利妥昔单抗伴病灶放射治疗早期弥漫性大细胞淋巴瘤

IF 1.8 Q3 HEMATOLOGY

Hematology, Transfusion and Cell Therapy Pub Date : 2025-07-01 DOI:10.1016/j.htct.2025.103895

Vera Kovalskaya , Natalya Falaleeva , Stanislav Shklyaev , Andrey Chelmakov , Ludmila Grivtsova , Marwa Abdelgawad , Ahmed Mubarek

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引用次数: 0

摘要

目的：在一项前瞻性、单臂多中心研究中，参与野放疗联合抗cd20抗体美罗华（MabThera）和参与野放疗治疗早期弥漫大细胞淋巴瘤（DLBCL）的疗效和安全性。方法45例I-II期FL患者接受8个周期的利妥昔单抗（375 mg/m2）和IF照射（30/40 Gy）。治疗开始后1年的无进展生存期（PFS）是主要终点。次要终点是完全缓解率、毒性、生活质量，随访时间为15个月。对于主要终点，意向治疗组1年的PFS为85%。在选定的地点捕获长期数据，并在Per Protocol （PP）集中进行事后分析评估：1年PFS为78%，中位随访时间分别为15个月。PP组有17/45例复发，其中14例仅在辐射体积外。前15个月共发生9例严重不良事件（其中3例与治疗有关）。结论if放疗联合利妥昔单抗治疗早期DLBCL耐受性好，疗效高，1年复发率低。疗效与更积极的治疗方法相当，不影响生活质量，并维持超过3年的延长随访。

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RITUXIMAB WITH INVOLVED FIELD IRRADIATION FOR EARLY-STAGE DIFFUSE LARGE CELL LYMPHOMA

Objective

Efficacy and safety of Involved Field (IF) radiotherapy in combination for anti-CD20 antibody Rituximab (MabThera) and Involved field Radiotherapy for early-stage Diffuse Large Cell lymphoma (DLBCL) in a prospective, single-arm multicenter study.

Methodology

Forty-five stage I–II FL patients received 8 cycles of Rituximab (375 mg/m²) and IF irradiation (30/40 Gy). Progression-Free Survival (PFS) 1-year from treatment start is the primary endpoint. Secondary endpoints were complete response rates, toxicity, quality of life with protocol defined visits up to month 15.

Results

For the primary endpoint, PFS at 1-year was 85% for the intention-to-treat set. Long-term data were captured in selected sites and evaluated as post hoc analysis in the Per Protocol (PP) set: PFS was 78% at 1-year with a median follow-up of 15 months, respectively. There were 17/45 recurrences in the PP set, of which 14 were outside the radiation volume only. There were 9 serious adverse events (3 related to the therapy) during the first 15 months.

Conclusion

IF radiotherapy combined with Rituximab is well tolerated and highly efficient with low rates of recurrence in the first years in early-stage DLBCL. The efficacy is comparable with more aggressive therapy approaches without compromising the quality of life and maintains for an extended follow-up of more than 3 years.

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