Transoral laser microsurgery for supraglottic carcinomas: results of a prospective multicenter trial (SUPRATOL)

Abstract

Background: A limited number of single institutions have published retrospective cohort studies on transoral laser microsurgery for supraglottic laryngectomy (TLM-SGL). These studies have shown that the oncologic outcomes of TLM-SGL are comparable to those of open SGL. However, there is limited information available regarding swallowing rehabilitation and quality of life (QoL).

Patients and methods: SUPRATOL is a prospective, multicenter trial assessing the functional outcomes of TLM-SGL +/- adjuvant radio-(chemo)-therapy. The primary endpoint was aspiration-free swallowing at 12 months, as established using fibreoptic endoscopic evaluation of swallowing (FEES) and defined as a grade < 6 on the penetration-aspiration scale. Secondary endpoints were swallowing- and voice-related QoL, the prevalence of temporary and permanent tracheostomy and percutaneous gastrostomy, local control, laryngectomy-free survival, overall survival, and disease-free survival, as well as the influence of treatment centers on outcomes.

Results: From April 2015 to February 2018, 102 patients were recruited from 26 German Otorhinolaryngology (ORL) hospitals. All patients had TLM-SGL and 96.1% underwent uni- or bilateral, mostly selective neck dissection. To 47.0% of patients, adjuvant radio-(chemo)-therapy (R(C)T) was administered. The median follow-up period was 24.1 months. At 12-month follow-up, completed by 84.3% of patients, 98.2%, 95.5%, and 98.8% were free of aspiration when tested with saliva, liquid, or pulp. Adjuvant R(C)T, pT category, and type of resection had no significant influence on swallowing rehabilitation. A total of 40.2% of patients had been tracheotomized, and in 46.1% of patients, a PEG tube was inserted. At the 24-month follow-up, 5.3% of patients still required a tracheostomy, and 8.0% continued to use a percutaneous endoscopic gastrostomy (PEG) tube. Deterioration of swallowing- and voice-related QoL was observed immediately after treatment, but patients recovered, and baseline values were reached again. The Kaplan-Meier 2-year rates for local control, laryngectomy-free survival, overall survival, and disease-free survival were 88%, 92%, 93%, and 82%, respectively.

Conclusions: Our prospective multicenter trial shows that, at 12 months post-TLM-SGL +/- R(C)T, 95.5%-98.8% of patients achieved aspiration-free swallowing. Morbidity was higher than previously reported. The rates of permanent tracheostomy and gastrostomy tube placement correspond to previous cohort studies. The 2-year oncologic outcomes are within the reported range.

Clinical trial registration: https://drks.de/search/en/trial/DRKS00004641, identifier (DRKS00004641).

Keywords: FEES; MDADI; VHI; functional outcomes; prospective multicenter trial; supraglottic carcinoma; transoral laser microsurgery.

Figure 1

CONSORT flow diagram.

Figure 2

Type of transoral laser microsurgical supraglottic laryngectomy (TLM-SGL). Resected laryngeal subsites and adjacent sites in percentage (n = 102 patients).

Figure 3

Longitudinal analysis of the distribution of dichotomized PAS in percentage (n = 102 patients). PAS, penetration–aspiration scale; FEES, fibreoptic endoscopic evaluation of swallowing. (A) Tested: saliva, PAS < 6, aspiration-free swallowing, PAS ≥ 6, aspiration. (B) Tested: liquid, PAS < 6, aspiration-free swallowing, PAS ≥ 6, aspiration. (C) Tested: pulp, PAS < 6, aspiration-free swallowing, PAS ≥6, aspiration.

Figure 4

Longitudinal analysis of the prevalence of tracheostoma and PEG tube in percentage (n = 102 patients). PEG, percutaneous endoscopic gastrostomy.

Figure 5

Longitudinal analysis of MDADI composite score (n = 102 patients). MDADI, MD Anderson Dysphagia Inventory.

Figure 6

Longitudinal analysis of VHI total score (n = 102 patients). VHI, Voice Handicap Index.