Feasibility of high-dose chemotherapy without stem cell support as a first-line treatment for non-Hodgkin's aggressive lymphoma: A pilot study

A regimen which incorporates cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) is the standard treatment for patients with non-Hodgki n's lymphoma (NHL), but it has not been effective in patients with aggressi ve NHL who are at high risk. The aim of the present trial was to investigat e the feasibility of high-dose chemotherapy (HDC) without stem cell support as a first-line treatment. The primary endpoint was a complete remission r ate. The second endpoint was survival. Fourteen patients with aggressive NH L entered the study and were treated according to the K93 protocol (3 cycle s of CHOP, high-dose etoposide and ifosfamide, and high-dose methotrexate) Eleven patients (79%) achieved complete remission (CR) and two (14%) achiev ed partial remission (PR). Overall survival (OS) after five years was 79%. The actuarial five year disease free survival (DFS) for the eleven cases of Cd was 75%. During chemotherapy, grade IV hematologic toxicity was observe d in all patients and grade IV non-hematologic toxicity in only one patient , who experienced oral ulcers. Peripheral blood stem cell (PBSC) apheresis was performed in eight cases. One harvesting was enough to provide an adequ ate number of CD34+ cells for the subsequent PBSC transplantation (PBSCT). In conclusion our study confirmed the efficacy of the K93 protocol in obtai ning a In conclusion our study confirmed the efficacy of the K93 protocol i n obtaining a good response (CR + PR) rate and a very good DFS rate in most cases of aggressive NHL, with acceptable toxicity. This regimen may improv e the outcome in cases of aggressive NHL without stem cell support. It seem s worthwhile to conduct a randomized controlled study comparing the K93 pro tocol with the standard CHOP regimen.