Morrison Vicki A, Le-Rademacher Jennifer, Bobek Olivia, Satele Daniel, Leonard John P, Jatoi Aminah
Department of Hematology & Oncology, University of Minnesota, Hennepin Healthcare, Minneapolis, MN, United States of America.
Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN, United States of America.
J Geriatr Oncol. 2025 Mar;16(2):102185. doi: 10.1016/j.jgo.2025.102185. Epub 2025 Jan 13.
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) therapy is the standard of care for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). However, detailed delineation of toxicity data is limited and has not been examined by age. We sought to examine adverse event data in patients receiving R-CHOP from the Cancer and Leukemia Group B (CALGB) 50303 trial to determine if there were differences in grade 3+ toxicities by age cohort or ECOG performance status (PS), and if outcome was impacted by age cohort or toxicity occurrence.
CALGB 50303 was an intergroup phase III study for previously untreated patients with DLBCL that included R-CHOP as one of the trial arms. In the subset of 235 evaluable, seemingly fit patients receiving R-CHOP on this trial, data regarding the occurrence of grade 3+ hematologic and non-hematologic toxicities by treatment arm, as well as completion of protocol therapy, overall response rate (ORR), and survival outcome parameters were collected and analyzed for Alliance A151930.
Data were available for further analysis from 235 of 243 patients evaluable for safety, i.e., those who received R-CHOP therapy on this trial, with 165 being <65 years of age, and 70 ≥ 65 years of age. There was an increased rate of grade 3+ non-hematologic (but not hematologic) toxicities in the older age cohorts, after controlling for disease stage and performance status (p < 0.001). One-year and three-year overall survival (OS) were inferior in patients ≥65 years of age, compared to those <65 years of age; there was no difference in one-year or in three-year progression-free survival (PFS) between the age cohorts.
Standard frontline therapy with R-CHOP can be effectively administered to an older age cohort. We found more grade 3+ non-hematologic, but not hematologic, toxicities in older patients. These data can be used in clinical trial and real-world settings to identify at-risk DLBCL subgroups for which pro-active measures can be utilized to ensure completion of therapy and optimization of clinical outcomes.
gov Identifier: NCT00118209 (CALGB 50303).
利妥昔单抗、环磷酰胺、多柔比星、长春新碱、泼尼松（R-CHOP）疗法是新诊断的弥漫性大B细胞淋巴瘤（DLBCL）患者的标准治疗方案。然而，毒性数据的详细描述有限，且尚未按年龄进行研究。我们试图研究癌症与白血病B组（CALGB）50303试验中接受R-CHOP治疗的患者的不良事件数据，以确定3级及以上毒性在不同年龄组或东部肿瘤协作组（ECOG）体能状态（PS）之间是否存在差异，以及年龄组或毒性发生情况是否会影响治疗结果。
CALGB 50303是一项针对既往未治疗的DLBCL患者的组间III期研究，R-CHOP是试验组之一。在该试验中235例可评估、看似健康且接受R-CHOP治疗的患者亚组中，收集并分析了按治疗组划分的3级及以上血液学和非血液学毒性发生情况的数据，以及方案治疗的完成情况、总缓解率（ORR）和生存结果参数，用于联盟A151930研究。
在243例可进行安全性评估的患者中，有235例患者的数据可供进一步分析，即那些在该试验中接受R-CHOP治疗的患者，其中165例年龄<65岁，70例年龄≥65岁。在控制疾病分期和体能状态后，老年组3级及以上非血液学（而非血液学）毒性的发生率有所增加（p<0.001）。与年龄<65岁的患者相比，年龄≥65岁的患者1年和3年总生存期（OS）较差；不同年龄组之间1年或3年无进展生存期（PFS）无差异。
R-CHOP标准一线疗法可有效地应用于老年组。我们发现老年患者有更多的3级及以上非血液学毒性，但血液学毒性无差异。这些数据可用于临床试验和实际临床环境，以识别有风险的DLBCL亚组，针对这些亚组可采取积极措施以确保治疗的完成和临床结果的优化。
美国国立医学图书馆临床试验注册中心标识符：NCT00118209（CALGB 50303）。
