title: Preoperative chemotherapy with epidoxorubicin, docetaxel and capecitabine plus pegfilgrastim in patients with primary breast cancer.
abstract: The objective of this pilot trial was to evaluate the safety and activity profile of epidoxorubicin, docetaxel and oral capecitabine plus pegfilgrastim (TEX+P) as preoperative first-line treatment for patients with breast cancer. Eleven consecutive patients were enrolled in this prospective clinical pilot trial. Preoperative treatment consisted of epidoxorubicin [75 mg/m2 body surface area (BSA)] and docetaxel (75 mg/m2 BSA) administered sequentially on day 1 in combination with oral capecitabine 2000 mg/m2 daily divided into two doses on days 1-14 of each 3-week treatment cycle. Pegfilgrastim 6 mg fixed dose was administered s.c. on day 2 of every treatment cycle. Patients received a total of 58 cycles (median 6 cycles, range 1-6) of this therapeutic regimen. Outpatient TEX+P was well tolerated. No WHO grade IV toxicity was observed. A pathological major response to this preoperative therapy regimen could be demonstrated in eight of nine evaluable patients leading to breast-conserving surgery in seven of nine evaluable patients. We conclude that outpatient TEX+P is safe in the neoadjuvant treatment of patients with primary breast cancer. Thus, this regimen can be considered for further clinical trials.
authors.affiliation: Department of Internal Medicine I, Division of Oncology, University of Vienna, Vienna, Austria.
authors.forename: Catharina
authors.initials: C
authors.lastname: Wenzel
authors.forename: Rupert
authors.initials: R
authors.lastname: Bartsch
authors.forename: Gottfried J
authors.initials: GJ
authors.lastname: Locker
authors.forename: Dagmar
authors.initials: D
authors.lastname: Hussian
authors.forename: Ursula
authors.initials: U
authors.lastname: Pluschnig
authors.forename: Ursula
authors.initials: U
authors.lastname: Sevelda
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gnant
authors.forename: Raimund
authors.initials: R
authors.lastname: Jakesz
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Zielinski
authors.forename: Guenther G
authors.initials: GG
authors.lastname: Steger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D000069585:Filgrastim; D005472:Fluorouracil / Q000031:analogs & derivatives; D005965:Glucuronates / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009361:Neoplasm Invasiveness / Q000473:pathology*; D010865:Pilot Projects; D011092:Polyethylene Glycols; D011300:Preoperative Care; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011994:Recombinant Proteins; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000069287:Capecitabine; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069585:Filgrastim; D005472:Fluorouracil; D005965:Glucuronates; D016179:Granulocyte Colony-Stimulating Factor; D011092:Polyethylene Glycols; D018719:Erb-b2 Receptor Tyrosine Kinases; D011994:Recombinant Proteins; D043823:Taxoids; C074868:epidoxorubicin glucuronide; C455861:pegfilgrastim