Doxil in patients with pretreated metastatic breast cancer (MBC): a dose-schedule finding study with pharmacokinetics (Meeting abstract).

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Doxil in patients with pretreated metastatic breast cancer (MBC): a dose-schedule finding study with pharmacokinetics (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 16:A516 1997. Unique Identifier : AIDSLINE MED/97622343
Gabizon A; Uziely B; Lotem M; Yehoshua Z; Tzemach D; Nathan S; Ganelin B; Brufman G; Hadassah Hebrew University Medical Center, Jerusalem 91120, Israel

Abstract: Doxil is a formulation of polyethylene-glycol coated liposomal doxorubicin used for the treatment of AIDS-related Kaposi's sarcoma. The aims of this study were to optimize the dose-schedule of Doxil and examine its pharmacokinetics in patients (pts) with MBC and previous chemotherapy. Four dose-schedules were investigated in 22 pts: 45 mg/m2 q3wk (5 pts), 50 mg/m2 q4wk (5 pts), 60 mg/m2 q4wk (6 pts), and 65 mg/m2 q5wk (6 pts). A total of 100 courses (median/pt, 4, ranges 1-13) with a median cumulative dose of 180 mg/m2 (ranges 60-591) have been administered (September 1995-November 1996). The most important toxicities were stomatitis and skin toxicity in the form of hand-foot syndrome. Stomatitis was clearly related to the dose, with higher incidence and severity at doses of 60-65 mg/m2. Skin toxicity developed only after 2 or more courses of treatment and was schedule-dependent with shorter dosing intervals leading to increased frequency and severity of manifestations. Myelosuppression was common but mild and clinically insignificant in most cases. Limited hair loss occurred in only three pts receiving 60-65 mg/m2. There is no evidence of cardiac toxicity as assessed by the left ventricle ejection fraction in pts receiving 5 or more courses. A median dose intensity of 11.5 mg/m2/wk (range 7.3-13.7) was achieved in 13 pts receiving 3 or more courses. Partial responses (2 pts) and improvements (6 pts) of relatively long duration (median time to treatment failure, 8+ mth, range 3 +/- 13+) were observed among 16 evaluable pts. Prior therapies of responding pts included anthracyclines (5 pts) and/or paclitaxel (4 pts). The pharmacokinetic data (n=11) point at a slow monoexponential clearance (median t1/2 63 hr, range 47-112). Doxil is an active agent in MBC and has a unique toxicity profile requiring a dosing interval longer than for conventional doxorubicin. (C) American Society of Clinical Oncology 1997

Keywords: *Antibiotics, Anthracycline/ADMINISTRATION & DOSAGE *Breast Neoplasms/DRUG THERAPY *Doxorubicin/ADMINISTRATION & DOSAGE
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