Abstract

7561 Background: [18F] FDG-PET after only 2–4 cycles of initial chemotherapy is highly prognostic in patients (pts) with aggressive lymphoma, with reported relapse rates of 71–100% if PET demonstrates residual viable disease. We hypothesized that midtreatment PET could optimize pt selection for preemptive transplantation through early risk stratification. Methods: A phase II, single center trial was activated in 2/2004. Pts with newly diagnosed aggressive non-Hodgkin’s lymphoma underwent PET-CT on days 11–20 of cycle 2 or 3 of (R)CHOP. Regardless of IPI, pts whose PET was considered positive for macroscopic residual lymphoma received 2 cycles of (R)ESHAP or (R)ICE, followed by autologous transplantation (busulfan-cyclophosphamide conditioning). Pts with negative interim PET completed standard therapy. We aimed to transplant ≥20 pts to detect a ≥25% absolute improvement in 2-year event-free survival (EFS) to 45%, versus 20% in a historical cohort of PET positive pts who did not receive early transplantation (85% power and two-sided alpha of 0.05). An ongoing imaging analysis of gradations of FDG uptake, scored as 0 to 4+, will be correlated with outcome. Results: As of 1/6/2006, 41 evaluable pts have been accrued, 39 with large B-cell lymphoma (8 primary mediastinal), 1 follicular large cell, 1 peripheral T-cell. Median age at diagnosis was 50 (20–78); 26 pts were stage III or IV. Twenty-five pts (61%) had a positive midtreatment PET. Of 26 pts with IPI of 0–2, 17 (65%) had positive PET; of 13 pts with IPI of ≥3, 8 (62%) were positive; 2 pts had undetermined IPI. The actuarial 1-year EFS from the time of midtreatment imaging is 78% for the group as a whole, 69% for PET positive pts, 81% for PET negative pts. Twenty pts have completed transplant, and 2 were ineligible because of early disease progression. Two transplant recipients have relapsed. Treatment-related mortality has been limited to 1 death from veno-occlusive disease. Conversion from PET positive to negative at initial post-transplant assessment occurred in 68%. The actuarial 1-year EFS after transplantation at 10 month median follow-up is 82%. Conclusions: Immediate intensification of therapy for poor-risk pts identified by midtreatment PET has been feasible and so far very promising. [Table: see text]

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