Capecitabine in the routine treatment of advanced breast cancer: results from a non-interventional observational study in 876 [corrected] patients.
BACKGROUND
This observational study evaluated patient characteristics, treatment schedule and setting, efficacy and tolerability of capecitabine in routine clinical practice in Germany.


METHODS
Patients with advanced breast cancer pretreated with or ineligible for anthracycline-containing therapy were treated with capecitabine. Data were collected until disease progression or completion of 12 cycles (with long-term follow-up in progression-free patients).


RESULTS
846 of the 876 [corrected] patients enrolled between 2002 and 2007 were eligible. Capecitabine was administered as monotherapy in 64% (median starting dose 1,070 mg/m(2) bis in diem (b.i.d.)) and combination chemotherapy (typically with vinorelbine or docetaxel) in 36% (median starting dose 987 mg/m(2) b.i.d.). Capecitabine was given as first-line therapy in 35% of patients. Objective response rate was 41% and median progression-free survival was 7.5 months. Good performance status at baseline was a significant predictor of efficacy. The most common non-hematological toxicity was hand-foot syndrome (all grades: 54%; grade 3: 7%). Myelosuppression and alopecia were substantially less common with capecitabine monotherapy than with capecitabine combination regimens.


CONCLUSIONS
Capecitabine, alone or in combination, is a feasible, effective treatment for breast cancer. Our findings in real-life clinical practice compare favorably with results from interventional studies, perhaps reflecting the longer treatment duration possible at more tolerable doses.
Siedentopf
Friederike
F
Praxis fur Gynakologie Dr. Schoenegg, Berlin, Germany. f.siedentopf@drk-kliniken-berlin.de
Gohler
Thomas
T
Hesse
Tobias
T
Nusch
Arud
A
Sulberg
Heiko
H
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008875:Middle Aged; D015995:Prevalence; D018570:Risk Assessment; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil