Lamonica Dominick, Graf Daniel A, Munteanu Mihaela C, Czuczman Myron S
Departments of Medicine and Nuclear Medicine, Roswell Park Cancer Institute, Buffalo, New York
Nuclear Medicine Residency, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York.
J Nucl Med. 2017 Jan;58(1):62-68. doi: 10.2967/jnumed.116.173542. Epub 2016 Jul 28.
In a single-arm, phase 2 clinical trial, bendamustine-rituximab (BR) demonstrated an overall response rate of 82% among 45 patients with relapsed or refractory mantle cell lymphoma (MCL), with manageable tolerability. A prespecified F-FDG PET analysis was conducted to assess the predictive value of the metabolic response to BR compared with the response by International Working Group (IWG) criteria.
Adult patients with relapsed or refractory MCL underwent F-FDG PET at screening and after 6 cycles of BR therapy. Scans were reviewed by a central facility and scored using the 5-point Deauville scale, comparing uptake to the liver and mediastinum in up to 6 lesions, to determine metabolic response rates, indicated by negative posttreatment scans. Metabolic responses were compared with study outcomes assessed by IWG criteria.
Complete F-FDG PET data were available for 32 of 45 patients. All patients had positive baseline scans, with baseline scores ranging from 4 to 5. Complete metabolic responses (CMR) were observed in 24 (75%) patients after 6 cycles of BR. Patients attaining a CMR had a 96% overall response rate by IWG criteria, with 62.5% achieving a complete response. Of the 8 patients not attaining a CMR, 6 responded to BR but none achieved a complete response. CMR was associated with a greater 1-y progression-free survival of 91.5%, compared with 12.5% without CMR; a longer median duration of response of 20.6 mo, compared with 7.8 mo; and improved overall survival at 1 y. F-FDG PET data from patients with refractory or advanced disease demonstrated CMR in more than half.
Compared with positive end-of-treatment F-FDG PET, negative scans, indicating a CMR, were predictive of improved 1-y survival, duration of response, and overall survival for patients with relapsed or refractory MCL receiving BR.
在一项单臂2期临床试验中，苯达莫司汀-利妥昔单抗（BR）在45例复发或难治性套细胞淋巴瘤（MCL）患者中显示出82%的总缓解率，耐受性可控。进行了一项预先设定的F-FDG PET分析，以评估与国际工作组（IWG）标准相比，BR代谢反应的预测价值。
复发或难治性MCL成年患者在筛查时和接受6个周期BR治疗后接受F-FDG PET检查。扫描由中央机构进行评估，并使用5分的多维尔量表进行评分，将多达6个病灶的摄取情况与肝脏和纵隔进行比较，以确定代谢缓解率，以治疗后扫描为阴性表示。将代谢反应与IWG标准评估的研究结果进行比较。
45例患者中有32例可获得完整的F-FDG PET数据。所有患者基线扫描均为阳性，基线评分范围为4至5。在接受6个周期BR治疗后，24例（75%）患者观察到完全代谢缓解（CMR）。达到CMR的患者按IWG标准的总缓解率为96%，其中62.5%达到完全缓解。在未达到CMR的8例患者中，6例对BR有反应，但均未达到完全缓解。CMR与1年无进展生存率更高相关，为91.5%，而未达到CMR的患者为12.5%；中位缓解持续时间更长，为20.6个月，而未达到CMR的患者为7.8个月；1年总生存率有所提高。难治性或晚期疾病患者的F-FDG PET数据显示，超过一半的患者有CMR。
与治疗结束时F-FDG PET阳性相比，显示CMR的阴性扫描可预测接受BR治疗的复发或难治性MCL患者1年生存率、缓解持续时间和总生存率的改善。
