Toxicity and health-related quality of life (HRQoL) in node-negative breast cancer (BC) patients (pts) receiving adjuvant treatment with TAC (docetaxel, doxorubicin, cyclophosphamide) or FAC (5-fluorouracil, doxorubicin, cyclophosphamide): Impact of adding prophylactic growth factors (GF) to TAC. GEICAM Study 9805

Abstract

604 Background: Node-positive BC pts treated with TAC have a longer disease-free and overall survival but a higher rate of febrile neutropenia (FN) compared with pts treated with FAC. We evaluated the toxicity and HRQoL of both regimens and assessed the impact of adding prophylactic granulocyte GF to TAC.Methods: 1059 pts with operable, high-risk (St Gallen, 1998), node-negative BC, 18–70 yrs old, were randomized to FAC (F 500 mg/m2, A 50 mg/m2, C 500 mg/m2) or TAC (T 75 mg/m2, A 50 mg/m2, C 500 mg/m2) day 1 every 3wks for 6 cycles. After enrolling 224 pts, the study was amended to require prophylactic GF for pts subsequently treated with TAC, but not FAC. The EORTC QLQ-C30 was administered at baseline, after each chemotherapy cycle and 6, 12 and 24 months after completion of chemotherapy. Rates of FN (fever ≥gr 2 with gr 4 neutropenia), severe asthenia, gr 3–4 diarrhea, and gr 2–4 mucositis were analyzed. Results: 530 pts received TAC, 114 without GF [TAC] and 416 with GF [TAC+G]; 520 received FAC. During chemotherapy, HRQoL was worse with TAC than with FAC (p=0.008), with a maximum difference of 8.0 points during cycle 4. However, no statistically significant differences in HRQoL were observed between TAC+G and FAC, with 6.1 points as the highest difference during cycle 3. During the follow-up period, no statistically significant differences in HRQoL were observed among TAC alone, TAC+G and FAC. The incidence[95%CI] of: FN was 2.3%[1.0–3.6%] for FAC, 24.6%[16.7–32.5%] for TAC, and 5.8%[3.53–8.01%] for TAC+G; gr 3–4 diarrhea 0.8% FAC, 7.0% TAC, and 2.6% TAC+G (p=0.0415); severe asthenia 1.8% FAC, 20.2% TAC, and 5.5% TAC+G (p<0.0001); gr 2–4 mucositis 24.4% FAC, 35.1% TAC, and 23.3% TAC+G (p=0.011). Conclusions: TAC transiently worsens HRQoL compared with FAC during chemotherapy. However, BC pts treated with TAC plus GF support experience the same HRQoL as pts treated with FAC. The addition of GF to TAC significantly reduces the incidence of FN, gr 3–4 diarrhea, severe asthenia, and gr 2–4 mucositis compared with TAC alone. No significant financial relationships to disclose.