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Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.
- Source :
-
Oral Oncology . Dec2020, Vol. 111, pN.PAG-N.PAG. 1p. - Publication Year :
- 2020
-
Abstract
- <bold>Objectives: </bold>IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).<bold>Methods: </bold>A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm2 were used to characterize immune responders (IR).<bold>Results: </bold>Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).<bold>Conclusions: </bold>The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386). [ABSTRACT FROM AUTHOR]
- Subjects :
- *IMMUNOSUPPRESSION
*SQUAMOUS cell carcinoma
*MOUTH
*LYMPHOCYTES
*CANCER vaccines
*IMMUNOTHERAPY
*THERAPEUTIC use of zinc
*PROTEIN analysis
*THERAPEUTIC use of cytokines
*THERAPEUTIC use of antineoplastic agents
*TISSUE arrays
*MOUTH tumors
*NONSTEROIDAL anti-inflammatory agents
*INDOMETHACIN
*RANDOMIZED controlled trials
*OMEPRAZOLE
*CYCLOPHOSPHAMIDE
*T cells
*IMMUNOSUPPRESSIVE agents
*GASTROINTESTINAL agents
*COMBINED modality therapy
*STATISTICAL sampling
*LYMPHOCYTE count
Subjects
Details
- Language :
- English
- ISSN :
- 13688375
- Volume :
- 111
- Database :
- Academic Search Index
- Journal :
- Oral Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 147267176
- Full Text :
- https://doi.org/10.1016/j.oraloncology.2020.104928