Phase II Study of Feasibility of Dose-Dense FEC Followed by Alternating Weekly Taxanes in High-Risk, Four or More Node-Positive Breast Cancer

• Published in: Clinical cancer research Vol. 10; no. 17; pp. 5754 - 5761
• Main Authors: DANG, Chau T, D'ANDREA, Gabriella M, HURRIA, Arti, PANAGEAS, Katherine S, NORTON, Larry, HUDIS, Clifford A, MOYNAHAN, Mary E, DICKLER, Maura N, SEIDMAN, Andrew D, FORNIER, Monica, ROBSON, Mark E, THEODOULOU, Maria, LAKE, Diana, CURRIE, Violante E
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA American Association for Cancer Research 01.09.2004
• Subjects: Adult; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Cyclophosphamide - administration & dosage; Disease-Free Survival; Dose-Response Relationship, Drug; Epirubicin - administration & dosage; Feasibility Studies; Female; Fluorouracil - administration & dosage; Granulocyte Colony-Stimulating Factor - administration & dosage; Humans; Lymph Nodes - pathology; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Pharmacology. Drug treatments; Pilot Projects; Risk Factors; Survival Rate; Taxoids - administration & dosage; Tumors; Mammary gland diseases; High risk; Phase II trial; Feasibility; Breast cancer; Mammary gland; Malignant tumor; Dose
• ISSN: 1078-0432; 1557-3265
• DOI: 10.1158/1078-0432.CCR-04-0634

Purpose: To develop a potentially superior adjuvant chemotherapy regimen, we conducted a pilot study of dose-dense 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by weekly alternating taxanes. The primary objective was to determine the feasibility of the regimen; the secondary objective was to estimate the disease-free and overall survival. Experimental Design: Patients with ≥4 node-positive breast cancer were studied. Treatment consisted of FEC at 500/100/500 mg/m 2 , respectively, ×6 at two-week intervals with granulocyte colony-stimulating factor, followed by weekly paclitaxel (80 mg/m 2 ) alternating with docetaxel (35 mg/m 2 ) ×18. Results: Between November 2001 and January 2003, 44 patients were enrolled. Median age was 46 years (range, 26–63 years), median number of positive nodes was 9 (range, 4–32), and median tumor size was 2.5 cm (range, 0.6–11.0 cm). Because of unexpected toxicities, the study was stopped when 17 (39%) had fully completed all of the planned treatment. Two of 17 (12%) developed grade 4 pericardial/grade 3 bilateral pleural effusions at treatment completion; both required pericardial window. The remaining patients were treated with taxanes using one of several standard dose and schedule combinations. Furthermore, 4 of 44 (9%) developed pneumonitis attributed to the FEC regimen. Hospital admissions were required for 12 of 44 (27%); 3 of 44 (7%) required blood transfusions. There were no treatment related deaths. Median disease-free and overall survival will not be estimatable because of early closure of study. Conclusion: FEC ×6 at 2-week intervals followed by 18 weeks of alternating taxanes is not feasible at the doses tested. Other strategies are needed to improve adjuvant systemic chemotherapy.