Table 1.
Studies included for long-term safety.
| Study [Reference] |
Median Follow-Up |
Total Patients (N) |
Arm and Patients (N) |
Duration of H Administration | Cardiotox Secondary | Cardiotox Primary | |
|---|---|---|---|---|---|---|---|
| eBC | HERA trial (BIG 1-01) [6] | 11 years | 5099 | 1 year H (1702) | 1 year | 4.4% | 1% |
| 2 years H (1700) | 2 years | 7.3% | 1% | ||||
| none (1697) | none | 0.9% | 0.1% | ||||
| NSABP B-31 [7] | 7 years | 1861 | AC → P + H (960) | 1 year | 5.3% | 3.9% | |
| AC → P (901) | none | 2.0% | 1.5% | ||||
| NCCTG N9831 (Alliance) [7] | 6 years | 1944 | AC → P (664) | None | - | 0.6% | |
| AC → P → H (710) | 1 year | - | 2.8% | ||||
| AC → P+H (570) | 1 year | - | 3.4% | ||||
| BCIRG 006 study [8] | 65 months | 3222 | AC → T (1073) | None | 11.2% | 0.7% | |
| AC → T+H (1074) | 1 year | 18.6% | 2.0% | ||||
| TCH (1075) | 1 year | 9.4% | 0.4% | ||||
| FinHer Trial [9] | 62 months | 232 | FEC → T or V (116) | None | 10.5% | 1.7% | |
| FEC → T or V + H (115) | 9 weeks | 6.8% | 0.9% | ||||
| Final analysis of the OHERA study [10] | 5 years | 3733 | H + cht | 11.8 months | 17.5% | 2.8% | |
| The Temporal Risk of HF Associated with Adjuvant Trastuzumab in BC Patients: A Population Study [11] | 5.9 years | 19074 | H + cht (3371) | 1 year | 5.2% | ||
| Cht (15,703) | none | 2.5% | |||||
| Cardiotoxicity and Cardiac Monitoring During Adjuvant Trastuzumab in Daily Dutch Practice: A Study of the Southeast Netherlands Breast Cancer Consortium [12] | 5 years | 230 | H + cht | 1 year | 3.9% | 8.7% | |
| MBC | LHORA study (long responder, first line PFS >3 years) [13] | 8 years | 154 | first line treatment with H + cht | 4.5 years | 2.2% | 0.7% |
| Trastuzumab for HER2+ metastatic breast cancer in clinical practice: Cardiotoxicity and overall survival [14] |
5 years | 681 | Any treatment with H | - | 7.2% | ||
| The Rollover Protocol (ROP) Study [15] | >5 years | 19 | Any treatment with H | 8.7 years | 0% | ||
| Long-term outcome of HER2 positive metastatic breast cancer patients treated with first-line trastuzumab [16] | 10 years | 215 | first line treatment with H + cht | 2.6 years | 13% | 2% | |
| e/M BC | Long-term tolerance and cardiac function in breast cancer patients receiving trastuzumab therapy [17] |
5 years | 94 | Adj or metastatic H | 15.7 months | 12.8% | - |
| Evaluation of LVEF in Breast Cancer Patients Undergoing Long-Term Trastuzumab Treatment [18] | 5 years | 105 | Adj or metastatic H | 15.7 months | 5.4% | ||
LEGEND: N = number. H = Herceptin, Trastuzumab. Cardiotox = cardiotoxicity. AC = anthracyclines + cyclophosphamide. P = paclitaxel, taxol. T = Taxotere, docetaxel. TCH: Taxotere + Carboplatin + Herceptin. FEC: 5-fluorouracyl + Epirubicin + Cyclophosphamide. V = vinorelbine. CHT = chemotherapy. eBC = early breast cancer. MBC = metastatic breast cancer.