Purpose: To evaluate the role of early intensification with high-dose therapy (HDT) and autologous stem-cell transplantation (ASCT) as front-line chemotherapy for patients with high-risk, histologically aggressive nonHodgkin's lymphoma (NHL). Patients and Methods: We planned a multicenter, randomized trial to compare a conventional chemotherapy regimen of methotrexate with leucovorin rescue, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B; arm A) with an abbreviated regimen of MACOP-B (8 weeks) followed by HDT and ASCT (arm B) for intermediate-high-risk/high-risk patients (according to the age-adjusted International Prognostic Index). From September 1994 to April 1998, 150 patients with aggressive lymphoma were enrolled onto the trial. Seventy-five patients were randomly assigned to arm A and 75 patients were randomly assigned to arm B. In both arms, involved-field radiation therapy (36 Gy) was delivered to the site of bulky disease. Results: The rate of complete response was 68% in arm A and 76% in arm B (P = not significant [NS]). Three toxic deaths (4%) occurred in arm B and one (11%) occurred in arm A (P = NS). In arm B, 30 patients (40%) did not undergo HDT and ASCT. According to the intention-to-treat analysis at a median follow-up of 24 months, 5-year overall survival probability in arms A and B was 65% and 64% (P =.95), 5-year progression-free survival was 49% and 61% (P =.21), and 5-year relapse-free survival was 65% and 77% (P =.22), respectively. Conclusion: Abbreviated chemotherapy followed by intensification with HDT-ASCT is not superior to conventional chemotherapy in patients with high-risk, aggressive NHL. Additional randomized trials will clarify whether HDT-ASCT as front-line therapy after a complete course of conventional chemotherapy improves survival in this group of patients. (C) 2003 by American Society of Clinical Oncology.

Martelli, M., Gherlinzoni, F., De Renzo, A., Zinzani, P.L., De Vivo, A., Cantonetti, M., et al. (2003). Early autologous stem-cell transplantation versus conventional chemotherapy as front-line therapy in high-risk, aggressive non-Hodgkin's lymphoma: An Italian multicenter randomized trial. JOURNAL OF CLINICAL ONCOLOGY, 21(7), 1255-1262 [10.1200/JCO.2003.01.117].

Early autologous stem-cell transplantation versus conventional chemotherapy as front-line therapy in high-risk, aggressive non-Hodgkin's lymphoma: An Italian multicenter randomized trial

CANTONETTI, MARIA;
2003

Abstract

Purpose: To evaluate the role of early intensification with high-dose therapy (HDT) and autologous stem-cell transplantation (ASCT) as front-line chemotherapy for patients with high-risk, histologically aggressive nonHodgkin's lymphoma (NHL). Patients and Methods: We planned a multicenter, randomized trial to compare a conventional chemotherapy regimen of methotrexate with leucovorin rescue, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B; arm A) with an abbreviated regimen of MACOP-B (8 weeks) followed by HDT and ASCT (arm B) for intermediate-high-risk/high-risk patients (according to the age-adjusted International Prognostic Index). From September 1994 to April 1998, 150 patients with aggressive lymphoma were enrolled onto the trial. Seventy-five patients were randomly assigned to arm A and 75 patients were randomly assigned to arm B. In both arms, involved-field radiation therapy (36 Gy) was delivered to the site of bulky disease. Results: The rate of complete response was 68% in arm A and 76% in arm B (P = not significant [NS]). Three toxic deaths (4%) occurred in arm B and one (11%) occurred in arm A (P = NS). In arm B, 30 patients (40%) did not undergo HDT and ASCT. According to the intention-to-treat analysis at a median follow-up of 24 months, 5-year overall survival probability in arms A and B was 65% and 64% (P =.95), 5-year progression-free survival was 49% and 61% (P =.21), and 5-year relapse-free survival was 65% and 77% (P =.22), respectively. Conclusion: Abbreviated chemotherapy followed by intensification with HDT-ASCT is not superior to conventional chemotherapy in patients with high-risk, aggressive NHL. Additional randomized trials will clarify whether HDT-ASCT as front-line therapy after a complete course of conventional chemotherapy improves survival in this group of patients. (C) 2003 by American Society of Clinical Oncology.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/15 - Malattie del Sangue
Settore MED/06 - Oncologia Medica
English
Con Impact Factor ISI
BONE-MARROW TRANSPLANTATION; HIGH-DOSE CHEMOTHERAPY; STANDARD REGIMEN CHOP; COMBINATION CHEMOTHERAPY; INTENSIVE CHEMOTHERAPY; PROGNOSTIC INDEX; MACOP-B; M-BACOD; CLASSIFICATION
Martelli, M., Gherlinzoni, F., De Renzo, A., Zinzani, P.L., De Vivo, A., Cantonetti, M., et al. (2003). Early autologous stem-cell transplantation versus conventional chemotherapy as front-line therapy in high-risk, aggressive non-Hodgkin's lymphoma: An Italian multicenter randomized trial. JOURNAL OF CLINICAL ONCOLOGY, 21(7), 1255-1262 [10.1200/JCO.2003.01.117].
Martelli, M; Gherlinzoni, F; De Renzo, A; Zinzani, P; De Vivo, A; Cantonetti, M; Falini, B; Storti, S; Meloni, G; Rizzo, M; Molinari, A; Lauria, F; Moretti, L; Lauta, V; Mazza, P; Pescarmona, L; Pileri, S; Mandelli, F; Tura, S
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2108/69211
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