improved to 1 or 0. After the first appearance of grade 3 HFS or after the second appearance of grade 2 HFS, dose reduction should occur on reinitiation of treatment, as described in the capecitabine package insert (http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020896s016lbl....
analysis led by the FDA, no correlation could be found between pCR and DFS for any subgroup of patients, including TNBC.6In other words, although pCR is useful in individual patient management, it is not appropriate as a primary end point in a trial to assess treatment efficacy. Hoffman LaR...
(see FDA-approved Patient Labeling) Patients and patients' caregivers should be informed of the expected adverse effects of capecitabine tablets, particularly nausea, vomiting, diarrhea, and hand-and-foot syndrome, and should be made aware that patient-specific dose adaptations during therapy are expec...
Despite this, both the FDA and the package insert recommend this dose. Retrospective analysis has demonstrated that dose adjustment does not appear to have a negative impact on efficacy [6, 11]. In view of the frequent toxicity associated with 2500 mg/m2/day of capecitabine and the apparent ...