Table 2.
Study | Randomization | Patients, n | ORR, % | CR, % | EFS (months) | OS (months) |
---|---|---|---|---|---|---|
Barlogie et al. [28] | Total therapy | 123 | 86 | 40 | 49 | 62 |
Single ASCT (historical controls) | 116 | 52 | NA | 22 | 48 | |
Attal et al. [29] | Double (VAD followed by ASCT1 with melphalan 140 mg/m2, ASCT2 with melphalan 140 mg/m2 and TBI) | 200 | 88 | 50 (CR + VGPR) | 30 | 58 |
Single (VAD followed by ASCT with melphalan 140mg/m2) | 199 | 84 | 42 (CR + VGPR) | 25 | 48 | |
Cavo et al. [30••] | Double (VAD followed by ASCT1 with melphalan 200 mg/m2, ASCT2 with melphalan 120 mg/m2 and busulfan 12 mg/kg) | 158 | NA | 47 (CR + near CR) | 35 | 71 |
Single (VAD followed by ASCT with melphalan 140mg/m2) | 163 | NA | 33 (CR + near CR) | 23 | 65 | |
Sonneveld et al. [31] | Double: VAD followed by IDM (melphalan 70 mg/m2×2) followed by CTX 120 mg/kg + TBI | 155 | 90 | 13 | 22 | 55 |
Single: VAD followed by IDM (melphalan 70 mg/m2×2) | 148 | 86 | 28 | 20 | 50 | |
Fermand et al. [32] | Double: VAD followed by ASCT1 with melphalan 140 mg/m2, followed by ASCT2 with melphalan 140 mg/m2, etoposide 30 mg/kg and TBI (12 Gy) | 99 | NA | 39 (CR + VGPR) | ND | ND |
Single: VAD followed by ASCT1 carmustine, etoposide, melphalan 140 mg/m2, CTX 60 mg/kg and TBI (12 Gy) | 94 | NA | 37 (CR + VGPR) | ND | ND |
ASCT, autologous stem cell transplantation; CR, complete remission; CTX, cyclophosphamide; EDAP, etoposide, dexamethasone, cytarabine and cisplatin; EFS, event-free survival; GM-CSF, granulocyte macrophage colony stimulating factor; HDCTX, high dose cyclophosphamide; IDM, intermediate dose melphalan; IFN, interferon; NA, not available; ND, no data; ORR, overall response rate; OS, overall survival; PBSC, peripheral blood stem cell; PR, partial remission; TBI, total body irradiation; VAD, vincristine, doxorubicin and dexamethasone; VGPR, very good partial response. Total therapy: VAD followed by HDCTX and GM-CSF for PBSC collection, EDAP followed by first ASCT with melphalan 200. If sustained PR or CR, a second ASCT with melphalan 200 was performed followed by IFN maintenance.