THE ASSOCIATION OF SOCIAL DISADVANTAGE WITH OUTCOMES IN PATIENTS WITH ADVANCED-STAGE, CLASSIC HODGKIN LYMPHOMA ENROLLED IN THE PHASE 3 INTERGROUP TRIAL S1826

IF 3.3 4区 医学 Q2 HEMATOLOGY
J. M. Kahn, J. M. Unger, H. Li, S. M. Castellino, H. Dillon, T. Hernandez, S. C. Rutherford, A. Punnett, M. LeBlanc, J. Y. Song, S. M. Smith, A. M. Evens, K. M. Kelly, J. W. Friedberg, A. Herrera
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Herrera equally contributing author.</p><p><b>Background</b>: The phase 3 randomized trial S1826 showed that among patients with advanced-stage classic Hodgkin lymphoma (cHL), nivolumab plus doxorubicin, vinblastine, and dacarbazine (N+AVD) resulted in longer progression-free survival (PFS) compared to brentuximab vedotin plus AVD (BV+AVD). We assessed whether the treatment benefits of N+AVD applied to potentially socioeconomically vulnerable populations.</p><p><b>Methods:</b> S1826 was a multicenter trial for patients ≥ 12 years old with stage III or IV newly diagnosed cHL. The trial was stopped early at its pre-specified second interim analysis due to efficacy of the N+AVD arm (hazard ratio [HR] for progression or death, 0.48; 95% confidence interval [CI], 0.27–0.87, <i>p</i> = 0.001). We assessed whether there was any evidence of differential benefit of N+AVD with respect to PFS according to categories of race/ethnicity (Black race and/or Hispanic ethnicity vs. others), rural versus urban residence, area-level socioeconomic deprivation (Area Deprivation Index [ADI] above median, yes vs. no), and insurance status (Medicaid or no insurance vs. others) using interaction tests. Analyses were conducted using Cox regression adjusting for the study-specified stratification variables including age (12 –17 vs. 18–60 vs. &gt; 60 years), the international prognostic score (IPS; 0–3 vs. 4–7), and intent to use radiation (yes vs. no). An overall Type I error rate of alpha = 0.10 was used; multiplicity was accounted for by specifying each individual test at the two-sided alpha = 0.025 level using Bonferroni. 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Overall survival analyses are ongoing.</p><p><b>Research</b> <b>funding declaration:</b> National Cancer Institute of the National Institutes of Health U10CA180888, U10CA180819; in part by BMS; Emmet &amp; Toni Stephenson Leukemia Lymphoma Society (LLS) Scholar Award; LRF Larry &amp; Denise Mason Clinical Scholar Career Development Award; V Foundation Lloyd Family Clinical Investigator Fund; LLS Clinical Research Scholar Award.</p><p><b>Keywords:</b> cancer health disparities</p><p>No potential sources of conflict of interest.</p>","PeriodicalId":12882,"journal":{"name":"Hematological Oncology","volume":"43 S3","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/hon.70094_368","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hematological Oncology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/hon.70094_368","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

J. M. Unger, H. Li, S. M. Castellino, H. Dillon, T. Hernandez, S. C. Rutherford, A. Punnett, M. LeBlanc, J. Y. Song, S. M. Smith, A. M. Evens, K. M. Kelly, J. W. Friedberg, and A. Herrera equally contributing author.

Background: The phase 3 randomized trial S1826 showed that among patients with advanced-stage classic Hodgkin lymphoma (cHL), nivolumab plus doxorubicin, vinblastine, and dacarbazine (N+AVD) resulted in longer progression-free survival (PFS) compared to brentuximab vedotin plus AVD (BV+AVD). We assessed whether the treatment benefits of N+AVD applied to potentially socioeconomically vulnerable populations.

Methods: S1826 was a multicenter trial for patients ≥ 12 years old with stage III or IV newly diagnosed cHL. The trial was stopped early at its pre-specified second interim analysis due to efficacy of the N+AVD arm (hazard ratio [HR] for progression or death, 0.48; 95% confidence interval [CI], 0.27–0.87, p = 0.001). We assessed whether there was any evidence of differential benefit of N+AVD with respect to PFS according to categories of race/ethnicity (Black race and/or Hispanic ethnicity vs. others), rural versus urban residence, area-level socioeconomic deprivation (Area Deprivation Index [ADI] above median, yes vs. no), and insurance status (Medicaid or no insurance vs. others) using interaction tests. Analyses were conducted using Cox regression adjusting for the study-specified stratification variables including age (12 –17 vs. 18–60 vs. > 60 years), the international prognostic score (IPS; 0–3 vs. 4–7), and intent to use radiation (yes vs. no). An overall Type I error rate of alpha = 0.10 was used; multiplicity was accounted for by specifying each individual test at the two-sided alpha = 0.025 level using Bonferroni. If no interaction was found, the marginal association of socioeconomic variables and PFS using multivariable Cox regression was examined.

Results: Of N = 970 eligible patients, 90% were < 60 years, and 56% were male; 11.8% were Black, 12.7% were Hispanic, and 32% had IPS 4–7. Among socioeconomic variables, the combined Black and/or Hispanic patients comprised 24.5%, 13.3% were from rural areas, 50% lived in areas above the median ADI level, and 23.2% had Medicaid or no insurance. In survival analyses, there was no statistically significant evidence that the effect of treatment on PFS differed between levels of the socioeconomic variables (Table). For instance, the PFS HR was 0.52 for Black and/or Hispanic patients and 0.41 for other patients (interaction p-value = 0.60). Across all patients, there was no statistically significant association of Black and/or Hispanic race/ethnicity (HR = 1.10, 95% CI: 0.72–1.69, p = 0.65), rural geography (HR = 1.11, 95% CI: 0.67–1.85, p = 0.67), high ADI (HR = 1.30, 95% CI: 0.89–1.88, p = 0.17), or Medicaid/no insurance (HR = 1.01, 95% CI: 0.63–1.60, p = 0.98) with PFS.

Conclusion: Among patients with advanced stage cHL enrolled on S1826, we found no evidence that the PFS benefit of N+AVD compared to BV+AVD was meaningfully attenuated by factors representing social disadvantage. This suggests widespread applicability of N+AVD for patients of different socioeconomic backgrounds. Overall survival analyses are ongoing.

Research funding declaration: National Cancer Institute of the National Institutes of Health U10CA180888, U10CA180819; in part by BMS; Emmet & Toni Stephenson Leukemia Lymphoma Society (LLS) Scholar Award; LRF Larry & Denise Mason Clinical Scholar Career Development Award; V Foundation Lloyd Family Clinical Investigator Fund; LLS Clinical Research Scholar Award.

Keywords: cancer health disparities

No potential sources of conflict of interest.

Abstract Image

参加3期组间试验的晚期经典霍奇金淋巴瘤患者的社会劣势与预后的关系[1826]
J. M.昂格,H.李,S. M.卡斯特利诺,H.狄龙,T.埃尔南德斯,S. C.卢瑟福,A.庞尼特,M. LeBlanc, J. Y.宋,S. M.史密斯,A. M.埃文斯,K. M.凯利,J. W.弗里德伯格和A.埃雷拉都是同样贡献的作者。背景:3期随机试验S1826显示,在晚期经典霍奇金淋巴瘤(cHL)患者中,纳武单抗联合阿霉素、长春花碱和达卡巴嗪(N+AVD)比布伦妥昔单抗联合AVD (BV+AVD)可获得更长的无进展生存期(PFS)。我们评估了N+AVD的治疗益处是否适用于潜在的社会经济弱势群体。方法:S1826是一项针对≥12岁的III期或IV期新诊断cHL患者的多中心试验。由于N+AVD组的疗效,该试验在预先指定的第二次中期分析中提前停止(进展或死亡的风险比[HR]为0.48;95%可信区间[CI], 0.27-0.87, p = 0.001)。根据种族/民族(黑人和/或西班牙裔与其他种族)、农村与城市居住、区域层面的社会经济剥夺(区域剥夺指数高于中位数,是与否)和保险状况(医疗补助或无保险与其他),我们使用相互作用测试评估了是否有任何证据表明N+AVD对PFS有不同的益处。使用Cox回归对研究指定的分层变量进行分析,包括年龄(12 -17岁vs. 18-60岁vs. >;60岁),国际预后评分(IPS;0-3 vs. 4-7),以及使用辐射的意图(是vs.否)。总体I型错误率为alpha = 0.10;多重性是通过使用Bonferroni在双侧alpha = 0.025水平上指定每个个体检验来解释的。如果没有发现相互作用,则使用多变量Cox回归检查社会经济变量与PFS的边际关联。结果:在970例符合条件的患者中,90%为<;60岁,男性占56%;11.8%为黑人,12.7%为西班牙裔,32%为IPS 4-7。在社会经济变量中,黑人和/或西班牙裔患者占24.5%,13.3%来自农村地区,50%生活在高于ADI中位数水平的地区,23.2%有医疗补助或没有保险。在生存分析中,没有统计学上显著的证据表明治疗对PFS的影响在不同的社会经济变量水平之间存在差异(表)。例如,黑人和/或西班牙裔患者的PFS HR为0.52,其他患者为0.41(相互作用p值= 0.60)。在所有患者中,黑人和/或西班牙裔人种/民族(HR = 1.10, 95% CI: 0.72-1.69, p = 0.65)、农村地理(HR = 1.11, 95% CI: 0.67 - 1.85, p = 0.67)、高ADI (HR = 1.30, 95% CI: 0.89-1.88, p = 0.17)或医疗补助/无保险(HR = 1.01, 95% CI: 0.63-1.60, p = 0.98)与PFS没有统计学意义的关联。结论:在S1826纳入的晚期cHL患者中,我们没有发现证据表明,与BV+AVD相比,N+AVD的PFS获益会因社会不利因素而显著减弱。这表明N+AVD广泛适用于不同社会经济背景的患者。总体生存分析正在进行中。科研经费声明:美国国立卫生研究院国家癌症研究所U10CA180888、U10CA180819;部分由BMS实现;埃米特,托尼斯蒂芬森白血病淋巴瘤学会(LLS)学者奖;拉里&;丹尼斯·梅森临床学者职业发展奖;V基金会劳埃德家庭临床研究者基金;LLS临床研究学者奖。关键词:癌症健康差异无潜在利益冲突来源
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来源期刊
Hematological Oncology
Hematological Oncology 医学-血液学
CiteScore
4.20
自引率
6.10%
发文量
147
审稿时长
>12 weeks
期刊介绍: Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
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