Tetracosactrin vs. methylprednisolone in the prevention of emesis in patients receiving FEC regimen for breast cancer.
0.5 mg tetracosactrin is considered to be equivalent to 40 mg methylprednisolone with regard to the induced cortisol secretion. 97 female breast cancer patients who received their first two FEC courses (epirubicin 50-75 mg/m2, 5-fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2) entered this randomised crossover study (76 had previously received an adjuvant treatment); tetracosactrin was administered intramuscularly and methylprednisolone intravenously immediately before chemotherapy administration. The tolerability was evaluated using a diary card during 5 days and patients were asked for their preference at the end of the two cycles. There was no difference either for vomiting (dry heaves were included) or nausea between the two treatments (the analysis was performed on day 1, the worse day of days 2 and 3 and the worse day of days 4 and 5). At day 1, 49% of the patients experienced no or mild nausea after tetracosactrin and 62% after methylprednisolone (not significant) (first period analysis); a complete control of vomiting (including dry heaves) was observed in 49% of the patients after tetracosactrin and 53% after methylprednisolone (not significant). No difference was observed between patients with or without previous chemotherapy. However, slightly more patients preferred tetracosactrin (P = 0.048).
Bonneterre
J
J
Centre Oscar Lambret, Lille, France.
Kerbrat
P
P
Fargeot
P
P
Metz
R
R
Roche
H
H
Bastit
P
P
Chevrier
A
A
Tubiana-Hulin
M
M
Geyer
G
G
Cappelaere
P
P
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003366:Cosyntropin / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000009:adverse effects; D015251:Epirubicin / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects; D006801:Humans; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D009325:Nausea / Q000517:prevention & control*; D011788:Quality of Life; D014839:Vomiting / Q000517:prevention & control*
D003366:Cosyntropin; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil; D008775:Methylprednisolone