Hagberg H, Gisselbrecht C
Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.
Ann Oncol. 2006 May;17 Suppl 4:iv31-2. doi: 10.1093/annonc/mdj996.
The multicentre phase III CORAL study aims to guide choice of salvage chemotherapy in diffuse large B-cell lymphoma (DLBCL) and assess the role of rituximab maintenance after autologous stem cell transplantation (ASCT). Patients are first randomised between ICE (ifosfamide, carboplatin, etoposide) and DHAP (dexamethasone, ara-C and cisplatin), both combined with rituximab (R-ICE or R-DHAP). After three courses, responders are treated by ASCT with BEAM. A second randomisation then allocates patients to maintenance treatment with rituximab 375 mg/m(2), one injection every 2 months six times, or observation. Accrual to the study is now proceeding well and the planned 400 patients are likely to be enrolled within the next 1.5 years. Results to date are very preliminary but suggest encouraging rates of response. However, they also indicate that initial exposure to rituximab may increase the difficulty of salvaging patients who fail first-line therapy.
多中心III期CORAL研究旨在指导弥漫性大B细胞淋巴瘤（DLBCL）挽救性化疗方案的选择，并评估自体干细胞移植（ASCT）后利妥昔单抗维持治疗的作用。患者首先在ICE（异环磷酰胺、卡铂、依托泊苷）和DHAP（地塞米松、阿糖胞苷和顺铂）之间进行随机分组，二者均联合利妥昔单抗（R-ICE或R-DHAP）。三个疗程后，缓解者接受含BEAM方案的ASCT治疗。然后进行第二次随机分组，将患者分配至接受375 mg/m²利妥昔单抗维持治疗组（每2个月注射一次，共六次）或观察组。该研究目前入组情况良好，计划入组的400例患者有望在未来1.5年内全部入组。迄今为止的结果非常初步，但显示出令人鼓舞的缓解率。然而，这些结果也表明，初次使用利妥昔单抗可能会增加挽救一线治疗失败患者的难度。
