Amyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, and.
Department of Molecular Medicine, University of Pavia, Pavia, Italy; and.
Blood. 2018 Feb 1;131(5):525-532. doi: 10.1182/blood-2017-04-780544. Epub 2017 Nov 3.
The management of light chain (AL) amyloidosis has improved in recent years thanks to accurate biomarker-based staging systems and response criteria and availability of novel effective therapies. However, previous studies have focused on newly diagnosed patients, and little is known on relapsed patients, despite the fact that trials of new agents are often performed in this setting. In the present study, we report the outcome of 259 patients who responded to up-front therapy. Ninety-two patients (35%) needed second-line therapy after a median of 49 months. Cardiac and renal progression were observed in 22% and 12% of patients who received second-line therapy, respectively. Complete response after up-front treatment and frontline therapy with combined bortezomib, melphalan, and dexamethasone independently prolonged time to second-line therapy. Median survival of relapsing patients was 59 months. Patients who had a "high-risk dFLC progression," which we defined as a difference between involved and uninvolved free light chains (dFLC) of >20 mg/L, a level >20% of baseline value, and a >50% increase from the value reached at best response, had a shorter survival after initiation of second-line therapy on univariate, but not on multivariate, analysis, where cardiac progression was the only independent predictor of survival after starting rescue treatment. Patients with AL amyloidosis who need second-line therapy after response to up-front treatment generally have a good outcome. A "high-risk dFLC progression" should trigger rescue treatment, and cardiac progression should not be awaited.
近年来,由于准确的基于生物标志物的分期系统和反应标准以及新型有效治疗方法的出现,轻链(AL)淀粉样变性的治疗得到了改善。然而,以前的研究主要集中在新诊断的患者身上,对于复发患者知之甚少,尽管新药物的试验通常在这种情况下进行。在本研究中,我们报告了 259 例对一线治疗有反应的患者的结果。92 例患者(35%)在中位数为 49 个月后需要二线治疗。在接受二线治疗的患者中,分别有 22%和 12%的患者出现心脏和肾脏进展。一线治疗后完全缓解和一线联合硼替佐米、美法仑和地塞米松治疗可独立延长二线治疗时间。复发患者的中位生存时间为 59 个月。我们将“高危 dFLC 进展”定义为受累游离轻链(dFLC)与未受累游离轻链之间的差异>20mg/L、基线值的>20%和与最佳反应时达到的水平相比增加>50%的患者,在单变量分析中,二线治疗开始后生存时间较短,但在多变量分析中,心脏进展是开始挽救治疗后生存的唯一独立预测因素。对一线治疗有反应后需要二线治疗的 AL 淀粉样变性患者通常有较好的预后。“高危 dFLC 进展”应引发挽救治疗,不应等待心脏进展。