Table 2.
Studies included in real world effectiveness analysis.
| Study [Reference] |
Median Follow-Up | Patients (N) |
Arm And Patients (N) |
Duration of H Administration | DFS/PFS/RFS (% or Median) |
OS/BCSS (% or Median) |
|
|---|---|---|---|---|---|---|---|
| eBC | Effectiveness of neoadjuvant trastuzumab and cht in HER2+ BC [9] | 32 months | 205 | NACT + H | 24 weeks (median) | 5 y DFS 73.3% | 5 y CSS: 82.8% |
| Real-Life Use and Effectiveness of Adjuvant Trastuzumab in eBC Patients: A Study of the Southeast Netherlands Breast Cancer Consortium [19] | 5 years | 476 | Cht + H (230) | 17 cycles (median) | 5 y DFS 80.7% | 5 y OS: 90.7% | |
| Cht (246) | - | 5 y DFS 68.2% | 5 y OS: 77.4% | ||||
| Treatment Challenges and Survival Analysis of Human Epidermal Growth Factor Receptor 2-positive Breast Cancer in Real World [20] | 7 years | 212 | Cht + H (76) | NA | 5 y DFS 92% | 5 y OS: 90.5% | |
| Cht (136) | - | 5 y DFS 52.6% | 5 y OS: 41.7% | ||||
| The RETROHER study [21] | 65 months | 925 | Cht + H (573) | 52 weeks (median) | 5 y DFS 88.6% | OS 5 y: 96%; 10 y: 93.3% |
|
| Cht (352) | - | 5 y DFS 71% | OS 5 y: 88.4%; 10 y: 72.3% |
||||
| “Triple positive” early breast cancer: an observational multicenter retrospective analysis of outcome [22] |
78 months | 872 | Cht + H (506) | 52 weeks (median) | 5 y RFS 89.9% | BCSS 5 y: 97.4%; 10 y: 92% |
|
| Cht (366) | - | 5 y RFS 78.2% | BCSS 5 y: 93.9%; 10 y: 82% |
||||
| Observational study on adjuvant trastuzumab in HER2-positive early breast cancer patients [23] | 50 months | 1245 | Cht + H | NA | 10.9% RFS | - | |
| No adj therapy | - | 22.6% RFS | - | ||||
| The Promher Study [24] | 39 months | 303 | Cht + H (204) | NA | 5y DFS 95% | - | |
| Cht alone (65) | - | 5y DFS 94.3% | - | ||||
| No adj therapy (34) | - | 5y DFS 69.6% | - | ||||
| JBCRG-C03 study [25] | 42 months | 829 | NACT + H | NA | 3y DFS 87% | - | |
| Trastuzumab in HER2+ eBC: Results of a Prospective, Noninterventional Study on Routine Treatment Between 2006 and 2012 in Germany [26] |
39 months | 4027 | Cht + H | 18 cycles (median) | 3y DFS 90% 5y DFS 82.8% |
3y OS 96.8% 5y OS 90% |
|
| MBC | LHORA study (long responder, first line PFS > 3 y) [13] | - | 128 | Cht + H | 5.3 y (median) | Median PFS 6.4y | - |
| Trastuzumab for metastatic breast cancer: Real world outcomes from an Australian whole-of-population cohort (2001–2016) [27] | 6.7 years | 5899 | 2001–08 (3122) | 15 m (median) | - | Median 27 m | |
| 2009–15 (2777) | 18.4 m (median) | - | Median 37.7 m | ||||
| Real-World Evidence: A Comparison of the Australian Herceptin Program and Clinical Trials of Trastuzumab for HER2+ Metastatic Breast Cancer [28] | 1.7 years | 3617 | H + cht | 51.9 weeks (median) | Median PFS 8.3 m | Median 29.8 m | |
| Long-term survival in trastuzumab-treated patients with HER2- positive metastatic breast cancer: real-world outcomes and treatment patterns in a whole-of-population Australian cohort (2001–2016) [29] | 9.4 years | 1082 | H + cht alive > 5 years from initial treatment | 58.9 m (median) | - | Median 78.9 m (from 5th year) |
|
| First-Line Treatment Patterns and Clinical Outcomes in Patients With HER2+ and Hormone Receptor-Positive MBC From registHER [30] | 27 months | 964 | HR+/HER2+ (530) | NA | Median PFS 11.7 m | Median 41.5 m | |
| HR−/HER2+ (434) | NA | Median PFS 8.8 m | Median 28.6 m | ||||
| Trastuzumab for HER2+ metastatic breast cancer in clinical practice: Cardiotoxicity and overall survival [14] | 5 years | 681 | H + cht | NA | - | 5 y: 37.2% | |
| Treatment patterns and clinical outcomes in elderly patients with HER2-positive metastatic breast cancer from the registHER observational study [31] | 27 months | 209 | H in first line | NA | Median PFS 11.7 m | Median 31.2 m | |
| No H in first line | - | Median PFS 4.6 m | Median 29.5m | ||||
| e/MBC | Disparities of Trastuzumab Use in Resource-Limited or Resource-Abundant Regions and Its Survival Benefit on HER2 Positive Breast Cancer: A Real-World Study from China [32] | - | 1139 | eBC, yes H (397) | 12 m | Median DFS 30 m | - |
| eBC, no H (486) | - | Median DFS 21 m | - | ||||
| MBC, yes H (366) | 10 m | Median PFS 13 m | - | ||||
| MBC, no H (354) | - | Median PFS 7 m | - |
LEGEND: N = number. DFS = disease free survival. PFS = progression free survival. RFS = recurrence free survival. OS = overall survival. CSS = cancer specific survival. BCSS = breast cancer specific survival. NACT = neoadjuvant chemotherapy. H = Herceptin, Trastuzumab. Y = years. M = months. CHT = chemotherapy. HR+ = hormone receptor positive. HR− = hormone receptor negative. HER2+ = human epidermal growth factor receptor 2 positive. eBC = early breast cancer. MBC = metastatic breast cancer. NA = not available.