Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma
Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma
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DOI：
10.1182/blood-2012-12-472027
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发表时间：
2013-07-25
期刊：
影响因子：
20.3
通讯作者：
Moskowitz, Craig H.
中科院分区：
文献类型：
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作者：
Matasar, Matthew J.;Czuczman, Myron S.;Moskowitz, Craig H.
符合移植条件的复发性弥漫性大B细胞淋巴瘤（DLBCL）患者的标准治疗包括利妥昔单抗和含铂化疗，异环磷酰胺、卡铂和依托泊苷（ICE）或地塞米松、阿糖胞苷和顺铂（DHAP），对于化疗敏感性疾病患者，采用自体移植巩固治疗。尽管如此，利妥昔单抗、环磷酰胺、阿霉素、长春新碱和泼尼松（R-CHOP）治疗失败的患者的结局并不理想。我们进行了一项多中心II期试验，研究奥法木单抗（一种抗CD 20的单克隆抗体）联合ICE或DHAP二线治疗复发性或难治性DLBCL、3b级滤泡性淋巴瘤或转化型滤泡性淋巴瘤患者的安全性和疗效。61例患者接受奥法木单抗-ICE（35）或奥法木单抗-DHAP（26）治疗。总有效率（ORR）为61%，完全缓解（CR）率为37%。根据二线、年龄校正的国际预后指数，在有2或3个不良风险因素的患者中，ORR为59%，CR为31%，在早期复发或原发难治性疾病患者中，ORR为55%，CR为30%。毒性主要是血液学的，45例患者中有43例成功进行了干细胞动员。在R-CHOP失败后，在标准二线方案中用奥法木单抗替代利妥昔单抗是一种有前途的方法。本试验在www.clinicaltrials.gov上注册为NCT 00823719。
Standard treatment of transplant-eligible patients with relapsed diffuse large B-cell lymphoma (DLBCL) consists of rituximab and platinum-based chemotherapy, either ifosfamide, carboplatin, and etoposide (ICE) or dexamethasone, cytarabine, and cisplatin (DHAP), with autologous transplant consolidation for those with chemosensitive disease. Nonetheless, outcomes are suboptimal for patients failing rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We performed a multi-center phase II trial investigating the safety and efficacy of ofatumumab, a monoclonal antibody against CD20, combined with ICE or DHAP second-line therapy in patients with relapsed or refractory DLBCL, grade 3b follicular lymphoma, or transformed follicular lymphoma. Sixty-one patients were treated with either ofatumumab-ICE (35) or ofatumumab-DHAP (26). The overall response rate (ORR) was 61%, and the complete response (CR) rate was 37%. In patients with 2 or 3 adverse risk factors according to the second-line, age-adjusted, international prognostic index, the ORR was 59% and CR 31%, and in patients with early-relapsing or primary refractory disease, the ORR was 55% and CR 30%. Toxicity was largely hematologic, and stem cell mobilization was successful in 43 of 45 patients. Substitution of ofatumumab for rituximab in standard second-line regimens following failure of R-CHOP is a promising approach. This trial was registered at www.clinicaltrials.gov as NCT00823719.