VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group.

作者：Gino Santini, Luigi Salvagno, Pietro Leoni, Teodoro Chisesi, Cármino Antônio De Souza, M.R. Sertoli, ALESSANDRA RUBAGOTTI, Angela Marina Congiu, Riccardo Centurioni, Attilio Olivieri, Lucilla Tedeschi, Michele Vespignani, S Nati, Monica Soracco, Antonio Porcellini, Antonio Silverio Contu, Clara Guarnaccia, Norbert Pescosta, Ignazio Majolino, Mauro Spriano, Renato Vimercati, Elio Giovanni Rossi, G Zambaldi, Lina Mangoni, Vittorio Rizzoli · 发表于：Journal of Clinical Oncology · 年份：1998 · DOI：10.1200/jco.1998.16.8.2796 · 被引用次数：208 · 研究领域：Lymphoma Diagnosis and Treatment、Radiopharmaceutical Chemistry and Applications、Chronic Lymphocytic Leukemia Research

PURPOSE: The aim of this multicenter randomized study was to compare conventional therapy with conventional plus high-dose therapy (HDT) and autologous bone marrow transplantation (ABMT) as front-line treatment for poor-prognosis non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS: Between October 1991 and June 1995, 124 patients, aged 15 to 60 years, with diffuse intermediate- to high-grade NHL (Working Formulation criteria), stages II bulky (> or = 10 cm), III, or IV were enrolled. Sixty-one patients were randomized to receive etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (VACOP-B) for 12 weeks and cisplatin, cytarabine, and dexamethasone (DHAP) as a salvage regimen (arm A), and 63 to receive VACOP-B for 12 weeks plus HDT and ABMT (Arm B). RESULTS: There was no significant difference in terms of complete remissions (CRS) in the two groups: 75% in arm A, and 73% in arm B. The median follow-up observation time was 42 months. The 6-year survival probability was 65% in both arms. There was no difference in disease-free survival (DFS) or progression-free survival (PFS) between the two groups. DFS was 60% and 80% (P = .1) and PFS was 48% and 60% (P = .4) for arms A and B, respectively. Procedure feasibility was the major problem. In arm B, 29% of enrolled patients did not undergo HDT and ABMT. A statistical improvement in terms of DFS (P = .008) and a favorable trend in terms of PFS (P = .08) for intermediate-/high- plus high-risk group patients ...