RANDOMIZED TRIAL OF MYELOPREVENTION BY GORALATINE VS PLACEBO FOR PATIENTS WITH HEAD AND NECK SQUAMOUS-CELL CARCINOMA, TREATED BY CARBOPLATIN-FLUOROUROCILE

Eighty-four patients with locally advanced, non metastatic squamous ce ll carcinoma of head and neck or esophagus, were included in a multice ntric double-blind randomized trial, comparing goralatide (12.5 or 62. 5 ug/kg/day, d1-d4) to placebo, associated with carboplatin (400 mg/m( 2), d1) and 5-fluorouracile (1 g/m(2)/d continuous IV over 96 hours). Haematological tonicity was analysed on 221 cycles of chemotherapy, Al l but one patient were evaluable because of early death without haemat ological toxicity. No significant difference was observed for mean nad ir of leukocytes, granulocytes, platelets counts and hemoglobin level. Duration of haematological toxicity was no significantly different fo r the two groups of patients. Anemia and lymphopenia were more frequen t in the goralatide treated patients. Clinical and biological tolerabi lity of goralatide was excellent.