Table 4.
Findings of the phase III ECHELON-1 randomized trial comparing six cycles of BV-AVD versus ABVD in stage III/IV cHL [17,77,78,80,84].
| Patients’ Characteristics and Key Outcome and Toxicity Measures | BV–AVD | ABVD | Difference | Hazard Ratio (95%CI) | p-Value |
|---|---|---|---|---|---|
| Patients (#) and patient characteristics | n = 664 | n = 670 | |||
| Age (median(range)) | 35 (18–82) | 37 (18–83) | NA | ||
| Stage IV (%) | 64 | 63 | NA | ||
| IPS 4–7 (%) | 25 | 27 | NA | ||
| Outcome measures | |||||
| All patients | |||||
| Two-year mPFS per IRC (%) (primary endpoint) | 82.1 | 77.2 | +4.9% | 0.77 (0.60–0.98) | 0.03 |
| Two-year mPFS per INV (%) | 81.0 | 74.4 | +6.6% | 0.73 (0.67–0.92) | 0.007 |
| Two-year OS (%) | 96.6 | 94.9 | +1.7% | 0.72 (0.44–1.17) | 0.19 |
| Stage IV or extranodal site subgroup | |||||
| Two-year mPFS per IRC, Stage IV (%) | 82.0 | 74.9 | +7.1% | 0.71 (0.53–0.96) | 0.023 |
| Two-year mPFS per IRC, extranodal ≥1 (%) | 82.4 | 74.9 | +7.5% | NR | 0.018 |
| Two-year mPFS per IRC, extranodal ≥2 (%) | 80.2 | 71.1 | +9.1% | 0.67 (0.44–1.00) | 0.049 |
| Two-year OS, stage IV (%) | 97.4 | 93.4 | +4.0% | 0.51 (0.27–0.97) | 0.037 |
| Two-year OS, extranodal ≥ 1 (%) | 97.5 | 93.4 | +4.1% | 0.43 (0.22–0.85) | 0.013 |
| Elderly patients ( ≥ 60 years) | n = 84 | n = 102 | |||
| Two-year mPFS per IRC, all elderly (%) | 70.3 | 71.4 | −1.1% | 1.00 (0.58–1.72) | 0.99 |
| Two-year mPFS per IRC, stage IV elderly (%) | 71.3 | 66.1 | +5.2% | 0.80 (0.42–1.53) | 0.51 |
| Two-year mPFS per INV, stage IV elderly (%) | 74.0 | 59.9 | +14.1% | 0.66 (0.35–1.27) | 0.21 |
| Toxicity | |||||
| Toxic deaths, all patients [# (%)] | 9 (1.4) | 13 (1.9) | −0.5% | - | - |
| Toxic deaths, elderly [# (%)] | 2/84 (2.4) | 5/102 (4.9) | −2.5% | - | - |
| Hospitalization, all patients (%) | 37 | 28 | +9% | - | - |
| Peripheral sensory neuropathy, all patients, all grades (%) | 29 | 17 | +12% | - | - |
| Peripheral sensory neuropathy, all patients, grade ≥ 3 (%) | 5 | < 1 | +4% | - | - |
| Peripheral motor neuropathy, all patients, all grades (%) | 11 | 4 | +7% | ||
| Febrile neutropenia, all patients (%) | 19 | 8 | +11% | - | - |
| Febrile neutropenia, elderly (%) | 37 | 17 | +20% | - |
ABVD = Adriamycin, Bleomycin, Vinblastine and Dacarbazine; BV-AVD = Brentuximab Vedotin, Adriamycin, Vinblastine and Dacarbazine; IPS = International Prognostic Score.