Table 2.
Summary of clinical trials combining BV with salvage regimens used to mobilize stem cells prior to autoSCT either in sequential or concurrent design.a
| Author | Regimen | Pts (#) | Median age (range) | Primary refr (%) |
CR definition | ORR (%) | CMR (%) | ASCT performed (%) |
P(E)FS |
|---|---|---|---|---|---|---|---|---|---|
| Moskowitz99,100 | BVx2b plus AugICE if no CMR | 45 | 31 (13–65) |
56 | D5PS 1-2 | NR | 27 to BV 76 to bothf |
98f | 80% at 3 years |
| Moskowitz100 | BVx3b plus AugICE if no CMR | 20 | 35 (19–59) |
45 | D5PS 1-2 | NR | 30 to BV 80 to both |
100 | 85% at 2 years |
| Chen101; Herrera102 | BVx2-4c plus chemo if no CMR | 37 | 34 (11–67) |
65 | Per Cheson116 | 68 to BV (25/37) |
35 to BV 75 to bothg |
92j | 72% at 2 yearsk |
| Herrera103 | BVx4d plus additional Tx at physician’s discretion | 20 | 25 (15–57) |
60 | Per Cheson116 | 75 to BV (15/20) |
50 to BV 70 to both |
90 (18/20) |
NR |
| Garcia-Sanz104 | BrESHAP x3 + BV x1 plus consBV x3 | 66 | 36 (18–66) |
61 | Per Cheson116 | 91 | 70h | 91 | 71% at 2.5 years |
| Hagenbeek105 | BV-DHAP x3 | 61 | 29 (19–71) |
38 (no CR) | NR | 87 | 79 | 87 | 76% at 2 years |
| Cassaday106 | BV-ICE x2e | 16 | 32 (23–60) |
69 (no CR) | Per Cheson116 | 94 | 88 | 75 | 19% relapses at medfup 6.5 months |
| Stamatoullas107 | BV-ICE × 2-3 | 39 | 30 (18–65) |
NR | D5PS 1–3 | 95 | 69 | 20 | 69% at 12 months |
| Cole108 | BV-Gemcitabine | 46 | 17.6 (5.4–18.7) |
29 (64%) |
D5PS 1–2 | 74 | 67 | 34 | NR |
| Abuelgasim109 | BV-IGEV + post-SCT BV consolidation |
28 | 25 (14–49) |
NR | D5PS 1–3 | 95 | 71 | NR | Post-SCT; 87.1% at 2 years |
| Herrera110 | BV-Nivo | 62 | 36 (18–69) |
45 | Per Lugano173,174 | 83 | 50i | 89l | 89% at 6 months |
ASCT, autologous stem-cell transplantation; AugICE, augmented ICE; BV, brentuximab vedotin; CMR, complete metabolic response; CR, complete response; D5PS, Deauville 5-point scale; DHAP, (dexamethasone, high-dose cytarabine, cisplatin); EFS, event-free survival; ICE, (ifosfamide, carboplatin, etoposide); IF-RT, involved-field radiation therapy; IGEV, (ifosfamide, gemcitabine, vinorelbine, prednisone); LFU, lost to follow up; medfup, medium follow up; Nivo, nivolumab; NR, not reported; ORR, overall response rates; PET, positron emission tomography; PFS, progression-free survival; PR, partial response; SCT, stem-cell transplantation; SD, stable disease.
Reference 109 represents a retrospective analysis. All the other presented studies are prospective.
BV 1.2 mg/kg on days 1, 8, and 15 of each cycle.
Standard BV cycles 1.8 mg/kg every 21 days.
Escalated to 2.4 mg/kg every 21 days if no CMR achieved with two standard 21-day cycles at 1.8 mg/kg.
BV 1.5 mg/kg on days 1 and 8 combined with ICE every 21 days.
80% (36/45) if D5PS score 3 considered as CR. A single patient LFU after a positive PET with BVx2.
Five additional patients were forwarded to autoSCT directly after BV with a positive PET (4 PR, 1 SD with IF-RT).
76% if D5PS score 3 considered as CR (similar outcomes for D5PS scores 3 and 2).
60% if D5PS score 3 considered as CR.
Including 2 patients who received alloSCT for PR and SD after chemo.
Only the 32/37 patients who received autoSCT were included (80% for those transplanted after BV only).
42 patients proceeded to autoSCT after BV+Nivo and 12 after additional salvage therapy.