Page 159 - 18F-FDG PET as biomarker in aggressive lymphoma; technical and clinical validation

Rituximab intensification during R-CHOP in DLBCL
years and with an age-adjusted IPI score of 1 to 3 and patients between age 66 and 80 years and an age-adjusted IPI score of 0 to 3 were eligible. Central pathology review was performed as part of quality control (HOVON Pathology Facility and Biobank). CNS involvement, testicular DLBCL, primary mediastinal B-cell lymphoma, transformed indolent lymphoma, any solid malignancy in the preceding 5 years, and illnesses precluding study treatment rendered patients ineligible.
Computed tomography (CT) scanning and bone marrow biopsies were minimum mandatory staging procedures. Baseline 18F-fluorodeoxyglucose positron emission tomography (PET) scans were recommended but not mandated.
Random Assignment
After providing written informed consent, patients were randomly allocated to receive either R-CHOP-14 (arm A) or R-CHOP-14 with intensification of rituximab in the first 4 cycles (RR-CHOP-14; arm B). Random assignment was stratified by center, age group (18-65 v 66-80 years), and age-adjusted IPI score using a minimization procedure, ensuring balance within each stratum and overall balance.
Treatment and Response Assessment
The R-CHOP-14 regimen consisted of 14-day cycles of intravenous cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/ m2 (maximum, 2 mg), and rituximab 375 mg/m2 on day 1 and prednisone 100 mg once daily on days 1 to 5, for a total of 8 cycles [13]. Pegfilgrastim was administered on day 2 of each cycle. Patients randomly assigned to arm B received extra intravenous rituximab 375 mg/m2 on day 8 of the first 4 cycles (RR- CHOP-14). Initially, inclusion was limited to elderly patients (age 66-80 years). In July 2009, the protocol was amended to also include patients age 18 to 65 years. At the same time, because of the results of the RICOVER-60 trial, the number of CHOP-14 cycles for patients age 66 to 80 years was reduced to 6, whereas the number of rituximab cycles was maintained at 8[2]. Details regarding prephase and supportive measures during treatment are provided in the Appendix (online only). Consolidation radiotherapy was not allowed.
Response at the end of induction treatment was assessed using PET-CT scans [14,15].Patients with progressive disease on CT scan after 4 cycles went off
157
6b