Table 2.
Application of Radiotherapy for Patients Qualifying for Radiotherapy (n = 467)
| R-CHOP-21 (n = 81) |
R-CHOP-14 (n = 81) |
R-CHOP-21 + Radiotherapy (n = 155) |
R-CHOP-14 + Radiotherapy (n = 150)a |
|
|---|---|---|---|---|
| Radiotherapy given | ||||
| According to protocol | - | - | 133 (86%) | 135 (90%) |
| Protocol violationb | 2 (2%) | 1 (1%) | - | - |
| Due to interim analysisc | 4 (5%) | 3 (4%) | - | - |
| Radiotherapy not given | ||||
| According to protocol | 75 (93%) | 77 (95%) | - | - |
| Insufficient response | - | - | 4 (3%) | 7 (5%) |
| Toxicityd | - | - | 3 (2%) | - |
| Protocol violation | - | - | 5 (3%) | 4 (3%) |
| Patients decision | - | - | 6 (4%) | 1 (1%) |
| Concomitant disease | - | - | 1 (1%) | - |
| Other reason | - | - | 3 (2%) | 3 (2%) |
| Radiotherapy given after R-CHOP, due to final restaging with result partial response | 5/81 (6%) | 5/81 (6%) | - | - |
| Radiotherapy given | 11/81 (14%) | 9/81 (11%) |
133/155 (86%) | 135/150 (90%) |
aFor 1 patient, qualification for radiotherapy was no longer further present after randomization.
bRadiotherapy after final restaging with result CR/CRu.
cAfter interim analysis, the observation-arms were closed and radiotherapy was performed also in observation-arms.
dToxicity occurred during the course of R-CHOP chemotherapy.
CR/CRu = complete response/unconfirmed complete response; R-CHOP = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.