A Cochrane review [Abstract] 1 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 overall survival (OS) and disease free survival (DFS) estimated in the meta-analysis. The absolute differences in safety were obtained using their RRs, estimated in the meta-analysis.
Another meta-analysis 3 included 7 randomised trials with a total of 13 864 patients. Mean scheduled treatment duration was 14.4 months and median follow-up was 10.7 years. The risks of breast cancer recurrence (RR 0.66, 95% CI 0.62 to 0.71; p<0.0001) and death from breast cancer (0.67, 0.61 to 0.73; p<0.0001) were lower with trastuzumab plus chemotherapy than with chemotherapy alone. Absolute 10-year recurrence risk was reduced by 9.0% (p<0·0001) and 10-year breast cancer mortality was reduced by 6.4% (p<0·0001), with a 6.5% reduction in all-cause mortality, and no increase in death without recurrence. Proportional recurrence reductions were similar irrespective of recorded patient and tumour characteristics, including ER status. The more high risk the tumour, the larger the absolute reductions in 5-year recurrence.
Date of latest search: 2022-01-03
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