Emma Verner, Amanda Johnston, Nalini Pati, Eliza A Hawkes, Hui-Peng Lee, Tara Cochrane, Chan Y Cheah, Robin Filshie, Duncan Purtill, Hanlon Sia, Anoop Kumar Enjeti, Christina Brown, Nicholas Edward Murphy, Jennifer Curnow, Kenneth Lee, Maher K Gandhi, Mannu Walia, Belinda Butcher, Judith Trotman
{"title":"Ibrutinib plus rituximab and mini-CHOP in very elderly patients with newly diagnosed DLBCL: A phase II ALLG study.","authors":"Emma Verner, Amanda Johnston, Nalini Pati, Eliza A Hawkes, Hui-Peng Lee, Tara Cochrane, Chan Y Cheah, Robin Filshie, Duncan Purtill, Hanlon Sia, Anoop Kumar Enjeti, Christina Brown, Nicholas Edward Murphy, Jennifer Curnow, Kenneth Lee, Maher K Gandhi, Mannu Walia, Belinda Butcher, Judith Trotman","doi":"10.1182/bloodadvances.2024014035","DOIUrl":null,"url":null,"abstract":"<p><p>The multicenter, prospective phase II Australasian Leukaemia and Lymphoma Group (ALLG) NHL29 trial (ACTRN12615000551594) was conducted to assess the addition of ibrutinib to R-mini-CHOP (IRiC) in patients aged ≥75 years with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Treatment consisted of six 21-day cycles of ibrutinib-R-mini-CHOP followed by two 21-day cycles of rituximab-ibrutinib. Co-primary endpoints were deliverability and 2-year overall survival (OS). All six cycles of R-mini-CHOP were completed in 63/79 patients (80%) with the median Average Relative Total Dose and Average Relative Dose Intensity for the entire regimen both 97% (IQR 82, 100; 88, 100). With a median follow-up of 35.5 months, the 2-year OS was 68% (95% CI, 55.6 - 77.4) with a 2-year PFS of 60.0% (95% CI, 47.7- 70.3). Median OS and PFS were 72 months (95% CI, 35 - not reached) and 40 months (95% CI, 20.4 - not reached) respectively. The overall response rate (ORR) was 76% (61/79 patients), with a complete response (CR) rate of 71% (56/79 patients). Deaths occurred in 34/79 patients (43%), including 17 from progressive disease and 5 treatment related. 67% patients experienced at least one serious adverse event. Most common adverse events were infections and diarrhea (majority grade 1-2). In both health-related quality of life measures, there was an improvement in functional and symptom scales, median health state classification score and median visual analogue scale in responders over time. In conclusion, this study showed that the addition of ibrutinib to R-mini-CHOP was both deliverable and efficacious in elderly DLBCL patients.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":null,"pages":null},"PeriodicalIF":7.4000,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood advances","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1182/bloodadvances.2024014035","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The multicenter, prospective phase II Australasian Leukaemia and Lymphoma Group (ALLG) NHL29 trial (ACTRN12615000551594) was conducted to assess the addition of ibrutinib to R-mini-CHOP (IRiC) in patients aged ≥75 years with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Treatment consisted of six 21-day cycles of ibrutinib-R-mini-CHOP followed by two 21-day cycles of rituximab-ibrutinib. Co-primary endpoints were deliverability and 2-year overall survival (OS). All six cycles of R-mini-CHOP were completed in 63/79 patients (80%) with the median Average Relative Total Dose and Average Relative Dose Intensity for the entire regimen both 97% (IQR 82, 100; 88, 100). With a median follow-up of 35.5 months, the 2-year OS was 68% (95% CI, 55.6 - 77.4) with a 2-year PFS of 60.0% (95% CI, 47.7- 70.3). Median OS and PFS were 72 months (95% CI, 35 - not reached) and 40 months (95% CI, 20.4 - not reached) respectively. The overall response rate (ORR) was 76% (61/79 patients), with a complete response (CR) rate of 71% (56/79 patients). Deaths occurred in 34/79 patients (43%), including 17 from progressive disease and 5 treatment related. 67% patients experienced at least one serious adverse event. Most common adverse events were infections and diarrhea (majority grade 1-2). In both health-related quality of life measures, there was an improvement in functional and symptom scales, median health state classification score and median visual analogue scale in responders over time. In conclusion, this study showed that the addition of ibrutinib to R-mini-CHOP was both deliverable and efficacious in elderly DLBCL patients.
期刊介绍:
Blood Advances, a semimonthly medical journal published by the American Society of Hematology, marks the first addition to the Blood family in 70 years. This peer-reviewed, online-only, open-access journal was launched under the leadership of founding editor-in-chief Robert Negrin, MD, from Stanford University Medical Center in Stanford, CA, with its inaugural issue released on November 29, 2016.
Blood Advances serves as an international platform for original articles detailing basic laboratory, translational, and clinical investigations in hematology. The journal comprehensively covers all aspects of hematology, including disorders of leukocytes (both benign and malignant), erythrocytes, platelets, hemostatic mechanisms, vascular biology, immunology, and hematologic oncology. Each article undergoes a rigorous peer-review process, with selection based on the originality of the findings, the high quality of the work presented, and the clarity of the presentation.