A FDG-PET driven consolidation strategy in diffuse large B-cell lymphoma: Final results of a randomized phase II study.
Tous les auteurs :
Casasnovas RO, Ysebaert L, Thieblemont C, Bachy E, Feugier P, Delmer A, Tricot S, Gabarre J, Andre M, Fruchart C, Mounier N, Delarue R, Meignan M, Berriolo-Riedinger A, Bardet S, Emile JF, Jais JP, Haioun C, Tilly H, Morschhauser F
Dose-dense induction and upfront consolidation with autologous stem cell transplantation (ASCT) remain controversial issues when treating high-risk diffuse large B cell lymphoma patients. GELA designed a randomized phase II trial evaluating the efficacy of either R-ACVBP or R-CHOP14 induction and a PET-driven ASCT or standard immunochemotherapy (SIC) consolidation in aaIPI2-3 patients. PET was done at baseline, after 2 (PET2) and 4 induction cycles (PET4) and centrally assessed using international harmonization project (IHP) criteria. PET2-/PET4- patients were assigned SIC, PET2+/PET4- ASCT and PET4+ patients treated with investigator' choice. The primary end-point was the 2007 international working group CR rate after induction. ΔSUVmax PET assessment was explored. 211 patients were randomized to R-ACVBP (n=109) or R-CHOP14 (n=102). PET4-/CR rates were 53/47% with R-ACVBP and 41/39% with R-CHOP14 (CR 95%CI: 38%-67% v 28%-54%; p=0.076). Consolidation in the R-ACVBP and R-CHOP14 arms was SIC in 26% and 23% of patients and ASCT in 28% and 18%, respectively. PET4 positivity was higher with R-CHOP14 (54% v 41%; p=0.08) leading to more salvage therapy (37% v 26%; p=0.07) and lower EFS (4y-EFS= 31% v 43%; p<0.01) but PFS and OS were similar in both arms. PET2-/PET4- and PET2+/PET4- patients had similar outcome. Using ΔSUVmax, 79% patients were PET2-/PET4-. ΔSUVmaxPET0-4>70% was associated with better outcome (4y-PFS: 84% v 35%; 4y-OS: 91% v 57%, p<0.0001) whatever the consolidation. Superiority of R-ACVBP over R-CHOP14 was not established as IHP criteria did not properly reflect disease control. ΔSUVmax may help better select patients needing alternative to SIC, including ASCT.
Adult, Antineoplastic Combined Chemotherapy Protocols, adverse effects, Consolidation Chemotherapy, Endpoint Determination, Female, Fluorodeoxyglucose F18, chemistry, Hematopoietic Stem Cell Transplantation, Humans, Lymphoma, Large B-Cell, Diffuse, diagnostic imaging, Male, Middle Aged, Positron-Emission Tomography, Reproducibility of Results, Treatment Outcome, Young Adult
Blood. 2017 Jul;: