Page 175 - 18F-FDG PET as biomarker in aggressive lymphoma; technical and clinical validation

Rituximab intensification during R-CHOP in DLBCL
of 574 eligible patients [1%]), the multivariable Cox regression analyses were restricted to patients with complete data. Kaplan-Meier curves by treatment arm were generated to illustrate survival.
All analyses were performed according the intention-to-treat (ITT) principle. However, patients initially randomly assigned but considered ineligible in retrospect based on information that should have been available before random assignment were excluded from the respective analyses (modified ITT).
Two interim analyses were planned after the inclusion of 200 and 400 evaluable patients, primarily to guard against unfavorable results in the experimental arm, and the results were presented confidentially to an independent data and safety monitoring board. All reported P values are 2 sided and were not adjusted for multiple testing.
Rituximab Pharmacokinetics
Rituximab pharmacokinetics were evaluated in 6 patients in the R-CHOP-14 arm and 4 patients in the RR-CHOP-14 (R-CHOP-14 with intensification of rituximab in the first 4 cycles) arm during the induction phase. Thirty to 60 minutes before each rituximab infusion, 5 mL of blood was drawn, and samples were centrifuged at 1,000 g for 10 minutes at room temperature and stored at −20°C until shipping on dry ice for analysis. Rituximab serum levels were measured by enzyme-linked immunosorbent assay at Xendo Laboratories (Groningen, the Netherlands).
Acknowledgement
We acknowledge all local data managers and the HOVON Data Center trial team for trial management and central data management. We thank the members of the data and safety monitoring board, E. Brusamolino (Pavia, Italy), B. Coiffier (deceased; Lyon, France), and statistician W.C.J. Hop (deceased; Rotterdam, the Netherlands) for their contribution to the conduct of the study and also thank all collaborators and patients who participated in this study.
173
6b