Patients and baseline characteristics of the IRIS study group (551 patients) and the CML91 group (325 patients)
. | IRIS study . | CML91 study . | . |
|---|---|---|---|
| Variable . | Patients in study . | Patients in study . | P . |
| No. of patients | 551 | 325 | – |
| Sex, no. (%) | .039 | ||
| Male | 341 (62) | 178 (55) | – |
| Female | 210 (38) | 147 (45) | – |
| Age at diagnosis, y, median (range) | 50 (18-70) | 50 (18-71) | – |
| Splenomegaly | |||
| No. assessable patients | 442 | 325 | – |
| Median cm under costal margin (range) | 0 (0-27) | 0 (0-21) | – |
| No. of patients with splenomegaly (%) | 192 (43) | 150 (46) | – |
| Median spleen size larger than 0 cm (range) | 7 (1-27) | 7 (1-21) | – |
| WBC at diagnosis | – | ||
| No. assessable patients | 532 | 322 | – |
| WBC count, × 109/L (range) | 96.4 (3.5-537) | 74.8 (4.2-665) | – |
| Peripheral blood blasts cells at diagnosis | – | ||
| No. assessable patients | 469 | 325 | – |
| Blasts (%) total | 0.4 (0-38)* | 0 (0-9) | < .001 |
| No. of patients with more than 0 blasts (%) | 236 (69) | 105 (31) | < .001 |
| Median blasts more than 0, % (range) | 2 (0.01-38) | 2 (1-9) | .018 |
| Basophils at diagnosis, median % (range) | 3 (0-27)* | 4 (0-18) | .001 |
| No. assessable patients | 474 | 321 | – |
| Eosinophils at diagnosis, median % (range) | 2 (0-37) | 2 (0-9) | – |
| No. assessable patients | 474 | 321 | – |
| Hemoglobin at diagnosis, g/L (range) | 123 (43-219) | 125 (66-170) | – |
| No. assessable patients | 518 | 322 | – |
| Platelets at diagnosis, × 109/L (range) | 372 (53-3070) | 389 (81-2385) | – |
| No. assessable patients | 521 | 325 | – |
| Sokal risk group, no. (% all patients/% assessable patients) | |||
| Low | 201 (36/52) | 163 (50) | < .001 |
| Intermediate | 111 (20/29) | 124 (38) | .007 |
| High | 71 (13/19) | 38 (12) | – |
| Not known | 168 (30/0) | 0 (0) | – |
| No. assessable patients | 383 | 325 | – |
| Duration of randomized treatment, mo, median (range) | 41.8 (0.16-42.0) | 30.7 (0.30-42.0) | – |
| Median follow-up | |||
| No. assessable patients | 551 | 325 | – |
| All patients, mo (range) | 42.0 (0.59-42.0) | 42.0 (5.32-42.0) | – |
| Surviving patients, mo, range (no. patients) | 0.59-42.0 (504) | 34.66-42.0 (292) | – |
. | IRIS study . | CML91 study . | . |
|---|---|---|---|
| Variable . | Patients in study . | Patients in study . | P . |
| No. of patients | 551 | 325 | – |
| Sex, no. (%) | .039 | ||
| Male | 341 (62) | 178 (55) | – |
| Female | 210 (38) | 147 (45) | – |
| Age at diagnosis, y, median (range) | 50 (18-70) | 50 (18-71) | – |
| Splenomegaly | |||
| No. assessable patients | 442 | 325 | – |
| Median cm under costal margin (range) | 0 (0-27) | 0 (0-21) | – |
| No. of patients with splenomegaly (%) | 192 (43) | 150 (46) | – |
| Median spleen size larger than 0 cm (range) | 7 (1-27) | 7 (1-21) | – |
| WBC at diagnosis | – | ||
| No. assessable patients | 532 | 322 | – |
| WBC count, × 109/L (range) | 96.4 (3.5-537) | 74.8 (4.2-665) | – |
| Peripheral blood blasts cells at diagnosis | – | ||
| No. assessable patients | 469 | 325 | – |
| Blasts (%) total | 0.4 (0-38)* | 0 (0-9) | < .001 |
| No. of patients with more than 0 blasts (%) | 236 (69) | 105 (31) | < .001 |
| Median blasts more than 0, % (range) | 2 (0.01-38) | 2 (1-9) | .018 |
| Basophils at diagnosis, median % (range) | 3 (0-27)* | 4 (0-18) | .001 |
| No. assessable patients | 474 | 321 | – |
| Eosinophils at diagnosis, median % (range) | 2 (0-37) | 2 (0-9) | – |
| No. assessable patients | 474 | 321 | – |
| Hemoglobin at diagnosis, g/L (range) | 123 (43-219) | 125 (66-170) | – |
| No. assessable patients | 518 | 322 | – |
| Platelets at diagnosis, × 109/L (range) | 372 (53-3070) | 389 (81-2385) | – |
| No. assessable patients | 521 | 325 | – |
| Sokal risk group, no. (% all patients/% assessable patients) | |||
| Low | 201 (36/52) | 163 (50) | < .001 |
| Intermediate | 111 (20/29) | 124 (38) | .007 |
| High | 71 (13/19) | 38 (12) | – |
| Not known | 168 (30/0) | 0 (0) | – |
| No. assessable patients | 383 | 325 | – |
| Duration of randomized treatment, mo, median (range) | 41.8 (0.16-42.0) | 30.7 (0.30-42.0) | – |
| Median follow-up | |||
| No. assessable patients | 551 | 325 | – |
| All patients, mo (range) | 42.0 (0.59-42.0) | 42.0 (5.32-42.0) | – |
| Surviving patients, mo, range (no. patients) | 0.59-42.0 (504) | 34.66-42.0 (292) | – |
Continuous variables are presented with median and range. Binary and categoric variables are presented with frequency and percentage. Unless otherwise indicated, the number of patients assessable was 551 in the IRIS study and 325 in the CML91 study.
– indicates not applicable/not assessed
Despite high percentage of blasts or basophils at time of diagnosis, these patients were kept in the analysis as they fit the inclusion criteria at randomization