title: Oral capecitabine in anthracycline- and taxane-pretreated advanced/metastatic breast cancer.
abstract: An open-label, non-randomized, compassionate-use study was carried out to investigate the effects of oral capecitabine at a dose of 1 250 mg/m2 twice daily on days 1 to 14 every 21 days in anthracycline- and taxane-pretreated advanced/metastatic breast cancer patients. Forty-eight patients were enrolled from April 2000 to December 2001. Twenty-four patients (50%) had metastases to the liver, 18 to bone, 13 to lung, 10 to regional lymph nodes, 8 to pleura, 7 to the thoracic wall, 5 to skin, 3 to the mediastinum, 1 to breast and 1 had metastasis to the abdomen. Thirty-three patients (69%) had metastases to more than one site. Median age of the patients was 55 years (range 35-74). Three patients had an ECOG performance status (PS) of 0, 32 PS 1 and 13 PS 2, respectively. Fourteen patients (29%; 95% CI 16 to 42%) obtained a partial response (PR) while 16 (33%) had stable disease (SD) as the best response, of whom 6 had stabilization for more than 24 weeks. This gives a clinical benefit (PR + SD > 24 weeks) of 42% (95% CI 28 to 56). Dose reduction was necessary in 29% of the patients. Median dose reduction was 25%. Grades 2 and 3 hand-foot syndrome (PPE) was observed in 17 patients (36%). Eleven patients experienced grades 2 and 3 gastrointestinal toxicity, and haematological toxicity grade 3 was observed in 3 patients (6%). Median time to progression was 107 days (CI 95% 85 to 129), and median overall survival was 281 days (CI 95% 164 to 398). Third-line, oral capecitabine in anthracycline- and taxane-pretreated metastatic breast cancer appears to be effective and has an acceptable toxicity profile.
authors.affiliation: Department of Oncology, Ullevål University Hospital, Oslo, Norway. erik.wist@ioks.uio.no
authors.forename: Erik A
authors.initials: EA
authors.lastname: Wist
authors.forename: Hilde H
authors.initials: HH
authors.lastname: Sommer
authors.forename: Bjørn
authors.initials: B
authors.lastname: Ostenstad
authors.forename: Terje
authors.initials: T
authors.lastname: Risberg
authors.forename: Yngve
authors.initials: Y
authors.lastname: Bremnes
authors.forename: Ingvild
authors.initials: I
authors.lastname: Mjaaland
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000633:toxicity; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001952:Bridged-Ring Compounds / Q000627:therapeutic use; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000633:toxicity; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011355:Prodrugs / Q000008:administration & dosage* / Q000633:toxicity; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000964:Antimetabolites, Antineoplastic; D001952:Bridged-Ring Compounds; D011355:Prodrugs; D043823:Taxoids; D003841:Deoxycytidine; C080625:taxane; D000069287:Capecitabine; D005472:Fluorouracil