• Annals of surgery · Jan 2022

    Clinical Trial

    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.

    • Takushi Yasuda, Kohei Nishiki, Yoko Hiraki, Hiroaki Kato, Mitsuru Iwama, Osamu Shiraishi, Atsushi Yasuda, Masayuki Shinkai, Yutaka Kimura, Yasushi Sukegawa, Yasutaka Chiba, Motohiro Imano, Kazuyoshi Takeda, Takao Satou, Hitoshi Shiozaki, and Yusuke Nakamura.
    • Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
    • Ann. Surg. 2022 Jan 1; 275 (1): e155e162e155-e162.

    ObjectivesTo 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 DataESCC 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.MethodsThis 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.ResultsThirty 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).ConclusionsOur cancer peptide vaccine might improve the survival of ESCC patients, which is warranted to be verified in the phase III randomized controlled study.Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.

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