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, Roberto Buzzoni

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)2155-2161
Number of pages7
JournalJournal of Clinical Oncology
Volume23
Issue number10
DOIs
Publication statusPublished - 2005

Fingerprint

Breast Neoplasms
Safety
Therapeutics
Capecitabine
Poisons
Dyspnea
Nausea
Fatigue
Disease Progression
Diarrhea
Kidney
Incidence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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 journalArticle

Bajetta, Emilio ; Procopio, Giuseppe ; Celio, Luigi ; Gattinoni, Luca ; Della Torre, Silvia ; Mariani, Luigi ; Catena, Laura ; Ricotta, Riccardo ; Longarini, Raffaella ; Zilembo, Nicoletta ; Buzzoni, Roberto. / Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 10. pp. 2155-2161.
@article{1b3de199f0a1417dbf2c3ed51412328a,
title = "Safety and efficacy of two different doses of capecitabine in the treatment of advanced breast cancer in older women",
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.",
author = "Emilio Bajetta and Giuseppe Procopio and Luigi Celio and Luca Gattinoni and {Della Torre}, Silvia and Luigi Mariani and Laura Catena and Riccardo Ricotta and Raffaella Longarini and Nicoletta Zilembo and Roberto Buzzoni",
year = "2005",
doi = "10.1200/JCO.2005.02.167",
language = "English",
volume = "23",
pages = "2155--2161",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "10",

}

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.

UR - http://www.scopus.com/inward/record.url?scp=20244368234&partnerID=8YFLogxK

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 -