Table 3.
Response Rates in the Final Response Assessment
| Response | Qualifying for Radiotherapy (n = 467) | Not Qualifying for Radiotherapy (n = 228) | ||||
|---|---|---|---|---|---|---|
| R-CHOP-21 (n = 81)a |
R-CHOP-14 (n = 81)a |
R-CHOP-21 +radiotherapy (n = 155)b |
R-CHOP-14 +radiotherapy (n = 150)b |
R-CHOP-21 (n = 114)a |
R-CHOP-14 (n = 114)a |
|
| Complete response/unconfirmed complete response 95% CI |
64 (79%) (69-87) |
64 (79%) (69-87) |
141 (91%) (85-95) |
133 (89%) (83-94) |
109 (96%) (91-99) |
105 (92%) (85-96) |
| Complete response/unconfirmed complete response and additional treatment | 2 (2%) | 1 (1%) | 2 (1%) | 1 (1%) | 1 (1%) | 2 (2%) |
| 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 deathc | 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%) |
Remark: Five (0/0/1/0/2/2) patients terminated CHOP earlier due to excessive toxicity. Four patients achieved a complete remission and 1 patient deceased after cycle 1.
aFinal response was assessed 2 weeks after start of the sixth cycle of R-CHOP.
bFinal response was assessed after end of radiotherapy simultaneously with first follow-up.
cAll deaths related to study treatment were related to R-CHOP chemotherapy (sudden cardiac arrest, traffic accident, suicide, cardiogenic shock during percutaneous coronary intervention, liver failure).
CI = confidence interval; R-CHOP = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.