V.G. Espeli , A. Gomez , P. Balermpas , G. Treglia , A. Stathis
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引用次数: 0
摘要
我们对 2008 年 1 月 1 日至 2023 年 8 月 31 日期间发表的专门针对头颈部鳞状细胞癌患者的 I 期试验进行了系统性回顾。我们使用以下术语组合检索了 PubMed 和 Cochrane Library 数据库："（（头颈部）或（头颈部）） AND （（癌症*）或（肿瘤*）或（肿瘤*）或（肿瘤*）或（癌*）或（癌*）或（恶性*）)AND ((phase 1) OR (phase I)) "以确定包括大多数淋巴瘤患者在内的 I 期剂量试验。其中，53项试验符合纳入/排除标准并被纳入本次分析：32项试验（60%）只纳入了头颈部癌症患者，21项试验（40%）也纳入了其他实体瘤患者。在临床活动方面，反应率（RR）的中位数为16%，与通常报告的未选择实体瘤患者群体的I期试验反应率一致。
A systematic review of contemporary phase I trials in patients with recurrent/metastatic head and neck cancer
We performed a systematic review of phase I trials specifically conducted for patients with head and neck squamous cell carcinoma published between January 1, 2008 and August 31, 2023. PubMed and Cochrane Library databases were searched using a combination of terms: “((head and neck) OR (head & neck)) AND ((cancer*) OR (tumor*) OR (tumour*) OR (neoplasm*) OR (carcinoma*) OR (malignan*)) AND ((phase 1) OR (phase I))"to identify phase I dose-finding trials including a majority of lymphoma patients.
Eighty-five trials (H&N patients N = 1714) were included. Among them, 53 trials complying with inclusion/exclusion criteria and were included in the current analysis: 32 (60 %) enrolled only patients with head and neck cancer, while 21 (40 %) included also patients with other solid tumors.
The median rate of grade 3-4 adverse events was 41 %. With regards to clinical activity, the median response rate (RR) was 16 %, which is in line with the usually reported rate for phase I trials enrolling unselected populations of patients with solid tumors.
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