title: Pathological complete response rates comparing 3 versus 6 cycles of epidoxorubicin and docetaxel in the neoadjuvant setting of patients with stage II and III breast cancer.
abstract: We conducted a prospective randomized study to compare the results of 3 cycles of epidoxorubicin/docetaxel to 6 cycles of epidoxorubicin/docetaxel prior to surgery in breast cancer patients with clinical stages II and III. Forty-five patients eligible for neoadjuvant chemotherapy were randomly assigned to receive either 3 (group 1) or 6 (group 2) cycles of epidoxorubicin/docetaxel prior to surgery. Chemotherapy consisted of epidoxorubicin 75 mg/m and docetaxel 75 mg/m on day 1 in 3-week cycles. The primary endpoint was the pathological complete response (pCR) rate; secondary endpoints were the rates of breast-conserving surgery and the axillary lymph node status in both groups. A pCR occurred in 10% (two of 20) in Group 1 and in 36% (nine of 25) in Group 2, which was statistically significant (p=0.045). Breast-conserving surgery could be performed in 70% (14 of 20) in Group 1 and in 76% (19 of 25) in Group 2 (p=0.065). Axillary lymph node status was negative in 45% (nine of 20) in Group 1 and 52% (13 of 25) in Group 2 (p=0.86). We conclude that 6 cycles of pre-operative epidoxorubicin/docetaxel versus 3 cycles of pre-operative epidoxorubicin/docetaxel significantly increases the pCR rates for breast cancer patients.
authors.affiliation: Department of Senology, Breast Center, University Hospital Salzburg, Paracelsus Private Medical School Salzburg, Austria. r.reitsamer@salk.at
authors.forename: Roland
authors.initials: R
authors.lastname: Reitsamer
authors.forename: Florentia
authors.initials: F
authors.lastname: Peintinger
authors.forename: Eva
authors.initials: E
authors.lastname: Prokop
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hitzl
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D018275:Carcinoma, Lobular / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; 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; D009367:Neoplasm Staging; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012074:Remission Induction; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000077143:Docetaxel; D015251:Epirubicin; D005965:Glucuronates; D016179:Granulocyte Colony-Stimulating Factor; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; C074868:epidoxorubicin glucuronide