Table 4.
ASCT (N, age range) |
Non- ASCT (N, age range) |
Treatment | Median PFS (months) | Median OS (months) | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
ASCT group |
Non-ASCT group |
P value | ASCT group |
Non- ASCT group |
Hazard Ratio | P value | |||||
Present study |
Retrospective cohort study |
62 (65– 74) |
84 (65– 77) |
ASCT: Various induction, Mel 140– 200 mg/m2 Non-ASCT: Various |
NR | NR | 56 | 33.1 | 0.54 (95% CI 0.35–0.82) |
0.004 | |
Facon (IFM99- 06) (26) |
Randomized controlled trial |
N=126 | MPT arm N=125 MP arm N=196 |
ASCT: VAD × 2, chemomobilization, Melphalan 100mg/m2 , repeated 2 months later MPT: × 12 cycles MP: × 12 cycles |
19.4 | MPT: 27.5 MP: 17.8 |
P=0.0002 | 38.3 | MPT:51.6 MP: 33.2 |
NR | MPT vs MEL100 P=0.027 |
Lenhoff(25) | Population- based registry |
120 (60– 64) |
97 (60– 64) |
ASCT: VAD then ASCT and IFN alfa- 2B maintenance Non-ASCT: MP +/− IFN alfa-2B |
EFS 24 |
NR | P=0.02 | 48 | 28 | Risk ratio 0.65, (95% CI 0.42–0.92) |
0.02 |
Offidani (40) |
Post-hoc analysis of Phase II trial |
26 (65– 75) |
62 (65– 91) |
Non-ASCT: ThaDD × 6 cycles, then maintenance thalidomide ASCT: ThaDD × 4 then ASCT |
32 | 29 | NS | 3Yr OS 82% 5Yr OS 49% |
3Yr OS 66% 5Yr OS 46% |
NR | NS |
Kumar (3) |
Retrospective cohort study |
1038 (52% over age 65) |
Various | NR | NR | Not reached (95%CI 5.4 years –not reached) |
3.1 years (95% CI 2.5–3.7) |
NR | <0.01 | ||
Ozaki (28) |
Retrospective cohort study |
N=17 ASCT + novel agents; N=21 conventional chemotherapy +ASCT (Age 65– 70) |
N=192 conventional chemotherapy; N=88 novel agents (Age 65– 70) |
Various | Not reached |
57.9 months |
<0.001 |
ASCT, autologous stem cell transplant; PFS, progression-free survival; OS, overall survival; NS, nonsignificant; NR, not reported; MPT, melphalan, prednidone and thalidomide; MP, melphalan and prednisone; VAD, vincristine, doxorubicin and dexamethasone; IFN, interferon; ThaDD, thalidomide, pegylated liposomal doxorubicin and dexamethasone.