Because immune responses within the tumor microenvironment may be important predictors of tumor biology, correlations of specific types of tumor infiltrating lymphocytes (TILs) with clinical variables and outcomes were determined in 278 previously untreated patients with head and neck cancer (HNSCC). Methods Infiltrating levels of CD4 (helper T cells), CD8 (cytotoxic/suppressor T cells), FoxP3, regulatory T cells), CD68 (myeloid derived suppressor cells) and CD1a (Langerhan) cells were retrospectively measured by immunohistology in tissue mircoarrays. Cox models tested associations with patient outcomes after adjusting for all known prognostic factors. Median follow up was 36.6 months. Results Higher CD4 and CD8 TIL levels were associated with improved overall (HR 0.77 [0.65 –0.93] p=.005 and HR 0.77 [0.64–0.94] p=.008 respectively), and relapse free survival (p=.03, and .05 respectively). After controlling for prognostic factors, higher CD4 levels predicted improved overall and disease specific survival (p=.003 and .004 respectively). Conclusions The findings suggest that TILs are a significant independent prognostic factor and potential biomarker for HNSCC that differ by treatment.

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Background: Platinum-based therapy in combination with 5-fluorouracil with cetuximab has shown the best survival in pts with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The purpose of this study is to evaluate the efficacy and tolerability of carboplatin, pemetrexed and to assess differential outcomes in patients with oropharyngeal primary and HPV related disease.Patients and Methods: The charts of consecutive patients with R/M SCCHN were reviewed. All patients receiving at least one cycle of the two-drug regimen (pemetrexed 500 mg/m2, carboplatin area under the curve of five intravenously), were included for assessment of response, safety, toxicity, and survival.Results: A total of 86 patients received this regimen between January 2008 and December 2012, of which, 63 were included in this analysis. Forty-one percent (26) of the patients had cancers of the oropharynx, and of those, 50% had HPV-positive disease, 32% (20) had cancers of the larynx, and 24% (15) of the oral cavity. Median number of cycles administered was 4 (range 1–14 cycles) with 50% of the patients receiving four or more cycles. Half the patients achieved stable disease as their best response, 8% (5) attained a partial response, 24% progressed on therapy, and the remaining patients (12) could not have their response assessed. On the basis of Kaplan–Meier analysis, median progression-free survival (PFS) was 5.1 months (95% CI 3.2, 6.2) and median overall survival (OS) was 9.4 months (95% CI 4.3, 13.1). Among pts with oropharyngeal primary (n = 26), median PFS was 6.4 months (95% CI 2.8, 7.9) and median OS was 16.6 months (95% CI 9.6, 19.5). Among HPV+ pts (n = 13), median PFS was 7.0 months (95% CI 4.8, ne) and median OS was 17.1 months (95% CI 11.2, 21.7).Conclusion: Combination carboplatin-pemetrexed is an effective and well-tolerated treatment, associated with a median PFS of 5.1 months and a clinical benefit in at least 57% of the patients treated.

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