Table 3.
Highest WHO degree of treatment-related toxicity observed with TCID versus VID versus VCID therapy (percentage of patients)
| VRID (n = 46) | TCID (n = 46) | VID (n = 46) | P-value | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Refractory (n = 25) | Relapsed (n = 21) | Overall (n = 46) | Refractory (n = 24) | Relapsed (n = 22) | Overall (n = 46) | Refractory (n = 46) | Relapsed (n = 0) | Overall (n = 46) | |||||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | ||
| A | |||||||||||||||||||
| Hematological toxicity (WHO Grade III/IV) | 22 | 88 | 17 | 81 | 39 | 85 | 13 | 54 | 14 | 64 | 27 | 59 | 24 | 52 | – | – | 24 | 52 | 0.002 |
| B | |||||||||||||||||||
| Hematological toxicity (WHO Grade III/IV) | |||||||||||||||||||
| Anemia | 2 | 8.0 | 2 | 9.5 | 4 | 8.7 | 5 | 20.8 | 4 | 18.2 | 9 | 19.6 | – | – | – | – | – | – | 0.231 |
| Leukopenia | 1 | 4.0 | 0 | 0.0 | 1 | 2.2 | 11 | 45.8 | 13 | 59.1 | 24 | 52.2 | – | – | – | – | – | – | <0.05 |
| Thrombocytopenia | 2 | 8.0 | 4 | 19.0 | 6 | 13.0 | 5 | 20.8 | 8 | 36.4 | 13 | 28.3 | – | – | – | – | – | – | 0.121 |
| Red blood cell transfusion | 11 | 44.0 | 7 | 33.3 | 18 | 39.1 | 8 | 33.3 | 6 | 27.3 | 14 | 30.4 | – | – | – | – | – | – | 0.332 |
| Platelet transfusion | 1 | 4.0 | 3 | 14.3 | 4 | 8.7 | 3 | 12.5 | 2 | 9.1 | 5 | 10.9 | – | – | – | – | – | – | 1.000 |
| C | |||||||||||||||||||
| Non hematological toxicity (WHO Grade III/IV) | |||||||||||||||||||
| Cardiac toxicity | 12 | 48 | 7 | 33 | 19 | 41 | 0 | 0 | 0 | 0 | 0 | 0 | – | – | – | – | – | – | <0.05 |
| Nausea/emesis | 2 | 8 | 0 | 0 | 2 | 4 | 0 | 0 | 2 | 9 | 2 | 4 | – | – | – | – | – | – | 1.000 |
| Stomatitis | 4 | 16 | 0 | 0 | 4 | 9 | 1 | 4 | 0 | 0 | 1 | 2 | – | – | – | – | – | – | 0.361 |
| Diarrhoea | 4 | 16 | 0 | 0 | 4 | 9 | 1 | 4 | 1 | 5 | 2 | 4 | – | – | – | – | – | – | 0.677 |
| Obstipation | 1 | 4 | 0 | 0 | 1 | 2 | 1 | 4 | 1 | 5 | 2 | 4 | – | – | – | – | – | – | 1.000 |
Response criteria according to EBMT definition. n.e. not evaluable due to discontinuance of treatment. Data are presented for the refractory group, the relapsed group and the overall group separately. Refractory is here defined as PD or NC after standard treatment
* Data were measured before therapy with VRID, thus they do not demonstrate the hematological toxicity of VRID therapy