Impacto pronóstico de la respuesta patológica completa y del estado ganglionar en pacientes con cáncer de mama avanzado tratadas con dosis alta de epirrubicina neoadyuvante

Abstract

Objective

The primary endpoint was to assess the pathological complete response (pCR) rate, and the secondary endpoint was to determine the survival of the patients with advanced breast cancer treated with high doses of neoadjuvant epirubicin, and for different treatment periods.

Patients and methods

The patients received FE₁₀₀C (5-fluorouracil 500 mg/m², epirubicin 100 mg/m², cyclophosphamide 600 mg/m²) in either 4 or 6 cycles.

A logistic regression analysis was performed to identify the relationship of pCR with predictive factors. Kaplan-Meier plots and Cox proportional hazard were performed. The groups were compared using log-rank test.

Results

The study included 60 patients per group. A non-significant increase in the pCR rate (16.7%; p=.283) was observed after receiving 6 FE₁₀₀C. The logistic regression analysis revealed that only clinical stage IIIA (OR, 11; p=.023) was more likely to achieve a pCR. The univariate analysis showed a statistically significant difference in favour of IIIA tumours (82%; p=.042), and negative axillary lymph nodes (96%; p=.000) in disease-free survival. In the multivariate analysis, the group with more than 4 positive lymph nodes (hazard ratio [HR], 19.6; p=.003) had the worst prognosis. The treatment effect was not significant for the pCR (HR, 3.9; p=.184), or the number of cycles given (HR, 1.3; p = .412) on disease free survival.

Conclusion

The results show a slight increase in the effectiveness (pCR) with 6 FE₁₀₀C, however there was no chance of improving the disease-free survival and the post-chemotherapy negative lymph node rates compared with a shorter treatment period.