89锆标记西妥昔单抗的正电子发射断层显像（PET）：一项针对头颈癌和肺癌患者的I期试验。
PET imaging of zirconium-89 labelled cetuximab: A phase I trial in patients with head and neck and lung cancer.
作者信息
van Loon Judith, Even Aniek J G, Aerts Hugo J W L, Öllers Michel, Hoebers Frank, van Elmpt Wouter, Dubois Ludwig, Dingemans Anne-Marie C, Lalisang Roy I, Kempers Pascal, Brans Boudewijn, Winnepenninckx Véronique, Speel Ernst-Jan, Thunnissen Eric, Smits Kim M, Boellaard Ronald, Vugts Danielle J, De Ruysscher Dirk, Lambin Philippe
机构信息
Department of Radiation Oncology (MAASTRO), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands.
Department of Radiation Oncology (MAASTRO), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, The Netherlands.
出版信息
Radiother Oncol. 2017 Feb;122(2):267-273. doi: 10.1016/j.radonc.2016.11.020. Epub 2016 Dec 21.
BACKGROUND AND PURPOSE
PET imaging of cetuximab uptake may help selecting cancer patients with the highest chance of benefit. The aim of this phase I trial was to determine the safety of the tracer Zr-cetuximab and to assess tumour uptake.
METHODS
Two dose schedules were used; two consecutive doses of 60MBq Zr-cetuximab or a single dose of 120MBq, both preceded by 400mg/m of unlabelled cetuximab. Toxicity (CTCAE 3.0) was scored twice weekly. PET-CT scans were acquired on days 4, 5 and 6 (step 1) or 5, 6, 7 (step 2). Because tumour uptake could not be assessed satisfactorily, a third step was added including EGFR overexpressing tumours.
RESULTS
Nine patients were included (6 NSCLC; 3 HNC). No additional toxicity was associated with administration of Zr-cetuximab compared to standard cetuximab. A tumour to blood ratio (TBR)>1 was observed in all but one patient, with a maximum of 4.56. TBR was not different between dose schedules. There was a trend for higher TBR at intervals>5days after injection.
CONCLUSIONS
Both presented Zr-cetuximab administration schedules are safe. The recommended dose for future trials is 60MBq, with a minimum time interval for scanning of 6days.
背景与目的
西妥昔单抗摄取的PET成像可能有助于挑选出最有可能从治疗中获益的癌症患者。这项I期试验的目的是确定示踪剂Zr-西妥昔单抗的安全性并评估肿瘤摄取情况。
方法
采用了两种给药方案；连续两次给予60MBq的Zr-西妥昔单抗或单次给予120MBq，两种方案均在给予400mg/m²未标记的西妥昔单抗之后进行。毒性（采用CTCAE 3.0标准）每周评估两次。在第4、5和6天（步骤1）或第5、6、7天（步骤2）进行PET-CT扫描。由于无法令人满意地评估肿瘤摄取情况，因此增加了第三步，纳入表皮生长因子受体（EGFR）过表达的肿瘤。
结果
纳入了9例患者（6例非小细胞肺癌；3例头颈部癌）。与标准西妥昔单抗相比，给予Zr-西妥昔单抗未出现额外的毒性。除1例患者外，所有患者的肿瘤与血液比值（TBR）均>1，最高达4.56。两种给药方案的TBR无差异。注射后间隔>5天时有TBR升高的趋势。
结论
所呈现的两种Zr-西妥昔单抗给药方案均安全。未来试验的推荐剂量为60MBq，扫描的最短时间间隔为6天。
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