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 non-Hodgkin'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 (1%) 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.
RCT Entities:
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 non-Hodgkin'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 (1%) 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.
Authors: I Vaxman; R Ram; A Gafter-Gvili; L Vidal; M Yeshurun; M Lahav; O Shpilberg Journal: Bone Marrow Transplant Date: 2015-02-09 Impact factor: 5.483
Authors: Patrick J Stiff; Joseph M Unger; James R Cook; Louis S Constine; Stephen Couban; Douglas A Stewart; Thomas C Shea; Pierluigi Porcu; Jane N Winter; Brad S Kahl; Thomas P Miller; Raymond R Tubbs; Deborah Marcellus; Jonathan W Friedberg; Kevin P Barton; Glenn M Mills; Michael LeBlanc; Lisa M Rimsza; Stephen J Forman; Richard I Fisher Journal: N Engl J Med Date: 2013-10-31 Impact factor: 91.245
Authors: Craig C Hofmeister; Nita Williams; Susan Geyer; Erinn M Hade; Mindy A Bowers; Christian T Earl; John Vaughn; Anissa Bingman; Kristina Humphries; Gerard Lozanski; Robert A Baiocchi; Samantha M Jaglowski; Kristie Blum; Pierluigi Porcu; Joseph Flynn; Sam Penza; Don M Benson; Leslie A Andritsos; Steven M Devine Journal: Leuk Lymphoma Date: 2014-11-20
Authors: Ulrich J M Mey; Vandana Jha; John W Strehl; Marcus Gorschlueter; Christian Rabe; Eckfried Hoebert; Henning Popp; Ingo G H Schmidt-Wolf Journal: Ger Med Sci Date: 2007-06-19