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Purpose: OnabotulinumtoxinA is approved in the Republic of Korea for the treatment of moderate-to-severe crow's feet lines (CFL) and glabellar lines (GL), separately or in combination. We assessed safety and effectiveness of onabotulinumtoxinA in real-world clinical practice. Patient and methods: This 4-year postmarketing surveillance study was conducted in the Republic of Korea in subjects with moderate-to-severe CFL. Subjects aged 18 to 75 years received onabotulinumtoxinA injections for CFL alone or in combination with GL. Safety assessments included adverse events (AEs), serious AEs (SAEs), and unexpected AEs (not noted in Korean prescribing information). Investigators assessed effectiveness via change from baseline in CFL. Results: The full analysis set comprised 695 subjects; 667 were in the safety set and 376 in the effectiveness set. In the safety set, mean ± SD age was 40.9±13.0 years; most subjects (87.3%) were female. More subjects were treated for CFL (69.9%) than CFL and GL simultaneously (30.1%). Eleven subjects experienced 14 AEs; 12 were mild in severity and 11 resolved without sequelae. Two cases of injection site pain in 2 subjects each were deemed possibly related to onabotulinumtoxinA. One unexpected SAE (acute renal failure) occurred in 1 subject (0.15%). All unexpected AEs (n=4) were mild and considered unrelated to treatment. Overall change from baseline showed CFL was improved in 375 subjects (99.7%) and unchanged in 1 subject (0.3%). Conclusion: OnabotulinumtoxinA was well tolerated and effective for treatment of CFL with or without GL in a real-world Korean population. No new safety concerns were identified. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Acoustic evaluation of speech is the least explored method of speech evaluation in patients with oral cavity and oropharyngeal cancer. The purpose of this study was to explore acoustic parameters of speech and their correlation with questionnaire evaluation and perceptual evaluation in patients with oral cavity and oropharyngeal cancer. Methods One hundred seventeen subjects (65 consecutive patients with oral cavity and oropharyngeal cancer and 52 controls) participated in this study. Formant frequencies (by Linear Predictive Coding), Speech Handicap Index, and London Speech Evaluation scale were used for acoustic evaluation, questionnaire evaluation, and perceptual evaluation, respectively. Results Men showed significant elevation in second formant (F2) values for patients with oral cavity cancer and those who underwent surgery alone. Female patients with early T classification cancers and those who underwent surgery and chemoradiation showed significant reduction in the mean F2 values. Importantly, however, acoustic evaluation parameters did not correlate with either perceptual evaluation or questionnaire evaluation parameters, although there was moderate correlation between questionnaire evaluation and perceptual evaluation speech parameters. Conclusion Acoustic evaluation modalities have no clear role in the management of patients with oral cavity and oropharyngeal cancer. © 2015 Wiley Periodicals, Inc. Head Neck 38: 670-676, 2016 [ABSTRACT FROM AUTHOR]

This work aimed at evaluating patients' swallowing functions by a newly validated swallow-specific questionnaire, the Sydney Swallow Questionnaire (SSQ), in a cohort of oral and oropharyngeal cancer patients. Mean/median SSQ scores were calculated and compared with study variables using the Mann-Whitney U test and Kruskal-Wallis test. The mean composite SSQ scores (SD) for the base of tongue, oral tongue, and tonsillar cancer patients were 663.8 (382.8), 456.2 (407.6), and 283.0 (243.1), respectively ( p = 0.005); for advanced vs. early T stage disease they were 918.1 (319.5) vs. 344.8 (292.1) ( p ≤ 0.001); for patients <60 years vs. ≥60 years they were 549.3 (415.1) vs. 314.0 (247.3) ( p = 0.02); and for patients with reconstruction vs. without reconstruction they were 676.5 (410.5) vs. 331.9 (286.5) ( p = 0.002). SSQ is a useful tool for evaluation of swallowing in head and neck cancer patients. Site of cancer, T stage, patient's age, and reconstruction directly affect post-treatment swallow outcome. [ABSTRACT FROM AUTHOR]

There are insufficient data on swallowing and the consequences of its dysfunction in patients with cancers of the oral cavity (OC) and oropharynx (OP) that are treated with primary surgery. The study attempts to explore the effect of important clinico-demographic variables on post-treatment swallowing and related quality of life (QOL) in post-surgical OC and OP cancer patients. Sixty-two consecutive OC and OP cancer patients completed the MD Anderson Dysphagia Inventory (MDADI) questionnaire. Mean scores were computed. Comparison of scores based on mean ranks were performed using Mann-Whitney U test or Kruskal-Wallis test. Level of significance was set at P ≤ 0.02. Adjustments were made for multiple comparisons. Significantly worse mean (SD) QOL scores were observed in late T-stage (T3/T4) versus early T-stage (T1/T2) patients for global domain, physical domain, functional domain and emotional domains [44.4 (21.9) vs. 78.7 (22.7) ( P < 0.001); 50.0 (9.4) vs. 75.9 (16.3), ( P < 0.0001); 57.8 (20.6) vs. 84.1 (16.7), ( P < 0.001) and 55.2 (18.0) vs. 78.5 (16.3), ( P < 0.001)], respectively. Patients undergoing reconstruction versus without reconstruction had worse QOL scores; 58.8 (26.9) versus 79.5 (22.8), ( P < 0.01); 61.2 (15.1) versus 76.4 (17.5), ( P = 0.002); 65.4 (20.5) versus 86.3 (15.9), ( P < 0.0001) and 63.3 (18.8) versus 79.8 (16.3), ( P < 0.01), respectively, for global, physical, functional and emotional domains. Advanced T-stage, reconstruction, younger age and base of tongue tumours have a negative impact on post-treatment swallow function and related QOL in these patients. [ABSTRACT FROM AUTHOR]

The aim was to explore the impact of important clinico-demographic factors on the post-treatment quality of life (QOL) in surgically treated oral and oropharyngeal cancer patients. 63 consecutive follow-up oral and oropharyngeal cancer patients treated primarily with surgery were recruited. 55 patients sent the completed questionnaires and finally included in this study. QOL and important sub-domains of the QOL were assessed. Mean QOL scores (SD) were computed, level of significance was set at P < 0.05. The mean composite QOL score and standard deviation (SD) for oral and oropharyngeal cancer patients were 76.6 (15.2) and 73.4 (13.9), respectively. Patients with higher T-stage (T3 and T4) and higher overall-stage (III and IV) had lower mean QOL scores as against early T (T1 and T2) and overall early-stage (I and II); mean scores (SD) 64.3 (13.6) and 72.3 (13.8), and 76.6 (13.6) and 81.7 (14.1), respectively. Younger patients had lower mean scores (SD) than older patients; mean QOL scores (SD) 69.7 (14.0) and 79.6 (SD), respectively. Patients with reconstruction had lower mean QOL scores as compared to those without reconstruction; mean scores (SD) 67.6 (16.0) and 77.4 (12.5), respectively. In conclusion, tumor-stage, overall-stage, age of patients, and reconstruction had a significant direct effect on the post-treatment QOL of oral and oropharyngeal cancer patients. [ABSTRACT FROM AUTHOR]

Background. Posttreatment speech problems are seen in nearly half of patients with head and neck cancer. Although there are many voice-specific scales, surprisingly there is no speech-specific questionnaire for English-speaking patients with head and neck cancer. The aim of this study was to validate the Speech Handicap Index (SHI) as the first speech-specific questionnaire in the English language. Method. In all, 55 consecutive patients in follow-up for oral and oropharyngeal cancer completed the SHI and University of Washington Quality of Life Questionnaire (UWQOL V.04). Thirty-two patients completed both questionnaires again 4 weeks later to address test-retest reliability. Results. Internal consistency, test-retest reliability, construct validity, and group validity of the SHI were found to be highly significant (p < .01) using Cronbach's alpha, Spearman's correlation coefficient (r), and Mann-Whitney U tests. Conclusions. The SHI is a precise, highly reliable, and valid speech assessment tool for patients with head and neck cancer. Further dedicated studies using the SHI in patients with head and neck cancer would be useful. [ABSTRACT FROM AUTHOR]