Gender disparities in head and neck cancer chemotherapy clinical trials participation and treatment.

OBJECTIVES: To characterize the representation of women in clinical trials directing the National Comprehensive Cancer Network (NCCN) guidelines for chemotherapy use in head and neck squamous cell carcinoma (HNSCC), as well as the relationship between gender and chemotherapy administration in the definitive treatment of HNSCC in the United States. METHODS: A review of all HNSCC chemotherapy clinical trials cited by the 2018 NCCN guidelines was performed. Sex-based proportions were compared with the corresponding proportions in the general U.S. population of patients with HNSCC between 1985 and 2015, derived from the Surveillance, Epidemiology, and End Results (SEER) program. A second analysis using the National Cancer Database (NCDB), identified 63,544 adult patients diagnosed with stages III-IVB HNSCC between 2004 and 2014 and treated with definitive radiotherapy or chemoradiotherapy. Univariable and multivariable logistic regression analyses were used to identify predictors of chemotherapy administration. RESULTS: While women comprised 26.2% of U.S. patients with HNSCC between 1985 and 2015, they comprised only 17.0% of patients analyzed in U.S. NCCN-cited chemotherapy clinical trials between 1985 and 2017. On multivariable analysis, women had decreased odds of receiving chemotherapy (Odds Ratio [OR]: 0.875; 95% Confidence Interval [CI]: 0.821-0.931; p < 0.001). CONCLUSION: Women are underrepresented in HNSCC chemotherapy clinical trials cited by the national guidelines. Additionally, women are less likely than men to receive definitive chemoradiotherapy as oppose to definitive radiotherapy. Reasons for these disparities warrant further investigation as well as re-evaluation of eligibility criteria and enrollment strategies, in order to improve relevance of clinical trials to women with HNSCC.

Clinically node-negative head and neck mucosal melanoma: An analysis of current treatment guidelines & outcomes.

OBJECTIVES: To analyze head and neck mucosal melanoma (MM) treatment patterns, and their association with survival, relative to National Comprehensive Cancer Network (NCCN) guidelines. MATERIAL & METHODS: Adult head and neck MM patients with clinically-staged T3/4aN0 disease were identified in a retrospective analysis of the National Cancer Database (2010-2014) and stratified into sinonasal cavity (SN) and oral cavity, oropharynx, larynx, or hypopharynx (non-SN) cohorts. RESULTS: We identified 353 SN and 79 non-SN MM cases. The majority of patients were treated with surgery (SN: 92.4%; non-SN 84.8%), within NCCN guidelines. Treatment within the non-SN MM NCCN recommendation of elective neck dissection (END) was approximately 26.6%. END is not recommended for SN MM and was not performed in 91.5% of cases. Radiotherapy (RT) is recommended in both SN and non-SN MM and was utilized in 63.5% of SN patients and 46.8% of non-SN patients. END was not independently associated with OS compared to surgery alone (SN HR: 1.350 [95% CI: 0.733-2.485]; non-SN HR: 3.460 [95% CI: 0.912-13.125]). RT was independently associated with improved OS in SN MM cases (HR: 0.679 [95% CI: 0.479-0.963]), but not in non-SN MM cases (HR: 0.824 [95% CI: 0.331-2.051]). CONCLUSION: The majority of patients with head and neck MM are not treated within NCCN guidelines. The use of recommended END in non-SN patients is low. Similarly, adjuvant RT utilization is low. Our analysis shows that while greater use of RT may increase survival rates in this disease, the utility of END is unclear.