JCO Early Release, published online ahead of print Feb 14 2005
Journal of Clinical Oncology, 10.1200/JCO.2005.02.167
Received February 24, 2004
Accepted July 20, 2004
Safety and Efficacy of Two Different Doses of Capecitabine in the Treatment of Advanced Breast Cancer in Older Women
Emilio Bajetta *, Giuseppe Procopio , Luigi Celio , Luca Gattinoni , Silvia Della Torre , Luigi Mariani , Laura Catena , Riccardo Ricotta , Raffaella Longarini , Nicoletta Zilembo , and Roberto Buzzoni
From the Medical Oncology Unit 2, Unit of Medical Statistics and Biometry, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
* To whom correspondence should be addressed. E-mail: emilio.bajetta{at}istitutotumori.mi.it
Purpose: To evaluate the safety and efficacy of capecitabine in older women with advanced breast cancer.
Patients and Methods: Seventy-three eligible patients (median age, 73 years; range, 65 to 89 years) were enrolled. The first 30 patients received oral capecitabine 1,250 mg/m2 twice daily on days 1 to 14 every 21 days. Due to the occurrence of two toxic deaths, capecitabine 1,000 mg/m2 twice daily was given to the subsequent 43 patients.
Results: All patients were assessable for safety and efficacy. A total of 351 treatment cycles were administered (median, six per patient; range, one to eight cycles). Dose reductions due to toxicities were required in 30% of patients in the standard-dose group, but capecitabine was given without a dose reduction to 95% of patients in the low-dose group. Capecitabine demonstrated a favorable safety profile. The overall incidence of grade 3/4 toxicities was low: the most common events reported in  10% of the patients were fatigue, diarrhea, dyspnea, and nausea. In the standard-dose group, the response rate was 36.7% (95% CI, 19.9% to 56.1%). An additional seven patients had disease stabilization at  24 weeks. In the low-dose group, the response rate was 34.9% (95% CI, 21% to 50.9%). An additional 15 patients had prolonged stabilization. The median time to disease progression was 4 months in either group.
Conclusion: This study shows that capecitabine is safe and effective in the elderly breast cancer patient. Based on the overall results, the capecitabine dose of 1,000 mg/m2 twice daily merits consideration as "standard" for older patients who do not have severely impaired renal function.
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