生物类似药时代弥漫性大B细胞淋巴瘤的真实世界结局
Real-world outcomes of diffuse large B-cell lymphoma in the biosimilar era.
作者信息
Nair Reena, Bhat Gull Mohammad, Agrawal Narendra, Sengar Manju, Malhotra Pankaj, Nityanand Soniya, Lele Chitra, Reddy Pramod, Kankanwadi Suresh, Maharaj Narendra
机构信息
Department of Clinical Haematology, Tata Medical Centre, Kolkata, West Bengal, India.
Department of Medical Oncology, Sher-I-Kashmir Institute of Medical Sciences, Srinagar, Jammu & Kashmir, India.
出版信息
Front Oncol. 2023 Oct 3;13:1248723. doi: 10.3389/fonc.2023.1248723. eCollection 2023.
BACKGROUND
Diffuse large B-cell lymphoma (DLBCL) is an aggressive and the most common type of non-Hodgkin lymphoma (NHL). The clinical use of rituximab has improved the treatment response and survival of patients with DLBCL. The introduction of rituximab biosimilar into healthcare system has helped in providing a cost-effective treatment to B-cell lymphoid malignancies as standard of care and has improved access to patients worldwide. The aim of this study was to observe the real-world effectiveness and safety of Reditux™ and Ristova in DLBCL patients.
METHODS
Observational study in adults with DLBCL receiving Reditux™ or Ristova across 29 centers in India (2015-2022). Effectiveness and safety were assessed up to 2 years after first dose.
RESULTS
Out of 1,365 patients considered for analysis, 1,250 (91.6%) were treated with Reditux™ and 115 (8.42%) with Ristova. At 2 years, progression-free survival (PFS) 69% [hazard ratio (HR), 1.16; 95% CI, 0.80-1.67], overall survival (OS) 78.7% (HR, 1.20; 95% CI, 0.78-1.86), response rates, quality of life (QoL), and overall safety in both the cohorts were comparable. The best overall response rate (BORR) at 6 months was comparable with no statistically significant differences between the Reditux™ and the Ristova cohorts (89.2% vs. 94.3%). In multivariate analysis, BCL-2 and VAS were significant prognostic factors for PFS.
CONCLUSION
Reditux™ and Ristova were comparable in real-world setting.
CLINICAL TRIAL REGISTRATION
ISRCTN registry, identifier (ISRCTN13301166).
背景
弥漫性大B细胞淋巴瘤（DLBCL）是侵袭性最强且最常见的非霍奇金淋巴瘤（NHL）类型。利妥昔单抗在临床上的应用改善了DLBCL患者的治疗反应和生存率。将利妥昔单抗生物类似药引入医疗保健系统有助于为B细胞淋巴恶性肿瘤患者提供具有成本效益的标准治疗，并改善了全球患者的可及性。本研究的目的是观察雷迪妥（Reditux™）和利妥昔单抗（Ristova）在DLBCL患者中的真实疗效和安全性。
方法
对印度29个中心接受雷迪妥或利妥昔单抗治疗的成年DLBCL患者进行观察性研究。在首次给药后长达2年的时间里评估疗效和安全性。
结果
在纳入分析的1365例患者中，1250例（91.6%）接受了雷迪妥治疗，115例（8.42%）接受了利妥昔单抗治疗。在2年时，无进展生存期（PFS）为69%[风险比（HR），1.16；95%置信区间（CI），0.80 - 1.67]，总生存期（OS）为78.7%（HR，1.20；95%CI，0.78 - 1.86），两个队列的缓解率、生活质量（QoL）和总体安全性相当。6个月时的最佳总体缓解率（BORR）相当，雷迪妥和利妥昔单抗队列之间无统计学显著差异（89.2%对94.3%）。在多变量分析中，BCL-2和视觉模拟评分（VAS）是PFS的显著预后因素。
结论
在真实世界中，雷迪妥和利妥昔单抗具有可比性。
临床试验注册
ISRCTN注册库，标识符（ISRCTN13301166）。
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