title: Paclitaxel and epidoxorubicin or doxorubicin versus cyclophosphamide and epidoxorubicin as first-line chemotherapy for metastatic breast carcinoma: a randomised phase II study.
abstract: Fifty-eight patients with metastatic breast cancer were randomly treated with a combination of cyclophosphamide 500 mg/m2 on days 1 and 2 plus epidoxorubicin 90 mg/m2 on day 1 every 3 weeks (group A = 18 patients), or paclitaxel 175 mg/m2 cycle plus doxorubicin 50 mg/m2/cycle every 3 weeks (group B = 20 patients), or paclitaxel as above plus epidoxorubicin 90 mg/m2/cycle every 21 days (group C = 20 patients). The trial was designed as a randomized, multi-institutional phase II study where the cyclophosphamide/epidoxorubicin regimen represented the calibration arm. The overall response rate was 50% (95% CL 26-74%) for arm A, 65% (95% CL 41-85%) for arm B and 70% (95% CL 46-88%) for arm C. The complete response rate was 6% for arm A, 10% for arm B and 15% for arm C. Although this trial was non comparative, the median duration of response and median overall survival were almost superimposable in all arms. The taxane-based regimens were associated with significant neurotoxicity in nearly 20% of cases, while febrile neutropenia represented the most severe side-effect. Our data suggest that the anthracycline/taxane combinations are more effective than the epidoxorubicin/cyclophosphamide regimen, at least in terms of objective response rates. These regimens may represent the treatment of choice when oncologists are faced with aggressive visceral metastatic breast cancer in non elderly women.
authors.affiliation: University of Palermo, Medical Oncology Unit, La Maddalena Clinic for Cancer, Palermo, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Livio
authors.initials: L
authors.lastname: Blasi
authors.forename: Nicolo
authors.initials: N
authors.lastname: Borsellino
authors.forename: Michele
authors.initials: M
authors.lastname: Caruso
authors.forename: Vita
authors.initials: V
authors.lastname: Leonardi
authors.forename: Biagio
authors.initials: B
authors.lastname: Agostara
authors.forename: Roberto
authors.initials: R
authors.lastname: Valenza
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D015251:Epirubicin; D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel