Bennedsen Tine Litske, Simonsen Mikkel Runason, Jensen Paw, Brown Peter, Josefsson Pär, Khurana Arushi, Maurer Matthew, Clausen Michael Roost, Dessau-Arp Andriette, Jørgensen Jennifer Bøgh, Jørgensen Judit, Larsen Thomas Stauffer, Pedersen Lars Møller, Jakobsen Lasse Hjort, El-Galaly Tarec Christoffer
Department of Hematology, Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark.
Department of Internal Medicine Thisted, Aalborg University Hospital, Thisted, Denmark.
Eur J Haematol. 2025 May;114(5):832-839. doi: 10.1111/ejh.14373. Epub 2025 Jan 9.
The development of new first-line treatments for patients with follicular lymphoma (FL) is becoming increasingly challenging due to already excellent survival outcomes. The present study investigated the outcomes of patients with FL who underwent contemporary first-line therapies but would not have been eligible for inclusion in recent trials and explored how commonly used in/exclusion criteria impacted their survival outcomes. This study included adult patients diagnosed with FL in the period 2000-2018 registered in the Danish Lymphoma Registry. Through searches on ClinicalTrials.gov, four recent 1st line phase 3 randomized controlled trials with R-Bendamustine, R-CVP, and/or R-CHOP as control or experimental arms were included. Inclusion and exclusion criteria for each trial were retrieved and categorized. Patients were then divided into trial-eligible and ineligible groups according to blood test results correlated to organ function and ECOG performance score (PS). Survival outcomes were significantly worse among trial-ineligible patients, with adjusted differences between trial-eligible and ineligible patients of 12%-20% in five-year overall survival (OS) overall. Inclusion criteria based on PS and renal function were the main drivers of OS differences. More inclusive trials will lead to faster recruitment and secure focus on developing medicines for the group of patients with the worst outcomes.
由于滤泡性淋巴瘤（FL）患者目前已取得出色的生存结果，开发新的一线治疗方法正变得越来越具有挑战性。本研究调查了接受当代一线治疗但不符合近期试验纳入标准的FL患者的结局，并探讨了常用的纳入/排除标准如何影响其生存结局。本研究纳入了2000年至2018年期间在丹麦淋巴瘤登记处登记的成年FL患者。通过在ClinicalTrials.gov上搜索，纳入了四项近期的一线3期随机对照试验，这些试验以R-苯达莫司汀、R-CVP和/或R-CHOP作为对照或试验组。检索并分类了每个试验的纳入和排除标准。然后根据与器官功能和东部肿瘤协作组体能状态评分（PS）相关的血液检测结果，将患者分为符合试验标准组和不符合试验标准组。不符合试验标准的患者生存结局明显较差，符合试验标准和不符合试验标准的患者在五年总生存期（OS）方面的调整差异总体为12%-20%。基于PS和肾功能的纳入标准是OS差异的主要驱动因素。包容性更强的试验将加快招募速度，并确保专注于为结局最差的患者群体开发药物。
