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[Rinsho ketsueki] The Japanese journal of clinical hematology最新文献

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[Diffuse large B-cell lymphoma: current treatment strategy and future outlook]. [弥漫大b细胞淋巴瘤:目前的治疗策略和未来展望]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1055
Shinichi Makita

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of lymphoma in Japan. Approximately half of all patients can be cured with frontline rituximab-containing chemoimmunotherapy. However, patients with relapsed or refractory disease after standard chemotherapy often have a poor prognosis. Various novel therapies have been developed to improve outcomes in this population. In particular, immunotherapies such as chimeric antigen receptor (CAR) T-cell therapy and bispecific antibody therapies have significantly transformed the treatment landscape for relapsed or refractory DLBCL. Several ongoing clinical trials are also investigating incorporation of these novel agents into frontline treatment regimens. This review outlines current treatment strategies for DLBCL and highlights recent advances in clinical development, with a focus on emerging immunotherapies.

弥漫大b细胞淋巴瘤(DLBCL)是日本最常见的淋巴瘤亚型。大约一半的患者可以通过一线含利妥昔单抗的化学免疫疗法治愈。然而,标准化疗后复发或难治性疾病的患者往往预后较差。已经开发了各种新疗法来改善这一人群的预后。特别是,嵌合抗原受体(CAR) t细胞疗法和双特异性抗体疗法等免疫疗法显著改变了复发或难治性DLBCL的治疗前景。一些正在进行的临床试验也在研究将这些新药纳入一线治疗方案。本综述概述了目前DLBCL的治疗策略,并强调了临床发展的最新进展,重点是新兴的免疫疗法。
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引用次数: 0
[Drug-drug interactions between antifungal agents and molecular-targeted agents]. [抗真菌药物和分子靶向药物之间的药物相互作用]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1215
Takeo Yamagiwa

Drug interactions occur when the concomitant use of multiple drugs enhances or reduces their pharmacological effects, or causes unexpectedly strong adverse reactions. Major mechanisms include alterations in cytochrome P450 (CYP) enzyme activity, chelation within the gastrointestinal tract, and inhibition of renal transporters. In the treatment of hematologic malignancies, combination of molecular targeted therapies with immunosuppressants often increases the risk of infections due to drug-induced cytopenia and immunosuppression. Azole antifungal agents, frequently used for the prevention and treatment of fungal infections, are known to inhibit CYP enzymes. This inhibition can increase the plasma concentrations of targeted therapies, thereby enhancing their toxicity and increasing the risk of severe adverse effects. The degree of interaction is influenced not only by specific drug combinations but also by interindividual variability. Advanced pharmacokinetic approaches such as concentration ratio-interaction risk methods, physiologically based pharmacokinetic modeling, and population pharmacokinetic analysis allow for the prediction and evaluation of such interactions. These tools enable more precise drug selection and dosage adjustments tailored to individual patients, supporting treatment personalization and promoting safer, more effective drug therapy in clinical practice.

当多种药物同时使用增强或减弱其药理作用,或引起意想不到的强烈不良反应时,就会发生药物相互作用。主要机制包括细胞色素P450 (CYP)酶活性的改变、胃肠道内的螯合作用和肾转运蛋白的抑制。在血液系统恶性肿瘤的治疗中,分子靶向治疗与免疫抑制剂联合使用往往会增加药物性细胞减少和免疫抑制引起的感染风险。唑类抗真菌药物常用于预防和治疗真菌感染,已知可抑制CYP酶。这种抑制可以增加靶向治疗的血浆浓度,从而增强其毒性并增加严重不良反应的风险。相互作用的程度不仅受到特定药物组合的影响,还受到个体间变异性的影响。先进的药代动力学方法,如浓度比相互作用风险方法、基于生理学的药代动力学建模和群体药代动力学分析,可以预测和评估这种相互作用。这些工具能够更精确地为个体患者选择药物和调整剂量,支持治疗个性化,并在临床实践中促进更安全、更有效的药物治疗。
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引用次数: 0
[Advancing treatment goals for paroxysmal nocturnal hemoglobinuria to align with quality of life improvements in the era of anti-complement therapy]. [推进阵发性夜间血红蛋白尿的治疗目标,与抗补体治疗时代生活质量的改善保持一致]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1589
Shikiko Ueno

Patients with paroxysmal nocturnal hemoglobinuria (PNH) experience a significant decline in quality of life (QOL) due to various symptoms and organ damage associated with intravascular hemolysis. Red blood cell transfusions and other traditional supportive therapies offer only limited symptomatic relief and fail to prevent critical complications such as thrombosis and chronic kidney disease. Eculizumab, a C5 inhibitor introduced in 2010, directly inhibits intravascular hemolysis, and thus not only resolves hemolysis-related symptoms but also prevents organ damage and improves survival. This has resulted in a paradigm shift in the treatment of PNH. In this era of anti-complement therapy, the goal of PNH therapy can now be elevated to preventing intravascular hemolysis. However, the emergence of new issues, such as primary resistance due to C5 gene polymorphisms, breakthrough hemolysis, and extravascular hemolysis have hindered improvement of QOL. Various drugs have been developed to address these issues, including long-acting C5 inhibitors (ravulizumab and crovalimab) and proximal complement inhibitors capable of blocking extravascular hemolysis, such as a C3 inhibitor (pegcetacoplan), a factor B inhibitor (iptacopan), and a factor D inhibitor (danicopan). In particular, proximal complement inhibitors further enhance QOL because they inhibit both intravascular and extravascular hemolysis, resulting in greater improvement of hemoglobin levels and transfusion independence, and thereby further enhancing of QOL. Today, it is possible to achieve optimal improvement in QOL by appropriately selecting one of the three C5 inhibitors as first-line therapy or one of the three proximal complement inhibitors as second-line therapy, based on the patient's clinical condition and lifestyle.

阵发性夜间血红蛋白尿(PNH)患者由于与血管内溶血相关的各种症状和器官损害而导致生活质量(QOL)显著下降。红细胞输注和其他传统的支持疗法只能提供有限的症状缓解,并不能预防血栓形成和慢性肾脏疾病等严重并发症。Eculizumab是2010年推出的C5抑制剂,直接抑制血管内溶血,不仅可以缓解溶血相关症状,还可以预防器官损伤,提高生存率。这导致了PNH治疗模式的转变。在这个抗补体治疗的时代,PNH治疗的目标现在可以提升到预防血管内溶血。然而,C5基因多态性引起的原发耐药、突破性溶血、血管外溶血等新问题的出现阻碍了生活质量的改善。为了解决这些问题,已经开发了各种药物,包括长效C5抑制剂(ravulizumab和crovalimab)和能够阻断血管外溶血的近端补体抑制剂,如C3抑制剂(pegcetacoplan),因子B抑制剂(iptacopan)和因子D抑制剂(danicopan)。特别是,近端补体抑制剂进一步提高了生活质量,因为它们同时抑制了血管内和血管外的溶血,导致血红蛋白水平和输血独立性的更大改善,从而进一步提高了生活质量。今天,根据患者的临床状况和生活方式,适当选择三种C5抑制剂中的一种作为一线治疗或三种近端补体抑制剂中的一种作为二线治疗,可以达到最佳的生活质量改善。
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引用次数: 0
[Dysfunction and premature aging of hematopoietic stem cells in Down syndrome]. [唐氏综合征中造血干细胞功能障碍和早衰]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1545
Mariko Morii
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引用次数: 0
[Phase II study of glucarpidase in Japanese patients with delayed methotrexate clearance after high-dose methotrexate therapy]. 【高剂量甲氨蝶呤治疗后延迟甲氨蝶呤清除率的日本患者的葡糖苷酶II期研究】。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1431
Keiko Okada, Chitose Ogawa, Rishu Kayatani, Sakiko Azuma, Natsumi Kikuchi, Mayuko Noguchi, Kazuki Tanimura, Kai Yamasaki, Chika Nitani, Hiroyuki Fujisaki, Bunpei Miyazaki, Ayumu Arakawa, Kazunari Miyairi, Tokihiro Ro, Atsushi Ogawa

Objective: The objective of this study was to evaluate the efficacy and safety of glucarpidase in eight Japanese patients with delayed methotrexate (MTX) elimination following high-dose methotrexate therapy (HD-MTX) under near-clinical conditions.

Methods: This was a multicenter, single-arm, open-label, phase II clinical study. Glucarpidase was administered in accordance with the criteria for delayed MTX elimination described in the package insert, and supportive care for HD-MTX was continued after glucarpidase dosing.

Results: The plasma MTX concentration 48 hours after the first dose of glucarpidase decreased by at least 90% from baseline in all patients. Moreover, 87.5% of patients had plasma MTX concentrations below 1 µmol/l. Grade ≥3 adverse events were reported in 25.0% of patients, but no adverse events were found to be causally related to glucarpidase.

Conclusion: The results of this study are similar to those of previous clinical studies, and indicate that glucarpidase should be effective and safe in clinical practice.

目的:本研究的目的是评估葡糖苷酶在8例近临床条件下高剂量甲氨蝶呤治疗(HD-MTX)后延迟甲氨蝶呤(MTX)消除的日本患者中的疗效和安全性。方法:这是一项多中心、单臂、开放标签的II期临床研究。根据说明书中描述的延迟MTX消除标准给予葡糖苷酶,并在葡糖苷酶给药后继续进行HD-MTX的支持治疗。结果:所有患者首次给药后48小时血浆MTX浓度较基线下降至少90%。87.5%的患者血浆MTX浓度低于1µmol/l。25.0%的患者报告了≥3级不良事件,但未发现与葡糖苷酶相关的不良事件。结论:本研究结果与以往临床研究结果相似,提示葡糖苷酶在临床应用中是安全有效的。
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引用次数: 0
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1506
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引用次数: 0
[Fulminant streptococcal toxic shock syndrome developing under dasatinib therapy]. [达沙替尼治疗下发生的暴发性链球菌中毒性休克综合征]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.1298
Miku Saito, Yusuke Wada, Ai Takahashi, Takayuki Yamada, Ayano Fukano, Yasuyo Oyama, Fumiaki Urase

Patient 1 was a 65-year-old woman diagnosed with chronic myeloid leukemia (CML) in 2016. She was treated with dasatinib at a dose of 100 mg. After achievement of deep molecular remission (DMR) in 2018, the dasatinib dose was decreased to 50 mg a day. In April 2021, the patient suddenly developed high fever, skin swelling and redness, muscle swelling, and pain in bilateral lower extremities. Detection of G type hemolytic streptococcus in blood culture led to a diagnosis of streptococcal toxic shock syndrome (STSS). The patient recovered from disseminated intravascular coagulation and multiple organ failure by treatment with several antibiotics, fresh frozen plasma (FFP), and plasma exchange over a period of 2 months. Patient 2 was a 53-year-old man who developed CML in 2011. He was prescribed nilotinib, but efficacy could not be evaluated due to poor treatment adherence. Treatment with dasatinib was started instead within a year. DMR was achieved, but the patient developed STSS in July 2021. Both of these cases of STSS occurred in patients treated with dasatinib, which suggests that STSS may be related to dasatinib treatment in CML patients. We conducted a literature review to determine whether CML treatment selection was appropriate in these patients.

患者1是一名65岁的女性,于2016年被诊断患有慢性髓性白血病(CML)。她接受了100毫克的达沙替尼治疗。在2018年达到深度分子缓解(DMR)后,达沙替尼的剂量减少到每天50毫克。2021年4月,患者突然出现高热、皮肤红肿、肌肉肿胀、双下肢疼痛。血培养中检测到G型溶血性链球菌,诊断为链球菌中毒性休克综合征(STSS)。经多种抗生素、新鲜冷冻血浆(FFP)和血浆置换治疗2个月后,患者从弥散性血管内凝血和多器官功能衰竭中恢复。患者2是一名53岁的男性,于2011年患上CML。他开了尼罗替尼,但由于治疗依从性差,无法评估疗效。在一年内开始使用达沙替尼治疗。实现了DMR,但患者在2021年7月出现了STSS。这两例STSS均发生在接受达沙替尼治疗的患者中,提示STSS可能与CML患者的达沙替尼治疗有关。我们进行了文献回顾,以确定CML治疗选择是否适合这些患者。
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引用次数: 0
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.134
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引用次数: 0
[Long-term remission achieved with allogeneic hematopoietic stem cell transplantation at first complete remission in a pediatric patient with TCF7::SPI1 fusion-positive T-cell acute lymphoblastic leukemia]. [同种异体造血干细胞移植在TCF7::SPI1融合阳性t细胞急性淋巴细胞白血病患儿首次完全缓解中实现长期缓解]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.49
Mayuko Noguchi, Kai Yamasaki, Sakiko Azuma, Natsumi Kikuchi, Chika Nitani, Keiko Okada, Nobutaka Kiyokawa, Kiyotaka Isobe, Junko Takita, Hiroyuki Fujisaki, Junichi Hara

T-cell acute lymphocytic leukemia (T-ALL) with SPI1 fusion, a leukemia subtype first identified in Japan, has a very poor prognosis. A 7-year-old boy was admitted to our hospital with fever, cervical lymphadenopathy, eyelid edema, and purpura. White blood cell count was markedly increased (551,000/µl). Flow cytometric analysis revealed cyCD3, CD1a, CD8, and HLA-DR positive T-ALL, and fusion gene screening identified TCF7::SPI1 fusion. The patient was treated according to the JPLSG ALL-T11 protocol. He responded poorly to prednisolone, but favorably to L-asparaginase. After completion of early intensification therapy, molecular remission was confirmed. However, due to the patient's poor response to prednisolone, and the presence of the SPI1 fusion gene, hematopoietic stem cell transplantation from an HLA-matched unrelated donor was performed in first remission. So far, the patient has been in remission for 36 months from the time of onset. Hematopoietic stem cell transplantation in first remission may be effective treatment for patients with T-ALL and SPI1 fusion.

SPI1融合的T细胞急性淋巴细胞白血病(T-ALL)是在日本首次发现的一种白血病亚型,预后极差。一名 7 岁男孩因发热、颈淋巴结病、眼睑水肿和紫癜入院。白细胞计数明显升高(551,000/µl)。流式细胞分析显示 cyCD3、CD1a、CD8 和 HLA-DR 阳性 T-ALL,融合基因筛查发现 TCF7::SPI1 融合。患者按照 JPLSG ALL-T11 方案接受了治疗。他对泼尼松龙的反应不佳,但对L-天冬酰胺酶反应良好。在完成早期强化治疗后,分子缓解得到了证实。然而,由于患者对泼尼松龙的反应不佳,且存在SPI1融合基因,因此在首次缓解期进行了HLA匹配的非亲缘供体造血干细胞移植。到目前为止,该患者从发病到现在已经缓解了 36 个月。首次缓解期的造血干细胞移植可能是治疗T-ALL和SPI1融合患者的有效方法。
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引用次数: 0
[Treatment outcomes of axicabtagene ciloleucel for relapsed/refractory diffuse large B-cell lymphoma: a retrospective analysis at a single institution]. [阿昔巴他基西鲁塞治疗复发/难治性弥漫性大b细胞淋巴瘤的疗效:单一机构的回顾性分析]。
Pub Date : 2025-01-01 DOI: 10.11406/rinketsu.66.81
Wataru Kitamura, Nobuharu Fujii, Chihiro Kamoi, Toshiki Terao, Akira Yamamoto, Hiroki Kobayashi, Takumi Kondo, Keisuke Seike, Hideaki Fujiwara, Keiko Fujii, Noboru Asada, Daisuke Ennishi, Yoshinobu Maeda

The advent of anti-CD19 chimeric antigen receptor-T cell therapy has dramatically changed the treatment strategy for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Three products are recently available in Japan, but to the best of our knowledge, real-world data are only available for tisagenlecleucel. This study was a retrospective analysis of 27 patients who received axicabtagene ciloleucel (axi-cel) for R/R DLBCL at our institution. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome occurred in 24 (88.9%) and 8 patients (29.6%), respectively, and corticosteroids were used in 19 patients (70.4%). The median follow-up period was 8.1 months (range, 1.0-23.2), and the 6-month progression-free survival and overall survival rates were 80.2% (95% confidence interval [CI], 58.8-91.3) and 92.0% (95%CI, 71.6-97.9), respectively. Although our study was limited by its small sample size and short follow-up period, it demonstrated that axi-cel was highly effective and safe at our institution.

抗 CD19 嵌合抗原受体-T 细胞疗法的出现极大地改变了复发/难治弥漫大 B 细胞淋巴瘤(R/R DLBCL)的治疗策略。日本最近上市了三种产品,但据我们所知,目前仅有tisagenlecleucel的真实世界数据。本研究是一项回顾性分析,研究对象是本院接受阿昔单抗西洛ucel(axi-cel)治疗R/R DLBCL的27名患者。24名患者(88.9%)和8名患者(29.6%)分别出现了细胞因子释放综合征和免疫效应细胞相关神经毒性综合征,19名患者(70.4%)使用了皮质类固醇。中位随访期为8.1个月(1.0-23.2个月),6个月无进展生存率和总生存率分别为80.2%(95%置信区间[CI],58.8-91.3)和92.0%(95%CI,71.6-97.9)。虽然我们的研究受样本量小和随访时间短的限制,但它证明了在我们的机构中,axi-cel是非常有效和安全的。
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引用次数: 0
期刊
[Rinsho ketsueki] The Japanese journal of clinical hematology
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