ZINECARD at a dose of 500 mg/m² has been administered in combination with FAC in randomized, placebo-controlled, double-blind studies to patients with metastatic breast cancer. The dose of doxorubicin was 50 mg/m² in each of the trials. Courses were repeated every three weeks, provided recovery from toxicity had occurred. Table 3 below lists the incidence of adverse experiences for patients receiving FAC with either ZINECARD or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving ZINECARD or placebo with FAC beginning with their first course of therapy (columns 1 and 3, respectively). Adverse experiences occurring at course 7 and beyond for patients who received placebo with FAC during the first six courses and who then received either ZINECARD or placebo with FAC are also displayed (columns 2 and 4, respectively).
|EXPERIENCE||FAC + ZINECARD||FAC + PLACEBO|
|Courses ≥ 7
N = 102
|Course ≥ 7
N = 99
|Pain on injection||12||13||3||0|
|Recall Skin Reaction||1||1||2||0|
The adverse experiences listed above are likely attributable to the FAC regimen with the exception of pain on injection that was observed mainly on the ZINECARD arm.
Patients receiving FAC with ZINECARD experienced more severe leukopenia, granulocytopenia, and thrombocytopenia at nadir than patients receiving FAC without ZINECARD, but recovery counts were similar for the two groups of patients.
Hepatic and Renal
Some patients receiving FAC + ZINECARD or FAC + placebo experienced marked abnormalities in hepatic or renal function tests, but the frequency and severity of abnormalities in bilirubin, alkaline phosphatase, BUN, and creatinine were similar for patients receiving FAC with or without ZINECARD.