Flowchart.
sepsis, peripheral T-cell lymphoma, PTCL
PERIPHERAL T-CELL LYMPHOMA, INFUSION REACTION, ADVERSE EVENTS, DISEASE, MYELODYSPLASTIC SYNDROME, CYTOMEGALOVIRUS INFECTION, ADVERSE EVENT, SEPTIC SHOCK, EVENTS, SEPSIS
PTCL: peripheral T-cell lymphoma; Ro-CHOEP: Romidepsin, cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone; SCT: stem cell transplantation.Among the 86 patients evaluable for response at the end of treatment after SCT, the final ORR was 57% (49 patients), with 56% (48) CR.Forty of 53 patients in CR at end of induction underwent SCT (39 auto-SCT, 1 allo-SCT due to mobilization failure); at restaging after SCT 35 (87.5%) were in CR. Four of eight patients in PR underwent SCT: two received allo-SCT and two auto-SCT (one medical decision, one lack of donor). One patient experienced an adverse event after allo-SCT (septic shock) whereas at restaging, one patient converted to CR, one patient maintained PR, one patient had PD.Overall 42 of 86 were not transplanted for different reasons: 25 progressive disease, 8 poor mobilizers, 8 adverse events (3 sepsis, 1 cytomegalovirus infection, 2 cardiological events, 1 myelodysplastic syndrome, and 1 withdrawal from the study due to an infusion reaction to romidepsin), 1 medical decision (patient too frail to underwent SCT).The interim analysis performed on the first 79 patients enrolled (August, 2020) observed a PFS at 18 months of 53%, resulting into a Z interim test = -0.357, clearly lower than the minimum value required for trial continuation (Z = 0.650), therefore the enrollment was stopped for inefficacy.Considering the all cohort of 86 patients, at a median follow-up of 28 months, the 18-month PFS was 46.2% (95% CI: 35.0–56.7) and the OS was 73.1% (95% CI: 61.6–81.7), Fig. 