Inotuzumab Ozogamicin治疗复发/难治性急性淋巴细胞白血病成人患者的真实世界数据:一项grela -智利研究

IF 3.1 2区 医学 Q2 ONCOLOGY
Cancer Medicine Pub Date : 2025-09-12 DOI:10.1002/cam4.71230
Marcela Espinoza, Jorge Rojas-Vallejos, Nicolás Rodríguez, Gonzalo Guerrero, Miguel López, Natalia Aranguiz, Guillermo Conte, Francisco Samaniego, Nicolás Quinteros, Daniel Astete, Lucas Carcamo, Constanza Flores, Ximena Huerta, Mauricio Chandía, Jorge Valenzuela, Marcelo Navarrete, Yorman Flores, Agatha Larrazabal, Edgar Zapata, Joaquín Jerez
{"title":"Inotuzumab Ozogamicin治疗复发/难治性急性淋巴细胞白血病成人患者的真实世界数据:一项grela -智利研究","authors":"Marcela Espinoza,&nbsp;Jorge Rojas-Vallejos,&nbsp;Nicolás Rodríguez,&nbsp;Gonzalo Guerrero,&nbsp;Miguel López,&nbsp;Natalia Aranguiz,&nbsp;Guillermo Conte,&nbsp;Francisco Samaniego,&nbsp;Nicolás Quinteros,&nbsp;Daniel Astete,&nbsp;Lucas Carcamo,&nbsp;Constanza Flores,&nbsp;Ximena Huerta,&nbsp;Mauricio Chandía,&nbsp;Jorge Valenzuela,&nbsp;Marcelo Navarrete,&nbsp;Yorman Flores,&nbsp;Agatha Larrazabal,&nbsp;Edgar Zapata,&nbsp;Joaquín Jerez","doi":"10.1002/cam4.71230","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Inotuzumab Ozogamicin (InO) has shown efficacy in relapsed/refractory acute lymphoblastic leukemia (R/R ALL), but evidence from Latin America is scarce. We evaluated the outcomes of Chilean patients treated with InO in public and private health centers.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>We retrospectively analyzed 35 patients with R/R ALL (median age 33 years; 54% male). Twenty percent had BCR::ABL-positive ALL, 78% expressed CD22, and 91% expressed CD19. Response rates, measurable residual disease (MRD), survival outcomes, and treatment-related toxicities were assessed. Multivariate analyses explored prognostic factors.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Complete remission or remission with incomplete recovery (CR/CRi) was achieved in 74% of patients. Among those evaluated, 82% reached MRD &lt; 0.01%. Patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after InO had superior overall survival (OS) compared with those who did not (24.2 vs. 5.2 months). Median progression-free survival (PFS) was 6.9 months and median OS was 8.8 months. Sinusoidal obstruction syndrome occurred in 14% of patients but was generally mild. Multivariate analysis identified comorbidities and high blast counts as adverse prognostic factors, whereas MRD negativity and subsequent Allo-HSCT were associated with improved outcomes.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>InO demonstrated high remission and MRD negativity rates in Chilean patients with R/R ALL, with OS and PFS comparable to existing research. Although SOS incidence was higher, it was generally mild. Achieving MRD negativity and proceeding to Allo-HSCT provided the greatest survival benefit. Study limitations include short follow-up and limited data.</p>\n </section>\n </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 18","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71230","citationCount":"0","resultStr":"{\"title\":\"Real-World Data on Inotuzumab Ozogamicin for Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia: A GRELAL-Chile Study\",\"authors\":\"Marcela Espinoza,&nbsp;Jorge Rojas-Vallejos,&nbsp;Nicolás Rodríguez,&nbsp;Gonzalo Guerrero,&nbsp;Miguel López,&nbsp;Natalia Aranguiz,&nbsp;Guillermo Conte,&nbsp;Francisco Samaniego,&nbsp;Nicolás Quinteros,&nbsp;Daniel Astete,&nbsp;Lucas Carcamo,&nbsp;Constanza Flores,&nbsp;Ximena Huerta,&nbsp;Mauricio Chandía,&nbsp;Jorge Valenzuela,&nbsp;Marcelo Navarrete,&nbsp;Yorman Flores,&nbsp;Agatha Larrazabal,&nbsp;Edgar Zapata,&nbsp;Joaquín Jerez\",\"doi\":\"10.1002/cam4.71230\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Inotuzumab Ozogamicin (InO) has shown efficacy in relapsed/refractory acute lymphoblastic leukemia (R/R ALL), but evidence from Latin America is scarce. We evaluated the outcomes of Chilean patients treated with InO in public and private health centers.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>We retrospectively analyzed 35 patients with R/R ALL (median age 33 years; 54% male). Twenty percent had BCR::ABL-positive ALL, 78% expressed CD22, and 91% expressed CD19. Response rates, measurable residual disease (MRD), survival outcomes, and treatment-related toxicities were assessed. Multivariate analyses explored prognostic factors.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Complete remission or remission with incomplete recovery (CR/CRi) was achieved in 74% of patients. Among those evaluated, 82% reached MRD &lt; 0.01%. Patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after InO had superior overall survival (OS) compared with those who did not (24.2 vs. 5.2 months). Median progression-free survival (PFS) was 6.9 months and median OS was 8.8 months. Sinusoidal obstruction syndrome occurred in 14% of patients but was generally mild. Multivariate analysis identified comorbidities and high blast counts as adverse prognostic factors, whereas MRD negativity and subsequent Allo-HSCT were associated with improved outcomes.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>InO demonstrated high remission and MRD negativity rates in Chilean patients with R/R ALL, with OS and PFS comparable to existing research. Although SOS incidence was higher, it was generally mild. Achieving MRD negativity and proceeding to Allo-HSCT provided the greatest survival benefit. Study limitations include short follow-up and limited data.</p>\\n </section>\\n </div>\",\"PeriodicalId\":139,\"journal\":{\"name\":\"Cancer Medicine\",\"volume\":\"14 18\",\"pages\":\"\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2025-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71230\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/cam4.71230\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Medicine","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cam4.71230","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

Inotuzumab Ozogamicin (InO)已显示出对复发/难治性急性淋巴细胞白血病(R/R ALL)的疗效,但来自拉丁美洲的证据很少。我们评估了智利在公立和私立卫生中心接受InO治疗的患者的结果。方法回顾性分析35例R/R ALL患者(中位年龄33岁,男性占54%)。20%的人有BCR: abl阳性ALL, 78%表达CD22, 91%表达CD19。评估了缓解率、可测量的残留疾病(MRD)、生存结局和治疗相关的毒性。多变量分析探讨预后因素。结果74%的患者达到完全缓解或缓解伴不完全恢复(CR/CRi)。在被评估的产品中,有82%达到了0.01%的MRD。接受同种异体造血干细胞移植(Allo-HSCT)的患者在InO后的总生存期(OS)优于未接受移植的患者(24.2个月vs 5.2个月)。中位无进展生存期(PFS)为6.9个月,中位OS为8.8个月。14%的患者发生了窦状窦阻塞综合征,但通常是轻微的。多变量分析发现合并症和高细胞计数是不良预后因素,而MRD阴性和随后的同种异体造血干细胞移植与预后改善有关。结论:InO在智利R/R ALL患者中显示出高缓解率和MRD阴性率,OS和PFS与现有研究相当。虽然SOS发生率较高,但一般较轻。实现MRD阴性并继续进行Allo-HSCT提供了最大的生存益处。研究的局限性包括随访时间短和数据有限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Real-World Data on Inotuzumab Ozogamicin for Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia: A GRELAL-Chile Study

Real-World Data on Inotuzumab Ozogamicin for Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia: A GRELAL-Chile Study

Background

Inotuzumab Ozogamicin (InO) has shown efficacy in relapsed/refractory acute lymphoblastic leukemia (R/R ALL), but evidence from Latin America is scarce. We evaluated the outcomes of Chilean patients treated with InO in public and private health centers.

Methods

We retrospectively analyzed 35 patients with R/R ALL (median age 33 years; 54% male). Twenty percent had BCR::ABL-positive ALL, 78% expressed CD22, and 91% expressed CD19. Response rates, measurable residual disease (MRD), survival outcomes, and treatment-related toxicities were assessed. Multivariate analyses explored prognostic factors.

Results

Complete remission or remission with incomplete recovery (CR/CRi) was achieved in 74% of patients. Among those evaluated, 82% reached MRD < 0.01%. Patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after InO had superior overall survival (OS) compared with those who did not (24.2 vs. 5.2 months). Median progression-free survival (PFS) was 6.9 months and median OS was 8.8 months. Sinusoidal obstruction syndrome occurred in 14% of patients but was generally mild. Multivariate analysis identified comorbidities and high blast counts as adverse prognostic factors, whereas MRD negativity and subsequent Allo-HSCT were associated with improved outcomes.

Conclusions

InO demonstrated high remission and MRD negativity rates in Chilean patients with R/R ALL, with OS and PFS comparable to existing research. Although SOS incidence was higher, it was generally mild. Achieving MRD negativity and proceeding to Allo-HSCT provided the greatest survival benefit. Study limitations include short follow-up and limited data.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Cancer Medicine
Cancer Medicine ONCOLOGY-
CiteScore
5.50
自引率
2.50%
发文量
907
审稿时长
19 weeks
期刊介绍: Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信