Swallowing in advanced oral cancers: A prospective observational study.

BACKGROUND: Advanced head and neck cancers are known to cause swallowing dysfunction due to anatomical and post-treatment changes. Literature is sparse on post-surgical and/or multi-modality therapy-associated swallowing function in advanced oral cancers. We conducted this study to longitudinally assess and compare the pre- and post-therapy swallowing dysfunction associated with locally advanced oral cancers. METHODS AND MATERIAL: A prospective observational longitudinal study was conducted at a tertiary cancer center from 2017 to 2018 including treatment-naive cT4a oral cancer patients (AJCC 7th edition). The assessment was done pre-surgery, post-surgery, and post-adjuvant setting as per the scales (Dysphagia score, Penetration aspiration scale, and Yale pharyngeal residue (vallecular and pyriform fossa). RESULTS: Of the 30 patients in the study, 47.4%, 47.4%, 52.6%, and 47.4% experienced deterioration of Dysphagia score, Penetration-Aspiration Scale (PAS), vallecula residue, and pyriform residue scores in the postoperative period. And 52.6%, 47.4%, 68.4%, and 57.9% had inferior dysphagia score, PAS, vallecula, and pyriform residue scores even 6 months after completion of adjuvant therapy. The dysphagia score correlated well with other objective assessment scores at different time points. CONCLUSION: Swallowing functions are significantly affected by surgery and adjuvant therapy and continue to be affected even 6 months after completion of treatment. Appropriate rehabilitation and intervention must be offered to patients to reduce this problem. Dysphagia scores can predict the swallowing status similar to other objective assessments.

Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation.

PURPOSE: There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation. METHODS: This was a randomized phase II/III study. Adult patients (age ≥ 18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS). RESULTS: The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value = .002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value = .035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value = .035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P < .001), odynophagia (33.5% v 52.5%; P < .001), and dysphagia (33% v 49.7%; P = .002) with the addition of docetaxel. CONCLUSION: The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.[Media: see text].

Low-Dose Immunotherapy in Head and Neck Cancer: A Randomized Study.

PURPOSE: The regimens approved for the treatment of advanced head and neck squamous cell carcinoma are accessible to only 1%-3% of patients in low- and middle-income countries because of their cost. In our previous study, metronomic chemotherapy improved survival in this setting. Retrospective data suggest that a low dose of nivolumab may be efficacious. Hence, we aimed to assess whether the addition of low-dose nivolumab to triple metronomic chemotherapy (TMC) improved overall survival (OS). METHODS: This was a randomized phase III superiority study. Adult patients with recurrent or newly diagnosed advanced head and neck squamous cell carcinoma being treated with palliative intent with an Eastern Cooperative Oncology Group performance status of 0-1 were eligible. Patients were randomly assigned 1:1 to TMC consisting of oral methotrexate 9 mg/m2 once a week, celecoxib 200 mg twice daily, and erlotinib 150 mg once daily, or TMC with intravenous nivolumab (TMC-I) 20 mg flat dose once every 3 weeks. The primary end point was 1-year OS. RESULTS: One hundred fifty-one patients were randomly assigned, 75 in TMC and 76 in the TMC-I arm. The addition of low-dose nivolumab led to an improvement in the 1-year OS from 16.3% (95% CI, 8.0 to 27.4) to 43.4% (95% CI, 30.8 to 55.3; hazard ratio, 0.545; 95% CI, 0.362 to 0.820; P = .0036). The median OS in TMC and TMC-I arms was 6.7 months (95% CI, 5.8 to 8.1) and 10.1 months (95% CI, 7.4 to 12.6), respectively (P = .0052). The rate of grade 3 and above adverse events was 50% and 46.1% in TMC and TMC-I arms, respectively (P = .744). CONCLUSION: To our knowledge, this is the first-ever randomized study to demonstrate that the addition of low-dose nivolumab to metronomic chemotherapy improved OS and is an alternative standard of care for those who cannot access full-dose checkpoint inhibitors.

Transoral Robotic Surgery for Recurrent Tumors of the Upper Aerodigestive Tract (RECUT): An International Cohort Study.

BACKGROUND: Transoral robotic surgery (TORS) is an emerging minimally invasive surgical treatment for residual, recurrent, and new primary head and neck cancers in previously irradiated fields, with limited evidence for its oncological effectiveness. METHODS: A retrospective observational cohort study of consecutive cases performed in 16 high-volume international centers before August 2018 was conducted (registered at clinicaltrials.gov [NCT04673929] as the RECUT study). Overall survival (OS), disease-free survival, disease-specific survivals (DSS), and local control (LC) were calculated using Kaplan-Meier estimates, with subgroups compared using log-rank tests and Cox proportional hazards modeling for multivariable analysis. Maximally selected rank statistics determined the cut point for closest surgical resection margin based on LC. RESULTS: Data for 278 eligible patients were analyzed, with median follow-up of 38.5 months. Two-year and 5-year outcomes were 69.0% and 62.2% for LC, 71.8% and 49.8% for OS, 47.2% and 35.7% for disease-free survival, and 78.7% and 59.1% for disease-specific survivals. The most discriminating margin cut point was 1.0 mm; the 2-year LC was 80.9% above and 54.2% below or equal to 1.0 mm. Increasing age, current smoking, primary tumor classification, and narrow surgical margins (≤1.0 mm) were statistically significantly associated with lower OS. Hemorrhage with return to theater was seen in 8.1% (n = 22 of 272), and 30-day mortality was 1.8% (n = 5 of 272). At 1 year, 10.8% (n = 21 of 195) used tracheostomies, 33.8% (n = 66 of 195) used gastrostomies, and 66.3% (n = 53 of 80) had maintained or improved normalcy of diet scores. CONCLUSIONS: Data from international centers show TORS to treat head and neck cancers in previously irradiated fields yields favorable outcomes for LC and survival. Where feasible, TORS should be considered the preferred surgical treatment in the salvage setting.

Results of sequential swallowing assessments in patients undergoing upfront surgery for oral tongue squamous cell carcinoma.

BACKGROUND: The swallowing outcomes in patients undergoing glossectomy have been inconsistently reported in the literature owing to variable follow up times, different tools for assessment and lack of single institution large scale studies. The aim of our study was to assess the patterns of swallowing outcomes over time and identify factors affecting nasogastric tube dependency at 1-year post-surgery. MATERIALS AND METHODS: This was a retrospective study of treatment naïve patients with oral tongue carcinoma who underwent surgery and attended the speech and swallow clinic between January 2016 and December 2019 at our institute were included in the study. The findings of swallowing assessment by a speech language pathologist at three time points were recorded. RESULTS: A total of 606 patients were found eligible for the study. The median age of the patients was 50 years with the 211 (34.8%) patients having T3/T4 disease. The swallowing outcomes in terms of tube dependence and the spectrum of diet tolerance seem to improve over time with an increasing number of patients switching over to a solid diet by 1 year. A higher defect class (HR = 24.43 [3.48-171.27]) and presence of co-morbidities (HR = 4.17 [1.59-10.92]) were associated with sustained feeding tube dependency status at 1 year. A nomogram was developed based on these findings. CONCLUSION: The swallowing outcomes in terms of tube dependence and the spectrum of diet tolerance seem to improve over time. A higher defect class and presence of co-morbidities were associated with NGT dependency at 1 year.

Comparative study of functional outcomes following surgical treatment of early tongue cancer.

BACKGROUND: Speech and swallowing are important outcomes following resection in early tongue cancers. AIM: This prospective study was performed to compare speech, swallowing, and tongue mobility between secondary intention healing (SH) and primary closure (PC) in glossectomy for early tongue cancers. METHODS: Forty T1/T2 tongue cancers underwent wide excision followed by either PC or SH. Operative time, tube feeding, complications, speech, and swallowing were assessed in both groups at 1, 6, 12, and 24 weeks after surgery. RESULTS: SH showed better tongue mobility, less errors in continuous speech, and articulation as compared to PC at all-time points. Operative time, bleeding, duration of tube feeding, and pain scores were comparable in both groups. There were no major complications except minor secondary hemorrhage in one patient with SH. CONCLUSION: Following early tongue cancer resection, secondary intention healing can result in better speech and tongue mobility with minimum morbidity.

Implications of limited exolaryngeal disease and cricoarytenoid joint involvement in organ conservation protocols for laryngopharyngeal cancers: Results from a prospective study.

BACKGROUND: To identify clinicoradiological factors that determine functional outcomes in laryngopharyngeal cancers treated with chemoradiotherapy. METHODS: One hundred patients of locally advanced laryngopharyngeal cancers who were treated with chemoradiotherapy were accrued in this prospective study. The coprimary endpoint of the study was local control (LC) and functional larynx preservation survival (FLPS). RESULTS: The median follow-up was 39 months. Thirty-nine patients had a local failure of which 17 underwent a salvage laryngectomy. A dysfunctional larynx with clinic-radiologically disease was seen in only 1 patient. Factors significant for LC were thyroid cartilage erosion/lysis and cricoarytenoid joint involvement. Within the T4a subset, patients with exolaryngeal disease through the soft tissue framework had significantly better LC and FLPS than those with cartilage erosion/lysis. CONCLUSIONS: Patients with limited exolaryngeal disease through the soft-tissue framework can be considered for functional organ preservation, while those with thyroid cartilage involvement and cricoarytenoid joint involvement are not suitable.

Results of pretreatment swallowing evaluation in patients with stage III/IV laryngeal and hypopharyngeal carcinoma.

INTRODUCTION: Laryngeal and hypopharyngeal carcinoma are among the common head and neck cancers causing considerable swallowing dysfunction. The functional status of the organ (larynx) is an important point of contention while considering the patients for organ preservation protocol. METHODOLOGY: The aim of this retrospective study was to assess the swallowing status in stage III/IV laryngeal and hypopharyngeal carcinoma and its influence on treatment decision. We evaluated all treatment naïve patients who were referred to the swallowing clinic in 2017 (Jan-Dec) for assessment of swallowing prior to treatment initiation. RESULTS: One hundred patients satisfied the eligibility criteria and were included in the study. The site and stage of laryngeal and hypopharyngeal cancer cases were almost equal in number. Their median age was 58 years. Fiberoptic endoscopic evaluation of swallowing (FEES) was done in all patients. 30% of the patients only had swallowing difficulties. Only advanced T-stage (p = 0.04) had an influence on the pretreatment swallowing status. Thirty-seven patients required nasogastric tube (NGT) for feeding. By 2 month post-treatment completion, most patients on NGT could resume oral feeding. CONCLUSIONS: Pretreatment swallowing assessment alone did not significantly seem to influence our decisions for organ preservation treatment. However, patients with aspiration could be identified and managed appropriately. Most patients on NGT could resume oral feeds post-treatment completion.

The results of sequential swallowing assessments after total laryngectomy for laryngeal and hypopharyngeal malignancies.

BACKGROUND: Swallowing after total laryngectomy (TL) is altered and the swallowing related issues are largely underreported. It is important to identify factors that may negatively influence swallowing after TL in order to rehabilitate these patients appropriately. METHODS: The study included patients who underwent TL from June 2015 to November 2017 for laryngeal and hypopharyngeal malignancy. Sequential swallowing assessment was done in these patients over time. The assessments were done using the FOIS scale and the PSS-HN normalcy of diet scores and analysed to assess the presence of swallowing related issues, factors influencing swallowing and its recovery over time. RESULTS: Sixty-seven who underwent total laryngectomy (TL) were included in the study. Swallowing assessments were done once in 3 months. Overall there was an improvement in swallowing over time. Both the FOIS (Median score of 3.82 in first to 5.77 in the fifth visit) and the PSS-HN scores (median score of 33.63 at first visit to 63.66 at fifth visit) improved over time. Patients undergoing TL after treatment failure with chemoradiotherapy (p value < 0.001) and those with advanced stage disease (p-value < 0.001) did poorly in terms of swallowing. At the last follow up only 8 patients were dependent on feeding tube; the rest of the patients were able to take food orally. CONCLUSION: Following total laryngectomy swallowing gradually improves in the first 18 months after surgery. It is essential to identify factors influencing swallowing negatively so that these patients can get appropriate attention to improve swallowing.

Multiples of multiple: Case series of mirror aneurysms and review of literature.

INTRODUCTION: Mirror aneurysms are a rare subtype of multiple aneurysms, located in identical or adjacent arterial segment bilaterally. We report a case series of 3 such patients amongst whom one of them had 3 sets of mirror aneurysms and the other patient had 2 sets of mirror aneurysm on the same arterial segment which has not been reported till date. METHODS: A retrospective analysis of 3 patients with incidentally detected multiple mirror aneurysms, who were treated with microsurgical clipping and coiling, was conducted. A systematic search was performed using the PUBMED database and relevant articles were reviewed with particular attention to incidence, associated conditions, risk factors and management strategies. Written informed consent was obtained from all of the patients for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request. This research work has been reported in line with the PROCESS criteria (Agha et al., 2018). RESULTS: All the 3 patients were females with incidentally detected multiple mirror aneurysms. All the 3 patients were known Hypertensives. All the aneurysms were successfully clipped by a multistage, bilateral craniotomy except the one in the cavernous ICA, for which an endovascular procedure is planned. All of them had an uneventful postoperative course with the CT angiogram showing obliteration of all the clipped aneurysms except the one in the cavernous ICA. CONCLUSIONS: Multiple mirror aneurysms represent a rare occurrence of a diverse pathology. Both these described types of cases have not been reported so far in the literature. The treatment strategy for mirror aneurysms should be determined individually based on the location, size, and morphology of the aneurysms, as well as, on the clinical manifestations of each patient.

A Retrospective Study in Microsurgical Procedures of Large and Giant Intracranial Aneurysms: An Outcome Analysis.

OBJECTIVE: Intracranial aneurysms are considered large if >10 mm and giant if >25 mm. The risk of aneurysmal rupture compounds with increase in size of the aneurysm, thus, warranting appropriate intervention. In this study, we have analyzed the outcome and effectiveness of microsurgical procedures in large and giant aneurysms. METHODS: A retrospective analysis of all the patients who underwent microsurgical procedures for large and giant cerebral aneurysms from 2014-2018 in our institute was conducted. There were a total of 52 patients, in which direct clipping was performed in 42 (80.7%) patients, proximal trapping in 3 (5.7%) patients, trapping with bypass in 3 (5.7%) patients, suction decompression in 3 (5.7%) patients, and 1 (1.9%) patient underwent surgical reconstruction. RESULTS: Among the 52 patients, in the postoperative period, 1 (1.9%) patient became comatose, 1 (1.9%) patient developed hemiplegia, 1 (1.9%) patient had a transient hemiparesis, and 1 (1.9%) patient had transient lower cranial nerve palsy. Two (3.8%) patients had chronic subdural hematoma during the 3-month follow-up. There was no mortality in our series. CONCLUSIONS: There are several treatment strategies available to manage large and giant cerebral aneurysms. In this study, we had minimal morbidity (3.8%), favorable outcome (96.1%), and no mortality. Therefore, we would like to conclude that appropriate microsurgical procedures, in experienced hands, can be considered as first line in the management for large and giant intracranial aneurysms, especially those with complex anatomy, wide neck, mass effect, partial thrombosis, and the presence of critical perforating vessels from the aneurysm wall.

A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer.

BACKGROUND: Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings. METHODS: This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m2 ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT).The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed. RESULTS: In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01). CONCLUSIONS: The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT.

Carotid Endarterectomy: The Need for In vivo Optical Spectroscopy in the Decision-Making on Intraoperative Shunt Usage - A Technical Note.

BACKGROUND: Carotid endarterectomy (CEA) is the surgical excision of the atherosclerotic plaque in patients with severe carotid artery stenosis. It is a common surgical technique required by neurosurgeons that should be mastered. In this article, we provide an outline of the technique and multimodality adjuncts involved in performing an effective CEA with a better surgical outcome. MATERIALS AND METHODS: We have operated a total of 14 patients in our institute from 2015 to 2018. The male to female ratio is 13:1. Four (28.5%) patients were symptomatic and 10 (71.5%) were asymptomatic; with an average percentage of carotid stenosis being 81.2% in symptomatic and 76.6% in asymptomatic patients. Two patients have undergone bilateral CEA. Intraoperative monitoring was done with continuous in vivo optical spectroscopy (INVOS). Furui's double balloon shunt system was used to maintain blood flow from common carotid artery to the internal carotid artery, thus preventing cerebral ischemia in selected cases with significantly lateralized cerebral oximetry (CO) recordings. RESULTS: Of the 14 patients with 16 CEA procedures, continuous INVOS monitoring was used in 12 CEA procedures. Of the 12 cases, only 5 (41.6%) needed a shunt. Furui's shunt was not used in 7 (58.3%) CEA procedures, where there were no changes in the intraoperative CO and these patients had an uneventful postoperative period. INVOS monitoring not only reduced the use of routine intraoperative shunt but also reduced the total surgical time and thus aided in preventing neurological complications. CONCLUSION: CEA should be strongly considered for symptomatic patients with >70% of carotid stenosis and in patients with 50%-69% stenosis if no other etiological basis for the ischemic symptoms can be identified. Continuous INVOS monitoring is mandatory for the decision of the use of intraoperative shunt, which reduces the perioperative morbidity and mortality significantly.