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特瑞利珠单抗单药治疗未经治疗的早期经典型霍奇金淋巴瘤患者:一项真实世界研究。

Tislelizumab monotherapy in patients with previously untreated early-stage classical Hodgkin lymphoma: a real-world study.

机构信息

Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China.

State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, 510060, China.

出版信息

Ann Hematol. 2024 Mar;103(3):793-801. doi: 10.1007/s00277-023-05541-7. Epub 2023 Nov 13.

Abstract

The anti-PD-1 antibodies have been reported to show a striking effect in relapsed and refractory(R/R) classical Hodgkin lymphoma (cHL), however, there is still limited real-world data assessing the role of anti-PD-1 antibody monotherapy in early-stage cHL. In this retrospective analysis, we reported the effectiveness and safety of tislelizumab monotherapy in the first-line therapy of early-stage cHL. Twenty-three consecutive patients (10 males and 13 females) with previously untreated stage I A-II B cHL were included. At interim evaluation after 2 doses of tislelizumab monotherapy, 11 of 23 patients (47.8%) achieved complete response (CR). At the end of tislelizumab monotherapy (EOTM), objective response was observed in 22 of 23 patients (95.7%), with CR in 16 patients (69.6%). Among six patients with PR-EOTM, two patients underwent 4 cycles of ABVD chemotherapy and one patient underwent 4 cycles of tislelizumab plus AVD. One patient who developed progressive disease (PD) after 4 doses of tislelizumab subsequently underwent 4 cycles of ABVD chemotherapy. Except for four patients with CR-EOTM, consolidative radiotherapy was given to 19 patients. All patients obtained CR at the end of all treatments. With a median follow-up time of 21.3 months (range, 6.9-32.7 months), the estimated 2-year PFS rate and 2-year OS rate were 95.65% and 100%, respectively. Except for grade 3 lymphocyte count decreased, no other grade 3/4 TRAE was observed. In addition, no serious AE was reported. Our preliminary data observed that tislelizumab monotherapy was safe and highly effective in previously untreated early-stage cHL.

摘要

抗 PD-1 抗体已被报道在复发/难治性(R/R)经典型霍奇金淋巴瘤(cHL)中显示出显著疗效,然而,仍有限的真实世界数据评估抗 PD-1 抗体单药治疗在早期 cHL 中的作用。在这项回顾性分析中,我们报告了替雷利珠单抗单药治疗在早期 cHL 一线治疗中的有效性和安全性。纳入了 23 例未经治疗的 I 期 A-II B cHL 患者(10 例男性,13 例女性)。在替雷利珠单抗单药治疗 2 个剂量后的中期评估时,23 例患者中有 11 例(47.8%)达到完全缓解(CR)。在替雷利珠单抗单药治疗结束时(EOTM),23 例患者中观察到客观缓解,其中 16 例(69.6%)达到 CR。在 6 例 PR-EOTM 患者中,2 例接受 ABVD 化疗 4 个周期,1 例接受替雷利珠单抗加 AVD 化疗 4 个周期。1 例在接受替雷利珠单抗 4 个剂量后疾病进展(PD)的患者随后接受 ABVD 化疗 4 个周期。除了 4 例 CR-EOTM 患者外,19 例患者接受了巩固性放疗。所有患者在所有治疗结束时均获得 CR。中位随访时间为 21.3 个月(范围,6.9-32.7 个月),估计 2 年无进展生存率(PFS)和 2 年总生存率(OS)分别为 95.65%和 100%。除了 3 级淋巴细胞计数下降外,未观察到其他 3/4 级 TRAE。此外,未报告严重 AE。我们的初步数据观察到,替雷利珠单抗单药治疗在未经治疗的早期 cHL 中安全且高效。

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