新型新辅助免疫治疗方案在头颈部鳞状细胞癌中的安全性和生存获益。
Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer.
机构信息
Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.
出版信息
Head Neck. 2011 Dec;33(12):1666-74. doi: 10.1002/hed.21660. Epub 2011 Jan 31.
BACKGROUND
Cellular immune suppression is observed in head and neck squamous cell cancer (HNSCC) and contributes to poor prognosis. Restoration of immune homeostasis may require primary cell-derived cytokines at physiologic doses. An immunotherapy regimen containing a biologic, with multiple-active cytokine components, and administered with cytoxan, zinc, and indomethacin was developed to modulate cellular immunity.
METHODS
Study methods were designed to determine the safety and efficacy of a 21-day neoadjuvant immunotherapy regimen in a phase 2 trial that enrolled 27 therapy-naïve patients with stage II to IVa HNSCC. Methods included safety, clinical and radiologic tumor response, disease-free survival (DFS), overall survival (OS), and tumor lymphocytic infiltrate (LI) data collection.
RESULTS
Acute toxicity was minimal. Patients completed neoadjuvant treatment without surgical delay. By independent radiographic review, 83% had stable disease during treatment. OS was 92%, 73%, and 69% at 12, 24, and 36 months, respectively. Histologic analysis suggested correlation between survival and tumor LI.
CONCLUSION
Immunotherapy regimen was tolerated. Survival results are encouraging.
背景
头颈部鳞状细胞癌（HNSCC）存在细胞免疫抑制，这与预后不良有关。恢复免疫稳态可能需要生理剂量的原代细胞衍生细胞因子。本研究开发了一种免疫治疗方案，其中包含一种生物制剂，具有多种活性细胞因子成分，并与环磷酰胺、锌和吲哚美辛联合使用，以调节细胞免疫。
方法
该研究方法旨在确定 27 例未经治疗的 II 期至 IVa 期 HNSCC 患者接受 21 天新辅助免疫治疗方案的安全性和有效性。方法包括安全性、临床和影像学肿瘤反应、无病生存（DFS）、总生存（OS）和肿瘤淋巴细胞浸润（LI）数据收集。
结果
急性毒性极小。患者在无手术延迟的情况下完成了新辅助治疗。通过独立的影像学评估，83%的患者在治疗期间疾病稳定。12、24 和 36 个月的 OS 分别为 92%、73%和 69%。组织学分析表明，生存与肿瘤 LI 之间存在相关性。
结论
免疫治疗方案可耐受。生存结果令人鼓舞。
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