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Report of Southwest Oncology Group Phase 2 Trial S9709

Amit Agrawal, MD; James Moon, MS; R. Kim Davis, MD; Wael A. Sakr, MD; Shankar P. G. Giri, MD; Joseph Valentino, MD; Michael LeBlanc, PhD; John M. Truelson, MD; George H. Yoo, MD; John F. Ensley, MD; David E. Schuller, MD

Arch Otolaryngol Head Neck Surg. 2007;133(10):1044-1050.

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 (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.

Author Affiliations: The Ohio State University Comprehensive Cancer Center, Columbus (Drs Agrawal and Schuller); Southwest Oncology Group Statistical Center, Seattle, Washington (Mr Moon and Dr LeBlanc); University of Utah Health Science Center, Salt Lake City (Dr Davis); Wayne State University Medical Center, Detroit, Michigan (Drs Sakr, Yoo, and Ensley); Baylor Medical School, Houston, Texas (Dr Giri); University of Kentucky Medical Center, Lexington (Dr Valentino); University of Texas Southwestern Medical Center, Dallas (Dr Truelson).