Page 173 - 18F-FDG PET as biomarker in aggressive lymphoma; technical and clinical validation

Rituximab intensification during R-CHOP in DLBCL
Supplemental materials
Prephase Treatment and Supportive Measures During R-CHOP-14 Treatment
Prephase treatment
A prephase treatment before the start of study treatment was mandatory in all elderly patients (age 66-80 years) and was left at the discretion of the treating physician in young patients (age 18-65 years). The prephase treatment consisted of a 5-day course of 100 mg of prednisone once daily.
Allopurinol
Allopurinol was applied according to local practices. The dose should have been adapted if the creatinine clearance was decreased.
Prednisone tapering
A gradual reduction of the prednisone dose was recommended to prevent marked fatigue after prompt discontinuation of prednisone. Prednisone 50 mg could be administered on day 6, 25 mg on day 7, and 10 mg on day 8. For patients complaining of fatigue after tapering of prednisone, hydrocortisone 20 mg orally in the morning and 10 mg orally at 1200 was recommended.
Prophylaxis of infection
Pneumocystis jiroveci and herpes infection prophylaxis was mandatory in all patients. This consisted of oral cotrimoxazol 480 mg once daily and oral valaciclovir 500 mg twice per day, starting with the prephase treatment until 4 weeks after the last rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-14) cycle.
Intrathecal prophylaxis for CNS relapse was at the discretion of the treating physician.
Sample Size Calculation
The sample size was calculated to have a sufficient number of patients available for the second randomization (R2); thereafter, the statistical power for the first randomization (R1) was determined. To detect with 80% power an improvement in failure-free survival (FFS) from R2 with a hazard ratio (HR) of 0.60 (2-sided significance level, α = 0.05), 126 events were required. Assuming a proportional
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