Characteristics and response of Philadelphia-positive ALL study groups
. | No. (%) . | . | . | . | ||
|---|---|---|---|---|---|---|
| Parameter . | VAD . | Hyper-CVAD . | Hyper-CVAD + imatinib mesylate . | P . | ||
| No. treated | ||||||
| Total | 31 | 50 | 20 | — | ||
| Status at study entry | ||||||
| Active disease | 31 | 50 | 15 (75) | — | ||
| In CR | — | — | 5 (25) | — | ||
| Age, y [median, range] | ||||||
| 60 or older | 8 (26) | 15 (30) | 4 (20) | NS | ||
| [47, 19-73] | [44, 16-79] | [42, 19-75] | ||||
| Performance, ECOG | ||||||
| 0 | 7 (23) | 3 (6) | 4 (20) | .07 | ||
| 1 to 2 | 23 (74) | 45 (90) | 16 (80) | |||
| Hemoglobin, g/L | ||||||
| Less than 100 | 14 (45) | 35 (70) | 13 (65) | .08 | ||
| WBC, × 109/L | ||||||
| 30 or higher | 15 (48) | 22 (44) | 4 (20) | NS | ||
| Platelet count, × 109/L | ||||||
| Lower than 50 | 15 (48) | 29 (58) | 7 (35) | NS | ||
| Albumin, g/L | ||||||
| Lower than 30 | 4 (13) | 7 (14) | 7 (35) | .08 | ||
| LDH, U/L | ||||||
| More than 620 | 30 (97) | 46 (92) | 12 (60) | < .01 | ||
| CNS disease | ||||||
| Yes | — | 1 (2) | 3 (15) | .02 | ||
| Karyotype | ||||||
| Ph or complex Ph | 12 (39) | 17 (34) | 8 (40) | NS | ||
| Ph, −5, −7 | 6 (19) | 4 (8) | 1 (5) | |||
| Ph and others (+8, +21) | 13 (42) | 28 (58) | 11 (55) | |||
| B2 microglobulin, mg % | 13/19 | 19/39 | 4/18 | .03 | ||
| More than 3 | (68) | (49) | (22) | |||
| Response | ||||||
| CR | 19 (61) | 47 (94) | 15/15 | < .01 | ||
| PR | 4 (13) | — | — | |||
| Resistant | 8 (26) | 3 (6) | — | |||
| CR at start | — | — | 5 (25) | |||
| Death | — | — | — | |||
| Courses to CR | ||||||
| 1 | 16 (84) | 33 (70) | 14 (93) | NS | ||
| 2 | 3 (16) | 6 (13) | 1 (7) | |||
| More than 2 | — | 8 (17) | — | |||
| Median days to response [range] | ||||||
| CR | 24 [19-42] | 20 [11-32] | 19 [15-22] | NS | ||
| ANC 109/L or higher | 22 [6-27] | 23 [15-30] | 20 [17-28] | |||
| PLT 100 × 109/L or higher | 24 [20-48] | 25 [18-107] | 21 [17-44] | |||
| Incidence during induction* | ||||||
| FUO | 10 (22) | 31 (41) | 4 (25) | NS | ||
| Infections | 8 (17) | 27 (36) | 5 (31) | |||
| Pneumonia | 4 | 9 | 3 | |||
| Sepsis/bacteremia | 2 | 12 | — | |||
| Fungemia | 1 | 1 | 1 | |||
| Other (minor) | 1 | 5 | 1 | |||
. | No. (%) . | . | . | . | ||
|---|---|---|---|---|---|---|
| Parameter . | VAD . | Hyper-CVAD . | Hyper-CVAD + imatinib mesylate . | P . | ||
| No. treated | ||||||
| Total | 31 | 50 | 20 | — | ||
| Status at study entry | ||||||
| Active disease | 31 | 50 | 15 (75) | — | ||
| In CR | — | — | 5 (25) | — | ||
| Age, y [median, range] | ||||||
| 60 or older | 8 (26) | 15 (30) | 4 (20) | NS | ||
| [47, 19-73] | [44, 16-79] | [42, 19-75] | ||||
| Performance, ECOG | ||||||
| 0 | 7 (23) | 3 (6) | 4 (20) | .07 | ||
| 1 to 2 | 23 (74) | 45 (90) | 16 (80) | |||
| Hemoglobin, g/L | ||||||
| Less than 100 | 14 (45) | 35 (70) | 13 (65) | .08 | ||
| WBC, × 109/L | ||||||
| 30 or higher | 15 (48) | 22 (44) | 4 (20) | NS | ||
| Platelet count, × 109/L | ||||||
| Lower than 50 | 15 (48) | 29 (58) | 7 (35) | NS | ||
| Albumin, g/L | ||||||
| Lower than 30 | 4 (13) | 7 (14) | 7 (35) | .08 | ||
| LDH, U/L | ||||||
| More than 620 | 30 (97) | 46 (92) | 12 (60) | < .01 | ||
| CNS disease | ||||||
| Yes | — | 1 (2) | 3 (15) | .02 | ||
| Karyotype | ||||||
| Ph or complex Ph | 12 (39) | 17 (34) | 8 (40) | NS | ||
| Ph, −5, −7 | 6 (19) | 4 (8) | 1 (5) | |||
| Ph and others (+8, +21) | 13 (42) | 28 (58) | 11 (55) | |||
| B2 microglobulin, mg % | 13/19 | 19/39 | 4/18 | .03 | ||
| More than 3 | (68) | (49) | (22) | |||
| Response | ||||||
| CR | 19 (61) | 47 (94) | 15/15 | < .01 | ||
| PR | 4 (13) | — | — | |||
| Resistant | 8 (26) | 3 (6) | — | |||
| CR at start | — | — | 5 (25) | |||
| Death | — | — | — | |||
| Courses to CR | ||||||
| 1 | 16 (84) | 33 (70) | 14 (93) | NS | ||
| 2 | 3 (16) | 6 (13) | 1 (7) | |||
| More than 2 | — | 8 (17) | — | |||
| Median days to response [range] | ||||||
| CR | 24 [19-42] | 20 [11-32] | 19 [15-22] | NS | ||
| ANC 109/L or higher | 22 [6-27] | 23 [15-30] | 20 [17-28] | |||
| PLT 100 × 109/L or higher | 24 [20-48] | 25 [18-107] | 21 [17-44] | |||
| Incidence during induction* | ||||||
| FUO | 10 (22) | 31 (41) | 4 (25) | NS | ||
| Infections | 8 (17) | 27 (36) | 5 (31) | |||
| Pneumonia | 4 | 9 | 3 | |||
| Sepsis/bacteremia | 2 | 12 | — | |||
| Fungemia | 1 | 1 | 1 | |||
| Other (minor) | 1 | 5 | 1 | |||
VAD indicates vincristine, doxorubicin, and dexamethasone; PLT, platelet count; —, not applicable; NS, not significant; and FUO, fever of unknown origin.
Only 15 of 20 patients evaluable for induction course toxicity for hyper-CVAD and imatinib mesylate (5 patients in CR at start).