INTENSIVE CONCOMITANT CHEMORADIOTHERAPY IN LOCALLY ADVANCED UNRESECTABLE SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - A PHASE-II STUDY OFRADIOTHERAPY WITH CISPLATIN AND 7-WEEK CONTINUOUS INFUSIONAL FLUOROURACIL

Purpose: To evaluate an intensive concomitant chemoradiotherapy protoc ol of conventional radiotherapy with intermittent cisplatin (CDDP) and continuous-infusion fluorouracil (5-FU) in unresectable, locally adva nced squamous cell carcinoma of the head and neck (SCCHN). Patients an d Methods: Fifty-seven patients with unresectable stage IV MO disease (International Union Against Cancer [UICC]/American Joint Committee on Cancer [AJCC], 1987) received radiotherapy 70 Gy followed by CDDP 80 mg/m(2) and 5-FU 300 mg/m(2)/d. Response was assessed 2 months after t reatment completion. Results: Thirty patients (52%) received the full treatment schedule; 53 (93%) received full-dose radiotherapy, while 48 (84%) were given at least 75% of the planned chemotherapy doses. Seve re mucositis [World Health Organization [WHO]) grade 3 to 4 was the li miting toxicity and was seen in 79% of patients. The median time for m ucositis resolution was 8 weeks. Other toxicities were generally manag eable, but there were four treatment-related deaths (7%). Fifty patien ts were assessable for activity, with an overall response rate of 70% (95% confidence interval [CI], 58% to 82%). Complete response (CR) and partial response (PR) rates were 42% and 28%, respectively. Conclusio n: This simultaneous combined-modality regimen was feasible at the cos t of severe mucosal toxicity, which required hospitalization with nutr itional, parenteral, and hydroelectrolytic support. The high response rate achieved (70%) did not translate into improved survival, probably due to patient eligibility. The likelihood of cure of this high-tumor al-volume patient population remains low (similar to 10%), despite the association of two therapeutic modalities at full standard therapeuti c intensity. (C) 1996 by American Society of Clinical Oncology.