Treatment of supraglottic squamous cell carcinoma with advanced technologies: observational prospective evaluation of oncological outcomes, functional outcomes, quality of life and cost-effectiveness (SUPRA-QoL)

Abstract Background Over the past decade, therapeutic options in head and neck supraglottic squamous cell carcinoma have constantly evolved. The classical total laryngectomy has been partially replaced by alternative organ- and function-sparing techniques with the same prognosis but less morbidity, such as Radiotherapy, Transoral Laser Microsurgery (TLM) and Trans-Oral Robotic Surgery (TORS). Up to now, a prospective comparison of these innovant techniques has not been conducted. Methods/design We will conduct an original international multicentric prospective nonrandomized clinical trial to compare the efficacy between these treatments (Arm 1: Radiotherapy ± chemotherapy; Arm 2: TLM and Arm 3: TORS) with 4 classes of outcomes: quality of life (QoL), oncological outcomes, functional outcomes and economic resources. The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma. The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108). Discussion In the current literature, no prospective head-to-head trials are available to compare objectively these different treatments. With the increase of highly efficient treatments and the increase of oncological survival, it is imperative also to develop management strategies that optimize QoL and functional results. We will conduct this innovate prospective trial in order to obtain objective data in these two main issues. Trial registration NCT05611515 posted on 10/11/2022 (clinicaltrial.fgov)

Patent foramen ovale and implantable cardioverter defibrillator.

A case of patent foramen ovale opening was observed concomitantly to a defibrillation threshold determination in the setting of an internal cardioverter defibrillator implantation. The subsequent transient right-to-left shunt was confirmed by a peroperative transoesophageal echocontrast study. The underlying mechanism of this incident may be related to a transient reversal of the interatrial gradient, due to the pre-existence of pulmonary hypertension and tricuspid regurgitation, associated with ongoing mechanical ventilation and modifications of intracardiac pressures regimen secondary to the succeeding ventricular tachyarrhythmia and defibrillation. Paradoxical embolism can be an aetiology for neurologic injury during internal cardioverter defibrillator implantation

Individualized prophylactic neck irradiation in cN0 head and neck cancer patients based on sentinel lymph node(s) identification: definitive results of a prospective phase I-II study.

This prospective, non-randomized, interventional phase I-II study investigated the individualization of the elective node irradiation in clinically N0 (cN0) head and neck squamous cell carcinoma (HSNCC) by sentinel lymph node (SLN) mapping with SPECT/CT and its impact on tumor control and radiation-related toxicity. Forty-four cN0 HNSCC patients treated with definitive (chemo-)radiotherapy were imaged with SPECT/CT after 99mTc nanocolloid injection around the tumor. The neck levels containing up to the four hottest SLN were selected for prophylactic irradiation (CTVn-LS). A comparative virtual planning was performed with the selection of neck levels based on the current international guidelines (CTVn-IG). The regional control was monitored in function of the selected volume. Dosimetric data to the organs-at-risk (OAR) were compared between both plans. Normal tissue complication probability (NTCP) rates were derived for xerostomia, dysphagia and hypothyroidism to predict the clinical benefit and correlated to quality of life (QoL) assessments at 6 months. Sixteen percent of patients presented unpredicted lymphatic drainage and 48% drained unilaterally. CTVn-LS were smaller than the CTVn-IG by a factor of two (p < 0.0001). After a median follow-up of 46 months, only 1 patient experienced a regional relapse in a non-irradiated area. Significant median dose reductions to OAR were observed, particularly to contralateral salivary glands in patients with unilateral drainage [14.6 Gy-28.1 Gy] and to the thyroid gland in all patients [22.4 Gy-48.9 Gy]. Median NTCP reductions were observed for xerostomia [0.3%-13.7%], dysphagia [1.7%-10.8%] and hypothyroidism [14.0%-36.1%]. QoL at 6 months was improved, particularly in patients irradiated unilaterally. Neck SLN mapping with SPECT/CT individualizes and reduces the elective nodal target volumes without compromising the regional control. The NTCP rates were reduced and favorable QoL were observed in all patients, particularly in case of unilateral irradiation