A reduced conversion of capecitabine to inactive metabolites means that the standard dose is a more than 100-fold overdose. 3633. Background: Capecitabine is an oral fluoropyrimidine commonly used in a cycling 21 day schedule with 14 days on and 7 days off with a daily dose of 2000 to 2500 mg/m 2.The major limiting toxicities with this dose and schedule are diarrhea and hand/foot syndrome. Hand-foot syndrome (HFS) has proven to be a chronic dose-limiting toxicity of capecitabine, leading to significant morbidity in patients receiving this agent. MRI tumour regression grade. The principal dose‐limiting toxicity was neutropenia and tumor responses were seen in 21 (91%) of 23 patients treated. Dose limiting toxicity. Introduction.Capecitabine (Xeloda®) is a systemic prodrug of 5-fluorouracil (5-FU), which is administered in an oral formulation. The following are the recommended dose modifications for toxicity: Capecitabine Accord 150 mg and 500mg film-coated tablets. Non-haematological Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and handfoot syndrome. Table 3 Capecitabine dose reduction schedule (3-weekly cycle or continuous treatment).
Doses of capecitabine omitted for toxicity are not replaced. Secondary Endpoints Ability to deliver enadenotucirev concurrently with chemoradiation Assessment of treatment tolerance as measured by the proportion of patients completing at least 80% of the intended Capecitabine dose and at least 20 fractions of radiotherapy by the end of week 9 Dose modifications for toxicity when Capecitabine Tablets are used as a 3 weekly cycle in combination with other agents should be made according to Table 3 above for Capecitabine Tablets and according to the appropriate summary of product characteristics for the other agent(s). Toxicity can be managed by symptomatic treatment and/or modification of the dose (treatment If recovered, restart capecitabine, using dose adjustment guidelines below, according to worst grade of haematological toxicity recorded. Another phase I study showed that capecitabine plus vinorelbine combination therapy is well tolerated and clinically active in breast cancer patients . Use an alternative drug; if not possible, determine the residual DPD activity in mononuclear cells from peripheral blood and adjust the initial dose accordingly, or adjust the initial dose based on efficacy and toxicity.