Table 4.
EFS, PFS and OS Rates, EFS-events and Relapse Rates
| Qualifying for Radiotherapy (n = 467) | Not Qualifying for Radiotherapy (n = 228) | |||||
|---|---|---|---|---|---|---|
| R-CHOP-21 (n = 81) |
R-CHOP-14 (n = 81) |
R-CHOP-21 + Radiotherapy (n = 155) |
R-CHOP-14 + Radiotherapy (n = 150) |
R-CHOP-21 (n = 114) |
R-CHOP-14 (n = 114) |
|
| 3-y EFS (%) | 65 | 72 | 83 | 86 | 81 | 86 |
| 95% CI (%) | (55-76) | (62-81) | (77-89) | (80-91) | (74-88) | (79-92) |
| 3-y PFS (%) | 79 | 84 | 86 | 91 | 84 | 91 |
| 95% CI (%) | (70-88) | (76-92) | (81-92) | (86-96) | (78-91) | (85-96) |
| 3-y OS (%) | 94 | 92 | 93 | 94 | 94 | 95 |
| 95% CI (%) | (89-99) | (87-98) | (88-97) | (90-98) | (89-98) | (91-99) |
| EFS-events | ||||||
| Without event (censored) | 51 (63%) | 56 (69%) | 126 (81%) | 123 (82%) | 89 (78%) | 92 (81%) |
| Complete response/unconfirmed complete response and additional treatment | 2 (2%) | 1 (1%) | 2 (1%) | 1 (1%) | 1 (1%) | 2 (2%) |
| Complete response/unconfirmed complete response and relapse | 12 (15%) | 8 (10%) | 13 (8%) | 9 (6%) | 18 (16%) | 7 (6%) |
| Complete response/unconfirmed complete response and death | 1 (1%) | 0 (0%) | 2(1%) | 1 (1%) | 2 (2%) | 6 (5%) |
| Partial response (received additional therapy) | 8 (10%) | 10 (12%) | 4 (3%) | 3 (2%) | 0 (0%) | 3 (3%) |
| No change | 0 (0%) | 1 (1%) | 0 (0%) | 2 (1%) | 0 (0%) | 0 (0%) |
| Progressive disease | 4 (5%) | 2 (2%) | 4 (3%) | 6 (4%) | 1 (1%) | 0 (0%) |
| Therapy associated deatha | 0 (0%) | 1 (1%) | 2 (1%) | 0 (0%) | 0 (0%) | 2 (2%) |
| Unknown | 3 (4%) | 2 (2%) | 2 (1%) | 5 (3%) | 3 (3%) | 2 (2%) |
| Relapse rates | 12/64 (19%) |
8/64 (12%) |
13/141 (9%) |
9/133 (7%) |
18/109 (16%) |
7/105 (7%) |
| 95% CI (%) | (10-31) | (5-23) | (5-15) | (3-13) | (10-24) | (3-14) |
Remark: Five (0/0/1/0/2/2) patients terminated CHOP earlier due to excessive toxicity. Four patients achieved a CR and 1 patient deceased after cycle 1.
aÁll deaths related to study treatment were related to R-CHOP chemotherapy (sudden cardiac arrest, traffic accident, suicide, cardiogenic shock during percutaneous coronary intervention, and liver failure).
CI = confidence interval; EFS = event-free survival; OS= overall survival; PFS = progression-free survival; R-CHOP = rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone.