7. Effect of TASCT compared to SASCT on OS, EFS and "TRM".
| Follow‐up months (mo) |
Kaplan‐Meier curve | Median OS | Kaplan‐Meier curve | Median EFS | Treatment‐ or Transplant‐related mortality | Notes | ||||
| Study | OS | TASCT | SASCT | EFS | TASCT | SASCT | TASCT | SASCT | ||
| IFM94 | 75 mo (median) |
TASCT superior; separation of curves after ca. 26 mo; |
58 mo* | 48 mo* P=0.01 |
TASCT superior; separation of curves after ca. 18 mo; |
30 mo* | 25 mo* P=0.03 |
Treatment‐related deaths (including induction) N= 12 (6%) Transplantation‐related deaths (sepsis) N=5 |
Treatment‐related deaths (including induction) N= 8 (4%) Transplantation‐related deaths (sepsis) N=3 |
Five additional causes of death listed; Long term follow‐up (11.6 years) OS P=0.08 EFS P=0.06 |
| MAG95 | 73 mo (median) |
SASCT inferior; (overall transient) separation of curves after cluster of events in control arm after 2‐4 and 35 months; |
75 mo | 57 mo | No KM‐curve | 34 mo | 31 mo | Toxic death (interim data§): 7% "Early mortality" N=8 (7%) |
Toxic death (interim data§): 9% "Early mortality" N= 13 (12%); |
Final OS survival proportions similar |
| Bologna96 | 70 mo (median for survivors) | no KM‐curve (inconsistent median OS and 7 year OS (TASCT 43 vs SASCT 46%) indicate crossing curves) |
71 mo | 65 mo | TASCT superior; separation of curves after 18 mo; 5 y EFS: 29% vs 17% |
35 mo* | 23 mo* P=0.001 |
Transplantation‐related deaths Table 5 4% |
Transplantation‐related deaths Table 5 3% |
Compliance with second ASCT: 65% |
| GMMG‐HD2 | Unclear 2003: 36 mo 2005: 24 mo 2007 (final): NR |
ITT: superimposable curves (multiple crossings); PP: SASCT slightly superior |
ca. 77 mo | ca. 72 mo | ITT: TASCT transiently superior; crossing of curves at 38 mo; PP: similar to ITT |
ca. 29 mo | ca. 25 mo | So‐called TRM Table 5 1st 2% 2nd 3% (population unclear) |
So‐called TRM Table 5 2% (population unclear) |
Compliance with second ASCT: 52% of evaluable patients |
| DSMM‐I | ca. 48 months (reported as median follow‐up; according to KM: total follow‐up) | TASCT initially superior; crossing of KM curves at 36 mo; 4 yr OS 72% in both arms |
Not reached | Not reached | TASCT initially superior; crossing of KM curves at 22 mo |
36,4 mo | ca. 43.4 mo | So‐called TRM (excluding induction)
Table 5 4% (population?); (OS at 100% for 400 d according to KM‐curve) |
So‐called TRM (excluding induction)
Table 5 3% (population?) |
high proportion of cross‐over; |
* statistically significant difference; ca. = read from Kaplan‐Meier plots
§ interim data with 85% of enrolled patients