Younes A, Hilden P, Coiffier B, Hagenbeek A, Salles G, Wilson W, Seymour J F, Kelly K, Gribben J, Pfreunschuh M, Morschhauser F, Schoder H, Zelenetz A D, Rademaker J, Advani R, Valente N, Fortpied C, Witzig T E, Sehn L H, Engert A, Fisher R I, Zinzani P-L, Federico M, Hutchings M, Bollard C, Trneny M, Elsayed Y A, Tobinai K, Abramson J S, Fowler N, Goy A, Smith M, Ansell S, Kuruvilla J, Dreyling M, Thieblemont C, Little R F, Aurer I, Van Oers M H J, Takeshita K, Gopal A, Rule S, de Vos S, Kloos I, Kaminski M S, Meignan M, Schwartz L H, Leonard J P, Schuster S J, Seshan V E
Lymphoma Service.
Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, USA.
Ann Oncol. 2017 Jul 1;28(7):1436-1447. doi: 10.1093/annonc/mdx097.
In recent years, the number of approved and investigational agents that can be safely administered for the treatment of lymphoma patients for a prolonged period of time has substantially increased. Many of these novel agents are evaluated in early-phase clinical trials in patients with a wide range of malignancies, including solid tumors and lymphoma. Furthermore, with the advances in genome sequencing, new "basket" clinical trial designs have emerged that select patients based on the presence of specific genetic alterations across different types of solid tumors and lymphoma. The standard response criteria currently in use for lymphoma are the Lugano Criteria which are based on [18F]2-fluoro-2-deoxy-D-glucose positron emission tomography or bidimensional tumor measurements on computerized tomography scans. These differ from the RECIST criteria used in solid tumors, which use unidimensional measurements. The RECIL group hypothesized that single-dimension measurement could be used to assess response to therapy in lymphoma patients, producing results similar to the standard criteria. We tested this hypothesis by analyzing 47 828 imaging measurements from 2983 individual adult and pediatric lymphoma patients enrolled on 10 multicenter clinical trials and developed new lymphoma response criteria (RECIL 2017). We demonstrate that assessment of tumor burden in lymphoma clinical trials can use the sum of longest diameters of a maximum of three target lesions. Furthermore, we introduced a new provisional category of a minor response. We also clarified response assessment in patients receiving novel immune therapy and targeted agents that generate unique imaging situations.
近年来，可安全用于长期治疗淋巴瘤患者的获批和研究性药物数量大幅增加。这些新型药物中的许多都在包括实体瘤和淋巴瘤在内的多种恶性肿瘤患者的早期临床试验中进行评估。此外，随着基因组测序技术的进步，出现了新的“篮子”临床试验设计，根据不同类型实体瘤和淋巴瘤中特定基因改变的存在情况来选择患者。目前用于淋巴瘤的标准反应标准是卢加诺标准，该标准基于[18F]2-氟-2-脱氧-D-葡萄糖正电子发射断层扫描或计算机断层扫描上的二维肿瘤测量。这些标准与实体瘤中使用的RECIST标准不同，后者采用一维测量。RECIL小组假设一维测量可用于评估淋巴瘤患者的治疗反应，产生与标准标准相似的结果。我们通过分析来自10项多中心临床试验的2983例成人和儿童淋巴瘤患者的47828次影像测量来检验这一假设，并制定了新的淋巴瘤反应标准（RECIL 2017）。我们证明，淋巴瘤临床试验中肿瘤负荷的评估可使用最多三个靶病灶最长直径之和。此外，我们引入了一个新的微小反应临时类别。我们还明确了接受新型免疫治疗和产生独特影像情况的靶向药物的患者的反应评估。
