Quality of life with functional pharyngeal preservation in advanced carcinomas of the base tongue complex using an integrated trimodality approach.

Standard management of advanced carcinoma arising from the base of the tongue or infiltrating that region from contiguous areas (henceforth referred to as base of tongue complex [BTC] tumors) with radical surgery and postoperative radiation therapy results in extensive loss of function affecting deglutition, speech, and physical appearance. From January 1995, 16 patients with advanced stage BTC tumors were entered in this phase II study. Eleven patients (74%) had N2-3 neck disease. To optimize neck control, those with clinical N+ nodes at presentation had neck dissection. This was followed by hyperfractionated radiotherapy at 120 cGy twice daily to a median dose of 7,320 cGy to the primary and 6,240 cGy to areas with pathologically positive nodes. Concomitant chemotherapy was administered during weeks 1 and 4 of the radiation therapy using bolus cisplatin 75 to 100 mg/m2 on day 1 and continuous infusional 5-fluorouracil 750 to 1,000 mg/m2/d from days 1 to 4 of each chemotherapy cycle. Survival curves were plotted for various events, using actuarial life table methods. A functional assessment was made at least 1 year after completion of treatment using a previously validated Head/Neck Performance Status Scale. The median follow-up period was 23 months. There was a 100% complete response to the treatment at the primary site. The actuarial 4-year local (primary site) control was 100%, locoregional control (including nodes) was 69%, and disease-specific survival was 70% at 4 years. The predominant acute toxicity (63% incidence) was reversible grade III mucositis resulting in a median of 9 days' interruption in treatment. All of the patients were able to complete the prescribed treatment course, and there were no treatment-related deaths. Quality of Life assessment after treatment examined all facets of oropharyngeal function. Of note, none of the patients required long-term tube feedings. For the nine patients who responded to the functional assessment questionnaire, the results were excellent (score >75). The mean score for ability to eat in public was 75, mean of 76 for normalcy of diet, and 91 for understandability of speech. Concomitant hyperfractionated chemoradiation therapy produced excellent functional preservation with good long-term control in this patient group with historically poor prognosis. A 4-year actuarial local control rate of 69% was obtained, which is comparable to results of radical surgery and adjuvant radiation therapy. Further studies with modifications of fractionation and use of newer chemotherapy agents/radioprotectors will improve on these gains while reducing toxicity.