Dakhil Shaker, Hermann Robert, Schreeder Marshall T, Gregory Stephanie A, Monte Marc, Windsor Kevin S, Hurst Deborah, Chai Akiko, Brewster Michael, Richards Paul
Cancer Center of Kansas , Wichita, KS , USA.
Leuk Lymphoma. 2014 Oct;55(10):2335-40. doi: 10.3109/10428194.2013.877135. Epub 2014 Mar 7.
This phase III, multicenter, single-arm trial investigated the impact of 90 min rituximab infusions on infusion-related reactions (IRRs) in patients with untreated diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Patients received six or eight cycles of rituximab plus cyclophosphamide, vincristine, doxorubicin and prednisone for DLBCL or plus cyclophosphamide, vincristine and prednisolone for FL. A total of 425 patients received the first rituximab infusion per standard guidelines; median duration 240 min. Patients who did not experience grade ≥ 3 IRRs received subsequent infusions over 90 min (363 patients). A total of 303 patients received ≥ 6 cycles of rituximab. Fifty-three patients withdrew after cycle 1; 10 for grade 3 or 4 IRRs and one for a grade 3 adverse event. During cycle 2, 139 patients had IRRs, including four grade 3 IRRs. A 90 min rituximab infusion is well tolerated and feasible for patients with DLBCL or FL who tolerate the first standard rate infusion.
这项III期多中心单臂试验研究了90分钟利妥昔单抗输注对未经治疗的弥漫性大B细胞淋巴瘤（DLBCL）或滤泡性淋巴瘤（FL）患者输注相关反应（IRR）的影响。DLBCL患者接受六个或八个周期的利妥昔单抗联合环磷酰胺、长春新碱、阿霉素和泼尼松治疗，FL患者接受六个或八个周期的利妥昔单抗联合环磷酰胺、长春新碱和泼尼松龙治疗。共有425例患者按照标准指南接受了首次利妥昔单抗输注；中位持续时间为240分钟。未发生≥3级IRR的患者随后接受90分钟的输注（363例患者）。共有303例患者接受了≥6个周期的利妥昔单抗治疗。53例患者在第1周期后退出；10例因3级或4级IRR退出，1例因3级不良事件退出。在第2周期，139例患者发生IRR，其中包括4例3级IRR。对于能够耐受首次标准速率输注的DLBCL或FL患者，90分钟利妥昔单抗输注耐受性良好且可行。
