NEOADJUVANT CHEMOTHERAPY WITH CISPLATIN AND 5-FLUOROURACIL IN ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - A RANDOMIZED PHASE-III STUDY

Background and purpose: In 1986 a prospective, randomized, multi-centr e trial for evaluation of neoadjuvant chemotherapy with cisplatin and 5-fluorouracil in the treatment of advanced squamous cell carcinoma of the head and neck was initiated. As survival in this group of patient s is poor the purpose was to find a possible survival benefit of the c hemotherapy in addition to radiotherapy compared to radiotherapy only. Methods. Four-hundred sixty-one patients from Denmark, Norway and Swe den with tumors in oral cavity, oropharynx, hypopharynx and larynx wer e randomized to receive either standard treatment (radiotherapy or rad iotherapy followed by surgery) or neoadjuvant chemotherapy followed by standard treatment. Chemotherapy included three courses of cisplatin 100 mg/m(2) i.v. infusion on day 1 followed by 5-fluorouracil 1000 mg/ m(2) per day continuous i.v. infusion for 120 hours. Radiotherapy 64-7 0 Gy in 2 Gy per fraction, 5 times/week, was given to patients in both treatment arms. Results: Response rate was 71% for patients randomize d to chemotherapy-radiotherapy and 66% for patients randomized to stan dard treatment (not statistically significant). Residual tumors were e xcised if possible. After surgery 62% of the patients randomized to ch emotherapy-radiotherapy and 60% of the patients in the standard treatm ent group were clinically tumor free. Conclusions: No statistically si gnificant benefit in survival was observed for patients treated with n eoadjuvant chemotherapy followed by radiotherapy, Nor was there any im pact of chemotherapy on the number of patients achieving loco-regional tumor control after primary treatment. (C) 1997 Elsevier Science Irel and Ltd.