Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy

Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma

开始日期2024-06-23

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

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403

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2024-09-08·Zhonghua bing li xue za zhi = Chinese journal of pathology

[Application value of immunohistochemistry INSM1 combined with periodic acid-Schiff stain double staining in glandular and neuroendocrine amphicrine carcinoma in the digestive tract].

Article

作者: Wang, J ; Xie, L W ; Bu, P ; Yang, X Q

目的： 探讨免疫组织化学INSM1联合过碘酸雪夫（PAS）染色双重染色（INSM1+PAS双染）在消化道具有腺和神经内分泌双向分化的癌（AC）中的应用价值。 方法： 收集山西省肿瘤医院2018年1月至2023年12月已经病理诊断为AC的病例15例。另外选取对照组包括：胃肠来源的神经内分泌癌（NEC）20例，低分化腺癌伴神经内分泌分化20例，混合性神经内分泌-非神经内分泌肿瘤（MiNEN）20例，正常胃肠道黏膜20例。用INSM1+PAS双染检测AC及对照组的表达情况，确定双染方法的阳性率、灵敏度、特异度。 结果： INSM1+PAS联合双染结果：在AC的同一个肿瘤细胞内可见INSM1阳性的棕色细胞核，胞质内可见PAS阳性的红染黏液物质。INSM1+PAS双染在AC中表达的阳性比例为8/15。在NEC、低分化腺癌伴神经内分泌分化、MiNEN、正常胃肠黏膜中均不表达，与AC差异有统计学意义（P<0.05）。INSM1+PAS在AC与NEC的鉴别诊断中灵敏度为53.3%，特异度为100%。 结论： 在AC同一个肿瘤细胞内可见INSM1阳性的棕色细胞核，胞质内可见PAS阳性的红染黏液物质，2种颜色对比清晰，容易识别，为诊断提供了一个简单有效的方法。建议本染色法在常规工作中开展。.

2024-09-01·Nature Medicine

Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial

Article

作者: Yang, Hao ; Hou, Zhiguo ; Qi, Yu ; Qin, Jianjun ; Zhang, Ruixiang ; Zhang, Yong ; Li, Bin ; Tan, Lijie ; Ni, Yunfeng ; Li, Yong ; Wang, Xiaoyuan ; Zhu, Wenqing ; Li, Lin ; Kang, Mingqiang ; Chen, Qixun ; Zhang, Chen ; Li, Hecheng ; Kang, Xiaozheng ; Lin, Jihong ; Zheng, Rongrong ; Tian, Hui ; Wang, Zhen ; Chen, Longqi ; Hao, Anlin ; Chen, Xiankai ; Fu, Junke ; Han, Yongtao ; Jiang, Hongjing ; Tian, Ziqiang ; He, Jie ; Wei, Li ; Zhang, Weiguo ; Liao, Yongde ; Chen, Yujie ; Jiang, Tao ; Xue, Liyan ; Li, Chengqiang ; Li, Yin ; Guo, Shiping ; Liu, Shuoyan ; Guo, Xiaofeng ; Li, Zhigang ; Ma, Jianqun ; Fu, Maoyong ; Dai, Tianyang ; Yang, Zhaoyang

AbstractRecent single-arm studies involving neoadjuvant camrelizumab, a PD-1 inhibitor, plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) have shown promising results. This multicenter, randomized, open-label phase 3 trial aimed to further assess the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab, compared to neoadjuvant chemotherapy alone. A total of 391 patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were stratified by clinical stage (I/II, III or IVA) and randomized in a 1:1:1 ratio to undergo two cycles of neoadjuvant therapy. Treatments included camrelizumab, albumin-bound paclitaxel and cisplatin (Cam+nab-TP group; n = 132); camrelizumab, paclitaxel and cisplatin (Cam+TP group; n = 130); and paclitaxel with cisplatin (TP group; n = 129), followed by surgical resection. Both the Cam+nab-TP and Cam+TP groups also received adjuvant camrelizumab. The dual primary endpoints were the rate of pathological complete response (pCR), as evaluated by a blind independent review committee, and event-free survival (EFS), as assessed by investigators. This study reports the final analysis of pCR rates. In the intention-to-treat population, the Cam+nab-TP and Cam+TP groups exhibited significantly higher pCR rates of 28.0% and 15.4%, respectively, compared to 4.7% in the TP group (Cam+nab-TP versus TP: difference 23.5%, 95% confidence interval (CI) 15.1–32.0, P < 0.0001; Cam+TP versus TP: difference 10.9%, 95% CI 3.7–18.1, P = 0.0034). The study met its primary endpoint of pCR; however, EFS is not yet mature. The incidence of grade ≥3 treatment-related adverse events during neoadjuvant treatment was 34.1% for the Cam+nab-TP group, 29.2% for the Cam+TP group and 28.8% for the TP group; the postoperative complication rates were 34.2%, 38.8% and 32.0%, respectively. Neoadjuvant camrelizumab plus chemotherapy demonstrated superior pCR rates compared to chemotherapy alone for LA-ESCC, with a tolerable safety profile. Chinese Clinical Trial Registry identifier: ChiCTR2000040034.

2024-08-01·Annals of Hematology

Efficacy of chidamide maintenance therapy versus autologous stem cell transplantation versus observation as a post-remission choice in the survival of adult patients with peripheral T-cell lymphoma: Post hoc analysis of a prospective, multicenter, phase 2 study in China

Article

作者: Song, Yu-Qin ; Wang, Wei ; Wang, Shu-Ye ; Luo, Jian-Min ; Wang, Quan-Shun ; Shen, Jing ; O'Connor, O A ; Zhang, Wei ; Jing, Hong-Mei ; Cen, Xi-Nan ; Su, Li-Ping ; Liu, Li-Hong ; Zhang, Hui-Lai ; Liu, Ai-Chun ; Zhou, Dao-Bin ; Gao, Yu-Huan ; Wang, Jing-Wen ; He, Jian-Xia ; Su, Hang ; Liu, Hui ; Li, Zeng-Jun

In this prospective, multicenter, Phase 2 clinical trial (NCT02987244), patients with peripheral T-cell lymphomas (PTCLs) who had responded to first-line chemotherapy with cyclophosphamide, doxorubicin or epirubicin, vincristine or vindesine, etoposide, and prednisone (Chi-CHOEP) were treated by autologous stem cell transplantation (ASCT) or with chidamide maintenance or observation. A total of 85 patients received one of the following interventions: ASCT (n = 15), chidamide maintenance (n = 44), and observation (n = 26). estimated 3 PFS and OS rates were 85.6%, 80.8%, and 49.4% (P = 0.001). The two-year OS rates were 85.6%, 80.8%, and 69.0% (P = 0.075).The ASCT and chidamide maintenance groups had significantly better progression-free survival (PFS) than the observation group (P = 0.001, and P = 0.01, respectively). The overall survival (OS) differed significantly between the chidamide maintenance group and the observation group ( P = 0.041). The multivariate and propensity score matching analyses for PFS revealed better outcomes in the subjects in the chidamide maintenance than observation groups (P = 0.02). The ASCT and chidamide maintenance groups had significant survival advantages over the observation group. In the post-remission stage of the untreated PTCL patients, single-agent chidamide maintenance demonstrated superior PFS and better OS than observation. Our findings highlight the potential benefit of chidamide in this patient subset, warranting further investigation through larger prospective trials. Clinical trial registration: clinicaltrial.gov, NCT02987244. Registered 8 December 2016, http://www.clinicaltrials.gov/ct2/show/NCT02987244 .

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