Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial

Wolf, Gregory T.; Liu, Siyu; Bell, R. Bryan; Sartor, Maureen A.; Rozek, Laura S.; Thomas, Dafydd; Nguyen, Ariane; Zarins, Katie R.; McHugh, Jonathan B.; Moyer, Jeff; Patel, Mihir R.; Saba, Nabil F.; Erman, Audrey B.; Martins, Wanessa A.; Newman, Jason G.; Kaplan, Michael; Oliveira, F.A.M. de; Victorina, Ana Paula; Bell, R. Bryan; Girotto, Gustavo; Nieva, Jorgé; Valentino, Joseph; Krempl, Greg A.; Cernea, Cláudio Roberto; Kraus, Dennis H.; Higgins, Kevin; Cruz, Felipe José Silva Melo; Panwar, Aru; Campos, Clodoaldo Zago; McCaul, Jim

doi:10.1016/j.oraloncology.2020.104928

Cited by 11 publications

(8 citation statements)

References 56 publications

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“…Overall, the studies report on a total of 920 patients (range 21–161), with studies coming from Europe ( n = 6, 40%) [ 30 , 31 , 32 , 33 , 34 , 35 ], China ( n = 3, 20%) [ 36 , 37 , 38 ], Japan ( n = 3, 20%) [ 39 , 40 , 41 ], Korea ( n = 2, 13%) [ 42 , 43 ], and the USA ( n = 1, 7%) [ 44 ]. The studies were published in the time range 2017–2021, with the vast majority appearing in the years 2020 and 2021.…”

Section: Resultsmentioning

confidence: 99%

“…The recommended scoring system with CPS was reported in three studies (20%), while the majority of studies either used TPS or scored tumor cells and immune cells separately. The conventional therapies administrated to patients consisted, in most of the studies, of platinum-based regimens with concurrent radiation therapy, but there were two studies that investigated the effect of other types of chemotherapy, such as a combination of cytokine preparation [ 44 ] and an inhibitor of apoptosis protein injection [ 32 ]. A study reported on the effect of radiotherapy only [ 43 ].…”

Section: Resultsmentioning

confidence: 99%

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Effect of Radio-Chemotherapy on PD-L1 Immunohistochemical Expression in Head and Neck Squamous Cell Carcinoma

Girolami

Marletta

Fiorentino

et al. 2023

JPM

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Background: Programmed death-ligand 1 (PD-L1) checkpoint inhibitors represent a mainstay of therapy in head and neck squamous cell cancer (HNSCC). However, little is known about the influence of combined therapy on PD-L1 expression. The study aims to gather evidence on this topic. Methods: A systematic search was carried out in electronic databases Pubmed-MEDLINE and Embase to retrieve studies on the comparison of PD-L1 expression before and after conventional therapy. Data were extracted and a quantitative analysis with pooled odds ratios (ORs) was performed when applicable. Results: Of 5688 items, 15 were finally included. Only a minority of studies assessed PD-L1 with the recommended combined positive score (CPS). The results are highly heterogeneous, with some studies reporting an increase in PD-L1 expression and others reporting a decrease. Three studies allowed for quantitative analysis and showed a pooled OR of 0.49 (CI 0.27–0.90). Conclusions: From the present evidence, a clear conclusion towards an increase or decrease in PD-L1 expression after combined therapy cannot be drawn, but even with few studies available, a trend towards an increase in expression in tumor cells at a cutoff of 1% can be noted in patients undergoing platinum-based therapy. Future studies will provide more robust data on the effect of combined therapy on PD-L1 expression.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Effect of Radio-Chemotherapy on PD-L1 Immunohistochemical Expression in Head and Neck Squamous Cell Carcinoma

Girolami

Marletta

Fiorentino

et al. 2023

JPM

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“…IRX-2 acts on T cells by preventing tumor-induced apoptosis and enhances its effector function, particularly in regional lymph nodes, to reinvigorate both innate and adaptive host immunity in the battle against tumor cells ( 44 ). A phase IIb trial (NCT02609386) in which 97 patients with stage II-IV OCSCC received perilymphatic injection of IRX-2 recently demonstrated a significant increase in immune response, particularly cytotoxic CD8+ T cells ( 45 ).. Its immune restorative effect on regional lymph nodes is particularly attractive in combination with other checkpoint inhibitors. The trial remains active and is pending final endpoint results on event-free and overall survival.…”

Section: Immune Response In Ocsccmentioning

confidence: 99%

Preoperative Immunotherapy in the Multidisciplinary Management of Oral Cavity Cancer

et al. 2021

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Despite advances in multimodal treatment for oral cavity squamous cell carcinoma, recurrence rates remain high, providing an opportunity for new therapeutic modalities that may improve oncologic outcomes. Much recent attention has been paid to the molecular interactions between the tumor cells with the adjacent peritumoral microenvironment, in which immunosuppressive molecular changes create a landscape that promotes tumor progression. The rationale for the introduction of immunotherapy is to reverse the balance of these immune interactions in a way that utilizes the host immune system to attack tumor cells. In the preoperative setting, immunotherapy has the advantage of priming the unresected tumor and the associated native immune infiltration, supercharging the adaptive anti-tumor immune response. It also provides the basis for scientific discovery where the molecular profile of responders can be interrogated to elucidate prognostic markers to aid in future patient selection. Preoperative immunotherapy is not without limitations. The risk of surgical delay due to immune adverse events must be carefully discussed by members of a multidisciplinary treatment team and patient selection will be critical. One day, the discovery of predictive biomarkers may allow for algorithms where pre-surgical immunotherapy decreases the size of surgical defect and impacts the intensity of adjuvant therapy leading to improved patient survival and decreased morbidity. With further study, immunotherapy could become a key component of future treatment algorithm.

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“…Oral cancers are characterized by extensive immune cell infiltration, and cancer-related inflammation plays a critical role in OSCC carcinogenesis and tumor progression. 25 , 26 , 27 EGFR activation and signaling also play a potential role in NLR protein assembly, linked to inflammation. 28 , 29 , 30 Recently, inflammasome-mediated cancer-related inflammation has been recognized in oncology, promoting tumor growth and metastasis.…”

Section: Introductionmentioning

confidence: 99%

CAR-T cells targeting HLA-G as potent therapeutic strategy for EGFR-mutated and overexpressed oral cancer

Lin¹,

Hua²,

Lu³

et al. 2023

iScience

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Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial

Cited by 11 publications

References 56 publications

Effect of Radio-Chemotherapy on PD-L1 Immunohistochemical Expression in Head and Neck Squamous Cell Carcinoma

Effect of Radio-Chemotherapy on PD-L1 Immunohistochemical Expression in Head and Neck Squamous Cell Carcinoma

Preoperative Immunotherapy in the Multidisciplinary Management of Oral Cavity Cancer

CAR-T cells targeting HLA-G as potent therapeutic strategy for EGFR-mutated and overexpressed oral cancer

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