[Randomized placebo trial of myeloprotection with goralatide in patients with squamous cell carcinoma of the upper respiratory and digestive tracts or esophagus, treated with a carboplatin-fluorouracil combination].
Eighty-four patients with locally advanced, non metastatic squamous cell carcinoma of head and neck or esophagus, were included in a multicentric double-blind randomized trial, comparing goralatide (12.5 or 62.5 micrograms/kg/day, d1-d4) to placebo, associated with carboplatin (400 mg/m2, d1) and 5-fluorouracile (1 g/m2/d continuous IV over 96 hours). Haematological toxicity was analysed on 221 cycles of chemotherapy. All but one patient were evaluable because of early death without haematological toxicity. No significant difference was observed for mean nadir of leukocytes, granulocytes, platelets counts and hemoglobin level. Duration of haematological toxicity was no significantly different for the two groups of patients. Anemia and lymphopenia were more frequent in the goralatide treated patients. Clinical and biological tolerability of goralatide was excellent.
Cappelaere
P
P
Centre Oscar-Lambret, Lille, France.
Hecquet
B
B
Rolland
F
F
Meeus
L
L
Domenge
C
C
Krakowski
I
I
De Gislain
C
C
Chauvergne
J
J
Dufour-Esquerré
F
F
Carde
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006412:Hematopoietic Stem Cells / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D010919:Placebos
D009842:Oligopeptides; D010919:Placebos; D016190:Carboplatin; C058504:goralatide; D005472:Fluorouracil
Essai randomisé avec placebo de myéloprotection par le goralatide des patients présentant un carcinome épidermoïde des voies aérodigestives supérieures ou de l'oesophage, traités par l'association carboplatine-5 fluorouracile.