title: Epidoxorubicin and paclitaxel as primary chemotherapy for T > 3 cm and T4 breast cancer patients.
abstract: The Anthracyclines/Taxanes combination is often used in adjuvant and advanced breast cancer.
  
  
  OBJECTIVE
  To evaluate the toxicity and pathological response of sequential epidoxorubicin/paclitaxel combination as primary chemotherapy for T > 3 cm and T4 breast cancer patients.
  
  
  METHODS
  Forty-eight patients with T2 > 3 cm, T3 and T4 breast tumours were treated with Epidoxorubicin (90 mg/m2, i.v.) on day one and paclitaxel (200 mg/m2 over 3 hours) on day 2 every 21 days for four courses. After the fourth cycle the patients underwent modified radical mastectomy or quadrantectomy plus axillary lymph node dissection followed by six courses of intravenous CMF regimen (days 1 and 8, every 4 weeks). Radiotherapy was given to patients undergoing conservative surgery or with T4 cancers. Tamoxifen was administered in ER or PgR positive patients.
  
  
  RESULTS
  Out of the 48 patients enrolled into this trial, 43 were evaluable for toxicity and pathological response. Primary chemotherapy with epidoxorubicin and paclitaxel was well tolerated: no heart toxicity was observed during primary chemotherapy and follow-up. Primary toxicity consisted of myalgia, grade 1 neuropathy and grade 3 alopecia. Disappearance of invasive tumours in the breast with node negative was observed in 11.6% of patients: pathological partial response was shown in 56% of patients. On the whole major pathological response was achieved in 67% of our series: in the remaining 33% we found a stable disease or a size reduction less than 50%. No progressive disease was observed. Conservative surgery was performed in 64.5% of T2 and T3 tumours.
  
  
  CONCLUSIONS
  These preliminary data showed that the epidoxorubicin/paclitaxel combination was safe and effective as primary chemotherapy for patients with T > 3 cm and T4 breast cancer patients.
authors.affiliation: Department of Gynaecology and Obstetrics, Unit of Oncology, University of Turin, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Bellino
authors.forename: P
authors.initials: P
authors.lastname: Cortese
authors.forename: S
authors.initials: S
authors.lastname: Danese
authors.forename: C
authors.initials: C
authors.lastname: De Sanctis
authors.forename: A
authors.initials: A
authors.lastname: Durando
authors.forename: F
authors.initials: F
authors.lastname: Genta
authors.forename: R
authors.initials: R
authors.lastname: Grio
authors.forename: G
authors.initials: G
authors.lastname: Giardina
authors.forename: D
authors.initials: D
authors.lastname: Katsaros
authors.forename: M
authors.initials: M
authors.lastname: Massobrio
authors.forename: G
authors.initials: G
authors.lastname: Richiardi
authors.forename: R
authors.initials: R
authors.lastname: Vicelli
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D015411:Mastectomy, Modified Radical; D015412:Mastectomy, Segmental; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil; D008727:Methotrexate