The expert reference panel supported publication of this protocol on the basis of the information summarised below. There are no randomised prospective studies comparing BEAM (carmustine, etoposide, cytarabine and melphalan) to other conditioning regimens.
A retrospective analysis reported by the GEL/TAMO group compared BEAM, CBV (carmustine, cyclophosphamide and etoposide), BEAC (carmustine, etoposide, cytarabine and cyclophosphamide) and Cy/TBI (cyclophosphamide/total body irradiation) in terms of efficacy and toxicity.r BEAM was associated with improved RFS (recurrence-free survival), DFS (disease-free survival and OS (overall survival) than CBV, although this did not reach statistical significance.
Furthermore, studies have demonstrated that BEAM conditioning followed by ABMT improves survival than chemotherapy alone.r Additionally, when comparing CBV and BEAM conditioning regimens, BEAM has been shown to be better tolerated than CBV.r
Evidence Level*
(NHMRC |
Study
Author/Ref nos.) |
Study Design |
Disease |
Is the conditioning regimen** consistent with the protocol |
IV |
Salar, A. et al. 2001r |
Retrospective registry data |
Diffuse large B-cell lymphoma (DLBCL) |
Yes |
III-2 |
Schmitz , N. et al. 2002r |
Comparative study |
Hodgkin disease |
Yes |
IV |
Puig, N. et al. 2006r |
Single centre retrospective study |
Non-Hodgkin lymphoma, Hodgkin disease
|
Yes |
III-3 |
Linch, D. et al. 1993r |
Randomised comparative study |
Hodgkin disease |
Yes |
IV |
Chopra , R. et al. 2006r |
Single centre retrospective study |
Hodgkin disease |
Yes |
IV |
Mills, W. et al. 1995r |
Single centre retrospective study |
Non-Hodgkin lymphoma |
Yes |
Efficacy
A summary of the evidence supporting the effect of this protocol is below:
Study |
Nos. of patients |
NRM/TRM |
Response* |
Relapse Rate |
OS |
DFS |
Salar, A. et al. 2001r |
395 |
10% |
CR 74% with SD at ASCT, CR 13% with RD at ASCT |
26% |
8 yr 44% |
39% at 8 years |
Schmitz , N. et al. 2002 r |
161 |
1.6% |
CR 55% |
18% |
2 yr 72% |
55% at 3 years |
Puig, N. et al. 2006r |
113 |
5% |
CR 37%, PR 31.5%, R 31.5% |
Not reported |
Not reported |
Not reported |
Linch, D. et al. 1993r |
40 |
10% |
OR 74% |
15% |
2 yr 75% |
53% at 3 years |
Chopra , R. et al. 2006 r |
155 |
10% |
CR 28% PR 26% R 16% |
21% |
5 yr 55% |
50% at 5 years |
Mills, W. et al. 1995r |
107 |
6.5% |
CR 41%, PR 32%, R 21% |
48% |
5 yr 41% |
35% at 5 years |
* OR = overall response; CR= complete response; PR=partial response; SD = stable disease; VGPR = very good partial response; R = refractory; NRM = non-relapse mortality; TRM = treatment-related mortality; OS = overall survival; DFS = disease-free survival; RD = refractory disease; ASCT = autologous stem cell transplant
Toxicity
The toxicity data may not be indicative of the most clinically significant toxicities as study numbers are generally small and thus data may be skewed.
A summary of the toxicities associated with this protocol are included in the table below:
Study |
Mucositis |
VOD/SOS |
Lung/IPS |
Infection* |
Comment |
Salar, A. et al. 2001r |
Not reported |
1% |
4% |
43% |
N = 395 |
Schmitz , N. et al. 2002r |
47% |
Not reported |
4% |
47% |
N = 51% |
Puig, N. et al. 2006r |
34% |
0 |
0 |
5% |
N = 38 |
Linch, D. et al. 1993r |
Not reported |
Not reported |
Not reported |
Not reported |
N =40 |
Chopra , R. et al. 2006r |
Not reported |
Not reported |
Not reported |
34% positive blood cultures |
N = 166 |
Mills, W. et al. 1995r |
100% |
1 patient |
2 patients |
42% |
N = 107 |
*Infection : include neutropenic sepsis, invasive fungal infection (IFI) and viral reactivation/disease where reported. VOD = veno-occlusive disease; SOS = sinusoidal obstruction syndrome; IPS = idiopathic pneumonia syndrome