Abstract 1631
Background
Since PD-1/PD-L1 blockade has displayed clinical efficacy in esophageal cancer patients, an immunological therapeutic approach such as a cancer vaccine will be realistic in clinics. NY-ESO-1, one of cancer-testis antigens, is expressed in approximately 30% esophageal squamous cell carcinoma (ESCC). Cholesteryl pullulan (CHP) is an antigen delivery system to antigen-presenting cells including macrophages. The complex of CHP and NY-ESO-1 protein (CHP-NY-ESO-1) is a vaccine that activates CD4+ and CD8+ T cells. We aimed to evaluate clinical efficacy of the CHP-NY-ESO-1 for esophageal cancer patients after radical surgery in a randomized phase II trial.
Methods
54 NY-ESO-1-expressing ESCC patients who underwent radical surgery following neoadjuvant chemotherapy of cisplatin/5-FU were randomized to two arms, CHP-NY-ESO-1 vaccine and observation as a control arm. The vaccine was composed of 200 mg full-length NY-ESO-1 protein, which was subcutaneously given 15 doses with 2 or 4-week interval for 12 months. Primary endpoints were disease-free survival (DFS) and safety. Secondary endpoints were immune-responses and overall survival (OS). 49 patients were evaluated for DFS and OS.
Results
DFS in 2 years are 56.0% and 58.3% in the vaccine arm and in the control. OS in 2 years are 76.0% and 79.2%, respectively. No differences were seen between the vaccine and the control group. Subgroup analysis demonstrated that T-bet+ CD8+ T cell infiltration was significantly correlated to DFS and that PD-L1-expression in tumors showed unfavorable tendency for the vaccine group. Exploratory analysis of intra-cohort correlations among the vaccinated patients revealed that 5% or more expression of NY-ESO-1 and high polymeric immunoglobulin receptor (PIGR)-gene expression in tumors were favorable factors.
Conclusions
The clinical trial revealed that CHP-NY-ESO-1 vaccine alone did not display clinical efficacy compared to the control. It suggested that CHP-NY-ESO-1 vaccine would be indicated to > 5% NY-ESO-1 and/or high PIGR gene-expressing esophageal tumors that are infiltrated with activated T cells.
Clinical trial identification
UMIN000007905.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Japan Agency for Medical Research and Development.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3047 - Health-related quality of life in Greek haematogical malignancies patients undergoing chemotherapy
Presenter: Maria Lavdaniti
Session: Poster Display session 3
Resources:
Abstract
1121 - Experiences of endocrine therapy after breast cancer surgery
Presenter: Susanne Ahlstedt Karlsson
Session: Poster Display session 3
Resources:
Abstract
2305 - The effects of progressive muscle relaxation and mindfulness meditation on fatigue, coping styles, and quality of life in breast cancer patients receiving adjuvant paclitaxel regimen: An-assessor blinded, three-arm randomized controlled trial
Presenter: Zehra Gok Metin
Session: Poster Display session 3
Resources:
Abstract
4561 - Agreement between breast cancer patients and oncologists on the severity of patients’ symptoms and functions during a one-year follow-up after treatment.
Presenter: Randi Reidunsdatter
Session: Poster Display session 3
Resources:
Abstract
1768 - Taste Changes and Associated Factors in Patients Receiving Chemotherapy
Presenter: Gulcan Bagcivan
Session: Poster Display session 3
Resources:
Abstract
1830 - CART-19: a comparative between literature versus experience
Presenter: Cassandra Andersson Vila
Session: Poster Display session 3
Resources:
Abstract
4027 - Unplanned emergency department use by people receiving ambulatory anti-cancer agents with potential febrile neutropenia
Presenter: Meritxell Casanovas-Blanco
Session: Poster Display session 3
Resources:
Abstract
4754 - Examining the benefits of medical exercise during radiotherapy in patients after mastectomy
Presenter: Nikolina Dodlek
Session: Poster Display session 3
Resources:
Abstract
2510 - Assessment Quality of Life with Hand-Foot Syndrome Induced by Apatinib Combined with Anti-PD-1 Therapy in NSCLC
Presenter: Qi Jiang
Session: Poster Display session 3
Resources:
Abstract
2989 - Adverse effects of chemotherapy influence the patients’ quality of life : Analysis of implicated factors
Presenter: Maria Lavdaniti
Session: Poster Display session 3
Resources:
Abstract