Dose-dense (DD) two-weekly docetaxel/doxorubicin/cyclophosphamide (TAC) with G-CSF support compared to standard adjuvant TAC in breast cancer patients

Abstract

11052 Background: TAC confers a significant disease free and overall survival benefits vs. FAC for patients with node positive breast cancer and prophylactic use of G-CSF is a reasonable supportive therapy to minimize myelosuppresive complications of this regimen. DD scheduling has shown improved clinical outcomes in breast cancer therapy. This study is trying to compare toxicities and tolerability of DD TAC with G-CSF support with TAC every 3 wks supported with G-CSF. Methods: Thirty seven patients were enrolled during the period 1/04 to 1/06. Cohort A (N=25) received six cycles of TAC (75/50/500 mg/m2 every 3 wks) plus GCSF started on day 5 and Cohort B (N=12) received six cycles of TAC (75/50/500 mg/m2 every 2 wks) plus GCSF started on day 2. All patients had normal cardiac, renal and liver function. Toxicities were evaluated by clinical assessment, CBC and liver function tests. Results: The incidence of febrile neutropenia was 15.8% and 16.7% in cohort A and B respectively (RR =1.06, 95% CI = 0.20–5.42). Grade III/IV anemia was detected in 5.3% of cohort A patients and 8.0 % of cohort B patients (RR=1.58, 95% CI=0.10–22.99). Ten percent of cohort A patients developed stomatitis grade III/IV while none of cohort B patients had this toxicity (RR=1.06, 95% CI = 0.94–1.17). Hospitalization due to chemotherapy complications (mainly neutropenia) in cohort A and B were 5.3% and 8.3% (RR =1.58, 95%CI = 0.10–22.99). Conclusions: DD two weekly TCA was reported to be feasible in patients with stage II - III breast cancer (Margolis et al. JCO, 2005). This study shows that DD TCA plus G-CSF has comparable toxicity profile with standard TCA regimen with shorter treatment period.