1. Phase I/II Trial of Adjuvant Dose-Dense Docetaxel/Epirubicin/Cyclophosphamide (TEC) in Stage II and III Breast Cancer.
- Author
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Burdette-Radoux, Susan, Wood, Marie E., Olin, Julie J., Laughlin, Rebecca S., Crocker, Abigail M., Ashikaga, Takamaru, and Muss, Hyman B.
- Subjects
BREAST cancer treatment ,BREAST cancer patients ,DRUG therapy ,DOCETAXEL ,CLINICAL trials ,MEDICAL research - Abstract
This phase I/II trial investigates the safety and feasibility of six cycles of concurrent taxane, anthracycline and cyclophosphamide on a dose dense schedule. Patients with stage II/III breast cancer were treated with docetaxel (T) 75 mg/m
2 , epirubicin (E) 75 mg/m2 (cohort 1, n = 3) or 100 mg/m2 (cohort 2, n = 12), and cyclophosphamide (C) 500 mg/m2 IV on day 1, with pegfilgrastim 6 mg subcutaneously on day 2, every 2 weeks for six cycles. Patients were assessed for toxicity every 2 weeks; cardiac function and response (if neoadjuvant) were assessed after six cycles. All patients in cohort 1 received 100% planned dose intensity; in cohort 2, five of twelve patients received 100% and 11/12 received >80%. There were no dose reductions or delays for day 1 myelotoxicity. Dose reductions as a result of febrile neutropenia (FN) occurred in cohort 2, with six of twelve patients experiencing FN in seven of sixty-nine cycles. Six patients had anemia ≥grade 3; five received RBC transfusion and seven received an erythropoietic growth factor. Four patients required dose reductions for nonhematologic toxicity (two mucositis; one neurotoxicity; one diarrhea + cellulitis). Four patients developed thrombophlebitis, which was associated with FN in one of four. Two of fourteen evaluable patients had asymptomatic decreases in LVEF >10%; all remained within normal range. All four patients receiving neoadjuvant TEC had significant clinical responses (one CR, three PR). No pathologic CRs were seen. Conclusions: Dose dense TEC chemotherapy is feasible, has acceptable toxicity at doses equivalent to TAC (docetaxel 75 mg/m2 , epirubicin 75 mg/m2 , cyclophosphamide 600 mg/m2 ), and has moderate but manageable toxicity using a higher epirubicin dose of 100 mg/m2 , with FN occurring in six of twelve patients at the higher dose. [ABSTRACT FROM AUTHOR]- Published
- 2007
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