{"title":"对于接受免疫化疗的弥漫大 B 细胞淋巴瘤患者来说,36 个月的无事件生存期是一个合适的终点:来自北日本血液学研究小组的实际证据。","authors":"Koh Izumiyama, Tasuku Inao, Hideki Goto, Shinpei Harada, Hajime Senjo, Keito Suto, Junichi Hashiguchi, Reiki Ogasawara, Tomoyuki Saga, Tetsuyuki Igarashi, Kentaro Wakasa, Ikumi Kasahara, Yukari Takeda, Keisuke Yamaguchi, Akio Shigematsu, Mutsumi Takahata, Katsuya Fujimoto, Yoshihito Haseyama, Takahiro Nagashima, Hajime Sakai, Yasutaka Kakinoki, Mitsutoshi Kurosawa, Isao Yokota, Takanori Teshima","doi":"10.3324/haematol.2023.284841","DOIUrl":null,"url":null,"abstract":"<p><p>Information regarding follow-up duration after treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL) is important. However, a clear endpoint has yet to be established. We enrolled a total of 2,182 patients newly diagnosed with DLBCL between 2008 and 2018. The median age of the patients was 71 years. All patients were treated with rituximab- and anthracycline-based chemotherapies. Each overall survival (OS) was compared with the age- and sex-matched Japanese general population (GP) data. At a median follow-up of 3.4 years, 985 patients experienced an event and 657 patients died. Patients who achieved an event-free survival (EFS) at 36 months (EFS36) had an OS equivalent to that of the matched GP (standard mortality ratio [SMR], 1.17; P=0.1324), whereas those who achieved an EFS24 did not have an OS comparable to that of the matched GP (SMR, 1.26; P=0.0095). Subgroup analysis revealed that relatively old patients (>60 years), male patients, those with limited-stage disease, those with a good performance status, and those with low levels of soluble interleukin 2 receptor already had a comparable life expectancy to the matched GP at an EFS24. In contrast, relatively young patients had a shorter life expectancy than matched GP, even with an EFS36. In conclusion, an EFS36 was shown to be a more suitable endpoint for newly diagnosed DLBCL patients than an EFS24. Of note, younger patients require a longer EFS period than older patients in order to obtain an equivalent life expectancy to the matched GP.</p>","PeriodicalId":12964,"journal":{"name":"Haematologica","volume":" ","pages":"3631-3640"},"PeriodicalIF":8.2000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532691/pdf/","citationCount":"0","resultStr":"{\"title\":\"Event-free survival at 36 months is a suitable endpoint for diffuse large B-cell lymphoma patients treated with immunochemotherapy: real-world evidence from the North Japan Hematology Study Group.\",\"authors\":\"Koh Izumiyama, Tasuku Inao, Hideki Goto, Shinpei Harada, Hajime Senjo, Keito Suto, Junichi Hashiguchi, Reiki Ogasawara, Tomoyuki Saga, Tetsuyuki Igarashi, Kentaro Wakasa, Ikumi Kasahara, Yukari Takeda, Keisuke Yamaguchi, Akio Shigematsu, Mutsumi Takahata, Katsuya Fujimoto, Yoshihito Haseyama, Takahiro Nagashima, Hajime Sakai, Yasutaka Kakinoki, Mitsutoshi Kurosawa, Isao Yokota, Takanori Teshima\",\"doi\":\"10.3324/haematol.2023.284841\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Information regarding follow-up duration after treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL) is important. However, a clear endpoint has yet to be established. We enrolled a total of 2,182 patients newly diagnosed with DLBCL between 2008 and 2018. The median age of the patients was 71 years. All patients were treated with rituximab- and anthracycline-based chemotherapies. Each overall survival (OS) was compared with the age- and sex-matched Japanese general population (GP) data. At a median follow-up of 3.4 years, 985 patients experienced an event and 657 patients died. Patients who achieved an event-free survival (EFS) at 36 months (EFS36) had an OS equivalent to that of the matched GP (standard mortality ratio [SMR], 1.17; P=0.1324), whereas those who achieved an EFS24 did not have an OS comparable to that of the matched GP (SMR, 1.26; P=0.0095). Subgroup analysis revealed that relatively old patients (>60 years), male patients, those with limited-stage disease, those with a good performance status, and those with low levels of soluble interleukin 2 receptor already had a comparable life expectancy to the matched GP at an EFS24. In contrast, relatively young patients had a shorter life expectancy than matched GP, even with an EFS36. In conclusion, an EFS36 was shown to be a more suitable endpoint for newly diagnosed DLBCL patients than an EFS24. 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引用次数: 0
摘要
有关新诊断弥漫大 B 细胞淋巴瘤(DLBCL)治疗后随访时间的信息非常重要。然而,明确的终点尚未确立。我们在2008年至2018年间共招募了2182名新诊断为DLBCL的患者。患者的中位年龄为71岁。所有患者均接受了基于利妥昔单抗和蒽环类药物的化疗。每名患者的总生存期(OS)都与年龄和性别匹配的日本普通人群(GP)数据进行了比较。在中位 3.4 年的随访中,985 名患者发生了事件,657 名患者死亡。获得 36 个月无事件生存期(EFS)(EFS36)的患者的 OS 与匹配的普通人群相当(标准死亡率比 [SMR],1.17;P=0.1324),而获得 EFS24 的患者的 OS 与匹配的普通人群不相当(SMR,1.26;P=0.0095)。亚组分析显示,年龄较大(大于 60 岁)的患者、男性患者、病程有限的患者、表现良好的患者以及可溶性白细胞介素 2 受体水平较低的患者在 EFS24 时的预期寿命与匹配的 GP 相当。相比之下,相对年轻的患者即使在 EFS36 时的预期寿命也比匹配的 GP 短。总之,与 EFS24 相比,EFS36 更适合作为新诊断 DLBCL 患者的终点。值得注意的是,年轻患者需要比年长患者更长的EFS期,才能获得与匹配GP相当的预期寿命。
Event-free survival at 36 months is a suitable endpoint for diffuse large B-cell lymphoma patients treated with immunochemotherapy: real-world evidence from the North Japan Hematology Study Group.
Information regarding follow-up duration after treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL) is important. However, a clear endpoint has yet to be established. We enrolled a total of 2,182 patients newly diagnosed with DLBCL between 2008 and 2018. The median age of the patients was 71 years. All patients were treated with rituximab- and anthracycline-based chemotherapies. Each overall survival (OS) was compared with the age- and sex-matched Japanese general population (GP) data. At a median follow-up of 3.4 years, 985 patients experienced an event and 657 patients died. Patients who achieved an event-free survival (EFS) at 36 months (EFS36) had an OS equivalent to that of the matched GP (standard mortality ratio [SMR], 1.17; P=0.1324), whereas those who achieved an EFS24 did not have an OS comparable to that of the matched GP (SMR, 1.26; P=0.0095). Subgroup analysis revealed that relatively old patients (>60 years), male patients, those with limited-stage disease, those with a good performance status, and those with low levels of soluble interleukin 2 receptor already had a comparable life expectancy to the matched GP at an EFS24. In contrast, relatively young patients had a shorter life expectancy than matched GP, even with an EFS36. In conclusion, an EFS36 was shown to be a more suitable endpoint for newly diagnosed DLBCL patients than an EFS24. Of note, younger patients require a longer EFS period than older patients in order to obtain an equivalent life expectancy to the matched GP.
期刊介绍:
Haematologica is a journal that publishes articles within the broad field of hematology. It reports on novel findings in basic, clinical, and translational research.
Scope:
The scope of the journal includes reporting novel research results that:
Have a significant impact on understanding normal hematology or the development of hematological diseases.
Are likely to bring important changes to the diagnosis or treatment of hematological diseases.