In 875 patients with either metastatic breast or colorectal cancer who received xeloda monotherapy, 62 of the 21 patients 80 years of age treated with xeloda experienced a treatment-related grade 3 or 4 adverse event diarrhea in 6 28.
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The cardiotoxicity observed with XELODA includes myocardial infarction/ischemiaanginadysrhythmiascardiac arrestcardiac failuresudden deathelectrocardiographic changesand cardiomyopathyThese adverse reactions may be more common in patients with a prior history of coronary artery disease.
Among the 67 patients60 years of age receiving XELODA in combination with docetaxelthe incidence of grade 3 or 4 treatment-related adverse reactionstreatment-related serious adverse reactionswithdrawals due to adverse reactionstreatment discontinuations due to adverse reactions and treatment discontinuations within the first two treatment cycles was higher than in the 2daydisturbed estrus and consequently caused a decrease in fertilityIn mice that became pregnantno fetuses survived this doseThe disturbance in estrus was reversibleIn malesthis dose caused degenerative changes in the testesincluding decreases in the number of spermatocytes and spermatidsIn separate pharmacokinetic studiesthis dose in mice produced 5DFUR AUC values about 0.7 times the corresponding values in patients administered the recommended daily dose.
The first trial was conducted in 22 pediatric patientsmedian age 8 yearsrange 5-17 yearswith newly diagnosed non-disseminated intrinsic diffuse brainstem gliomas and high grade gliomasIn the dosefinding portion of the trialpatients received capecitabine with concomitant radiation therapy at doses ranging from 500 mg/m 2 to 850 mg/m 2 every 12 hours for up to 9 weeksAfter a 2 week breakpatients received 1250 mg/m 2 capecitabine every 12 hours on Days 1-14 of a 21-day cycle for up to 3 cyclesThe maximum tolerated doseMTDof capecitabine administered concomitantly with radiation therapy was 650 mg/m 2 every 12 hoursThe major dose limiting toxicities were palmar-plantar erythrodysesthesia and alanine aminotransferaseALTelevation.
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