ISSN:
1573-7217
Keywords:
mitoxantrone
;
liver dysfunction
;
breast cancer
;
performance status
;
bilirubin elevation
Source:
Springer Online Journal Archives 1860-2000
Topics:
Medicine
Notes:
Abstract To determine the safety and efficacy of mitoxantrone use in hyperbilirubinemic breast cancer patients, a prospectively determined dosage schedule was evaluated in a multi-center trial. Pretreatment bilirubin prospectively defined three groups: Controls (with normal bilirubin) and two Study groups (with either moderate or severe bilirubin increase). Bilirubin determined initial mitoxantrone dose as well: bilirubin 〈 3.5 mg/dl, 14 mg/m2; and bilirubin ≥ 3.5 mg/dl, 8 mg/m2. Mitoxantrone at 14 mg/m2 was well tolerated in patients with moderate hepatic dysfunction. Patients with severe hepatic dysfunction demonstrated a mixed toxicity picture, with performance status (ECOG level 3) defining a population with limiting myelosuppression and/or early death. The survival of Study patients with severe hepatic dysfunction (median 17 days) was significantly worse than both Control (p 〈 0.01) and Study (p 〈 0.05) patients with lower bilirubin. Entry performance status (ECOG level 0–2 versus level 3) profoundly influenced survival (median survival 222 days versus 25 days, respectively, p 〈 0.0001). Objective responses were seen in patients with both normal and elevated bilirubin. Bilirubin reduction following mitoxantrone commonly occurred, representing at least an indicator of favorable prognosis. Recommendations for mitoxantrone use include: 1. Patients with moderate bilirubinemia tolerate 14 mg/m2 mitoxantrone with reasonable chance for benefit. 2. Patients with severe hepatic dysfunction and poor performance status should not be given mitoxantrone. A definitive recommendation regarding use of reduced 8 mg/m2 mitoxantrone in patients with severe hyperbilirubinemia and favorable performance status requires further study.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1007/BF01806298
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