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Oral cavity squamous carcinoma is characterized by alterations in cell mediated tumor immunity including a lack of immune reactive tumor infiltrating lymphocytes (TILs). To determine if a novel neoadjuvant injection of a multi-cytokine biologic (IRX-2) can restore immune reactivity and enhance patient survival, a randomized Phase 2 clinical trial was conducted in patients with Stage II-IV OSCC undergoing surgical resection (NCT 02609386).The intention-to-treat (ITT) enrollment included 105 previously untreated patients, however 9 were excluded from the secondary endpoint analysis group for wrong histology, no treatment or patient refusal. A total of 96 patients comprised the final analytic group and were randomized (2:1) to receive the IRX-2 regimen (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2). Toxicity, tumor and immune responses, event-free (EFS) and overall (OS) survival were determined. Kaplan-Meier estimates for OS and EFS and inferential comparisons and asymptotoic log-rank testing between the two treatments were determined.In prior preliminary analysis, significant increases in TILs and DMBT1 gene expression were noted for the IRX arm. No significant correlations of immunologic or tumor responses with survival outcomes were found. For the ITT population (n = 105) there were no significant differences in OS by treatment arm. OS [95 % CI] at 48 mo. was 70.4 [57.6, 80.0] vs 66.3 [47.5, 79.8] mos. (Regimen 1 vs Regimen 2, respectively). Conclusions: Significant differences in survival were not seen, however, the trial demonstrated the feasibility of the neoadjuvant immunotherapy and differing immune modulation in each treatment arm. No correlations of immune biomarkers or tumor size changes with survival outcomes were identified.

Aim: Current guidelines recommend p16 immunohistochemistry (IHC) for testing human papillomavirus (HPV) in oropharyngeal carcinoma (OPSCC). We evaluated the value of adding DNA in situ hybridization (ISH) to p16 IHC. Methods: Fifty patients with OPSCC were analyzed. Concordance between HPV–DNA ISH and p16 IHC was measured by Gwet's agreement coefficient. Results: p16 IHC was positive in 35/48 (72.9%), negative in 8/48 (16.7%) patients. Wide spectrum DNA–ISH was positive in 9/23 (39%) and negative in 14/23 (60.9%) patients. High-risk 16/18 (HR) HPV DNA–ISH was positive in 11/23 (47.8%) and negative in 12 (52.2%) patients. The agreement between HPV DNA–ISH and p16 IHC is fair (Gwet's AC1 = 0.318). Conclusion: The agreement between p16 IHC and HPV–DNA ISH was fair. However, ISH sensitivity was low. Our findings add to the current data that p16 IHC testing is reliable and may be enough as a stand-alone test for HPV detection in OPSCC.

We report two patients with leptomeningeal metastases from squamous cell cancer of the skin. In one patient cauda equina metastases appeared 6 years after initial presentation; the tumor from radical neck dissection demonstrated perineural invasion suggesting a possible route for subarachnoid dissemination. The other patient presented 2 years after initial diagnosis with confusion and cranial nerve seven and twelve palsies. Both patients died from complications of leptomeningeal metastases. [ABSTRACT FROM AUTHOR]