Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 2155-2161 |
| Number of pages | 7 |
| Journal | Journal of Clinical Oncology |
| Volume | 23 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2005 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
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Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. / Bajetta, Emilio; Procopio, Giuseppe; Celio, Luigi; Gattinoni, Luca; Della Torre, Silvia; Mariani, Luigi; Catena, Laura; Ricotta, Riccardo; Longarini, Raffaella; Zilembo, Nicoletta; Buzzoni, Roberto.
In: Journal of Clinical Oncology, Vol. 23, No. 10, 2005, p. 2155-2161.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women
AU - Bajetta, Emilio
AU - Procopio, Giuseppe
AU - Celio, Luigi
AU - Gattinoni, Luca
AU - Della Torre, Silvia
AU - Mariani, Luigi
AU - Catena, Laura
AU - Ricotta, Riccardo
AU - Longarini, Raffaella
AU - Zilembo, Nicoletta
AU - Buzzoni, Roberto
PY - 2005
Y1 - 2005
N2 - 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.
AB - 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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UR - http://www.scopus.com/inward/citedby.url?scp=20244368234&partnerID=8YFLogxK
U2 - 10.1200/JCO.2005.02.167
DO - 10.1200/JCO.2005.02.167
M3 - Article
C2 - 15710946
AN - SCOPUS:20244368234
VL - 23
SP - 2155
EP - 2161
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 10
ER -