Same-day pegfilgrastim and chemotherapy.

Pegylated filgrastim is a new formulation of a neutrophil colony-stimulating factor that has a long circulating half-life, permitting a single dose of filgrastim per cycle of chemotherapy. The pegylated filgrastim is recommended to be administered not less than 24 hours following chemotherapy and not less than 14 days prior to chemotherapy based on the theoretic concern that marrow suppression would be accentuated. This schedule of usage for pegylated filgrastim may compromise its application for weekly chemotherapy schedules.

Tumor response and survival end points in clinical trials: a clinician's perspective.

Survival has become the gold standard for determining the relative effectiveness of chemotherapy regimens in phase III clinical trials and is measured generally as the median survival. Response could be a surrogate for survival in evaluating clinical trials for chemotherapy, but it has become a controversial measurement parameter because of the quantitative variability in measurement and the fact that differences in response rates are not commonly translated into differences in survival. However, if response is indeed a determinant of survival, the median survival (the point at which 50% of the patients are alive) will not be impacted because response rates (RR) for most advanced cancers are less than 50%.

Capecitabine: fixed daily dose and continuous (noncyclic) dosing schedule.

Background: Oral fluoropyrimidines are presumed to emulate a parenteral continuous low-dose infusion delivery of the drug and the commonly used schedule is a 14 day on, 7 day off cycle at a total daily dose of 2500 mg/m2 dose. There is a substantial incidence of diarrhea and hand/foot syndrome with this dose schedule.

Objective: To retrospectively analyze a clinical experience with a fixed-unit daily dose of capecitabine employed continuously (open ended without cycling) as a single agent, in combination with other agents, or combined with radiation to determine the drug tolerability with regard to stomatitis, diarrhea, and hand/foot syndrome, compared with the "standard" dose schedule.