Details on treatments received by the 164 patients randomized for postremission therapy
| . | Ambulatory arm . | Intensive arm . | P value . |
|---|---|---|---|
| No. patients randomized | 82 | 82 | NA |
| Patients who received the planned treatment†, no. | 76 | 67 | .06 |
| Consent withdrawal after R2 | 1 | 14* | .001 |
| Treatment interruption‡ | 5 | 1 | .21 |
| Days under therapy§, median (range) | 247 (215-316) | 82 (63-160) | <.001 |
| Need of rehospitalization and transfusion§ | |||
| No. of days, median (range) | 0 (0-31) | 27 (20-84) | <.001 |
| Patients with febrile neutropenia, % | 39 | 100 | <.001 |
| Transfusion requirements | |||
| RBC units, median (range) | 2 (0-24) | 6 (0-12) | .007 |
| Platelet transfusions, median (range) | 1 (0-18) | 4 (1-15) | <.001 |
| . | Ambulatory arm . | Intensive arm . | P value . |
|---|---|---|---|
| No. patients randomized | 82 | 82 | NA |
| Patients who received the planned treatment†, no. | 76 | 67 | .06 |
| Consent withdrawal after R2 | 1 | 14* | .001 |
| Treatment interruption‡ | 5 | 1 | .21 |
| Days under therapy§, median (range) | 247 (215-316) | 82 (63-160) | <.001 |
| Need of rehospitalization and transfusion§ | |||
| No. of days, median (range) | 0 (0-31) | 27 (20-84) | <.001 |
| Patients with febrile neutropenia, % | 39 | 100 | <.001 |
| Transfusion requirements | |||
| RBC units, median (range) | 2 (0-24) | 6 (0-12) | .007 |
| Platelet transfusions, median (range) | 1 (0-18) | 4 (1-15) | <.001 |
NA indicates not applicable.
These 14 patients all received the ambulatory treatment.
For patients randomized in the ambulatory arm, it means until a total of 6 ambulatory cycles, relapse, or last contact.
Ambulatory therapy was prematurely interrupted after 3 to 5 ambulatory cycles in 4 patients while intensive therapy was not administered in 1 randomized patient, despite continuous CR.
Calculated in patients who had receive the whole planned post-remission therapy (6 ambulatory cycles or 1 intensive cycle) and had recover from all therapy-related toxicities at the lime of analysis (51 patients in the ambulatory arm vs 65 patients in the intensive arm); resources eventually associated with relapse management were not included.