Abstract

<h3>Purpose/Objective(s)</h3> Tobacco, marijuana, and alcohol use have all been associated with immune suppressive effect. This study assess the impact of smoking status, marijuana use and alcohol consumption on overall survival (OS) in patients (pts) with recurrent-metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with immune checkpoint inhibitors (ICI). <h3>Materials/Methods</h3> Between January 15<sup>th</sup> 2016 and April 9<sup>th</sup> 2020, 201 pts with R/M HNSCC were treated with ICI. Data on smoking status, marijuana use and alcohol consumption were collected through retrospective chart review. We had p16 status, hemoglobin, albumin, lactate dehydrogenase (LDH), neutrophil, lymphocyte and platelet count recorded initially at the time of starting ICI. OS was defined from the start of ICI to death. Progression Free Survival (PFS) was defined from the start of ICI to disease progression (PD) or death. <h3>Results</h3> 201 pts were analyzed, sex: 154 male (77%), 47 female (23%). Median age 61 (IQR: 55-68). ICI drug: pembrolizumab 100 (50%), nivolumab 91 (45%), ipilimumab+nivolumab 10 (5%). Line of therapy: first: 98 (49%), second and beyond: 103 (51%). Tumor site: oropharynx 84 (42%), oral cavity 45 (22%), others 72 (36%). p16 status: negative 132 (66%), positive 69 (34%). Smoking status: former 111 (55%), never 54 (27%), current 36 (18%), median pack-year 18 (IQR: 0-37). Alcohol use: yes 110 (55%), no 91 (54%). Marijuana use: yes 47 (23%), no 154 (77%). Laboratory values: median neutrophil count: 4.58 (IQR: 3.43-6.47), median lymphocyte count: 0.69 (IQR: 0.47-1.08), median platelet count: 229 (IQR: 187-300), hemoglobin: normal/low 101/100 (50%/50%), albumin: normal/low 156/45 (78%/22%), LDH: normal/high 124/77 (62%/38%). Overall response rate: 36 (18%). Median OS: 12 months (CI: 9.4-14.8), median PFS: 4 months (CI: 3.5-5.7). Tobacco: former [HR 0.92 (0.62-1.36), <i>p=0.3</i>], current [HR 0.66 (0.39-1.14), <i>p=0.3</i>]. Marijuana: yes [HR 0.66 (0.43-1.01), <i>p=0.054</i>]. Alcohol: yes [HR 0.91 (0.65-1.28), <i>p=0.6</i>]. The variables associated with OS were high neutrophil count [HR 1.28 (1.08 – 1.51), <i>p=0.004</i>], high lymphocyte count [HR 0.75 (0.60 – 0.95), <i>p=0.015</i>], albumin (low) [HR 2.06 (1.37 – 3.10), <i>p<0.001</i>], hemoglobin (low) [HR 1.64 (1.14 – 2.35), <i>p=0.007</i>], LDH (high) [HR 1.78 (1.23 – 2.56), <i>p=0.002</i>] and p16 status (positive) [HR 0.58 (0.39-0.87), <i>p=0.009</i>]. <h3>Conclusion</h3> In our single institutional cohort, smoking status, marijuana use and alcohol consumption did not appear to have a significant impact on OS in patients with R/M HNSCC treated with ICI. As we previously reported, the pre-treatment patient characteristics associated with OS include neutrophil count, lymphocyte count, hemoglobin, albumin, LDH and p16 status.

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