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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.

Authors :
Yasuda T
Nishiki K
Hiraki Y
Kato H
Iwama M
Shiraishi O
Yasuda A
Shinkai M
Kimura Y
Sukegawa Y
Chiba Y
Imano M
Takeda K
Satou T
Shiozaki H
Nakamura Y
Source :
Annals of surgery [Ann Surg] 2022 Jan 01; Vol. 275 (1), pp. e155-e162.
Publication Year :
2022

Abstract

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.<br />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.<br />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.<br />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).<br />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.<br />Competing Interests: The authors report no conflicts of interest.<br /> (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Details

Language :
English
ISSN :
1528-1140
Volume :
275
Issue :
1
Database :
MEDLINE
Journal :
Annals of surgery
Publication Type :
Academic Journal
Accession number :
33055588
Full Text :
https://doi.org/10.1097/SLA.0000000000003880