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CLINICAL TRIAL, PHASE II
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, N.I.H., EXTRAMURAL
Transoral carbon dioxide laser supraglottic laryngectomy and irradiation in stage I, II, and III squamous cell carcinoma of the supraglottic larynx: report of Southwest Oncology Group Phase 2 Trial S9709.
Archives of Otolaryngology - Head & Neck Surgery 2007 October
OBJECTIVE: To evaluate feasibility, functional outcome, and disease control of endoscopic surgery and irradiation in patients with squamous cell carcinoma of the supraglottic larynx.
DESIGN: Prospective, single-arm, phase 2 multi-institutional trial.
SETTING: Southwest Oncology Group trial S9709.
PATIENTS: Thirty-four patients diagnosed as having stage I, stage II, or selected stage III (T1-2N1M0) supraglottic laryngeal carcinoma enrolled from September 15, 1997, to December 1, 2001.
INTERVENTIONS: Transoral supraglottic laryngectomy by carbon dioxide laser followed by planned postoperative radiotherapy.
MAIN OUTCOME MEASURES: Three-year progression-free survival, proportion of patients requiring tracheostomy as a result of surgery, and time to adequate oral intake.
RESULTS: All 34 patients underwent surgery without major protocol deviation. Thirty-two patients (94%) completed planned postoperative radiotherapy without major deviation. At the time of analysis, only 1 patient (3%) had documented local disease recurrence at the primary disease site and required salvage total laryngectomy, and 2 patients (6%) had documented regional recurrence and required salvage neck dissection. Estimated 3-year progression-free survival and overall survival were 79% and 88%, respectively. No subjects required tracheostomy as a direct consequence of endoscopic resection. Patients who required tracheostomy before endoscopic resection due to either obstructive tumor bulk or unfavorable anatomy that precluded safe intubation (4 patients [12%]) were all decannulated in the early postoperative period (
CONCLUSIONS: Transoral endoscopic carbon dioxide laser excision of supraglottic tumors combined with postoperative radiotherapy appears feasible in a multi-institutional setting, with reasonable disease control. Although timing was variable, most patients recovered adequate swallowing in the early postoperative period.
DESIGN: Prospective, single-arm, phase 2 multi-institutional trial.
SETTING: Southwest Oncology Group trial S9709.
PATIENTS: Thirty-four patients diagnosed as having stage I, stage II, or selected stage III (T1-2N1M0) supraglottic laryngeal carcinoma enrolled from September 15, 1997, to December 1, 2001.
INTERVENTIONS: Transoral supraglottic laryngectomy by carbon dioxide laser followed by planned postoperative radiotherapy.
MAIN OUTCOME MEASURES: Three-year progression-free survival, proportion of patients requiring tracheostomy as a result of surgery, and time to adequate oral intake.
RESULTS: All 34 patients underwent surgery without major protocol deviation. Thirty-two patients (94%) completed planned postoperative radiotherapy without major deviation. At the time of analysis, only 1 patient (3%) had documented local disease recurrence at the primary disease site and required salvage total laryngectomy, and 2 patients (6%) had documented regional recurrence and required salvage neck dissection. Estimated 3-year progression-free survival and overall survival were 79% and 88%, respectively. No subjects required tracheostomy as a direct consequence of endoscopic resection. Patients who required tracheostomy before endoscopic resection due to either obstructive tumor bulk or unfavorable anatomy that precluded safe intubation (4 patients [12%]) were all decannulated in the early postoperative period (
CONCLUSIONS: Transoral endoscopic carbon dioxide laser excision of supraglottic tumors combined with postoperative radiotherapy appears feasible in a multi-institutional setting, with reasonable disease control. Although timing was variable, most patients recovered adequate swallowing in the early postoperative period.
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