Phase II Adjuvant Cancer-specific Vaccine Therapy for Esophageal Cancer Patients Curatively Resected After Preoperative Therapy With Pathologically Positive Nodes; Possible Significance of Tumor Immune Microenvironment in its Clinical Effects
Phase II Adjuvant Cancer-specific Vaccine Therapy for Esophageal Cancer Patients Curatively Resected After Preoperative Therapy With Pathologically Positive Nodes; Possible Significance of Tumor Immune Microenvironment in its Clinical Effects
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针对术前治疗后病理阳性淋巴结的食管癌患者进行二期癌症特异性疫苗辅助治疗；
DOI：
10.1097/sla.0000000000003880
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发表时间：
2020
影响因子：
9
通讯作者：
Yusuke Nakamura
中科院分区：
文献类型：
--
作者：
T. Yasuda;K. Nishiki;Yoko Hiraki;H. Kato;Mitsuru Iwama;O. Shiraishi;A. Yasuda;M. Shinkai;Y. Kimura;Y. Sukegawa;Y. Chiba;M. Imano;K. Takeda;T. Satou;H. Shiozaki;Yusuke Nakamura
补充数字内容可在文本中获得目标：阐明使用3种人类白细胞抗原（HLA）-A β 24限制性肿瘤特异性肽抗原的辅助疫苗单药治疗ESCC的疗效，上调肺癌10，细胞分裂周期相关1和癌症中过表达的含KH结构域蛋白1。背景数据总结：病理学阳性淋巴结（pN（+））的ESCC患者术后复发的风险很高，尽管术前治疗后进行了根治性切除。亚临床微转移是癌症疫苗的合适靶点。方法：这是一项非随机前瞻性II期临床试验（UMIN 000003557）。根据HLA-A状态，将pN（+）术前治疗后治愈切除的ESCC患者分为对照组和疫苗组（CG和VG）。术后每周10次，随后每两周10次向VG注射三种表位肽中的每一种1 mg。主要和次要终点分别为无复发生存期（RFS）和食管癌特异性生存期（ECSS）。结果：CG组30例，VG组33例。CG组和VG组的RFS无显著差异（5年RFS：32.5% vs 45.3%），但复发率随诱导抗原特异性细胞毒性T淋巴细胞的肽的数量而显著降低。VG组的5年ECSS显著高于CG组（60.0% vs 32.4%，P = 0.045），并且这种差异在CD 8+和程序性死亡配体1双阴性肿瘤患者中更为显著（68.0% vs 17.7%，P = 0.010）。结论：我们的癌肽疫苗可能会提高ESCC患者的生存率，这需要在III期随机对照研究中进行验证。
Supplemental Digital Content is available in the text Objectives: To elucidate the efficacy of adjuvant vaccine monotherapy using 3 Human Leukocyte Antigen (HLA)-A∗24-restricted tumor-specific peptide antigens for ESCC, upregulated lung cancer 10, cell division cycle associated 1, and KH domain-containing protein overexpressed in cancer 1. Summary of Background Data: ESCC patients with pathologically positive nodes (pN(+)) have a high risk for postoperative recurrence, despite curative resection after preoperative therapy. Subclinical micrometastases are an appropriate target for cancer vaccine. Methods: This is a non-randomized prospective phase II clinical trial (UMIN000003557). ESCC patients curatively resected after preoperative therapy with pN(+) were allocated into the control and vaccine groups (CG and VG) according to the HLA-A status. One mg each of three epitope peptides was postoperatively injected 10 times weekly followed by 10 times biweekly to the VG. The primary and secondary endpoints were relapse-free survival (RFS) and esophageal cancer-specific survival (ECSS), respectively. Results: Thirty were in the CG and 33 in the VG. No significant difference was observed in RFS between the CG and VG (5-year RFS: 32.5% vs 45.3%), but the recurrence rate significantly decreased with the number of peptides which induced antigen-specific cytotoxic T lymphocytes. The VG showed a significantly higher 5-year ECSS than the CG (60.0% vs 32.4%, P = 0.045) and this difference was more prominent in patients with CD8+ and programmed death-ligand 1 double negative tumor (68.0% vs 17.7%, P = 0.010). Conclusions: Our cancer peptide vaccine might improve the survival of ESCC patients, which is warranted to be verified in the phase III randomized controlled study.
影响因子：
11.2
作者：
Teng MW;Ngiow SF;Ribas A;Smyth MJ
通讯作者：
Smyth MJ