2018-19 Section 7-Neoplastic and Inflammatory Diseases of the Head and Neck eBook

declines in speech, eating, and overall QOL outcomes. 1,6 Specifically, CRT has been shown to cause severe symp- toms and side effects such as fatigue, drowsiness, lack of appetite, oral and oropharyngeal mucus issues, and taste problems. 15 Thus, patients who receive TORS alone pre- sent an interesting research opportunity to the head and neck surgeon who seeks a balance between maintaining patient QOL and achieving favorable clinical outcomes. Despite preliminary data showing that adjuvant therapy had negative effects on QOL, a detailed analysis on the specific type of adjuvant treatment (RT vs. CRT) has not been reported, as all patients who receive adju- vant therapy are often grouped together in these stud- ies. Although increasing in popularity, few studies have reported quality of life outcomes for oropharyngeal can- cer patients who receive TORS alone. 8,16,17 The aim of this study was to compare the clinical, functional, and QOL outcomes of patients who underwent TORS with adjuvant RT or CRT to those without adjuvant therapy in the treatment of oropharyngeal cancer. MATERIALS AND METHODS Institutional review board approval was granted by The Ohio State University Office of Responsible Research Practices (OSU-07061), and informed consent was signed by all of the participants. This study was conducted by performing a chart review to examine medical records from 111 patients treated for oropharyngeal cancers at a tertiary care academic comprehen- sive cancer center from April 2008 to July 2015. Intervention consisted of primary surgical resection via TORS and neck dis- section (selective level 2–5 neck dissection) as indicated. Main surgical interventions for primary sites were radical tonsillec- tomy, partial base of tongue resection, and limited pharyngec- tomy for tonsil, base of tongue cancer, and oropharyngeal extensions, respectively. None of the patients needed tissue transfer for reconstruction other than uvular or pharyngeal mucosal advancements in select cases. Contralateral tonsils were routinely addressed with regular tonsillectomy, unless there was a concern for pharyngeal stenosis due to extensive resection at the primary resection site. Patient enrollment, inclusion criteria, exclusion criteria, and treatment protocol were followed as previously described by Dzigielewski et al. 6 Of note, the 111 patients classified as hav- ing oropharyngeal cancer in this study were selected based on the tumor site of origin description in the surgical pathology report rather than by clinical diagnosis. Besides limited transo- ral exposure, patients with advanced-stage primary tumor necessitating extensive multiple oropharyngeal subsite resection with a need of tracheostomy and distant tissue transfer, and matted, N3, or lymph nodes with clinical and radiologic features of extracapsular spread (ECS) requiring radical neck dissections and possible adjuvant CRT were also excluded from the study. All patients were also evaluated with speech pathologists at their first clinic visit and speech and swallowing therapy was started preoperatively and continued during and after the adju- vant treatment until the personalized functional goals were achieved. Postoperative RT or concurrent CRT was offered to patients with high-risk disease features according to the National Comprehensive Cancer Network guidelines within 6 weeks of TORS. 18 Whereas all patients with adverse pathologic features (pT3 or pT4 primary, N2, N3 nodal disease, perineural and lymphovascular invasion) received adjuvant RT, CRT was recommended for patients with positive margins, ECS, and

occasionally with multiple, intermediate adverse features. Even though a majority of the patients had their adjuvant treatment at the James Cancer Hospital, patients willing to have their therapy at a local cancer center completed their regimen locally. Patients were administered the Head and Neck Cancer Inventory (HNCI) to evaluate health-related QOL preopera- tively, and at 3 weeks, 3 months, 6 months, and 1 year relative to the date of TORS in all patients including those who received adjuvant therapy. The HNCI is a validated, quantitative tool 19 that contains four domains (speech, eating, aesthetics, and social disruption) and an overall QOL score. Scores from each domain, as well as functional (ability to perform the task) and attitudinal (satisfaction with task performance) subdomain scores were compared between groups. Items on the HNCI are originally scored on an ordinal scale ranging from 1 to 5; how- ever, these were transformed to a scale of 0 to 100 to aid in interpretation of results as in previous analyses. 6 QOL data were compared between 13 patients treated with TORS alone, 31 with adjuvant RT, and 67 with adjuvant CRT using a linear mixed effects model to assess the group dif- ferences of QOL over time, with fixed effects for time and group and an unstructured variance covariance matrix assumed for the repeated measures within each subject. Group comparisons at each time point were estimated via the mixed model with no adjustments made for multiple comparisons. Square root trans- formations to the data were applied to normalize the distribu- tion when necessary. In addition to QOL data, demographic, clinicopathologic, and follow-up data were also collected as well as RT and CRT dosage, frequency, and complication rates. Overall survival was defined as time from the date of surgery to date of death with patients alive at the date of last observation censored. One non- compliant patient in the TORS alone group who declined adju- vant therapy was excluded from the locoregional and distant disease control and survival analysis. Cox proportional hazards models were used to assess univariate association between treatment group and survival. Comparisons between treatment groups were assessed via analysis of variance (ANOVA) (i.e., age and weight loss) and Kruskal-Wallis tests for quantitative variables or Fisher exact tests for categorical variables. All analyses were conducted in SAS version 9.3 (SAS Institute, Cary, NC). RESULTS A total of 111 patients were included in this study. Ninety-two patients were male (83.0%) and 19 were female (17.0%). Patient characteristics are listed in Table I. There were no significant differences in age, sex, or smoking status among the groups. Table II com- pares pathologic information among groups. The adju- vant RT and adjuvant CRT groups had a greater proportion of N2/N3 staging, ECS, and a greater number of positive lymph nodes compared to the TORS-alone group. A majority of patients had tumors with human papillomavirus and protein p16INKa positivity and a tonsillar site of origin in all three treatment groups. Adjuvant treatment details are summarized in Table III. There were no significant differences in dura- tion, dose, or fractions of RT delivered between the adju- vant RT and adjuvant CRT groups. Of the patients in the adjuvant CRT group for which data could be obtained, the most commonly used chemotherapeutic agents were cisplatin/carboplatin (71.6%) followed by cetuximab (13.4%). Specific chemotherapy details

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