Santini G, Salvagno L, Leoni P, Chisesi T, De Souza C, Sertoli M R, Rubagotti A, Congiu A M, Centurioni R, Olivieri A, Tedeschi L, Vespignani M, Nati S, Soracco M, Porcellini A, Contu A, Guarnaccia C, Pescosta N, Majolino I, Spriano M, Vimercati R, Rossi E, Zambaldi G, Mangoni L, Rizzoli V
Department of Haematology, San Martino Hospital, Genova, Italy.
J Clin Oncol. 1998 Aug;16(8):2796-802. doi: 10.1200/JCO.1998.16.8.2796.
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).
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).
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 assigned to HDT and ABMT was observed.
In this study, conventional chemotherapy followed by HDT and ABMT as front-line therapy seems no more successful than conventional treatment in terms of overall results. However, our results suggest that controlled studies of HDT plus ABMT should be proposed for higher risk patients.
这项多中心随机研究的目的是比较传统疗法与传统疗法加高强度疗法（HDT）及自体骨髓移植（ABMT）作为预后不良的非霍奇金淋巴瘤（NHL）一线治疗方案的效果。
在1991年10月至1995年6月期间，纳入了124例年龄在15至60岁之间、患有弥漫性中高级NHL（按照工作分类标准）、II期大包块（≥10 cm）、III期或IV期的患者。61例患者被随机分配接受依托泊苷、阿霉素、环磷酰胺、长春新碱、泼尼松和博来霉素（VACOP - B）治疗12周，并接受顺铂、阿糖胞苷和地塞米松（DHAP）作为挽救方案（A组），63例患者接受VACOP - B治疗12周加HDT及ABMT（B组）。
两组的完全缓解率（CRS）无显著差异：A组为75%，B组为73%。中位随访观察时间为42个月。两组的6年生存概率均为65%。两组之间的无病生存期（DFS）或无进展生存期（PFS）无差异。A组和B组的DFS分别为60%和80%（P = 0.1），PFS分别为48%和60%（P = 0.4）。手术可行性是主要问题。在B组中
