To analyze the efficacy, tolerability, toxicity profile, quality of life and pharmaco-economics of adjuvant TAC compared to FAC regimen in hormone receptor-positive breast cancer with more than four involved lymph nodes

Abstract

11043 Aim: To analyze the efficacy, tolerability, toxicity profile, quality of life, survival rates and pharmaco-economics of TAC vs. FAC in women with ER/PR positive breast cancer and >4 involved lymph nodes. Methods: 100 patients with >4 node-positive breast cancer were randomly assigned to receive either 6 cycles of taxane-based (TAC) or anthracycline-based (FAC) adjuvant chemotherapy. All the patients received adjuvant radiotherapy and hormonal therapy after completion of chemotherapy. The primary end point was to assess disease-free survival (2 years), toxicity profile, QOL and to analyze the pharmaco-economics of both therapies. All patients completed EORTC QLQ 30, BR 23 questionnaire before randomization and before every cycle of chemotherapy. Pharmaco-economic feasibility was determined using cost of drugs, duration of hospital stay, laboratory investigations, management of complications and loss of wages. Treatment: The treatment (dose in mg/m2) was as follows: TAC: docetaxel 75, doxorubicin 50, cyclophosphamide 500; CAF: 5 flourouracil 500, doxorubicin 50, cyclophosphamide 500. Results: The patient demographics and primary tumor characteristics were comparable in both the arms. Taxane- based regimen was associated with decreased global QOL and physical function. The cost of TAC regimen was 25 times more than FAC regimen. Conclusion: Although TAC regimen had longer DFS as compared to FAC, it was associated with a higher incidence of side effects and increased duration of hospital stay. Further, high cost precludes its wide-spread use, and FAC regimen still continues to be the first choice treatment of high-risk node and receptor-positive breast cancer in a third world country like India. [Table: see text] No significant financial relationships to disclose.