BACKGROUND The current study presents mature results from a Phase III randomized trial comparing radiation therapy and concurrent chemoradiotherapy in patients with resectable American Joint Committee on Cancer Stage III and IV disease. METHODS One hundred patients were randomized to receive either radiation therapy alone (Arm A) (at a dose of between 66–72 grays [Gy] at 1.8–2 Gy per day) and the identical radiation therapy with concurrent chemotherapy (Arm B) (5‐fluorouracil, 1000 mg/m2/day, and cisplatin, 20 mg/m2/day, both given as continuous intravenous infusions over 4 days beginning on Days 1 and 22 of the radiation therapy). Primary site resection was planned for patients with residual or recurrent local disease. Cervical lymph node dissection was performed for regional persistent disease or recurrence, or if N2‐3 disease was present at the time of presentation. RESULTS After completing all therapy including surgery, 82% of the patients in Arm A and 98% of the patients in Arm B had been rendered disease free (P = 0.02). At a median follow‐up of 5 years (range, 3–8 years), the 5‐year Kaplan–Meier projections for overall survival for Arm A versus Arm B were 48% versus 50% (P = 0.55). Kaplan–Meier projections for the recurrence free interval were 51% versus 62% (P = 0.04), projections for a distant metastasis free interval were 75% versus 84% (P = 0.09), projections for overall survival with primary site preservation were 34% versus 42% (P = 0.004), and projections for local control without surgical resection were 45% versus 77% (P < 0.001). Salvage surgery proved to be successful in 63% and 73%, respectively, of the Arm A and Arm B patients with primary site failure. Unrelated death while free of disease occurred in 22% and 32%, respectively, of Arm A and Arm B patients (P = 0.26). CONCLUSIONS The addition of concurrent chemotherapy to definitive radiation in patients with resectable Stage III and IV squamous cell carcinoma of the head and neck improves the likelihood of disease clearance, a recurrence free interval, and primary site preservation. However, overall survival does not appear to be improved, reflecting both effective surgical salvage after local recurrence and competing causes of death. Cancer 2000;88:876–83. © 2000 American Cancer Society.

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Background Treating the neck after organ‐preservation treatment with radiotherapy or chemoradiotherapy can be problematic. Methods To develop management guidelines, we reviewed the results of a 100‐patient phase‐3 trial that had compared outcome after radiotherapy alone with outcome after chemoradiotherapy for head and neck cancer. Patients were randomly assigned to receive radiotherapy alone or concurrent chemoradiotherapy. After completing therapy, patients were reassessed, and surgery was recommended for persistent disease at the primary site or neck and for all patients with stage N2–3 neck nodes regardless of clinical response. Results Of the 47 patients with stage N0–1, 43 had a complete response (CR); of the 18 N1 patients, all but 4 had a CR. One of these 4, as well as 5 others among the N0–1 patients, underwent neck dissection (n = 6). No disease was found on pathologic examination, and no patient had neck recurrence. Of the remaining 41 N0–1 patients, 3 had disease progression and received no further therapy. Of the 38 others, 4 had neck recurrence, with 3 recurring at the primary site. Of the 53 with stage N2–3, 23 had less than a complete response (

The rising popularity of surgery involving the laryngeal framework (surgical medialization of immobile vocal folds, vocal fold tightening, pitch variation, etc.) has resulted in increasing case experience. Little has appeared in the literature regarding complications or long-term results of this type of surgery. Several years' experience in a major referral center with various types of laryngeal framework surgery has led to a small number of complications. These have included late extrusion of the prosthesis and delayed hemorrhage. A review of these complications and recommendations for modification of technique to minimize them in the future are discussed.