Characteristics of all 533 eligible patients and of 418 patients achieving CR or PR of at least 75% after induction CTx and randomized for consolidation treatment
. | Eligible patients . | Patients randomized for consolidation treatment . | |||
---|---|---|---|---|---|
MOPP/ABV × 8 . | ABVPP × 8 . | MOPP/ABV × 6 + RTx . | ABVPP × 6 + RTx . | ||
No. of patients | 533 | 92 | 116 | 114 | 96 |
Male gender (%) | 66 | 73 | 68 | 68 | 67 |
Age | |||||
Median (y) | 32 | 32 | 32 | 32 | 32 |
≥45 y (%) | 23 | 21 | 16 | 17 | 22 |
Stage | |||||
IIIB (%) | 40 | 52 | 41 | 39 | 46 |
IVA (%) | 12 | 10 | 11 | 13 | 10 |
IVB (%) | 48 | 38 | 48 | 48 | 44 |
Mediastinum (%) | |||||
Uninvolved | 22 | 24 | 25 | 18 | 16 |
MT ratio <0.33 | 63 | 65 | 59 | 63 | 74 |
0.33 ≤ MT ≤ 0.45 | 6 | 4 | 8 | 9 | 4 |
MT >0.45 | 9 | 7 | 8 | 10 | 6 |
Tumor >10 cm (%) | 24 | 25 | 28 | 22 | 26 |
Inguinal involvement (%) | 19 | 13 | 19 | 22 | 26 |
Extranodal sites ≥2 (%) | 27 | 21 | 22 | 25 | 23 |
Bone marrow involvement (%) | 20 | 12 | 16 | 20 | 18 |
ECOG performance status ≥2 (%) | 12 | 8 | 10 | 11 | 11 |
Hemoglobin <10.5 g/L (%) | 29 | 24 | 34 | 21 | 22 |
LDH ratio >1 (%) | 44 | 36 | 40 | 42 | 45 |
Albumin <40 g/L (%) | 23 | 20 | 30 | 22 | 22 |
WBC ≥15 × 109/L (%) | 25 | 21 | 25 | 19 | 27 |
Lymphocyte count <0.6 × 109/L or <8% of WBC (%) | 13 | 8 | 16 | 12 | 8 |
International prognostic score (%) | |||||
0 | 2 | 0 | 4 | 0 | 2 |
1 | 8 | 10 | 11 | 11 | 6 |
2 | 29 | 31 | 25 | 37 | 32 |
3 | 28 | 30 | 27 | 24 | 27 |
4 | 19 | 21 | 22 | 15 | 22 |
≥5 | 14 | 8 | 11 | 13 | 11 |
. | Eligible patients . | Patients randomized for consolidation treatment . | |||
---|---|---|---|---|---|
MOPP/ABV × 8 . | ABVPP × 8 . | MOPP/ABV × 6 + RTx . | ABVPP × 6 + RTx . | ||
No. of patients | 533 | 92 | 116 | 114 | 96 |
Male gender (%) | 66 | 73 | 68 | 68 | 67 |
Age | |||||
Median (y) | 32 | 32 | 32 | 32 | 32 |
≥45 y (%) | 23 | 21 | 16 | 17 | 22 |
Stage | |||||
IIIB (%) | 40 | 52 | 41 | 39 | 46 |
IVA (%) | 12 | 10 | 11 | 13 | 10 |
IVB (%) | 48 | 38 | 48 | 48 | 44 |
Mediastinum (%) | |||||
Uninvolved | 22 | 24 | 25 | 18 | 16 |
MT ratio <0.33 | 63 | 65 | 59 | 63 | 74 |
0.33 ≤ MT ≤ 0.45 | 6 | 4 | 8 | 9 | 4 |
MT >0.45 | 9 | 7 | 8 | 10 | 6 |
Tumor >10 cm (%) | 24 | 25 | 28 | 22 | 26 |
Inguinal involvement (%) | 19 | 13 | 19 | 22 | 26 |
Extranodal sites ≥2 (%) | 27 | 21 | 22 | 25 | 23 |
Bone marrow involvement (%) | 20 | 12 | 16 | 20 | 18 |
ECOG performance status ≥2 (%) | 12 | 8 | 10 | 11 | 11 |
Hemoglobin <10.5 g/L (%) | 29 | 24 | 34 | 21 | 22 |
LDH ratio >1 (%) | 44 | 36 | 40 | 42 | 45 |
Albumin <40 g/L (%) | 23 | 20 | 30 | 22 | 22 |
WBC ≥15 × 109/L (%) | 25 | 21 | 25 | 19 | 27 |
Lymphocyte count <0.6 × 109/L or <8% of WBC (%) | 13 | 8 | 16 | 12 | 8 |
International prognostic score (%) | |||||
0 | 2 | 0 | 4 | 0 | 2 |
1 | 8 | 10 | 11 | 11 | 6 |
2 | 29 | 31 | 25 | 37 | 32 |
3 | 28 | 30 | 27 | 24 | 27 |
4 | 19 | 21 | 22 | 15 | 22 |
≥5 | 14 | 8 | 11 | 13 | 11 |