Hess Georg, Rule Simon, Jurczak Wojciech, Jerkeman Mats, Santucci Silva Rodrigo, Rusconi Chiara, Caballero Dolores, Joao Cristina, Witzens-Harig Mathias, Bence-Bruckler Isabelle, Cho Seok-Goo, Zhou Wenjiong, Goldberg Jenna D, Trambitas Cristina, Enny Christopher, Vermeulen Jessica, Traina Shana, Chiou Chiun-Fang, Diels Joris, Dreyling Martin
a Department of Hematology, Oncology and Pneumology , University Medical School of the Johannes Gutenberg University , Mainz , Germany.
b Derriford Hospital, Plymouth University Medical School , Plymouth , UK.
Leuk Lymphoma. 2017 Dec;58(12):2824-2832. doi: 10.1080/10428194.2017.1326034. Epub 2017 May 30.
Mantle cell lymphoma (MCL) is a rare, aggressive, incurable B-cell malignancy. Ibrutinib has been shown to be highly active for patients with relapsed/refractory (R/R) MCL. The RAY trial (MCL3001) was a phase 3, randomized, open-label, multicenter study that compared ibrutinib with temsirolimus in patients with R/R MCL. Active disease is frequently associated with impaired functional status and reduced well-being. Therefore, the current study employed two patient-reported outcome instruments, the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and the EQ-5D-5L, to assess symptoms, well-being, health status, and health-related quality of life of patients on treatment within the RAY trial. We found that patients on ibrutinib had substantial improvement in FACT-Lym subscale and total scores, and had improvement in EQ-5D-5L utility and VAS scores compared with temsirolimus patients, indicating a superior well-being. These improvements in well-being correlated with clinical response, indicating that better health-related quality of life was associated with decreased disease burden.
套细胞淋巴瘤（MCL）是一种罕见的、侵袭性的、无法治愈的B细胞恶性肿瘤。依鲁替尼已被证明对复发/难治性（R/R）MCL患者具有高度活性。RAY试验（MCL3001）是一项3期、随机、开放标签、多中心研究，比较了依鲁替尼与替西罗莫司在R/R MCL患者中的疗效。活动性疾病常与功能状态受损和幸福感降低相关。因此，本研究采用了两种患者报告结局工具，即癌症治疗-淋巴瘤功能评估（FACT-Lym）和EQ-5D-5L，以评估RAY试验中接受治疗的患者的症状、幸福感、健康状况以及与健康相关的生活质量。我们发现，与替西罗莫司治疗的患者相比，接受依鲁替尼治疗的患者在FACT-Lym子量表和总分上有显著改善，在EQ-5D-5L效用和视觉模拟量表（VAS）评分上也有所改善，表明其幸福感更高。这些幸福感的改善与临床反应相关，表明更好的与健康相关的生活质量与疾病负担减轻有关。
