Table 7.
Multicenter phase II trials evaluating the combination of brentuximab vedotin with AVD (sequential or concurrent) with or without radiotherapy on limited stage classical Hodgkin lymphoma.
| Study | Intervention | Patients | Age (Median (Range)) | Bulk and RF (EF/EU (%)) | Metabolic CR Rates | RT (%) | Median Follow-Up | PFS | OS |
|---|---|---|---|---|---|---|---|---|---|
| Abramson JS [110] | BV × 2(d1 + 15) →PET, BV-AVD × 4–6, based on PET | 34 | 36 (20–75) | non-bulky (all) 62/38 | BV × 2: 18/34 (50%) | 0 | 14 mo | 90% | 97% |
| BV-AVD × 2: 33/33 * (100%) | |||||||||
| BV-AVD × 4: 30/32 * (94%) | |||||||||
| Park [109] | ABVD × 2–6 (RF/iPET) **, BV × 6 (six weeks later) | 40 | 29 (19–68) | non-bulky (all) 55/45 | ABVD × 2: 29/40 (73%) (D5PS 1–2) | 2.5 | 22 mo | 92% at 2yrs | 97% at 2yrs |
| 37/40 (93%) (D5PS 1–3) | |||||||||
| EOT: 37/39 ** (95%) (D5PS 1–2) | |||||||||
| 38/39 (97%) (D5PS 1–3) | |||||||||
| Kumar [111] | BV-AVD × 4 30 Gy ISRT if PET-neg | 30 | 31 (18–59) | Bulky 57% 0/100 † | BV-AVD × 2: 14/29 (48%) (D5PS 1–2) | 83 § | 18.8 mo | 93% at 1 yr | NR |
| 26/29 (89%) (D5PS 1–3) | |||||||||
| BV-AVDx4: 24/29 (82%) (D5PS 1–2) | |||||||||
| 27/29 (92%) (D5PS1–3) | |||||||||
| EOT: 25/25 §§ |
EOT = end-of-treatment, RF = risk factors, EF/EU = early favorable or early unfavorable according to EORTC or German Hodgkin Study Group (GHSG) definition, NR = not reported. † Stage IIBX and/or IIBE included (GHSG definition), * one patient removed due to toxicity (gr.2 hypersensitivity and toxic death after AVD × 1 in an elderly patient, ** 11, 26, and 3 patients (27.5%, 65%, 7.5%, respectively) received 2, 4, or 6 AVD cycles, respectively; † Stage IIBX and/or IIBE included (GHSG definition); One toxic death on BV (sepsis/hepatic failure), § Five patients did not receive RT: 2 PD, 1 withdrawal after BV-AVD × 1 (gr.3 neuropathy), 2 patient’s desire, §§ including 2 patients with false-positive EOT-PET.