Department of Lymphoma, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.
BMC Cancer. 2023 Aug 11;23(1):746. doi: 10.1186/s12885-023-11268-5.
This study aimed to compare the efficacy and safety of high-dose methotrexate (HD-MTX) versus teniposide (TEN) in patients with newly diagnosed immunocompetent primary central nervous system lymphomas (PCNSLs).
The study included immunocompetent, adult patients with newly diagnosed PCNSL at 22 centers in China from 2007 to 2016. The patients received HD-MTX or TEN as first-line induction therapy. The objective response rate, progression-free survival, and overall survival were analyzed for each patient cohort.
A total of 96 patients were eligible: 62 received HD-MTX, while 34 received teniposide. The overall response rate was 73.2% and 72.7% in the MTX and the TEN cohorts, respectively (P = 0.627). The median progression-free survival was 28.4 months [95% confidence interval (CI): 13.7-51.2] in the MTX cohort and 24.3 months (95% CI: 16.6-32.1) in the TEN cohort (P = 0.75). The median overall survival was 31 months (95% CI: 26.8-35.2) in the MTX cohort and 32 months (95% CI: 27.6-36.4) in the TEN cohort (P = 0.77). The incidence of any grade of coagulopathy/deep-vein thrombosis and gastrointestinal disorders was significantly higher in the MTX cohort than in the TEN cohort; no significant difference was found in the incidence of other adverse events between the two cohorts.
This was the first multicenter study using TEN as the main agent compared with HD-MTX in newly diagnosed primary CNS lymphoma. The TEN-based regimen was non-inferior to the HD-MTX-based regimen with similar overall responses.
This study provided Class III evidence that the teniposide-based regimen was non-inferior to high-dose methotrexate - based regimen with similar overall responses and long-time survival in immunocompetent patients with PCNSL.
本研究旨在比较高剂量甲氨蝶呤(HD-MTX)与替尼泊苷(TEN)在新诊断的免疫功能正常的原发性中枢神经系统淋巴瘤(PCNSL)患者中的疗效和安全性。
该研究纳入了 2007 年至 2016 年期间在中国 22 个中心新诊断为 PCNSL 的免疫功能正常的成年患者。患者接受 HD-MTX 或 TEN 作为一线诱导治疗。分析了每个患者队列的客观缓解率、无进展生存期和总生存期。
共有 96 例患者符合条件:62 例接受 HD-MTX,34 例接受替尼泊苷。MTX 组和 TEN 组的总缓解率分别为 73.2%和 72.7%(P=0.627)。MTX 组的中位无进展生存期为 28.4 个月[95%置信区间(CI):13.7-51.2],TEN 组为 24.3 个月(95%CI:16.6-32.1)(P=0.75)。MTX 组的中位总生存期为 31 个月(95%CI:26.8-35.2),TEN 组为 32 个月(95%CI:27.6-36.4)(P=0.77)。MTX 组凝血功能障碍/深静脉血栓形成和胃肠道疾病的任何等级发生率明显高于 TEN 组;两组间其他不良反应发生率无显著差异。
这是第一项使用替莫唑胺作为主要药物与新诊断的原发性中枢神经系统淋巴瘤的 HD-MTX 进行比较的多中心研究。基于替莫唑胺的方案与基于 HD-MTX 的方案在总体反应率相似的情况下,非劣效于基于 HD-MTX 的方案。
这项研究提供了 III 级证据,表明在免疫功能正常的 PCNSL 患者中,基于替莫唑胺的方案与基于高剂量甲氨蝶呤的方案相比,在总体反应率和长时间生存方面无差异。