Marzolini Maria A V, Qian Wendi, Clifton-Hadley Laura, Patrick Pip, Warden June, Stevens Lindsey, Pocock Christopher F E, Miall Fiona, Cunningham David, Stephens Richard, Walewski Jan, Johnston Amanda, Seymour John F, Linch David C, Ardeshna Kirit M
Department of Haematology, University College London Hospital, London, UK.
Cambridge Clinical Trials Unit, Cambridge, UK.
Br J Haematol. 2025 Mar;206(3):876-886. doi: 10.1111/bjh.19918. Epub 2024 Nov 27.
Traditionally, patients with asymptomatic, advanced-stage follicular lymphoma were managed with a watchful-waiting approach until disease progression. The 'Watch and Wait' Phase-3 randomised international trial examined whether rituximab could delay the need for treatment and the effect on quality of life (QoL). In this article, we present the long-term results of the QoL aspect of the trial. Patients were randomised to watchful-waiting (Arm A), rituximab induction (Arm B) or rituximab induction followed by maintenance (Arm C). We present the QoL outcomes from 180 patients (Arm A), 188 patients (Arm C) and an exploratory analysis of 82 (Arm B) compared to 81 and 84 patients concurrently randomised to arms A and C. Arm C reported greater improvement in emotional well-being overtime (Month 37, p = 0.0078) and were significantly more likely to feel in control of their situation than watchful-waiting patients (Month 25, p = 0.0004; Month 37, p = 0.0476). Watchful-waiting patients were significantly more likely to avoid thinking about their illness, did not find learning about their illness helped them and were more likely to attach unpleasant connotations to clinic visits (Month 7, p = 0.0032; Month 13, p = 0.0015; Month 25, p = 0.0104). These results demonstrate improved QoL scores in the induction and maintenance rituximab arm, indicating that rituximab was not detrimental to QoL and resulted in an improved QoL in some domains.
传统上,无症状的晚期滤泡性淋巴瘤患者采用观察等待的方法,直至疾病进展。“观察与等待”3期随机国际试验研究了利妥昔单抗是否能延迟治疗需求以及对生活质量(QoL)的影响。在本文中,我们展示了该试验生活质量方面的长期结果。患者被随机分为观察等待组(A组)、利妥昔单抗诱导组(B组)或利妥昔单抗诱导后维持组(C组)。我们展示了180例患者(A组)、188例患者(C组)的生活质量结果,并对82例患者(B组)进行了探索性分析,同时与分别随机分配到A组和C组的81例和84例患者进行比较。C组报告随着时间推移情绪幸福感有更大改善(第37个月,p = 0.0078),并且比观察等待组患者更有可能显著感觉能够掌控自己的状况(第25个月,p = 0.0004;第37个月,p = 0.0476)。观察等待组患者显著更有可能避免思考自己的疾病,认为了解自己的疾病对他们没有帮助,并且更有可能将不愉快的含义与门诊就诊联系起来(第7个月,p = 0.0032;第1个月,p = 0.0015;第25个月,p = 0.0104)。这些结果表明,诱导和维持使用利妥昔单抗组的生活质量得分有所提高,这表明利妥昔单抗对生活质量没有不利影响,并且在某些领域改善了生活质量。