Severity of hematologic toxicity and hospitalization associated with consolidation therapy in the LPA99 and LPA2005 trials
| Toxicity . | Course 1 . | Course 2 . | Course 3 . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| LPA99 N (%) . | LPA2005 N (%) . | P . | LPA99 N (%) . | LPA2005 N (%) . | P . | LPA99 N (%) . | LPA2005 N (%) . | P . | |
| All patients, no. evaluable courses | 472 | 305 | 477 | 292 | 449 | 276 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 11 (0-52) | 16 (0-52) | 21 (0-91) | 15 (0-117) | 18 (0-90) | 19 (0-85) | |||
| Episodes > 15 d, n (%) | 205 (44) | 159 (52) | .02 | 352 (75) | 140 (48) | < .001 | 257 (53) | 156 (57) | .35 |
| Days with grade 4 neutropenia, median (range) | 17 (0-63) | 18 (0-54) | 22 (0-68) | 18 (0-78) | 20 (0-80) | 19 (0-78) | |||
| Episodes > 15 d, n (%) | 256 (54) | 182 (60) | .12 | 403 (84) | 179 (61) | < .001 | 259 (58) | 165 (60) | .58 |
| Days of hospitalization, median (range) | 4 (0-61) | 4 (0-37) | 10 (0-119) | 0 (0-36) | 0 (0-63) | 0 (0-64) | |||
| Episodes > 10 d, n (%) | 110 (24) | 100 (32) | .02 | 216 (46) | 75 (26) | < .001 | 70 (16) | 73 (26) | .35 |
| Low-risk patients, no. evaluable courses | 93 | 66 | 97 | 68 | 82 | 63 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 0 (0-37) | 0 (0-28) | 21 (0-36) | 0 (0-57) | 0 (0-67) | 0 (0-31) | |||
| Episodes > 15 d, n (%) | 12 (13) | 16 (24) | .08 | 60 (64) | 27 (40) | < .001 | 13 (16) | 11 (17) | .79 |
| Days with grade 4 neutropenia, median (range) | 0 (0-30) | 0 (0-31) | 21 (0-42) | 17 (0-35) | 0 (0-55) | 0 (0-52) | |||
| Episodes > 15 d, n (%) | 21 (23) | 21 (32) | .19 | 78 (80) | 37 (54) | < .001 | 17 (21) | 12 (19) | .80 |
| Days of hospitalization, median (range) | 0 (0-30) | 4 (0-36) | 8 (0-119) | 0 (0-36) | 0 (0-36) | 0 (0-17) | |||
| Episodes > 10 d, n (%) | 12 (13) | 17 (25) | .06 | 38 (39) | 15 (24) | .02 | 3 (3) | 3 (4) | .99 |
| Intermediate-risk patients, no. evaluable courses | 271 | 161 | 271 | 153 | 264 | 144 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 17 (0-52) | 16 (0-52) | 22 (0-91) | 0 (0-117) | 24 (0-86) | 20 (0-85) | |||
| Episodes > 15 d, n (%) | 149 (55) | 82 (50) | .34 | 212 (78) | 59 (38) | < .001 | 163 (62) | 84 (59) | .49 |
| Days with grade 4 neutropenia, median (range) | 19 (0-63) | 18 (0-54) | 22 (0-68) | 17 (0-61) | 23 (0-75) | 19 (0-78) | |||
| Episodes > 15 d, n (%) | 171(63) | 96 (60) | .47 | 232 (86) | 88 (57) | < .001 | 174 (66) | 92 (64) | .68 |
| Days of hospitalization, median (range) | 5 (0-61) | 4 (0-34) | 10 (0-49) | 0 (0-33) | 0 (0-63) | 0 (0-64) | |||
| Episodes > 10 d, n (%) | 73 (28) | 42 (26) | .51 | 124 (47) | 32 (21) | < .001 | 45 (18) | 34 (23) | .35 |
| High-risk patients, No. evaluable courses | 107 | 77 | 109 | 70 | 103 | 69 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 0 (0-34) | 18 (0-33) | 21 (0-64) | 24 (0-102) | 21 (0-90) | 26 (0-56) | |||
| Episodes > 15 d, n (%) | 43 (41) | 61 (81) | < .001 | 80 (77) | 54 (77) | .97 | 61 (61) | 61 (89) | < .001 |
| Days with grade 4 neutropenia, median (range) | 19 (0-46) | 20 (0-43) | 24 (0-64) | 22 (0-78) | 20 (0-80) | 22 (0-49) | |||
| Episodes > 15 d, n (%) | 63 (59) | 65 (84) | < .001 | 93 (85) | 54 (77) | .16 | 68 (66) | 61 (89) | < .001 |
| Days of hospitalization, median (range) | 0 (0-34) | 13 (0-37) | 11 (0-40) | 6 (0-28) | 0 (0-60) | 11 (0-37) | |||
| Episodes > 10 d, n (%) | 78 (23) | 41 (52) | < .001 | 53 (50) | 28 (39) | .13 | 22 (22) | 36 (51) | < .001 |
| Toxicity . | Course 1 . | Course 2 . | Course 3 . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| LPA99 N (%) . | LPA2005 N (%) . | P . | LPA99 N (%) . | LPA2005 N (%) . | P . | LPA99 N (%) . | LPA2005 N (%) . | P . | |
| All patients, no. evaluable courses | 472 | 305 | 477 | 292 | 449 | 276 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 11 (0-52) | 16 (0-52) | 21 (0-91) | 15 (0-117) | 18 (0-90) | 19 (0-85) | |||
| Episodes > 15 d, n (%) | 205 (44) | 159 (52) | .02 | 352 (75) | 140 (48) | < .001 | 257 (53) | 156 (57) | .35 |
| Days with grade 4 neutropenia, median (range) | 17 (0-63) | 18 (0-54) | 22 (0-68) | 18 (0-78) | 20 (0-80) | 19 (0-78) | |||
| Episodes > 15 d, n (%) | 256 (54) | 182 (60) | .12 | 403 (84) | 179 (61) | < .001 | 259 (58) | 165 (60) | .58 |
| Days of hospitalization, median (range) | 4 (0-61) | 4 (0-37) | 10 (0-119) | 0 (0-36) | 0 (0-63) | 0 (0-64) | |||
| Episodes > 10 d, n (%) | 110 (24) | 100 (32) | .02 | 216 (46) | 75 (26) | < .001 | 70 (16) | 73 (26) | .35 |
| Low-risk patients, no. evaluable courses | 93 | 66 | 97 | 68 | 82 | 63 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 0 (0-37) | 0 (0-28) | 21 (0-36) | 0 (0-57) | 0 (0-67) | 0 (0-31) | |||
| Episodes > 15 d, n (%) | 12 (13) | 16 (24) | .08 | 60 (64) | 27 (40) | < .001 | 13 (16) | 11 (17) | .79 |
| Days with grade 4 neutropenia, median (range) | 0 (0-30) | 0 (0-31) | 21 (0-42) | 17 (0-35) | 0 (0-55) | 0 (0-52) | |||
| Episodes > 15 d, n (%) | 21 (23) | 21 (32) | .19 | 78 (80) | 37 (54) | < .001 | 17 (21) | 12 (19) | .80 |
| Days of hospitalization, median (range) | 0 (0-30) | 4 (0-36) | 8 (0-119) | 0 (0-36) | 0 (0-36) | 0 (0-17) | |||
| Episodes > 10 d, n (%) | 12 (13) | 17 (25) | .06 | 38 (39) | 15 (24) | .02 | 3 (3) | 3 (4) | .99 |
| Intermediate-risk patients, no. evaluable courses | 271 | 161 | 271 | 153 | 264 | 144 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 17 (0-52) | 16 (0-52) | 22 (0-91) | 0 (0-117) | 24 (0-86) | 20 (0-85) | |||
| Episodes > 15 d, n (%) | 149 (55) | 82 (50) | .34 | 212 (78) | 59 (38) | < .001 | 163 (62) | 84 (59) | .49 |
| Days with grade 4 neutropenia, median (range) | 19 (0-63) | 18 (0-54) | 22 (0-68) | 17 (0-61) | 23 (0-75) | 19 (0-78) | |||
| Episodes > 15 d, n (%) | 171(63) | 96 (60) | .47 | 232 (86) | 88 (57) | < .001 | 174 (66) | 92 (64) | .68 |
| Days of hospitalization, median (range) | 5 (0-61) | 4 (0-34) | 10 (0-49) | 0 (0-33) | 0 (0-63) | 0 (0-64) | |||
| Episodes > 10 d, n (%) | 73 (28) | 42 (26) | .51 | 124 (47) | 32 (21) | < .001 | 45 (18) | 34 (23) | .35 |
| High-risk patients, No. evaluable courses | 107 | 77 | 109 | 70 | 103 | 69 | |||
| Days with grade 3-4 thrombocytopenia, median (range) | 0 (0-34) | 18 (0-33) | 21 (0-64) | 24 (0-102) | 21 (0-90) | 26 (0-56) | |||
| Episodes > 15 d, n (%) | 43 (41) | 61 (81) | < .001 | 80 (77) | 54 (77) | .97 | 61 (61) | 61 (89) | < .001 |
| Days with grade 4 neutropenia, median (range) | 19 (0-46) | 20 (0-43) | 24 (0-64) | 22 (0-78) | 20 (0-80) | 22 (0-49) | |||
| Episodes > 15 d, n (%) | 63 (59) | 65 (84) | < .001 | 93 (85) | 54 (77) | .16 | 68 (66) | 61 (89) | < .001 |
| Days of hospitalization, median (range) | 0 (0-34) | 13 (0-37) | 11 (0-40) | 6 (0-28) | 0 (0-60) | 11 (0-37) | |||
| Episodes > 10 d, n (%) | 78 (23) | 41 (52) | < .001 | 53 (50) | 28 (39) | .13 | 22 (22) | 36 (51) | < .001 |