Initial characteristics of randomized group B patients
| . | COPADM2 . | COPADM1 . | Total . | ||
|---|---|---|---|---|---|
| M1 standard . | No M1 . | M1 . | No M1 . | ||
| N | 160 | 161 | 161 | 155 | 637 |
| Cooperative group | |||||
| CCG | 76 | 76 | 78 | 76 | 306 |
| SFOP | 56 | 56 | 54 | 55 | 221 |
| UKCCSG | 28 | 29 | 29 | 24 | 110 |
| Male, no. (%) | 121 (76) | 122 (76) | 117 (73) | 114 (74) | 474 (74) |
| Age, y | |||||
| Mean (range) | 10 (2.7-19.5) | 9.7 (2.5-20.5) | 10.3 (2.9-20.4) | 10.7 (2.7-20.3) | 10.2 (2.5-20.5) |
| Older than 15, % | 14 | 13 | 14 | 22 | 16 |
| Weight loss | |||||
| 10%-20%, no. (%) | 14 (9) | 23 (14) | 27 (17) | 18 (12) | 82 (13) |
| More than 20%, no. (%) | 2 (1) | 2 (1) | 2 (1) | 0 (0) | 6 (1) |
| Pathologic diagnosis, no. (%) | |||||
| Burkitt | 101 (63) | 102 (63) | 100 (62) | 94 (61) | 397 (62) |
| Burkitt-like | 15 (9) | 11 (7) | 15 (9) | 13 (8) | 54 (8) |
| DLBCL | 27 (17) | 39 (24) | 37 (23) | 42 (27) | 145 (23) |
| T-cell–rich B | 4 (3) | 0 | 1 (1) | 1 (1) | 6 (1) |
| Eligible mature B-cell, not subclassified | 13 (8) | 9 (6) | 8 (5) | 5 (3) | 35 (5) |
| Primary site, no. (%) | |||||
| Thorax, not primary mediastinal DLBCL | 3 (2) | 3 (2) | 1 (1) | 2 (1) | 9 (1) |
| Primary mediastinal DLBC | 7 (4) | 8 (5) | 10 (6) | 7 (5) | 32 (5) |
| Abdomen | 99 (62) | 95 (58) | 96 (60) | 90 (58) | 379 (59) |
| Head and neck | 28 (17) | 36 (22) | 23 (14) | 33 (21) | 120 (19) |
| Peripheral lymph nodes | 14 (9) | 11 (7) | 19 (12) | 17 (11) | 61 (10) |
| Other tumor site | 8 (5) | 9 (6) | 11 (7) | 6 (4) | 34 (5) |
| Not specified | 1 (1) | 0 (0) | 1 (1) | 0 (0) | 2 (0.3) |
| BM involvement | 6 (4) | 10 (6) | 9 (6) | 7 (5) | 32 (5) |
| LDH, no. (%) | |||||
| More than 2N | 57 (36) | 62 (39) | 63 (39) | 53 (33) | 235 (37) |
| Missing | 5 | 2 | 4 | 3 | 14 |
| At least one tumor greater than 10 cm, no. (%) | 45 (28) | 50 (31) | 51 (32) | 50 (32) | 196 (31) |
| Prognostic stage, no. (%) | |||||
| I, not completely resected | 13 (8) | 14 (9) | 14 (9) | 14 (9) | 55 (9) |
| II, except abdominal resected | 36 (22) | 37 (23) | 30 (19) | 34 (22) | 137 (21) |
| III | 105 (66) | 100 (62) | 108 (67) | 100 (64) | 413 (65) |
| IV, CNS negative | 6 (4) | 10 (6) | 9 (6) | 7 (5) | 32 (5) |
| . | COPADM2 . | COPADM1 . | Total . | ||
|---|---|---|---|---|---|
| M1 standard . | No M1 . | M1 . | No M1 . | ||
| N | 160 | 161 | 161 | 155 | 637 |
| Cooperative group | |||||
| CCG | 76 | 76 | 78 | 76 | 306 |
| SFOP | 56 | 56 | 54 | 55 | 221 |
| UKCCSG | 28 | 29 | 29 | 24 | 110 |
| Male, no. (%) | 121 (76) | 122 (76) | 117 (73) | 114 (74) | 474 (74) |
| Age, y | |||||
| Mean (range) | 10 (2.7-19.5) | 9.7 (2.5-20.5) | 10.3 (2.9-20.4) | 10.7 (2.7-20.3) | 10.2 (2.5-20.5) |
| Older than 15, % | 14 | 13 | 14 | 22 | 16 |
| Weight loss | |||||
| 10%-20%, no. (%) | 14 (9) | 23 (14) | 27 (17) | 18 (12) | 82 (13) |
| More than 20%, no. (%) | 2 (1) | 2 (1) | 2 (1) | 0 (0) | 6 (1) |
| Pathologic diagnosis, no. (%) | |||||
| Burkitt | 101 (63) | 102 (63) | 100 (62) | 94 (61) | 397 (62) |
| Burkitt-like | 15 (9) | 11 (7) | 15 (9) | 13 (8) | 54 (8) |
| DLBCL | 27 (17) | 39 (24) | 37 (23) | 42 (27) | 145 (23) |
| T-cell–rich B | 4 (3) | 0 | 1 (1) | 1 (1) | 6 (1) |
| Eligible mature B-cell, not subclassified | 13 (8) | 9 (6) | 8 (5) | 5 (3) | 35 (5) |
| Primary site, no. (%) | |||||
| Thorax, not primary mediastinal DLBCL | 3 (2) | 3 (2) | 1 (1) | 2 (1) | 9 (1) |
| Primary mediastinal DLBC | 7 (4) | 8 (5) | 10 (6) | 7 (5) | 32 (5) |
| Abdomen | 99 (62) | 95 (58) | 96 (60) | 90 (58) | 379 (59) |
| Head and neck | 28 (17) | 36 (22) | 23 (14) | 33 (21) | 120 (19) |
| Peripheral lymph nodes | 14 (9) | 11 (7) | 19 (12) | 17 (11) | 61 (10) |
| Other tumor site | 8 (5) | 9 (6) | 11 (7) | 6 (4) | 34 (5) |
| Not specified | 1 (1) | 0 (0) | 1 (1) | 0 (0) | 2 (0.3) |
| BM involvement | 6 (4) | 10 (6) | 9 (6) | 7 (5) | 32 (5) |
| LDH, no. (%) | |||||
| More than 2N | 57 (36) | 62 (39) | 63 (39) | 53 (33) | 235 (37) |
| Missing | 5 | 2 | 4 | 3 | 14 |
| At least one tumor greater than 10 cm, no. (%) | 45 (28) | 50 (31) | 51 (32) | 50 (32) | 196 (31) |
| Prognostic stage, no. (%) | |||||
| I, not completely resected | 13 (8) | 14 (9) | 14 (9) | 14 (9) | 55 (9) |
| II, except abdominal resected | 36 (22) | 37 (23) | 30 (19) | 34 (22) | 137 (21) |
| III | 105 (66) | 100 (62) | 108 (67) | 100 (64) | 413 (65) |
| IV, CNS negative | 6 (4) | 10 (6) | 9 (6) | 7 (5) | 32 (5) |
The details of the different treatment arms (COPAM1, COPADM2, M1) are explained in Figure 1.
BM indicates bone marrow; CNS, central nervous system; LDH >2N, more than 2 times the upper limit of the institutional normal range.