İstanbul University, İstanbul Medical Faculty, Department of Internal Medicine, Division of Hematology, İstanbul, Turkey
İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Internal Medicine, Division of Hematology, İstanbul, Turkey
Turk J Haematol. 2022 Dec 1;39(4):254-261. doi: 10.4274/tjh.galenos.2022.2022.0142. Epub 2022 Jun 3.
Redditux (RED), as a biosimilar rituximab, was approved in Turkey for all indications of the original Mabthera (MAB) in March 2018. The aim of our study was to evaluate the efficacy and safety of RED in de novo diffuse large B-cell lymphoma.
Fifty-one patients received RED combined with the CHOP regimen. The median follow-up was 31 months. The historical control group included 219 patients treated with the MAB-CHOP regimen and the median follow-up time was 38 months. We compared the response rates and survival outcomes of these RED-CHOP and MAB-CHOP cohorts.
In the RED cohort, the overall response rate (ORR) at the end of the treatment protocol was 86%, with 37 (72.5%) cases of complete response (CR) and 7 (13.5%) cases of partial response (PR). In the historical MAB cohort, the ORR was 84%, with CR and PR rates of 82% and 2%, respectively. The 24-month progression-free survival (PFS) rates were 73.76% (95% confidence interval [CI]: 0.59-0.84) and 85.2% (95% CI: 0.79-0.90) for the RED and MAB cohorts, respectively (p=0.0106). The 24-month overall survival rates were 78.4% (95% CI: 0.64-0.87) and 81.4% (95% CI: 0.75-0.86) for the RED and MAB cohorts, respectively (p=0.7461). For patients with high revised International Prognostic Index scores, 24-month PFS was 45.5% (95% CI: 0.17-0.71) and 63% (95% CI: 0.37-0.80) for the RED and MAB cohorts, respectively (p=0.0711). In the RED cohort, central nervous system (CNS) relapse was significantly increased compared to the MAB cohort (10% vs. 1.83%, p=0.004). Among the RED cohort, bone involvement at the time of diagnosis was a risk factor for CNS relapse (p=0.028). Thirteen patients died in follow-up. There were no serious adverse events causing the cessation of the drugs.
RED has an ORR similar to that of MAB. However, PFS rates were worse in the RED cohort. Additionally, CNS relapse ratio was a major concern for our RED cohort. Large prospective controlled studies and real-life data with longer follow-up are needed to document the non-inferiority of RED compared to MAB.
Reddux（RED）是一种利妥昔单抗生物类似药，于 2018 年 3 月在土耳其获批用于 Mabthera（MAB）的所有适应证。本研究旨在评估 RED 在初治弥漫性大 B 细胞淋巴瘤中的疗效和安全性。
51 例患者接受 RED 联合 CHOP 方案治疗。中位随访时间为 31 个月。历史对照组包括 219 例接受 MAB-CHOP 方案治疗的患者，中位随访时间为 38 个月。我们比较了 RED-CHOP 和 MAB-CHOP 两组的缓解率和生存结局。
在 RED 组，治疗方案结束时的总缓解率（ORR）为 86%，其中完全缓解（CR）37 例（72.5%），部分缓解（PR）7 例（13.5%）。在历史 MAB 组中，ORR 为 84%，CR 和 PR 率分别为 82%和 2%。RED 和 MAB 组的 24 个月无进展生存率（PFS）分别为 73.76%（95%可信区间[CI]：0.59-0.84）和 85.2%（95% CI：0.79-0.90）（p=0.0106）。RED 和 MAB 组的 24 个月总生存率分别为 78.4%（95% CI：0.64-0.87）和 81.4%（95% CI：0.75-0.86）（p=0.7461）。对于高修订国际预后指数评分的患者，RED 和 MAB 组的 24 个月 PFS 分别为 45.5%（95% CI：0.17-0.71）和 63%（95% CI：0.37-0.80）（p=0.0711）。在 RED 组，中枢神经系统（CNS）复发率明显高于 MAB 组（10% vs. 1.83%，p=0.004）。在 RED 组中，诊断时存在骨受累是 CNS 复发的危险因素（p=0.028）。随访中有 13 例患者死亡。没有严重的药物不良反应导致药物停止使用。
RED 的总缓解率与 MAB 相似。然而，RED 组的 PFS 率较差。此外，CNS 复发率是我们 RED 组的一个主要关注点。需要进行更大规模的前瞻性对照研究和真实世界数据随访时间更长，以证明 RED 与 MAB 相比非劣效性。
