight decreased AE (grade 3-4) 0.98 [0.06, 16.11]< 10%1 study (1/-)50.6 %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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