Page 191 - 18F-FDG PET as biomarker in aggressive lymphoma; technical and clinical validation

R-CHOP with lenalidomide in MYC+ LBCL
Safety
Grade 2, 3 and 4 AE were seen in 27 (32%), 33 (39%) and 14 (16%) of all 85 registered patients respectively (Table 3). The most common grade 3–4 AE were neutropenia (18%), infections (14%) and gastrointestinal disorders (14%). Four patients experienced deep venous thrombosis (grade 2), and two patients pulmonary embolism (grade 3). Two of these patients (one with deep venous thrombosis and one with pulmonary embolism) had not received the mandatory thrombosis prophylaxis (protocol violation). One patient went off protocol due to grade 3 diarrhea. 71 serious AE were reported in 36 patients; 66 were due to hospitalization (42% infections, 26% gastrointestinal disorders), four to other conditions [two second primary malignancies, two recurrence of previously diagnosed (>5 year) malignancies]. One patient died during treatment due to progression. There were no treatment related deaths.
Figure 2. Survival analyses.
(A) Overall survival (OS; time from registration to death, n=82); (B) disease-free survival (DFS; time from achievement of first complete metabolic response [CMR] on protocol until relapse or death whichever comes first, n=69); (C) event-free survival (EFS; defined as the time from registration to lack of CMR on end of treatment [EOT] positron emission tomography [PET]-computer tomography [CT] scan, relapse or death, n=82) of MYC+ LBCL patients.
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