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Title: Functional outcomes in early (T1/T2) supraglottic cancer: a systematic review |
Abstract |
Objectives: Organ preserving surgery (OPS) and radiotherapy (RT) are both accepted treatment options for early stage supraglottic cancer (SGC). Radiation has supplanted surgery in most cases, because of the perception that surgery results in poorer functional outcomes. However, evidence suggests that OPS with a neck di... |
Methods: We searched Medline, EMBASE and Cochrane Central Register of Controlled Trials to identify studies. Studies were included if they reported functional outcomes on 10 or more patients with early stage SGC treated with radiation or OPS, including open partial laryngectomy, transoral laser microsurgery (TLM) or tr... |
Results: From 7720 references, we included 10 articles (n = 640 patients). 50% (n = 320) of patients were treated with surgery. Three head-to-head RT versus OPS papers were included, however different outcome measures were used for each group. Intractable aspiration management (including total laryngectomy or permanent... |
Conclusions: This systematic review revealed a paucity of objective measures and significant data heterogeneity, rendering the comparison of functional outcomes following OPS versus RT for early SGC limited. Future research should include objective measures of functional outcomes including laryngectomy rate, g-tube rat... |
Keywords: Early stage, Supraglottic squamous cell carcinoma, Supraglottic SCC, Outcomes, Systematic review, Functional outcomes |
Introduction |
Early stage supraglottic squamous cell carcinoma (SSCC) includes T1 tumours, isolated to one subsite of the supra- glottis with normal vocal cord function, or T2 tumours, involving more than one subsite of the supraglottis, glottis, or surrounding tissue, without evidence of regional disease spread [1]. A recent study ... |
Methods |
A systematic review protocol was developed a priori to en- sure the objectives and aims were outlined from the outset. Computerized bibliographic databases: Medline, EMBASE and Cochrane Central Register of Controlled Trials were searched to identify studies. English language records were included from January 1990 to O... |
Results |
The search strategy produced 7720 records. After dupli- cate records were removed from the search, 5218 unique records remained. After reviewing the titles, 1187 abstracts were deemed appropriate for abstract review. Following abstract review, 115 studies were appropriate for full text review. Ten studies met the final... |
CONCLUSIONS: |
There is an overall paucity of literature available regarding functional outcomes in the treatment of early stage SSCC patients, the majority of which is moderate in overall quality and retrospective in nature. The majority of the data does not reflect the treatment algorithms of today, with the introduction of focused... |
Study characteristics and methodologic quality |
There were no randomized controlled trials comparing the functional outcomes of primary surgery versus radiation. Of the 10 studies included in the analysis, 6 were retrospective cohort studies, 4 were case series. There were no prospective studies included. There were 320 patients treated with OPS, including open part... |
Aspiration |
Aspiration was deemed a primary functional outcome measure of assessment. It was reported in 5 studies [11, 14, 19–21]. In one paper, this was evaluated under direct visualization with a functional endoscopic examination of swallowing, where the authors documented liquid penetration. The remainder of the papers reporte... |
Intractable aspiration management |
In many of the studies, rate of functional laryngectomy and permanent tracheostomy dependence was reported. These statistics included some, but not all, of the pa- tients who experienced late complications associated with aspiration events. This was reported in 5 studies, accounting for 186 surgical patients and 198 ra... |
Permanent gastrostomy tube and swallowing dysfunction |
The rate of permanent gastrostomy tube was reported in four studies for the OPS group. This accounted for 198 patients. This outcome measure was not reported for the radiation group in any of the studies. The pooled event ratio for permanent gastrostomy tube dependence is 5.3% (95% CI 2.6–10.5%) (Fig. 8). |
Additionally, Chun et al. compared OPS to RT with respect to functional outcomes of swallowing and speech. To evaluate swallowing, patients underwent a functional endoscopic examination of swallowing (FEES) using videoesophagofluoroscopy. The researchers looked specifically for evidence of aspiration. Liquid aspiration... |
Quality of life and voice outcomes |
Quality of life data was reported in one study. Another study reported objective voice outcome measures. Oridate et al. compared VRQOL, VHI-10, and GRBAS scores for T2 N0 SSCC against T1a, T1b, and T2 N0 glottic carcin- omas and found no significant differences in functional outcomes [22]. |
Chun et al. used stroboscopy and acoustic waveform ana- lysis to objectively evaluate voice outcomes. Abnormalities were in mucosal waveforms were identified 13% of the OPS cohort (n = 2) and 20% of the RT group (n = 2). These find- ings were not statistically significant [11]. |
Discussion |
To our knowledge, this is the first systematic review evaluating the functional outcomes of surgery versus radiother- apy for early-stage SSCC. All studies that met inclusion criteria were retrospective in design and there were 3 head-to-head comparisons of surgery versus radiation. Aspiration events, management of int... |
Aspiration events were reported, in many cases, with little additional information. In some studies, these were clinically evident respiratory events, such as aspiration pneumonias that occurred late in the post-operative course, others reported only the number patients that experienced aspiration. Aspiration events ar... |
For intractable aspiration intervention, there was data from both the surgical and radiation cohorts from multiple studies. This was reported as permanent trache- ostomy dependence or conversion to a functional total laryngectomy. We calculated pooled event rates as well as pooled odds ratio. From the current data avai... |
With respect to permanent gastrostomy tube rate, there was no available data for the radiation cohort. Four papers reported this outcome measure for the surgical group (n = 198 patients). As a result, we were unable to make comparisons across the two treatment modalities. |
Subjective and objective measures of voice outcome were sparsely and inconsistently reported. Quality of life measures were found in just one study, which actually compared T2N0 supraglottic cancers to early glottic cancers. |
Surgery and radiotherapy for early stage SSCC |
Several factors are important in considering treatment options for patients with early laryngeal cancer. Survival outcomes are obviously at the forefront. While there is no RCT data comparing survival outcomes of patients with early SSCC, a 2016 meta-analysis by Patel et al. studying early stage SSCC suggests that pati... |
Over the last 40 years the treatment of early stage laryngeal cancer has evolved [23, 24]. Surgery, in the form of open partial laryngectomy, was initially popular how- ever many patients had poor functional outcomes including aspiration and impaired base of tongue and laryngeal movements leading to swallowing dysfunct... |
There are several advantages of RT. It preserves the laryngeal structures, it is generally well tolerated by patients, and increases surgical exposure to achieve excellent oncologic outcomes [26–29]. Radiation provides an effective treatment modality for patients not considered candidates for OPS due to their comorbid ... |
Surgical approaches include open surgery or transoral surgical approaches, including laser (TLM) and robotic (TORS). Organ-preserving surgery, both open and endoscopic approaches, offer several advantages over RT. As mentioned, patients with SSCC have reasonable 5-year overall survival rates, albeit with an increased r... |
Dombree et al. analyzed the cost of open supraglottic laryngectomy, TLM, and TORS in a Belgian model. Their study suggests the cost of open supraglottic laryn- gectomy similar to that of TLM in upfront surgical costs [31]. TORS tends to be more expensive primarily due to purchase and maintenance costs [31]. This study ... |
There are also disadvantages of surgery, including risk of general anesthetic, particularly in patients with comor- bidities, bleeding, and infection. Pharyngocutaneous fis- tula, dysphagia and permanent tracheostomy dependence are specific risks of supraglottic laryngectomies. A criti- cism of OPS are the associated p... |
Strengths |
There are several strengths to this review. To our know- ledge, this is the first comprehensive review of all available literature comparing functional outcomes between surgery versus radiation for patients with early stage SSCC. It was designed, conducted and reported in accordance with published guidelines (PRISMA) a... |
Limitations |
As with all systematic reviews, the strength of the conclu- sions that can be drawn from this study depend on the quality of the primary studies. The included studies were evaluated with the Newcastle-Ottawa Scale for Assessing Cohort Studies, most of which were of moderate in overall quality. Next, although we only in... |
All 10 studies that met the inclusion criteria were retrospective study designs and there were no randomized controlled trials. Retrospective studies have inherent biases including selection biases. Patient’s with medical comorbidities may not have been deemed appropriate surgical candidates and only offered radiothera... |
Significant heterogeneity was noted between the out- come measures of the included studies. In the surgical group, not all patients may have received the same type or extent of surgery, including elective neck dissections, TLM, and TORS operations. We only considered English language studies for our systematic review, ... |
The heterogeneity of the functional outcomes reported limited our ability to meta-analyze the data. Additionally, many of the outcomes were sparsely reported or reported for only one of the arms of study, either OPS or RT. The overall paucity of data limits our ability to draw conclusions. |
Given the lack of high level evidence guiding the opti- mal management of early stage supraglottic cancer and potential biases of retrospective studies, a head to head comparison between newer modalities such as TLM and TORS with RT is critical in determining the therapeutic algorithm that can yield better functional o... |
Traditionally, studies comparing surgery and radiation have been challenging to accrue patients to. Ongoing efforts comparing OPS to RT for oropharyngeal cancer are underway and actively accruing [60, 61], demonstrating that a head-to-head comparison of surgery and radiation is a possibility for patients with early sta... |
Conclusions |
There is an overall paucity of literature available regarding functional outcomes in the treatment of early stage SSCC patients, the majority of which is moderate in overall quality and retrospective in nature. The majority of the data does not reflect the treatment algorithms of today, with the introduction of focused... |
Moving forward, we propose that aspiration, intract- able aspiration intervention, permanent gastrostomy tube requirements, and objective quality of life scales as objective measures that should be included in future re- search on this topic. Future studies and research should include well designed prospective trials w... |
Title: Cannabinoid Use in the Treatment of Laryngeal Dystonia and Vocal Tremor: A Pilot Investigation |
Abstract: |
Objectives/hypothesis. Laryngeal dystonia and vocal tremor can be debilitating conditions with
suboptimal treatment options. Botulinum toxin chemodenervation is typically the first-line treatment and is considered the gold standard. However, patient response to botulinum toxin varies widely. There is anecdotal evidence... |
Study Design. This is a cross-sectional survey study. |
Methods. An eight-question anonymous survey was distributed to people with abductor spasmodic dysphonia adductor spasmodic dysphonia, vocal tremor, muscle tension dysphonia, and mixed laryngeal dystonia via the Dysphonia International (formerly National Spasmodic Dysphonia Association) email listserv. |
Results. 158 responses: 25 males and 133 females, (mean [range] age, 64.9 [22–95] years). 53.8% of participants had tried cannabinoids for the purposes of treating their condition at some point, with 52.9% of this subset actively using cannabis as part of their treatment. Most participants who have used cannabinoids as... |
Conclusions. People with laryngeal dystonia and/or vocal tremor currently use or have tried using cannabinoids as a treatment for their condition. Cannabinoids were better received as a supplementary treatment than as a stand-alone treatment. |
Key Words: Cannabinoids–Laryngeal dystonia–Muscle tension dysphonia–Vocal tremor–Spasmodic dysphonia–Botox chemodenervation. |
INTRODUCTION |
There is currently no curative treatment for laryngeal dystonia and vocal tremor. Laryngeal dystonia is a neurogenic condition that is categorized by spasms in the adductor muscles in the vocal folds, abductor muscles, or a mix of both muscle groups.1 Adductor spasmodic dysphonia is the most commonly diagnosed conditio... |
MATERIALS AND METHODS |
This study was approved by the Institutional Review Board of the University of Southern California (UP-21-00354). This study used a cross-sectional survey methodology utilizing a responsive questionnaire composed of eight primary questions. This electronic survey was developed using skip logic, presenting varied questi... |
RESULTS |
Participant demographics The survey included a total of 158 participants comprised of responses from 133 cisgender female participants and 25 cisgender male participants with a mean age of 64.8 years old and participant age ranging from 22 years old to 95 years old (Figure 1). Adductor spasmodic dysphonia was the most ... |
LIMITATIONS |
As an electronic survey, this study is limited to participants who have Internet access. The electronic link was distributed exclusively through the Dystonia International (previously National Spasmodic Dysphonia Association) listserv, limiting the diversity of the sample population. The intrinsic nature of online surv... |
CONCLUSION |
A considerable number of patients with vocal dystonia have tried using cannabinoid products or currently use cannabinoids to treat their laryngeal dystonia, vocal tremor, and MTD. Most participants considered cannabinoids as either less effective or similarly effective to other treatments in treating their vocal dyston... |
Title: Safety of Platelet-Rich Plasma Subepithelial Infusion for Vocal Fold Scar, Sulcus, and Atrophy |
Abstract |
Objective: To demonstrate the safety profile of platelet-rich plasma (PRP) as an injectable therapeutic for the treatment of vocal fold scarring and atrophy. |
Methods: Preliminary report on a prospective clinical trial of patients with vocal fold scar or atrophy undergoing unilateral vocal fold subepithelial infusion with autologous PRP. Enrolled patients underwent four sub- epithelial injections spaced 1 month apart. Adverse events were assessed peri and post-injection at e... |
Results: Twelve patients underwent unilateral vocal fold injection with autologous PRP prepared according to Eclipse ® |
Conclusion: This prospective study cohort demonstrated a favorable safety profile, with no adverse events or peri-procedural complications. Subjective improvements in vocal quality and reduction in vocal fatigue need to be clinically correlated with further study. |
Key Words: platelet-rich plasma, vocal fold scar, superficial lamina propria, vocal fold atrophy. Level of Evidence: 4 |
PRP system protocol. Forty-three injections were performed using a peroral or percutaneous approach. An average of 1.57 0.4 cc (range 0.6–2.0 cc) injectate was used. All patients tolerated the procedure without difficulty or peri-procedural complications. The average duration of follow-up was 3.6 1.8 months. No signifi... |
INTRODUCTION |
Vocal fold atrophy and scar are causes of dysphonia that pose major treatment challenges for laryngologists.1 The etiology of vocal fold scar is diverse, potentially stemming from phonotrauma, phonomicrosurgery, iatrogenic injury, malignancy, and radiation therapy.2,3 Addition- ally, loss of hyaluronic acid, elastic fi... |
The most common initial treatment for vocal fold atrophy condition is voice therapy administered by a specialized speech-language pathologist spaced out over multiple monthly sessions. Voice therapy introduces logistical strains in the elderly population, such as coordinating transportation across several sessions, and... |
For patients with vocal fold scar, a range of surgical procedures from augmentation laryngoplasty,9 angiolytic laser procedures,10 tissue grafting,11 and Gray’s mini- thyrotomy12 have been described, which also provide inconsistent improvement.13 Recent experimental studies have explored the prospect of restoring norma... |
Platelet-rich plasma (PRP) consists of platelets, growth factors, cytokines, and cell adhesion molecules derived from the patient’s own blood.16 PRP is believed to activate tissue regeneration by introducing high concentrations of platelet-derived growth factors and fibrin into damaged or atrophied tissue.17 Studies in... |
This study aims to evaluate the safety profile of autologous PRP for use as an injectable therapeutic in the vocal fold. Secondarily, we aim to determine the clini- cal efficacy of serial PRP vocal fold injections regarding patient-reported outcome measures and longevity of clinical effects from serial PRP vocal fold i... |
MATERIALS AND METHODS |
Study Population: This study was approved by the University of Southern California Institutional Review Board. Patients were enrolled as part of an ongoing prospective clinical trial (clinicaltrials. gov APP-18-05224) consisting of a series of four unilateral vocal fold injections with autologous platelet-rich plasma. ... |
Clinical Protocol: The clinical protocol for this clinical trial is outlined in Figure 1. As part of the initial intake, patients completed the Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI). During their initial visit, a complete history and physical examination were performed along with voice and lary... |
Drug/Device Information and Administration: The leukocyte poor platelet-rich plasma preparation was achieved via the Eclipse PRP® system manufactured by Eclipse® medical device (BK110035). Activation of PRP in our study is accomplished without exogenous substances by relying on shear force from injection and exposure t... |
Study Agent Administration system: Unilateral injection of 1.0–2.0 cc of PRP into the membra- nous vocal fold near the area of the scar on the pre-determined side was performed using a 23-gauge needle via previously described percutaneous methods for vocal fold injection (thyrohyoid, transoral approaches).8 Trans-cervi... |
Evaluation Criteria and Endpoint Definitions: Study completion was achieved after patients received four unilateral PRP injections and completed all follow-up post- injection clinic visits. The main objective of this study is to define the safety profile of PRP for use with serial vocal fold injections to treat vocal f... |
Statistical Analysis: Sample size calculations were performed based on data from prior studies for VHI-10 outcomes after vocal fold augmentation for vocal fold atrophy.23 These calculations were based on a planned comparison of VHI-10 scores before and after serial PRP injections via paired t-test statistics. All compa... |
RESULTS |
Twelve patients with vocal fold scar or atrophy under- went unilateral vocal fold injection with autologous PRP prepared according to Eclipse PRP system protocol. A total of 43 injections were performed using a peroral or percutaneous approach. An overview of study participant demo- graphics and pathology is outlined i... |
All patients continued to experience subjectively improved voice outcomes, with the improved overall quality, loudness, vocal endurance, and less strain and breathiness at 1 month. Two patients noted that the improvements were sustained until 3 weeks following the first injection when they experienced a slight deterior... |
DISCUSSION |
While the application of regenerative medicine techniques in laryngology holds great promise there is a pau- city of human data on the use of PRP. This prospective cohort study demonstrated a favorable safety profile for the use of serial in-office vocal fold injections of autologous PRP among patients with vocal distu... |
Lamina propria defects found in vocal fold atrophy and scar represent challenging pathologies to treat.3 Therapeutic interventions include surgical and non-surgical options including tissue transplantation, angiolytic laser treatments, and voice therapy. Surgeons must consider the diverse roles of the larynx during res... |
Despite these interventions, these patients continued to have residual vocal deficits despite temporary improve- ment seen in some instances. All participants expressed dissatisfaction with their vocal capabilities during the baseline evaluation. PRP is a biological material shown to stimulate host tissue rejuvenation ... |
All patients underwent treatment without difficulty or complications. There were no accounts of laryngeal edema, local inflammatory reaction, dysphagia, or dyspnea. Mild discomfort was noted on the side of injection in two patients 1 day after the initial injection. Patients in our trial expressed a variable range of v... |
VHI-10 and VFI scores mirror the trend of gradual improvement. At 1 week after the first PRP injection, the average VHI-10 and VFI scores began to downtrend to 27.5 10.2 and 42.9 16.4 but did not achieve the range of published minimally important clinical difference (MCID) for either questionnaire.36,37 However, by 1mo... |
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