Guideline - Adherence in advanced stage head and neck cancer is associated with improved survival - A National study.

OBJECTIVES: Understanding the prevalence of guideline non-adherence among patients with advanced head and neck cancer (HNC) and its impact on survival may facilitate increased adherence. Our objective was to perform a detailed analysis of overall National Comprehensive Care Network (NCCN) guideline adherence in a national cohort. METHODS: Using the National Cancer Database, we analyzed site-specific NCCN guideline adherence for treatment of 100,074 overall stage III and IVA HNC patients from 2004 to 2013. Main outcomes were guideline adherence rates and overall survival (OS). Adherence was categorized by treatment: surgery/ radiation. Reasons were categorized as: (1) high risk; (2) refusal; (3) not planned. RESULTS: After exclusion, the care of 25,620 patients was defined as non-adherent (25.6%), yet adherence rates significantly improved across the study's years. After multivariate analysis, non-adherence was associated with age ≥ 65, female gender, black race, comorbidity score ≥ 1, insurance status, clinical staging, primary site, and facility type. Patients not managed according to NCCN guidelines had a significantly reduced OS compared with patients treated on-guideline (hazard ratio (HR) = 1.51 (95 %CI 1.48-1.54), p < 0.001). 'Not planned' patients had reduced OS when compared to adherent patients (HR = 1.27 (95 %CI 1.23-1.30), p < 0.001). Off-guideline treated patients due to 'risk factors' had a decrease in overall survival (OS) compared with other reasons (p < 0.001 for all). CONCLUSIONS: Despite improvement over time, non-adherence to NCCN guidelines for advanced stage HNC remains high. Non-adherence is associated with decreased OS, regardless of the reason. Despite concerns from both patient and physician, efforts should be made to increase guideline awareness and adherence.

Changes in Population-Level and Institutional-Level Prescribing Habits of Radioiodine Therapy for Papillary Thyroid Cancer.

Background: In the past two decades, new evidence and guidelines have emerged to refine recommendations for the use of radioactive iodine (RAI) therapy after thyroidectomy for cancer. We aim to describe national trends in RAI utilization, assess the impact of individual hospitals on RAI utilization, and examine whether variation in prescribing habits has declined over time. Methods: The National Cancer Database (NCDB) was queried from 2004 to 2016 for patients with papillary thyroid cancer (PTC) who received total thyroidectomy. Trends were analyzed using Joinpoint analysis. Hospital-specific effects and variation in prescribing habits were assessed through a hierarchical, mixed regression model. Results: RAI utilization declined from 61.0% in 2004 to 43.9% in 2016. RAI use declined most profoundly in patients with T1a, N0/X, M0 PTC without extrathyroidal extension (34.8% in 2004 to 9.5% in 2015), but continues to be used commonly in patients with advanced disease for whom it is routinely recommended (73.4% in 2004 to 72.0% in 2015). Furthermore, ∼80% of hospitals in 2016 utilized at or below the median utilization rate in 2006. Variation in RAI utilization across hospitals decreased by ∼50% from 2004 to 2016 (Levene's test p < 0.001), with a significant decline (p = 0.002) in the variation after 2012 (confidence interval: 2010 to 2014). Conclusions: Recommendations for whom to prescribe RAI appear to have impacted both the number of patients receiving RAI and the variation in prescribing habits across hospitals. Hospital selection has contributed less to the probability of receiving RAI over time.

Multi-modality Treatment and Survival in Sinonasal Minor Salivary Gland Tumors.

Objectives The aim of this study was to analyze the effect of the multimodality treatment on survival in sinonasal minor salivary gland tumors. Methods Adult clinical American Joint Committee on Cancer (AJCC) tumor (T) 1-4a staged cases of sinonasal minor salivary gland tumors were isolated from the National Cancer Database (2004-2014). Multivariate regressions were performed to analyze the effect of multimodality treatment. A subset analysis was also performed in patients with positive margins following surgical management. Results We identified 556 cases, of which 293 (52.7%) patients were treated with surgery and radiotherapy (RT), 160 (28.8%) were treated with surgery alone, and 52 (9.4%) were treated with surgery and chemoradiotherapy (CRT). No patients were treated with chemotherapy alone. With surgery and CRT as a reference, the only treatment modality associated with decreased survival was RT alone (hazard ratio [HR]: 3.213 [95% confidence interval (CI): 1.578-6.543]; p = 0.001). Within a subset analysis of patients with positive margins, surgery was associated with decreased survival (HR: 2.021 [95% CI: 1.401-3.925]; p = 0.038), but not triple modality therapy (HR: 1.700 [95% CI: 0.798-3.662]) when compared with surgery with RT. Conclusion The most common treatment was surgery and RT, consistent with National Comprehensive Cancer Network (NCCN) guidelines which recommends chemotherapy (CT) only in the most concerning cases. However, we found no difference in survival among most treatment modalities when compared with triple modality therapy, with the exception of RT alone. Although margins were prognostic within these cancers, we found no evidence that adjuvant CRT provides any survival benefit over surgery and RT, though surgery alone was associated with decreased survival.

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.

Treatment guidelines and patterns of care in oral cavity squamous cell carcinoma: Primary surgical resection vs. nonsurgical treatment.

BACKGROUND: The 2017 National Comprehensive Cancer Network Clinical Practice Guidelines recommend surgical resection or definitive radiation therapy for early-stage oral cavity malignancies, and surgical resection or multimodality clinical trials for late-stage disease. Few studies have been conducted to identify predictors of choice of treatment modality for oral cavity malignancies. METHODS: All patients in the National Cancer Data Base (NCDB) diagnosed with oral cavity squamous cell carcinoma (OCSCC) between 1998 and 2011 were identified. Chi-square and binary logistic regression were used to identify factors predictive of surgical or nonsurgical treatment; multiple imputation was used for missing data. Cox proportional hazards models were generated to identify associations between treatment modality and overall survival (OS). RESULTS: Of 23,459 patients, 4139 (17.6%) underwent primary nonsurgical treatment. Among NCDB-registered facilities, there has been a decrease in use of nonsurgical treatment for OCSCC (OR 0.97, p<0.001). Older age, non-white race, Medicaid insurance, low income, low education, and later-stage disease were associated with nonsurgical therapy, while patients at academic/research programs were more likely to undergo surgery (OR 0.38, p<0.001). Nonsurgical treatment was associated with decreased OS (HR=2.02, p<0.001); this was upheld on subgroup analysis of early- and late-stage disease. CONCLUSIONS: Use of primary nonsurgical treatment for OCSCC has decreased over time among NCDB-registered facilities and is associated with factors related to access to care. Surgical resection for the primary treatment of oral cavity cancer may be associated with improved OS, though conclusions regarding survival are limited by the non-randomized nature of the data.

Trends and variations in the use of adjuvant therapy for patients with head and neck cancer.

BACKGROUND: The National Comprehensive Cancer Network guidelines recommend that patients with surgically resected head and neck cancers that have adverse pathologic features should receive adjuvant therapy in the form of radiotherapy (RT) or chemoradiation (CRT). To the authors' knowledge, the current study is the first analysis of temporal trends and use patterns of adjuvant therapy for these patients. METHODS: Patients with head and neck cancer and adverse pathologic features were identified in the National Cancer Data Base (1998-2011). Data were analyzed using chi-square, Student t, and log-rank tests; multivariate logistic regression; and Cox multivariate regression. RESULTS: A total of 73,088 patients were identified: 41.5% had received adjuvant RT, 33.5% had received adjuvant CRT, and 25.0% did not receive any adjuvant therapy. From 1998 to 2011, the increase in the use of adjuvant CRT was greatest for patients with oral cavity (6-fold) and laryngeal (5-fold) cancers. Multivariate analysis demonstrated that Medicare/Medicaid insurance (odds ratio [OR], 1.05; 95% confidence interval [95% CI], 1.01-1.11), distance ≥34 miles from the cancer center (OR, 1.66; 95% CI, 1.59-1.74), and academic (OR, 1.26; 95% CI, 1.20-1.31) and high-volume (OR, 1.10; 95% CI, 1.05-1.15) centers were independently associated with patients not receiving adjuvant therapy. Receipt of adjuvant therapy was found to be independently associated with improved overall survival (hazard ratio, 0.84; 95% CI, 0.81-0.86). CONCLUSIONS: Approximately 25% of patients are not receiving National Comprehensive Cancer Network guideline-directed adjuvant therapy. Patient-level and hospital-level factors are associated with variations in the receipt of adjuvant therapy. Further evaluation of these differences in practice patterns is needed to standardize practice and potentially improve the quality of care. Cancer 2014;120:3353-3360. © 2014 American Cancer Society.