Santini G, Coser P, Congiu A M, Salvagno L, De Souza C, Sertoli M R, Olivieri A, Chisesi T, Rubagotti A, Truini M, Contu A, Porcellini A, Zambaldi G, Nati S, Marino G, Rizzoli V
Divisione di Ematologia I, Azienda Ospedaliera S. Martino, Largo R. Benzi 10, 16132 Genova, Italy.
Haematologica. 2000 Feb;85(2):160-6.
Sequential treatment with the addition of high-dose therapy (HDT) and peripheral blood progenitor cell (PBPC) rescue has been reported to be active as front-line therapy in aggressive non-Hodgkin's lymphoma (NHL) with bone marrow (BM) involvement. We designed an intensive sequential therapy as front-line therapy in this subset of patients and conducted a phase II study.
Patients with aggressive non-Hodgkin's lymphoma and BM involvement at diagnosis received 8 weeks of VACOP-B chemotherapy as induction therapy. The second phase included high-dose cyclophosphamide (HDCY) (7 g/m(2)) with granulocyte colony-stimulating factor (G-CSF) followed by leukaphereses. The third phase included HDT according to the BEAM protocol or melphalan (140 mg/m(2)) plus total body irradiation (8 Gy in a single dose).
Forty patients were included in the study. According to the intention-to-treat, after VACOP-B, 11 (27.5%) and 22 (55%) patients achieved complete remission (CR) and partial remission (PR), respectively. Thirty-four received HDCY. After HDCY, 18 patients (45%) were in CR and 13 (32.5%) in PR. Twenty-nine underwent HDT plus peripheral blood cell rescue (PBPC) rescue. At the completion of treatment 29 patients (72.5%) were in CR, and 3 patients (7.5%) in PR. The actuarial 3-year overall survival, disease free survival and failure free survival are 48%, 55% and 40%, respectively. Overall severe toxicity was 7.5%.
This phase II study suggests that the intensified treatment described is feasible and active in aggressive NHL with BM involvement. A randomized trial is now underway to test this approach.
据报道，序贯治疗联合大剂量疗法（HDT）及外周血祖细胞（PBPC）解救作为一线治疗方案，对累及骨髓（BM）的侵袭性非霍奇金淋巴瘤（NHL）有效。我们针对这部分患者设计了一种强化序贯疗法作为一线治疗方案，并开展了一项II期研究。
诊断为侵袭性非霍奇金淋巴瘤且累及骨髓的患者接受8周的VACOP-B化疗作为诱导治疗。第二阶段包括给予大剂量环磷酰胺（HDCY）（7 g/m²）及粒细胞集落刺激因子（G-CSF），随后进行白细胞单采。第三阶段包括根据BEAM方案进行的HDT或美法仑（140 mg/m²）加全身照射（单次剂量8 Gy）。
40例患者纳入本研究。按照意向性分析，VACOP-B化疗后，分别有11例（27.5%）和22例（55%）患者达到完全缓解（CR）和部分缓解（PR）。34例患者接受了HDCY治疗。HDCY治疗后，18例患者（45%）达到CR，13例（32.5%）达到PR。29例患者接受了HDT联合外周血细胞解救（PBPC）。治疗结束时，29例患者（72.5%）达到CR，3例患者（7.5%）达到PR。3年总生存率、无病生存率和无失败生存率的精算值分别为48%、55%和40%。总体严重毒性为7.5%。
这项II期研究表明，所述强化治疗方案对累及骨髓的侵袭性NHL可行且有效。目前正在进行一项随机试验以验证该方法。
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