Leonard John P, Coleman Morton, Ketas Jamie, Ashe Michelle, Fiore Jennifer M, Furman Richard R, Niesvizky Ruben, Shore Tsiporah, Chadburn Amy, Horne Heather, Kovacs Jacqueline, Ding Cliff L, Wegener William A, Horak Ivan D, Goldenberg David M
Center for Lymphoma and Myeloma, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY 10021, USA.
J Clin Oncol. 2005 Aug 1;23(22):5044-51. doi: 10.1200/JCO.2005.13.821. Epub 2005 Jun 13.
To explore the safety and therapeutic activity of combination anti-B-cell monoclonal antibody therapy in non-Hodgkin's lymphoma (NHL).
Twenty-three patients with recurrent B-cell lymphoma received anti-CD22 epratuzumab 360 mg/m(2) and anti-CD20 rituximab 375 mg/m(2) monoclonal antibodies weekly for four doses each. Sixteen patients had indolent histologies (15 with follicular lymphoma) and seven had aggressive NHL (all diffuse large B-cell lymphoma [DLBCL]). Indolent patients had received a median of one (range, one to six) prior treatment, with 31% refractory to their last therapy and 81% with high-risk Follicular Lymphoma International Prognostic Index scores. Patients with DLBCL had a median of three (range, one to eight) prior regimens (14% resistant to last treatment) and 71% had high intermediate-risk or high-risk International Prognostic Index scores. All patients were rituximab naïve.
Treatment was well tolerated, with toxicities principally infusion-related and predominantly grade 1 or 2. Ten (67%) patients with follicular NHL achieved an objective response (OR), including nine of 15 (60%) with complete responses (CRs and unconfirmed CRs). Four of six assessable patients (67%) with DLBCL achieved an OR, including three (50%) CRs. Median time to progression for all indolent NHL patients was 17.8 months.
The full-dose combination of epratuzumab with rituximab was well tolerated and had significant clinical activity in NHL, suggesting that this combination should be tested in comparison with single-agent treatment.
探讨联合抗B细胞单克隆抗体疗法治疗非霍奇金淋巴瘤（NHL）的安全性及治疗活性。
23例复发性B细胞淋巴瘤患者接受抗CD22依帕珠单抗360 mg/m²和抗CD20利妥昔单抗375 mg/m²单克隆抗体治疗，每周各一次，共四剂。16例患者组织学类型为惰性（15例为滤泡性淋巴瘤），7例为侵袭性NHL（均为弥漫性大B细胞淋巴瘤[DLBCL]）。惰性淋巴瘤患者既往治疗的中位数为1次（范围1至6次），其中31%对末次治疗耐药，81%的滤泡性淋巴瘤国际预后指数评分处于高危。DLBCL患者既往治疗方案的中位数为3次（范围1至8次）（14%对末次治疗耐药），71%的国际预后指数评分处于高中危或高危。所有患者均未用过利妥昔单抗。
治疗耐受性良好，毒性主要与输注相关，且大多为1级或2级。10例（67%）滤泡性NHL患者获得客观缓解（OR），其中15例中的9例（60%）为完全缓解（CR和未确认的CR）。6例可评估的DLBCL患者中有4例（67%）获得OR，其中3例（50%）为CR。所有惰性NHL患者的中位疾病进展时间为17.8个月。
依帕珠单抗与利妥昔单抗的全剂量联合耐受性良好，在NHL中具有显著的临床活性，提示该联合方案应与单药治疗进行对比试验。
