Patient characteristics and estimated outcomes
. | . | . | Patients randomized for consolidation . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|---|
. | Eligible patients . | Patients not randomized for consolidation . | MOPP/ABV ×8 . | ABVPP ×8 . | MOPP/ABV + RT . | ABVPP ×6 + RT . | |||
| Patients' characteristics | |||||||||
| No. patients | 533 | 115 | 92 | 116 | 114 | 96 | |||
| Men, % | 66 | 57 | 73 | 68 | 68 | 67 | |||
| Age, median, y | 32 | 36 | 32 | 32 | 32 | 32 | |||
| Age at least 45, % | 23 | 40 | 21 | 16 | 17 | 22 | |||
| Stage IIIB, % | 40 | 25 | 52 | 41 | 39 | 46 | |||
| Stage 4, % | 60 | 75 | 48 | 59 | 61 | 54 | |||
| Extranodal sites at least 2, % | 27 | 62 | 21 | 22 | 25 | 23 | |||
| Bone marrow involvement, % | 20 | 33 | 12 | 16 | 20 | 18 | |||
| ECOG performance status at least 2, % | 12 | 22 | 8 | 10 | 11 | 11 | |||
| Hemoglobin level less than 10.5 g/L, % | 29 | 48 | 24 | 34 | 21 | 22 | |||
| Albumin level less than 40 g/L, % | 23 | 78 | 20 | 30 | 22 | 22 | |||
| WBC at least 15 G/L, % | 25 | 31 | 21 | 25 | 19 | 27 | |||
| Lymphocyte count less than 0.6 G/L or less than 8% of WBC | 13 | 23 | 8 | 16 | 12 | 8 | |||
| IPS 0 to 2, % | 39 | 23 | 41 | 40 | 48 | 40 | |||
| IPS 3 or higher, % | 61 | 77 | 59 | 60 | 42 | 60 | |||
| Additional treatment for refractory and relapsing disease, no. patients | |||||||||
| MINE, ASCT | 64 | 33 | 6 | 13 | 6 | 6 | |||
| Other CT, ASCT | 26 | 7 | 3 | 8 | 3 | 5 | |||
| CT without ASCT | 46 | 20 | 6 | 9 | 4 | 7 | |||
| CT and tandem ASCT | 11 | 5 | 2 | 1 | — | 3 | |||
| HDCT allogeneic BMT | 3 | 1 | — | 1 | — | 1 | |||
| RT alone | 3 | 1 | — | 1 | — | 1 | |||
| Outcomes, % (95% confidence interval) | |||||||||
| CR rate | — | — | 91 | 99 | 95 | 91 | |||
| 10-year DFS*† | 74 (69-78) | 59 (39-79) | 76 (67-86) | 70 (61-78) | 79 (69-88) | 76 (67-85) | |||
| 10-year event-free survival‡ | 61 (57-66) | 24 (16-32) | 71 (62-81) | 67 (60-77) | 77 (68-86) | 69 (59-78) | |||
| 10-year OS§ | 75 (71-79) | 50 (41-60) | 78 (68-85) | 90 (85-96) | 82 (74-90) | 77 (68-85) | |||
. | . | . | Patients randomized for consolidation . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|---|
. | Eligible patients . | Patients not randomized for consolidation . | MOPP/ABV ×8 . | ABVPP ×8 . | MOPP/ABV + RT . | ABVPP ×6 + RT . | |||
| Patients' characteristics | |||||||||
| No. patients | 533 | 115 | 92 | 116 | 114 | 96 | |||
| Men, % | 66 | 57 | 73 | 68 | 68 | 67 | |||
| Age, median, y | 32 | 36 | 32 | 32 | 32 | 32 | |||
| Age at least 45, % | 23 | 40 | 21 | 16 | 17 | 22 | |||
| Stage IIIB, % | 40 | 25 | 52 | 41 | 39 | 46 | |||
| Stage 4, % | 60 | 75 | 48 | 59 | 61 | 54 | |||
| Extranodal sites at least 2, % | 27 | 62 | 21 | 22 | 25 | 23 | |||
| Bone marrow involvement, % | 20 | 33 | 12 | 16 | 20 | 18 | |||
| ECOG performance status at least 2, % | 12 | 22 | 8 | 10 | 11 | 11 | |||
| Hemoglobin level less than 10.5 g/L, % | 29 | 48 | 24 | 34 | 21 | 22 | |||
| Albumin level less than 40 g/L, % | 23 | 78 | 20 | 30 | 22 | 22 | |||
| WBC at least 15 G/L, % | 25 | 31 | 21 | 25 | 19 | 27 | |||
| Lymphocyte count less than 0.6 G/L or less than 8% of WBC | 13 | 23 | 8 | 16 | 12 | 8 | |||
| IPS 0 to 2, % | 39 | 23 | 41 | 40 | 48 | 40 | |||
| IPS 3 or higher, % | 61 | 77 | 59 | 60 | 42 | 60 | |||
| Additional treatment for refractory and relapsing disease, no. patients | |||||||||
| MINE, ASCT | 64 | 33 | 6 | 13 | 6 | 6 | |||
| Other CT, ASCT | 26 | 7 | 3 | 8 | 3 | 5 | |||
| CT without ASCT | 46 | 20 | 6 | 9 | 4 | 7 | |||
| CT and tandem ASCT | 11 | 5 | 2 | 1 | — | 3 | |||
| HDCT allogeneic BMT | 3 | 1 | — | 1 | — | 1 | |||
| RT alone | 3 | 1 | — | 1 | — | 1 | |||
| Outcomes, % (95% confidence interval) | |||||||||
| CR rate | — | — | 91 | 99 | 95 | 91 | |||
| 10-year DFS*† | 74 (69-78) | 59 (39-79) | 76 (67-86) | 70 (61-78) | 79 (69-88) | 76 (67-85) | |||
| 10-year event-free survival‡ | 61 (57-66) | 24 (16-32) | 71 (62-81) | 67 (60-77) | 77 (68-86) | 69 (59-78) | |||
| 10-year OS§ | 75 (71-79) | 50 (41-60) | 78 (68-85) | 90 (85-96) | 82 (74-90) | 77 (68-85) | |||
ECOG indicates Eastern Cooperative Oncology Group; IPS, International Prognostic Score; MINE, salvage therapy with mitoguazone, ifosfamide, navelbine, and etoposide; ASCT, autologous stem cell transplantation; HDCT, high-dose chemotherapy; BMT, bone marrow transplantation; CT, chemotherapy; and RT, radiotherapy.
Three hundred ninety-four patients in CR were analyzed.
P = .09 for the comparison of the 4 treatment arms.
P = .23 for the comparison of the 4 treatment arms.
P = .03 for the comparison of the 4 treatment arms.