Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
N = 469
- Population
- Women with metastatic breast cancer that overexpressed HER2
- Design
- Randomised comparison of standard chemotherapy alone with standard chemotherapy plus trastuzumab; the chemotherapy backbone depended on prior adjuvant anthracycline exposure (doxorubicin or epirubicin with cyclophosphamide, or paclitaxel). Blinding, phase and registry number are not stated in the PubMed abstract.
- Arms
- Chemotherapy alone (control, n = 234): Doxorubicin (or epirubicin) plus cyclophosphamide, or paclitaxel, depending on prior adjuvant anthracycline
- Chemotherapy plus trastuzumab (experimental, n = 235): The same chemotherapy plus trastuzumab
- People
- Slamon DJ
Δ median TTP+2.8 monthsΔ ORR+18 pointsΔ median DOR+3 monthsΔ median OS+4.8 months
Show the numbers
| Endpoint | Analysis | Chemotherapy plus trastuzumab | Chemotherapy alone | Effect |
|---|---|---|---|---|
| TTPAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | median 7.4 months | median 4.6 months | P<0.001Reported as time to disease progression. |
| ORRAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | 50% | 32% | P<0.001 |
| DORAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | median 9.1 months | median 6.1 months | P<0.001 |
| OSAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | median 25.1 months | median 20.3 months | P=0.01The abstract also reports a 20 percent reduction in the risk of death but gives no hazard ratio or confidence interval, so none is entered here. |
| Endpoint | Analysis | Chemotherapy plus trastuzumab | Chemotherapy alone | Effect |
|---|---|---|---|---|
| TTPAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | median 7.4 months | median 4.6 months | P<0.001Reported as time to disease progression. |
| ORRAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | 50% | 32% | P<0.001 |
| DORAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | median 9.1 months | median 6.1 months | P<0.001 |
| OSAll randomised patients (analysis population not stated in the abstract) | primarySlamon 2001 | median 25.1 months | median 20.3 months | P=0.01The abstract also reports a 20 percent reduction in the risk of death but gives no hazard ratio or confidence interval, so none is entered here. |
- Chemotherapy alone (control)
- Chemotherapy plus trastuzumab (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Chemotherapy alone | Chemotherapy plus trastuzumab |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 5 | 47.1% | 62.6% |
| 9 | 25.8% | 43.0% |
| 14 | 12.1% | 26.9% |
| 19 | 5.7% | 16.9% |
- Chemotherapy alone (control)
- Chemotherapy plus trastuzumab (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Chemotherapy alone | Chemotherapy plus trastuzumab |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 6 | 50.6% | 63.3% |
| 11 | 28.7% | 43.3% |
| 17 | 14.5% | 27.4% |
| 23 | 7.3% | 17.3% |