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la/mBC - HER2 positive - 2nd Line (L2), 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) 0.85 [0.72, 1.00]< 171%8 studies (8/-)97.4 %some concernnot evaluable moderatecrucial-
iDFS 0.67 [0.50, 0.90]< 10%1 study (1/-)99.6 %NAnot evaluable important-
progression or deaths (PFS) 0.73 [0.63, 0.86]< 167%7 studies (7/-)100.0 %some concernnot evaluable moderateimportant-
RFS/DFS 0.63 [0.47, 0.85]< 10%1 study (1/-)99.9 %NAnot evaluable important-
DOR 0.50 [0.34, 0.73]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
objective responses (ORR) 1.45 [1.20, 1.76]> 14%6 studies (6/-)100.0 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE leading to treatment discontinuation (any grade) 1.38 [0.80, 2.36]< 10%2 studies (2/-)12.3 %some concernnot evaluable moderatenon 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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