Objectives: To test the effectiveness of concurrent chemoradiotherapy in patients with pyriform sinus carcinoma and to demonstrate the feasibility of an organ preservation approach.
Design: Clinical trial phase 2.
Setting: University Hospital Center, St-Etienne, France.
Patients: The study population comprised 46 male patients with resectable stage III and IV pyriform sinus carcinoma.
Methods: Two successive chemoradiation regimens were investigated. In protocol 1 (24 patients), carboplatin was given on days 1 through 5 and 28 through 33, with an area under the curve dose of 5 mg/mL for 1 minute per day and bifractionated radiotherapy (160 rad [1.6 Gy]/fraction) delivered on days 1 through 16 and 28 through 38. A treatment break was planned on days 16 through 27. In protocol 2 (22 patients), chemotherapy was given with the same dose of carboplatin on days 1 and 21, and fluorouracil (750 mg/m(2) per day) on days 1 through 7 and 21 through 28. Radiotherapy with a single fraction of 180 rad (1.8 Gy)/d was delivered during the first 2 weeks and then 150 rad (1.5 Gy) twice a day during the next 3 weeks.
Main outcome measures: Patients were evaluated for tumor response, toxic reactions, and organ preservation and survival rates. Statistical analysis of disease-free survival and overall survival was performed using the Kaplan-Meier method.
Results: A complete response was noted in 21 (88%) of the 24 patients following protocol 1 and 16 (73%) of the 22 patients following protocol 2. After 2 years of follow up, 16 patients (67%) (protocol 1) and 12 patients (55%) (protocol 2) retained their larynx without evidence of disease. During therapy, 15 patients (63%) (protocol 1) and 19 patients (86%) (protocol 2) required unplanned hospitalization for toxic effects. The overall survival and disease-free survival rates at 2 years were 58% (protocol 1) vs 53% (protocol 2) and 39% (protocol 1) vs 41% (protocol 2) (P =.80), respectively.
Conclusion: Concomitant chemotherapy and bifractionated radiotherapy, although toxic, leads to good locoregional control and therefore to a significant level of laryngeal preservation.