Originally published as JCO Early Release 10.1200/JCO.2005.02.167 on February 14 2005

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Safety and Efficacy of Two Different Doses of Capecitabine in the Treatment of Advanced Breast Cancer in Older Women

From the Medical Oncology Unit 2, Unit of Medical Statistics and Biometry, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy

Address reprint requests to Emilio Bajetta, MD, Medical Oncology Unit 2, Istituto Nazionale per lo Studio e la Cura dei Tumori, Via G. Venezian 1, 20133 Milano, Italy; 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.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 30-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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