A Cochrane review included 8 studies with a total of 11 991 patients to assess the efficacy and safety of therapy with trastuzumab with the standard chemotherapy regimen in patients with HER2-positive early breast cancer.
| Outcome | Number of participants (studies) | Assumed risk (moderate risk – control) | Corresponding risk (trastuzumab) | Relative effect (95% CI) | Quality of evidence (GRADE) |
|---|---|---|---|---|---|
| Overall survival (OS) | 9945 (8) | 300 per 1000 | 210 per 1000 (184 to 240) | HR 0.66 (0.57 to 0.77) | ⊕⊕⊕⊕ high |
| Disease free survival (DFS) | 9935 (8) | 300 per 1000 | 193 per 100 (163 to 224) | HR 0.6 (0.5 to 0.71) | ⊕⊕⊕⊕ high |
| Congestive heart failure | 10281 (8) | 20 per 1000 | 102 per 1000 (60 to 174) | RR 5.11 (3 to 8.72) | ⊕⊕⊕⊕ high |
| Left ventricular ejection fraction (LVEF) decline | 7939 (7) | 30 per 1000 | 55 per 1000 (41 to 74) | RR 1.83 (1.36 to 2.47) | ⊕⊕⊕ moderate |
| Brain metastasis as first relapse | 6881 (5) | 13 per 1000 | 23 per 1000 (17 to 32) | RR 1.75 (1.29 to 2.38) | ⊕⊕ low |
The results of the intervention and control groups are presented assuming moderate baseline risk in the control group. These absolute differences were obtained using the HR of OS and DFS estimated in the meta-analysis. The absolute differences in safety were obtained using their RRs, estimated in the meta-analysis.
Date of latest search: