A Phase II Trial of Neoadjuvant Gemcitabine, Epirubicin, and Docetaxel as Primary Treatment of Patients With Locally Advanced or Inflammatory Breast Cancer

• Published in: Clinical breast cancer Vol. 10; no. 3; pp. 217 - 223
• Main Authors: Yardley, Denise A, Peacock, Nancy W, Dickson, Natalie R, White, Melissa B, Vázquez, Elizabeth R, Foust, John T, Grapski, Richard, Hendricks, Linda K, Scott, William L, Hainsworth, John D
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2010
• Subjects: Adult; Aged; Anthracycline; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Epirubicin - administration & dosage; Epirubicin - adverse effects; Epirubicin - therapeutic use; Female; Hematology, Oncology and Palliative Medicine; Humans; Middle Aged; Myelosuppression; Neoadjuvant Therapy - adverse effects; Obstetrics and Gynecology; Pathologic complete response; Taxane; Taxoids - administration & dosage; Taxoids - adverse effects; Taxoids - therapeutic use; Treatment Outcome; Pathologic complete response; Myelosuppression; Taxane; Anthracycline
• ISSN: 1526-8209; 1938-0666
• DOI: 10.3816/CBC.2010.n.029

Abstract Background Three-drug regimens containing gemcitabine, an anthracycline, and a taxane produce response rates of 70%-90% in patients with metastatic breast cancer (MBC) although accompanied by considerable hematologic toxicity. We explored the combination of gemcitabine/epirubicin/docetaxel as neoadjuvant therapy. Docetaxel was administered weekly to decrease myelosuppression. Patients and Methods A total of 110 patients with locally advanced or inflammatory breast cancer received neoadjuvant gemcitabine 800 mg/m2 intravenously (I.V.) days 1 and 8, epirubicin 75 mg/m2 I.V. day 1, and docetaxel 30 mg/m2 I.V. days 1 and 8, repeated every 21 days for 4 cycles. Then patients had either mastectomy or breast conservation surgery, and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine 1000 mg/m2 I.V. days 1 and 8 and docetaxel 35 mg/m2 I.V. days 1 and 8 were administered at 21-day intervals. After patients completed chemotherapy, locoregional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. Results Treatment with 4 cycles of neoadjuvant gemcitabine, epirubicin, and weekly docetaxel resulted in an objective response in 79 of 110 patients enrolled (72%; 95% CI, 63-80%). Twenty of 103 patients (19%) who had surgery had pathologic complete response (pCR). Moderate hematologic toxicity was evident during neoadjuvant therapy, with grade 3/4 neutropenia in 41% and febrile neutropenia in 11% of the patients. Protocol-specified dose modifications were required in 35% of the patients, and 58% of the patients used myeloid growth factors. Conclusion The pCR rate of 19% achieved with gemcitabine, epirubicin, and weekly docetaxel confirms previous reports with similar 3-drug regimens. The use of a weekly schedule of docetaxel did not appear to reduce the incidence of grade 3/4 hematologic toxicity.