Archives of otolaryngology--head & neck surgery · 2007
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.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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История · было → стало
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Agrawal Amit, Moon James, Davis R Kim, Sakr Wael A, Giri Shankar P G, Valentino Joseph, LeBlanc Michael, Truelson John M, Yoo George H, Ensley John F, Schuller David E, Southwest Oncology Group
Аннотация
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 (<or=1 week). Of the 34 patients, 24 (71%) recovered adequate oral intake (no longer requiring supplemental intravenous fluids or tube feeding) in the early postoperative period (before hospital discharge) (median time, 2 days; range, 1-7 days), with an additional 7 patients (21%) achieving delayed recovery (2.7-9.8 months). Three patients (9%) remained dependent on a feeding tube at last documented follow-up.
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 (<or=1 week). Of the 34 patients, 24 (71%) recovered adequate oral intake (no longer requiring supplemental intravenous fluids or tube feeding) in the early postoperative period (before hospital discharge) (median time, 2 days; range, 1-7 days), with an additional 7 patients (21%) achieving delayed recovery (2.7-9.8 months). Three patients (9%) remained dependent on a feeding tube at last documented follow-up.
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.