Page 184 - 18F-FDG PET as biomarker in aggressive lymphoma; technical and clinical validation

Chapter 7
the primary endpoint,which was CMR by centrally reviewed 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)-computer tomography (CT) scan at EOT, as well as 2-year OS, DFS and EFS rates.
Methods
Screening program and patient eligibility
To support timely diagnosis of MYC+ LBCL and optimal enrolment in the present clinical trial, a nationwide diagnostic support program for MYC rearrangement assessment by fluorescence in situ hybridization (FISH) was implemented [18]. Patients ≥18 years with newly diagnosed DLBCL or with B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma (BLC-U) according to the WHO 2008 classification with a proven MYC rearrangement by FISH analysis including SH (not Burkitt lymphoma), DH or TH DLBCL were eligible. During the screening period one cycle of R-CHOP, a short course of steroids, or irradiation to control local symptoms was allowed. Patients with Ann Arbor stage II-IV, a WHO performance status (PS) of 0-3, ≥ one lesion of ≥1.5 cm on a contrast-enhanced CT scan and ≥one positive lesion on PET-CT scan were eligible. Patients diagnosed with any other subtype of aggressive B-cell lymphoma, a history of follicular lymphoma, proven CNS localization or HIV positivity were excluded.
Treatment
Treatment consisted of six cycles of standard R-CHOP every 3 weeks plus lenalidomide 15 mg orally on day 1-14 (R2CHOP; Online Supplementary Table S1), followed by two additional rituximab administrations. Prophylactic intrathecal methotrexate or cytarabine (≥4 administrations), pegfilgrastim, venous thromboembolism prophylaxis (with aspirin or low-molecular-weight-heparin), and Pneumocystis prophylaxis were mandatory.
Safety assessments
Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (AE), version 4.03. AE grade 1 were not reported.
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