Abstract

Concurrent chemotherapy and radiation has been shown to be effective treatment for unresectable squamous cell carcinomas of the head and neck (SCCHN). While initial data has been encouraging, few studies have reported 5-year survival in conjunction with patient-assessed functional quality of life (QOL) outcomes. This report details the long-term survival and laryngeal/pharyngeal functional outcome of a phase II trial evaluating the combination of weekly carboplatin (CBDCA), paclitaxel, and daily radiation for patients with locally advanced unresectable disease. From 1993–1998, 62 patients with Stage III-IV SCCHN were prospectively treated with RT to 70.2 Gy at 1.8 Gy/fraction/day with weekly chemotherapy consisting of paclitaxel (45 mg/m(2)/wk) and carboplatin (100 mg/m(2)/wk). All patients presented with locally advanced disease (93% Stage IV); 77% had T4 disease and 21% had T3 disease. Fifty-eight percent had N2b-N3 disease. Sixty patients were evaluated for response and survival with a mean follow-up of 52 months (range 2–119). In March 2004, long-term functional and symptom-related quality of life analysis was performed in surviving patients using the Quality of Life-Radiation Therapy Instrument HeadsNeck Module (QOL-RTI/H&N). This questionnaire assesses pain, appearance, speech, chewing and swallowing, mucous and saliva, taste, and cough on a 0–10 Likert type scale, with a QOL score (QS) of 10 representing the highest perceived toxicity. Ninety-eight percent of patients completed the prescribed therapy. A clinical complete response (CR) at the primary site was obtained in 82%, with a total (primary site and neck) CR rate of 75%. Local-control for the entire cohort at 1 year, 3 years, and 5 years was 76.6%, 66.9% and 62.1% respectively. Overall survival (OS) at 1 year, 3 years, and 5 years was 77.1%, 50.7%, and 38.9% respectively, with a median OS of 37.3 months. Nineteen patients were eligible for QOL analysis, with a mean survival of 75.7 months. The most significant decrement in QOL for surviving patients included a decrease in chewing function, with all cases due to teeth extraction (mean QS 5.91), difficulty swallowing solid foods (mean QS 5.73), thickened saliva (mean QS 5.64), decreased amount of saliva (mean QS 4.82), and decreased taste sensation (mean QS 4.45). Factors that had an intermediate effect on long-term QOL included frequent or severe cough (mean QS 2.00), eating in public (mean QS 2.18), increased mucous production (mean QS 2.27), and difficulty speaking (mean QS 2.82). Long-term QOL factors which were least affected by concurrent chemoradiation include (in descending order): pain in the mouth (mean QS 0.73), cosmesis of face or neck (mean QS 1.27), pain in the throat (mean QS 1.73), swallowing liquids (mean QS 1.82), and eating regular foods (mean QS 1.91). The long term survival analysis of this phase II institutional study supports our contention that weekly carboplatin and paclitaxel with definitive daily external beam radiation therapy provides excellent local control (62%) and improved survival (39%), in patients presenting with locally advanced unresectable SCCHN. In addition, this QOL assessment reveals that surviving patients were most significantly impacted by the long-term effects of xerostomia, and had minimal chronic toxicities related to pain and cosmesis

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