Journal of Clinical Oncology, Vol 15, 3149-3155, Copyright © 1997 by American Society of Clinical Oncology
Corticosteroids significantly delay the onset of docetaxel-induced fluid retention: final results of a randomized study of the European Organization for Research and Treatment of Cancer Investigational Drug Branch for Breast Cancer
MJ Piccart, J Klijn, R Paridaens, M Nooij, L Mauriac, R Coleman, M Bontenbal, A Awada, J Selleslags, A Van Vreckem and M Van Glabbeke
Jules Bordet Institute, Chemotherapy Unit, Brussels, Belgium. mpiccart@resulb.ulb.ac.be
PURPOSE: To confirm the efficacy of docetaxel in patients with breast
cancer previously treated with one chemotherapy regimen for advanced or
metastatic disease and to compare the incidence of fluid retention (FR) and
skin toxicity when docetaxel is administered with and without prophylactic
corticosteroids. PATIENTS AND METHODS: Eighty-three patients, pretreated
with one chemotherapy regimen for metastatic breast cancer (MBC) with
bidimensionally measurable and progressive disease, were eligible for this
randomized trial. Docetaxel with prophylactic oral antihistamine was
administered at a dose of 50 mg/m2 as a 1-hour infusion on days 1 and 8
every 21 days and patients were randomized to receive methylprednisolone
(40 mg days -1, 0, 1, 7, 8, and 9 of each cycle) (arm A) or no
methylprednisolone (arm B). RESULTS: Twenty-eight patients (34%, 95%
confidence interval [CI], 23% to 45%) achieved on objective response. The
median time to disease progression and median overall survival time were 5
and 13.5 months, respectively. In total, 415 cycles of docetaxel were
administered (arm A: N = 219, median = six; arm B: N = 196, median = five).
The most common toxicity observed was grade 3 or 4 neutropenia, which
occurred in 79% of patients. Clinically significant nonhematologic side
effects included skin reactions and asthenia. In an intent-to-treat
analysis, patients who received methylprednisolone premedication had a
delayed onset of FR (median time to onset of FR: arm A, 84 days; arm B, 62
days; P = .01) and received a higher median cumulative dose of docetaxel
before the onset of FR (arm A, 333 mg/m2; arm B, 215 mg/m2; P = .001).
There was no statistically significant difference in the incidence of skin
toxicity between the two arms. CONCLUSION: Docetaxel, at this dose and
schedule, has definite antitumor activity in pretreated MBC patients.
Moreover, this is the first randomized trial to show that corticosteroids
have a favorable impact on docetaxel-induced FR.
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