VOICE, SWALLOWING, AND QUALITY OF LIFE AFTER TOTAL LARYNGECTOMY RESULTS OF THE WEST OF SCOTLAND LARYNGECTOMY AUDIT

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1 ORIGINAL ARTICLE VOICE, SWALLOWING, AND QUALITY OF LIFE AFTER TOTAL LARYNGECTOMY RESULTS OF THE WEST OF SCOTLAND LARYNGECTOMY AUDIT Stuart M. Robertson, FRCSGlasg(ORL-HNS), 1 Justin C. L. Yeo, MRCS, 1 Catherine Dunnet, BSc(Hons), 2,3 David Young, PhD, 4 Kenneth MacKenzie, FRCS(Ed) 1,3 1 Department of Otolaryngology, Head and Neck Surgery, Glasgow Royal Infirmary, United Kingdom. stuart@glasgow.org 2 Department of Speech and Language Therapy, Glasgow Royal Infirmary, United Kingdom 3 West of Scotland Managed Clinical Network for Head and Neck Cancer, United Kingdom 4 Department of Mathematics and Statistics, Strathclyde University, United Kingdom Accepted 22 October 2010 Published online 17 March 2011 in Wiley Online Library (wileyonlinelibrary.com). DOI: /hed Abstract: Background. The purpose of this study was to determine the effects of radiotherapy and surgical voice restoration on functional outcome after total. Methods. Questionnaire packs were posted to all 258 in the West of Scotland Managed Clinical Network. Packs contained the Voice Symptom Scale (VoiSS), MD Anderson Dysphagia Inventory (MDADI), and University of Washington Quality of Life Questionnaire (UW-QOL). Results. Significantly better VoiSS and MDADI scores were reported by undergoing alone in comparison with receiving adjuvant radiotherapy and undergoing salvage (p <.02). Patients using tracheoesophageal voice reported significantly better VoiSS scores than using other communication methods (p <.005). Conclusion. Radiotherapy has a highly significant and detrimental effect on voice and swallowing outcome after total. Surgical voice restoration confers significant benefit in terms of self-reported voice outcome. These findings have implications for with advanced laryngeal cancer considering and organ preservation. VC 2011 Wiley Periodicals, Inc. Head Neck 34: 59 65, 2012 Keywords: ; voice; swallowing; quality of life Protocol-driven management based on the best available clinical evidence has become the standard of care in modern head and neck surgical oncology. 1 3 Accordingly, there has been a comprehensive change in the management of advanced laryngeal cancer in the past 20 years. The global adoption of organ preservation strategies utilizing chemoradiotherapy has resulted in the relative demise of primary surgery. The incidence of laryngeal cancer in Correspondence to: S. M. Robertson This work was presented at the Annual Scientific Meeting of the Australian Society of Otolaryngology Head and Neck Surgery in Sydney, Australia, on March 29, VC 2011 Wiley Periodicals, Inc. Scotland is rising and local audit data confirm the popularity of organ preservation, with a significant reduction in the number of cases performed annually since 2002 (Figures 1 and 2). In North America, where the landmark evidence supporting organ preservation originated, survival rates from laryngeal cancer have deteriorated in the last 20 years. 4 Accordingly, significant concerns have been raised in the recent literature regarding the contemporary dominance of organ-preservation strategies. 5 The pretreatment counseling of contemplating organ preservation remains problematic. It is difficult to give an accurate estimation of the likely success rate of primary organ preservation. In the landmark Veterans Affairs (VA) study, the failure rate of induction chemotherapy and subsequent radiotherapy was 29% for stage 3 disease and 56% for T4 disease. 6 The European Organization for Research and Treatment of Cancer trial randomized 194 with T2 to T4 squamous cell carcinoma of the pyriform sinus and aryepiglottic fold to either primary with adjuvant radiotherapy or organ preservation. 7 The failure rate of organ preservation was 44%. A total of 13% of organ-preserved survivors required a tracheostomy and 9% required enteral feeding. After publication of the Radiation Therapy Oncology Group (RTOG) trial in 1993, the use of induction chemotherapy to select suitable for organ preservation was widely abandoned in favor of primary chemoradiotherapy regimens. 8 This has created further difficulties with pretreatment counseling because the rate of mucosal toxicity in the chemoradiotherapy group of RTOG was nearly twice that of the other groups. After 1 year, 23% of these could only swallow a soft food or liquid diet and 3% could not swallow at all. 8 An important hypothesis of organ preservation is that a cure is achievable while maintaining a Determinants of Functional Outcome after Total Laryngectomy HEAD & NECK DOI /hed January

2 FIGURE 1. Changing incidence of laryngeal cancer in Scotland. (Source: Information Services Division, Edinburgh, Scotland 2004.) [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.] reasonable expectation that salvage will be avoided. This statement of intent is necessary because the surgical morbidity of salvage is significantly greater than that of primary. 9 Another hypothesis of organ preservation is that a superior functional outcome and better quality of life can be achieved with nonsurgical primary treatment. 6 The long-term follow-up data from the VA trial published in 1998 remains the best available evidence comparing the voice outcome of organpreserved and non organ-preserved survivors. 10,11 At a median follow-up time of 5 years after treatment, voice assessment was undertaken with perceptual and acoustic analysis of recorded speech and subjective voice assessment using an unvalidated adaptation of the Northwestern Otolaryngology Communication Profile questionnaire. 10 Organ-preserved demonstrated significantly better intelligibility and Communication Profile scores than after 5 years. 10 No difference in voice outcome was demonstrable after 10 years. 11 The relevance of these follow-up data to modern practice remains limited because of the communication methods available to in the 1980s. Less than one-third of in the VA cohort achieved tracheoesophageal voice and more than half communicated with an electrolarynx. 10 In modern practice, tracheoesophageal voice is routinely achieved by up to 90% of larygectomy. 12 In the VA cohort, larygectomy undergoing surgical voice restoration (SVR) achieved the most rapid recovery in speech intelligibility and regained their pretreatment Communication Profile score with a comparable reading rate. 10 Although there is a modern published consensus that SVR is desirable, there remains a comprehensive lack of data in the modern literature regarding the self-reported voice outcome of using tracheoesophageal voice. 1,2 The relevance of VA follow-up data to modern practice is limited further by the inherent mucosal toxicity of adjuvant radiotherapy in. Seventy five percent of the VA trial randomized to had a primary staging of less than or equal to T3 and 57% had N0 disease. Despite this, every individual received postoperative radiotherapy with a dose of between 66 Gy and 76 Gy delivered to the neopharynx. 6 There is a modern published consensus that primary surgery alone is an acceptable treatment for T3 laryngeal disease in the absence of specific adverse clinical and pathological features. 1 3 The specific impact of radiotherapy on the functional outcome of remains undefined but is of great relevance to the organ-preservation debate. Aims. The principal purpose of the West of Scotland Laryngectomy Audit was to quantify the detrimental effect of radiotherapy on the functional outcome of. A secondary purpose was to determine the specific effect of SVR on self-reported voice outcome. Ethical Considerations. Approval to conduct this study was granted by the Research Committee and Advisory Board of the West of Scotland Managed Clinical Network (MCN) for Head and Neck Cancer. MATERIALS AND METHODS Participants. In July 2009, all 258 total registered within the West of Scotland MCN for Head and Neck Cancer were sent a questionnaire pack to complete and return by post. The West of Scotland MCN comprises 8 clinical units providing head and neck cancer services to approximately 2.8 million and 60% of the Scottish population. Informed consent was assumed by the return and completion of the anonymous questionnaires. Patients were asked to complete a data FIGURE 2. Significant reduction in number of cases performed in North Glasgow since 1999 (p <.002). (Source: local audit data.) [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.] 60 Determinants of Functional Outcome after Total Laryngectomy HEAD & NECK DOI /hed January 2012

3 collection form, which detailed the length of time since undergoing total surgery, whether radiotherapy was received before or after surgery, and whether were currently supported by an enteral feeding route. To assess voice, swallowing, and quality of life, the Voice Symptoms Scale (VoiSS), MD Anderson Dysphagia Inventory (MDADI), and the University of Washington Quality of Life (UW- QOL) questionnaires were used, respectively. Hospital records were reviewed to identify cases in which flap reconstruction was undertaken in addition to. Questionnaires Voice Symptoms Scale. Patient-based subjective voice assessment is an established method of quantifying dysphonia and voice-related quality of life across a wide spectrum of voice disorders including benign and malignant disease. VoiSS is well validated and has been shown to correlate strongly with subjective voice analysis performed by speech and language therapists. 13 VoiSS is the most extensively validated and psychometrically robust voice questionnaire currently available. 14 In addition, VoiSS is innovative with the inclusion of a Physical domain to sample pharyngeal symptoms which are directly associated with dysphonia. The 30-item VoiSS questionnaire yields a score from 1 to 120 with a higher score reflecting a greater severity of dysphonia and poorer voice-related quality of life. 13 MD Anderson Dysphagia Inventory. The MDADI has been rigorously validated in populations of with head and neck cancer and comprises 20 statements related to dysphagia in 4 subscales. 15 The Global subscale reflects the impact of swallowing on daily routine and overall quality of life. The Emotional subscale reflects affective response to dysphagia, whereas the Functional subscale reflects the impact of swallowing on daily activities. The Physical subscale reflects how perceive their swallowing ability. Patients select 1 of 5 possible responses for each statement (strongly agree, agree, no opinion, disagree, and strongly disagree). This yields individual scores for each statement on a scale of 1 to 5 and a total score of 20 to 100. Responses were scored in the standard way for each subscale in the current study. 15 A higher MDADI total score reflects better swallowing function and swallowingrelated quality of life. University of Washington Quality of Life Questionnaire. This well-validated outcomes scale has 3 distinct parts. 16 The first part comprises 12 domains representing pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood, and anxiety. There are 3 to 5 possible responses yielding a score from 0 to 100 for each domain. The second part of UW-QOL enables the patient to choose which 3 of the 12 domains have been the most important in the past 7 days. The third part of the questionnaire comprises 3 general questions asking the patient to (1) compare current quality of life with perceived quality of life the month before diagnosis, (2) document health-related quality of life in the past 7 days, and (3) document overall quality of life in the past 7 days. 19 Higher questionnaire scores in each of the 3 domains reflect better quality of life. Statistical Analysis. Questionnaire responses were reported descriptively as medians and ranges. Between group comparisons were done using the Mann Whitney or Kruskal Wallis tests. All analyses were done using Minitab (version 15; Minitab, Las Vegas, NV) at a significance level of 5%. RESULTS Demographics and Treatment Groups. One hundred ninety of 258 returned fully completed questionnaires (73.6% response rate). Eleven were excluded from further analysis. Nine of these individuals had undergone surgery less than 12 months ago, 1 patient had an underlying diagnosis of laryngeal sarcoma, and another had received radiotherapy for nasopharyngeal carcinoma before being diagnosed with a second primary squamous carcinoma of the hypopharynx. This individual was treated with neoadjuvant chemoradiotherapy followed by laryngo-pharyngectomy. In the final cohort of 179, 141 were men and 38 were women (M:F ratio 3.7:1.0). The median age of was 68 years (range, 41 90). The median time elapsed since surgery was 96 months (range, ). There were no differences between the demographic profile or median time since surgery of the final cohort and the group of that did not return fully completed questionnaires (Table 1). Twenty-six had been treated with primary alone, 88 received postoperative radiotherapy, and 65 had undergone salvage after failure of organ preservation. Data on flap reconstruction were available for 145 of 179 (81%) of whom only 12 individuals (8%) underwent flap reconstruction. Table 1. Comparison of responder and nonresponder groups. Nonresponder Responder Male sex, % 75% 79% Median age, y 68 (53 89) 68 (16 90) Median years since operation 7 (1 21) 7 (0 27) Determinants of Functional Outcome after Total Laryngectomy HEAD & NECK DOI /hed January

4 Table 2. VoiSS scores subdivided into habitual communication types. Habitual communication type Tracheoesophageal voice Total VoiSS score Median Mouthing Esophageal voice Artificial larynx Abbreviation: VoiSS, Voice Symptom Scale. Voice Outcomes. One hundred fifty six of 179 (87.1%) confirmed that they used a tracheoesophageal prosthesis for communication (SVR ), 11 (6.1%) used a mouthing method, 6 (3.4%) used an artificial larynx device, and 6 (3.4%) used esophageal speech (Table 2). The overall median Total VoiSS score of the cohort was 44 (range, 7 120) with median Total scores of 42 (range, 7 120) for men and 53 (range, ) for women. The SVR reported significantly better median Total VoiSS scores (p ¼.0043; Mann Whitney test) and significantly better scores in the Impairment VoiSS domain (p ¼.0005; Mann Whitney test) than using other methods of communication (Table 3). There was no significant difference in the median VoiSS scores of with SVR when subdivided into groups based on time elapsed since undergoing surgery (p ¼.592; Kruskal Wallis test; Table 4). Patients with SVR treated with primary alone had significantly better median Total VoiSS scores than both the salvage cohort and the treated with primary and adjuvant radiotherapy (p ¼.014; Kruskal Wallis test; Table 5). Swallowing Outcomes. The median Total MDADI score in the cohort was 67.4 (range, 0 100). The median Global score was 60.0 with median Emotional, Functional, and Physical scores of 70.0, 72.0, and 65.0, Table 3. scores in SVR and non-svr. Total score Emotional score Physical score Impairment score SVR (n ¼ 163) Non-SVR (n ¼ 25) Mann Whitney test 42 (7 114) 65 (11 120) p ¼ (0 32) 14 (0 32) p ¼ (0 23) 11 (2 28) p ¼ (3 59) 42 (9 60) p ¼.0005 Abbreviations: VoiSS, Voice Symptom Scale; SVR, surgical voice restoration. Table 4. VoiSS scores of SVR subdivided into time since surgery. Years since VoiSS scores > > > Abbreviations: VoiSS, Voice Symptom Scale; SVR, surgical voice restoration. respectively (range, of 0 100). There were no significant changes in the median Total MDADI scores for each domain when subdivided into groups based on time elapsed since undergoing surgery (p ¼.802; Kruskal Wallis test; Table 6). Patients treated with primary alone reported significantly better median Total MDADI scores than both the salvage cohort and the treated with primary and adjuvant radiotherapy (p ¼.0004; Kruskal Wallis test; Table 7). There was no difference between the median Total MDADI scores of the salvage cohort and the treated with primary and adjuvant radiotherapy. Quality of Life. The median composite UW-QOL score in the cohort was 72.9 (range, ). The median scores for each domain are shown in Table 8. Male (median 73.8; range, ) reported significantly better composite quality of life scores than female (median, 67.9; range, ; p ¼.0359; Mann Whitney test). The domains identified as representing the most important quality of Table 5. VoiSS scores of SVR subdivided into treatment groups. Cohort with adjuvant radiotherapy Salvage VoiSS scores Abbreviations: VoiSS, Voice Symptom Scale; SVR, surgical voice restoration. Table 6. MDADI scores subdivided into years since surgery. Years since op MDADI scores > > > Abbreviations: MDADI, MD Anderson Dysphagia Inventory; op, operation. 62 Determinants of Functional Outcome after Total Laryngectomy HEAD & NECK DOI /hed January 2012

5 Table 7. MDADI scores subdivided into treatment groups. Cohort MDADI scores with adjuvant radiotherapy Salvage Abbreviations: MDADI, MD Anderson Dysphagia Inventory. life issues (over the past 7 days) are shown in Figure 3. Speech was the most commonly cited domain (n ¼ 76; 42.5%), followed by swallowing (n ¼ 67; 37.4%). In terms of overall QOL during the past 7 days, 63.1% of cited it as good or very good. The median UW-QOL Speech Domain score of with SVR was significantly better than that of using other methods of communication (p ¼.0004; Mann Whitney test; Table 9). The median UW-QOL Swallowing Domain score of undergoing alone was significantly better than those receiving radiotherapy (p ¼.0197; Kruskal Wallis test; Table 10). The median composite UW-QOL score of undergoing alone was also significantly better than those receiving radiotherapy (p ¼.0034; Kruskal Wallis test). No differences were found between the median composite UW-QOL scores of when comparing communication methods. Nutritional Support. Eight of 179 (4.5%) stated that they were currently using a gastrostomy tube for dietary intake at the time of completing the questionnaires. FIGURE 3. University of Washington Quality of Life Questionnaire (UW-QOL) scores issues reported as Most important in past 7 days. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.] in the current study. Significantly better voice and swallowing outcomes were reported by individuals undergoing total alone. Radiotherapy had a highly significant and detrimental effect on functional outcome. A previous study by Paleri et al 17 in 2001 failed to demonstrate this adverse treatment effect. This is presumably explained by the small sample size of this study (n ¼ 29). It is not disputed that organ preservation remains a very good treatment for many with advanced laryngeal disease. However, 1 in 3 total layngectomy in the West of Scotland have undergone salvage surgery after failure of organ preservation. The current study has confirmed that these specific individuals report by far the worst functional outcome of all. It is apparent that when total is required to achieve a cure, the best functional result is likely to be achieved by avoiding radiotherapy. In cases of T3 disease in DISCUSSION To our knowledge, the West of Scotland Laryngectomy Audit constitutes the largest such dataset of functional and quality of life outcomes in the literature. Voice and swallowing were cited as the most important quality of life issues by more than 80% of Table 8. Median UW-QOL scores for each domain. Table 9. Median UW-QOL Speech Domain scores subdivided into habitual communication types. Group Median UW-QOL Speech Domain Score Tracheoesophageal (0 100) voice Other methods (0 100) Abbreviation: UW-QOL, University of Washington Quality of Life Questionnaire. Domains Minimum Median Maximum Pain Appearance Activity Recreation Swallowing Chewing Speech Shoulder Taste Saliva Mood Anxiety Abbreviation: UW-QOL, University of Washington Quality of Life Questionnaire. Table 10. Median UW-QOL Swallowing Domain scores subdivided into treatment groups. Median UW-QOL Swallowing Domain score Group (30 100) (0 100) with adjuvant radiotherapy Salvage (0 100) Abbreviation: UW-QOL, University of Washington Quality of Life Questionnaire. Determinants of Functional Outcome after Total Laryngectomy HEAD & NECK DOI /hed January

6 which surgical treatment alone is feasible in the context of clear resection margins and favorable pathological features, a relatively good functional outcome may be realized. Treatment Algorithms in Advanced Laryngeal Cancer. With modern imaging modalities, the clinical distinction between T3 and T4 disease is relatively simple. Yet despite the clarity of published algorithms and protocols, determination of whether organ preservation is achievable or realistic remains difficult on an individual patient basis. Published guidelines advocate primary with adjuvant radiotherapy for cases of T4 disease with complete penetration of tumor through cartilage or significant extension into the extralaryngeal soft tissues. 1 3 Organ preservation is advocated for cases of T4a supraglottic disease with less than 1 centimeter of tongue base invasion and incomplete cartilage penetrance based on the results of the RTOG trial. 3,8 Modern treatment options for T3 disease include primary with or without neck dissection and adjuvant radiotherapy and primary radiotherapy with or without chemotherapy leaving the option of salvage surgery. Neck status, margin clearance, and tumor characteristics are all cited as factors relevant to this decision-making process. 1 3 It is accepted that T classification correlates poorly with tumor volume and with T3 disease represent a diverse population in terms of tumor volume and extent of disease. It has been demonstrated that tumor volume is a significant predictor of outcome for T3 glottic disease treated with radical radiotherapy. 18 Published United Kingdom protocols advocate management with primary organ preservation for low-volume T3 laryngeal disease and primary total for high-volume T3 disease with an emphasis on patient choice and performance status. 1,2 Although with T2 or early T3 disease may expect organ preservation rates exceeding 80%, as demonstrated by the RTOG trial, 8 it seems unlikely that such optimism could apply to where disease is staged as T3 but with vocal cord fixation, arytenoid fixation, or incomplete thyroid cartilage invasion. Accordingly, it remains difficult to quantify the odds of achieving successful primary organ preservation as part of a truly informed consent process. The toxicity of modern radical chemoradiotherapy regimens added to the significantly increased surgical morbidity of salvage makes this process even more difficult. 9 Voice-Related Quality of Life. There remains a published consensus that SVR with tracheoesophageal voice is desirable after total. 1,2 The current study has demonstrated that SVR rates approaching 90% are achievable in modern practice and that using tracheoesophageal voice have a significantly better self-reported voice outcome and voice-related quality of life than using other methods of communication. These results challenge the findings of a recent smaller study from a similar UK population which concluded that SVR and non-svr voice outcomes are comparable. 19 This finding may be explained by the small sample size of this study (n ¼ 53) and the fact that an SVR rate of less than 50% was achieved. The current study has confirmed the necessity of specialized speech and language therapy services to support the management and rehabilitation of voice in. It has been reported previously, albeit in much smaller cohorts, that the voice-related quality of life of is similar to that of with benign laryngeal disorders. 19 For the purposes of statistical comparison, the mean VoiSS scores of in the current study were calculated. As shown in Table 11, there was no difference between the mean Total VoiSS score of and the published mean Total VoiSS score of with benign laryngeal disease. 14 The mean Emotional VoiSS score of was significantly worse, although the mean Physical and Impairment domain scores were remarkably similar between the groups. 14 This analysis suggests that either the self-reported voice outcome of voice-restored is better than expected or the self-reported voice outcome of with benign laryngeal disease is worse than expected. Table 11. Comparing mean VoiSS scores between diagnostic groups. Group Mean Total VoiSS score (SD) Mean VoiSS Impairment score (SD) Mean VoiSS Emotional score (SD) Mean VoiSS Physical score (SD) Laryngectomy cohort (n ¼ 179) Benign laryngeal pathology (n ¼ 145) 14 p value (unpaired t test with Welch correction) 48.7 (24.1) 29.8 (12.5) 9.8 (9.4) 9.1 (5.0) 46.5 (20.4) 29.7 (12.3) 7.6 (4.4) 9.5 (4.8) Abbreviation: VoiSS, Voice Symptom Scale. 64 Determinants of Functional Outcome after Total Laryngectomy HEAD & NECK DOI /hed January 2012

7 The Future. Measuring the functional outcome and quality of life of with cancer remains a fundamentally important but difficult process. What constitutes a change in quality of life is likely to differ greatly between individuals and this may be particularly marked between from different socioeconomic groups. Pretreatment functional disability and quality of life must be taken into consideration. There remains a notable lack of published data characterizing self-reported voice, swallowing, and quality of life at the time laryngeal cancer is diagnosed. A prospective and multicenter clinical audit documenting the longitudinal changes in the functional outcome, quality of life, and survival of with advanced laryngeal cancer is clearly indicated. Such a study would clarify the failure rate of modern organ preservation for cases of advanced laryngeal cancer staged accurately with modern imaging modalities. A direct comparison between the self-reported functional outcome of cured with organ preservation and those cured with surgery alone would also be achieved. Patients with T3 laryngeal cancer in particular deserve better pretreatment counseling on the likely success rate of organ preservation and the functional outcome that may realistically be expected from both organ preserving and nonorgan preserving treatments. Acknowledgments. The authors would like to thank the following individuals for their contribution to data collection: Mrs. Sarah de Blieck (Speech and Language Therapist, Gartnavel General Hospital, Glasgow), Mrs. Lynsey Brennan (Speech and Language Therapist, Stobhill Hospital, Glasgow), Ms. Yvonne Hamilton (Speech and Language Therapist, Crosshouse Hospital, Kilmarnock), Mrs. Sandra Kinnear (Speech and Language Therapist, Stirling Royal Infirmary), Ms. Myra Lockhart (Speech and Language Therapist, Monklands Hospital, Airdrie), Mrs. Eleanor Slaven (Speech and Language Therapist, Southern General Hospital, Glasgow), and Mrs. Jan Stanier (Speech and Language Therapist, Royal Alexandra Hospital, Paisley). REFERENCES 1. Scottish Intercollegiate Guidelines Network (SIGN). Diagnosis and management of head and neck cancer (Guideline 90). Edinburgh; SIGN; British Association of Otolaryngologists, Head and Neck Surgeons (BAOHNS). Effective Head and Neck Cancer Management (Third Consensus Document). 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