■REFLECT是Sandoz生物仿制药利妥昔单抗(SDZ-RTX)在弥漫性大B细胞淋巴瘤(DLBCL)患者中的第一项前瞻性研究。
■评估SDZ-RTX作为DLBCL一线治疗的2年有效性和安全性。
■现实世界,多中心,开放标签,单臂,非干预性,SDZ-RTX联合环磷酰胺的批准后研究,阿霉素,长春新碱,和泼尼松(R-CHOP)治疗初治CD20阳性DLBCL患者。
■治疗-幼稚,CD20阳性的DLBCL成人患者(18岁)符合R-CHOP治疗条件,每2或3周接受SDZ-RTX-CHOP治疗6-8个周期。通过R-CHOP治疗结束时的完全反应(CR)率来衡量SDZ-RTX的有效性,由治疗医生评估。在24个月时评估无进展生存期(PFS)。
■共有169名患者[52.1%为女性,中位(范围)年龄70(24-94)岁]的DLBCL纳入完整分析集.在基线,19.5%和24.3%的患者患有AnnArbor病III或IV期,分别,大多数患者(80.5%)的东部肿瘤协作组表现状态为0或1。共有100名(59.2%)患者完成了24个月的观察期。总的来说,110例[65.1%;95%置信区间(CI):57.4-72.3]患者达到CR为最佳反应,50例(29.6%;95%CI:22.8-37.1)患者达到部分反应。总体最佳缓解率为94.7%(95%CI:90.1-97.5)。一年PFS为84.9%(95%CI:78.2-89.6),2年PFS为78.5%(95%CI:70.9~84.4);在观察期内未达到中位PFS.共有143名(84.6%)患者经历了1起不良事件,其中53例(31.4%)被怀疑与研究药物有关。
■这个现实世界,2年的研究再次证实,使用SDZ-RTX用R-CHOP一线治疗CD20阳性DLBCL是有效且耐受性良好的。
■不适用。
反思:一项评估Sandoz生物仿制药利妥昔单抗(Rixathon®)与CHOP联合治疗先前未治疗的弥漫性大B细胞淋巴瘤患者的研究。为什么要进行这项研究?•生物仿制药是与已经批准并已在患者中使用数年的参考生物药物高度相似的生物药物。•REFLECT研究是对一种称为弥漫性大B细胞淋巴瘤(DLBCL)的淋巴癌患者的生物仿制药(Sandoz生物仿制药利妥昔单抗)的第一项研究。研究人员做了什么?•Sandoz生物仿制药利妥昔单抗作为标准治疗的一部分(环磷酰胺,阿霉素,长春新碱,和泼尼松;R-CHOP)在以前未接受过治疗的DLBCL患者中。•研究人员旨在评估Sandoz生物类似药利妥昔单抗在2年期间的工作情况。•研究人员还旨在研究Sandoz生物类似药利妥昔单抗的安全性。•DLBCL患者必须年满18岁,需要治疗,并被他们的医生归类为适合用R-CHOP治疗。•患者每2或3周接受R-CHOP治疗,包括Sandoz生物仿制药利妥昔单抗,共6-8个周期。研究人员发现了什么?共纳入169名DLBCL患者。超过一半(52%)是女性,平均年龄为67岁。•近6/10(59%)的患者完成了为期2年的研究。•超过6/10(65%)的患者获得完全应答,并且3/10(30%)的患者获得部分应答。•总反应率为95%。1年无进展生存率为85%,2年无进展生存率为79%.关于安全,85%的患者经历了至少一次不良事件;其中超过3/10(31%)被怀疑与研究药物有关。这项为期2年的研究表明,包括Sandoz生物类似药利妥昔单抗在内的R-CHOP作为DLBCL患者的第一种治疗方法是有效且耐受性良好的。
UNASSIGNED: REFLECT is the first prospective study of Sandoz biosimilar rituximab (SDZ-RTX) in patients with diffuse large B-cell lymphoma (DLBCL).
UNASSIGNED: To evaluate the 2-year effectiveness and safety of SDZ-RTX as first-line treatment for DLBCL.
UNASSIGNED: Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-
CHOP) in patients with treatment-naïve CD20‑positive DLBCL.
UNASSIGNED: Treatment-naïve, CD20-positive adult patients (⩾18 years) with DLBCL eligible for therapy with R-CHOP were treated with SDZ-RTX-
CHOP every 2 or 3 weeks for 6-8 cycles. The effectiveness of SDZ-RTX was measured by the complete response (CR) rate at the end of R-CHOP treatment, as assessed by the treating physician. Progression-free survival (PFS) was assessed at 24 months.
UNASSIGNED: A total of 169 patients [52.1% female, median (range) age 70 (24-94) years] with DLBCL were included in the full analysis set. At baseline, 19.5% and 24.3% of patients had Ann Arbor disease stage III or IV, respectively, and most patients (80.5%) had Eastern Cooperative Oncology Group Performance Status of 0 or 1. A total of 100 (59.2%) patients completed the 24-month observation period. In total, 110 [65.1%; 95% confidence interval (CI): 57.4-72.3] patients achieved CR as best response and 50 (29.6%; 95% CI: 22.8-37.1) patients achieved partial response. Overall best response rate was 94.7% (95% CI: 90.1-97.5). One-year PFS was 84.9% (95% CI: 78.2-89.6), while 2-year PFS was 78.5% (95% CI: 70.9-84.4); median PFS was not reached within the observational period. A total of 143 (84.6%) patients experienced ⩾1 adverse event, 53 (31.4%) of which were suspected to be related to study drug.
UNASSIGNED: This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-
CHOP using SDZ-RTX is effective and well tolerated.
UNASSIGNED: N/A.
REFLECT: A
study evaluating Sandoz biosimilar rituximab (Rixathon ® ) in combination with
CHOP for the treatment of patients with previously untreated diffuse large B-cell lymphoma Why was this study done? • Biosimilars are biologic medicines that are highly similar to a reference biologic medicine that is already approved and has been used in patients for several years. • The REFLECT study was the first study of a biosimilar medicine (Sandoz biosimilar rituximab) in patients with a type of lymphatic cancer called diffuse large B-cell lymphoma (DLBCL). What did the researchers do? • Sandoz biosimilar rituximab was given as part of the standard treatment (cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) in patients with DLBCL who had not received treatment before. • The researchers aimed to evaluate how well Sandoz biosimilar rituximab worked over a 2-year period. • The researchers also aimed to look at the safety of Sandoz biosimilar rituximab. • Patients with DLBCL had to be ⩾18 years of age, in need of treatment, and were classed as suitable for treatment with R-CHOP by their doctor. • Patients were treated with R-CHOP including Sandoz biosimilar rituximab every 2 or 3 weeks for 6–8 cycles. What did the researchers find? • A total of 169 patients with DLBCL were included in the study. • Just over half (52%) were female and the average age was 67 years. • Nearly 6 out of 10 (59%) patients completed the 2-year study. • More than 6 out of 10 (65%) patients achieved complete response and 3 out of 10 (30%) achieved partial response. • The overall response rate was 95%. • One-year progression-free survival was 85%, and 2-year progression-free survival was 79%. • Regarding safety, 85% of patients experienced at least one adverse event; just over 3 out of 10 (31%) of these were suspected to be related to the study drug. What do the findings mean? • This 2-year
study shows that R-
CHOP including Sandoz biosimilar rituximab is effective and well tolerated as the first treatment given to patients with DLBCL.