EFFICACY OF TARGETED SUPRADOSE CISPLATIN AND CONCOMITANT RADIATION-THERAPY FOR ADVANCED HEAD AND NECK-CANCER - THE MEMPHIS EXPERIENCE

Purpose/Objective: To evaluate the feasibility, response rates, and to xicity of a Phase II study using targeted supradose cisplatin and conc urrent radiation therapy in unresectable Stage III-TV head and neck sq uamous cell carcinoma. Methods and Materials: Sixty patients presentin g between 6/93-9/94 were enrolled, 44 (73%) of whom had T4 and/or N2-N 3 nodal disease. All patients were treated with rapid targeted superse lective intraarterial infusions of cisplatin (150 mg/m(2) weekly X 4) and simultaneous sodium thiosulfate intravenously (9 g/m(2)) for syste mic neutralization of cisplatin. Concurrent (day 1) daily radiation th erapy was delivered to the primary tumor and overt nodal disease to 66 -74 Gy while the uninvolved lower neck received 50 Gy, at 2.0 Gy/fract ion. Results: Fifty-one (85%) patients completed the full RADPLAT prot ocol as planned. Fifty-seven of 60 patients were evaluable for respons e. Histological (n = 50) or clinical (n = 7) assessment of primary sit e revealed a complete response (CR) in 52 patients, partial response ( PR) in 4, and stable disease (SD) in 1. Of the 40 patients presenting with nodal metastases, pathological (n = 31) or clinical (n = 6) asses sment revealed a CR in 25, PR in 11, and SD in 1, while 3 were unevalu able. Overall, for both primary site and nodal disease, CR was attaine d in 44 (75%), PR in 12 (23%), and SD in 1 (2%) of the 57 evaluable pa tients. Only 2 (4%) of 57 evaluable patients have recurred above the c lavicle, 1 in the primary site and 1 in the regional lymph nodes. Twel ve patients (23%) have failed in distant sites. Grade III/VI toxicity has included gastrointestinal in 6, hematologic in 6, mucosal in 12, v ascular in 4, and neurological in 4 patients. Conclusion: Concurrent r adiation therapy and targeted supradose cisplatin (i.e., RADPLAT) can be safely delivered with high response rates and excellent loco-region al control in advanced Stage III/IV head and neck squamous cell carcin oma. (C) 1997 Elsevier Science Inc.