Department of Hematology, University Medicine Essen, Essen, Germany.
Oncological Practice, Naunhof, Germany.
Cancer Med. 2023 Feb;12(3):2739-2751. doi: 10.1002/cam4.5160. Epub 2022 Aug 26.
Rituximab has become a standard treatment for non-Hodgkin lymphoma. Clinical studies have demonstrated the efficacy of rituximab in combination with standard chemotherapies in the treatment of follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL) patients. This non-interventional study aimed to evaluate the effectiveness and safety of subcutaneous (SC) rituximab in routine clinical practice.
Adult patients with previously untreated CD20 positive DLBCL or FL who received rituximab SC and chemotherapy as first-line treatment were observed between 07/2014 and 07/2019 at 99 institutions in Germany. Primary endpoint was the (unconfirmed) complete remission (CR/CRu) rate. Primary outcome was analyzed inferentially; other variables were evaluated descriptively.
Overall 583 patients (247 FL; 336 DLBCL) were evaluated. CR/CRu rates were 51.4% (95% CI: 45.2; 57.6) in the FL set and 48.5% (95% CI: 43.2; 53.8) in the DLBCL set. Regarding progression-free survival in the FL group, the probability of being event-free was 94.2% in the first year and 86.2% in the second year. An overall response was achieved in 85.8% (FL) and 85.4% patients (DLBCL). Patient satisfaction at the end of study with the time saving simplification of the SC vs. intravenous route was 98% for FL and 97% for DLBCL. 45.3% of FL and 47.0% of DLBCL patients experienced an adverse event of grade ≥3. Serious adverse events of grade ≥3 occurred in 27.9% FL and 32.4% DLBCL patients, with the highest incidences for leucopenia, anemia, nausea, and fatigue. No new safety signals were detected.
The results confirmed the effectiveness and safety of rituximab SC in both the FL and the DLBCL group. Satisfaction of patients and nurses with SC administration was high.
利妥昔单抗已成为治疗非霍奇金淋巴瘤的标准治疗方法。临床研究表明，利妥昔单抗联合标准化疗治疗滤泡性淋巴瘤（FL）和弥漫性大 B 细胞淋巴瘤（DLBCL）患者具有疗效。本项非干预性研究旨在评估皮下（SC）利妥昔单抗在常规临床实践中的有效性和安全性。
2014 年 7 月至 2019 年 7 月，99 家德国机构观察了 583 例初治 CD20 阳性 DLBCL 或 FL 成年患者，这些患者接受了 SC 利妥昔单抗联合化疗的一线治疗。主要终点为（未经确认的）完全缓解（CR/CRu）率。主要结局采用推断性分析；其他变量采用描述性评估。
总体上，583 例患者（247 例 FL；336 例 DLBCL）得到了评估。FL 组的 CR/CRu 率为 51.4%（95%CI：45.2；57.6），DLBCL 组为 48.5%（95%CI：43.2；53.8）。在 FL 组中，无进展生存方面，第一年和第二年无事件生存概率分别为 94.2%和 86.2%。85.8%（FL）和 85.4%（DLBCL）的患者达到了总体缓解。研究结束时，患者对 SC 与静脉途径相比节省时间和简化治疗的满意度为 FL 组 98%，DLBCL 组 97%。45.3%的 FL 和 47.0%的 DLBCL 患者出现了≥3 级的不良事件。FL 患者中 27.9%和 DLBCL 患者中 32.4%出现了≥3 级的严重不良事件，发生率最高的是白细胞减少症、贫血、恶心和疲劳。未发现新的安全性信号。
结果证实了利妥昔单抗 SC 在 FL 和 DLBCL 组中的有效性和安全性。患者和护士对 SC 给药的满意度很高。
