The MS-275 oral formulation on the daily schedule was intolerable at a dose and schedule explored. The q14-day schedule is reasonably well tolerated. Histone deacetylase inhibition was observed in peripheral-blood mononuclear-cells. Based on PK data from the q14-day schedule, a more frequent dosing schedule, weekly x 4, repeated every 6 weeks is presently being evaluated.
Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose.
After completing this course, the reader should be able to:1. Describe the clinical trial that led to the approval of lapatinib in combination with capecitabine for the treatment of previously treated patients with HER-2-overexpressing metastatic breast cancer.2. Determine appropriate patients to receive lapatinib plus capecitabine treatment.3. Assess and manage the toxicities of lapatinib plus capecitabine treatment.This article is available for continuing medical education credit at CME.TheOncologist.com. ter TTP results of a prespecified interim analysis were made available, study enrollment was discontinued (399 patients enrolled).
CME CME
ABSTRACTThe median TTP was 27.1 versus 18.6 weeks (hazard ratio, 0.57; p ؍ .00013) favoring the lapatinib plus capecitabine arm. Response rates were 23.7% (lapatinib plus capecitabine) versus 13.9% (capecitabine alone). Survival data were not mature.Although the toxicities observed in the lapatinib and capecitabine combination arm were generally similar to those in the capecitabine alone arm, a higher incidence of diarrhea and rash was noted with the combination. Grade 3 or 4 adverse reactions that occurred with a frequency of >5% in patients on the combination arm were diarrhea (13%) and palmar-plantar erythrodysesthesia (12%). There was a 2% incidence of reversible decreased left ventricular function in the combination arm.
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