Dodero Anna, Patriarca Francesca, Milone Giuseppe, Sarina Barbara, Miceli Rosalba, Iori Anna, Barretta Francesco, Terruzzi Elisabetta, Mussetti Alberto, Pini Massimo, Bosi Alberto, Dominietto Alida, Cascavilla Nicola, Onida Francesco, Narni Franco, Farina Lucia, Rambaldi Alessandro, Corradini Paolo
Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Department of Hematology, University of Udine, Udine, Italy.
Biol Blood Marrow Transplant. 2017 Jul;23(7):1102-1109. doi: 10.1016/j.bbmt.2017.03.031. Epub 2017 Apr 5.
The treatment of patients with refractory/relapsed B cell non-Hodgkin lymphoma (NHL) is evolving because of the availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and mortality remain a matter of concern. We conducted a multicenter prospective phase II trial to evaluate the benefit of including only 1 dose of rituximab in the conditioning regimen before alloSCT. The primary endpoint was progression-free survival. The study enrolled 121 patients with relapsed/refractory B cell lymphomas. The conditioning regimen consisted of thiotepa, cyclophosphamide, fludarabine, and rituximab (500 mg/m). Rabbit antithymocyte globulin was administered only in case of unrelated donors. Sixty-seven (55%) and 54 (45%) patients received grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of nonrelapse mortality (NRM) was 21% at 3 years. The CCIs of chronic graft-verus-host disease (GVHD) at 3 years were 54% and 31% in recipients of matched sibling and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-year progression-free and overall survival were 50% and 61%, respectively. Long-term outcome was also evaluated with the composite endpoint of GVHD-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a prospective trial of lymphoma patients: the 1-year and 3-year GRFS were 40% and 34%, respectively. AlloSCT can cure a fraction of patients with rather low NRM and an encouraging PFS and GRFS.
由于新型药物的出现，难治性/复发性B细胞非霍奇金淋巴瘤（NHL）患者的治疗正在不断发展。异基因干细胞移植（alloSCT）可能治愈疾病，但其发病率和死亡率仍然令人担忧。我们进行了一项多中心前瞻性II期试验，以评估在alloSCT前的预处理方案中仅加入1剂利妥昔单抗的益处。主要终点是无进展生存期。该研究纳入了121例复发/难治性B细胞淋巴瘤患者。预处理方案包括噻替派、环磷酰胺、氟达拉滨和利妥昔单抗（500mg/m）。仅在无关供体的情况下给予兔抗胸腺细胞球蛋白。分别有67例（55%）和54例（45%）患者接受了来自相关和无关供体的移植物。3年时非复发死亡率（NRM）的粗累积发生率（CCI）为21%。3年时，同胞匹配和无关移植物受者慢性移植物抗宿主病（GVHD）的CCI分别为54%和31%。在中位随访41个月时，估计3年无进展生存率和总生存率分别为50%和61%。还采用无GVHD和无复发生存率（GRFS）的复合终点评估长期结局。这是第一项在前瞻性淋巴瘤患者试验中评估GRFS的研究：1年和3年GRFS分别为40%和34%。alloSCT可以治愈一部分患者，其NRM相当低，无进展生存期（PFS）和GRFS令人鼓舞。
