Bajetta E, Procopio G, Celio L, Gattinoni L, Della Torre S, Mariani L, Catena
L, Ricotta R, Longarini R, Zilembo N, Buzzoni R.
Medical Oncology Unit 2, Unit of Medical Statistics and Biometry, Istituto
Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
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/m(2) twice daily on days 1 to 14
every 21 days. Due to the occurrence of two toxic deaths, capecitabine 1,000
mg/m(2) 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/m(2) twice daily merits consideration as "standard" for older
patients who do not have severely impaired renal function.
Source :
http://www.docguide.com/news/content.nsf/PaperFrameSet?OpenForm&newsid=8525697700573E1885256FAC003B6BB2&topabstract=1&u=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=15710946