Outcomes of metastatic breast cancer patients older than 60 years treated with FEC or ET regimens: A retrospective analysis

Background: we recently demonstrated that, in a cohort of 640 patients enrolled into 6 consecutive studies on Ist line MBC from 1984 to 2001, the introduction of P resulted into an improved outcome. Purpose: the purpose of this subgroup analysis was to evaluate if this benefit was equally distributed in all patients, or if we could identify a class of patients in whom such an aggressive CT might not be worthwhile. Methods: Prospectively collected data from 6 successive epirubicin-containing protocols for the treatment of metastatic breast carcinoma were evaluated. Treatment outcome was analysed depending on age: < 50 years (220 pts), 51-60 (251 pts) and > 60 years (169 pts), and Results: In patients aged < 50 years overall response rate (ORR) was 51% in NoTax patients and 78% in Tax patients (p 0.0001), and complete response rate (CRR) was 14% and 27% (p 0.0001), respectively. In patients aged 51-60 years ORR was 49% in NoTax patients and 58% in Tax patients (p ns), and CRR was 15% and 14% (p = ns), respectively. In patients aged < 60 years ORR was 51% in NoTax patients and 62% in Tax patients (p = ns), and CRR was 18% and 7% (p 0.06), respectively. Median progression free survival (PFS) was: 8.4 months (epi) (95% CI: 10.9-12.3 months) and 13.7 months (ET) (95% CI: 10.9-12.3 months), (p = 0.0001) in patients < 50 years; 8.6 months (epi) (95% CI: 10.9-12.3 months) and 10.1 months (ET) (95% CI: 10.9-12.3 months), (p = 0.0001) in patients 51-60 years, and 11.5 months (epi) (95% CI: 10.9-12.3 months) and 10.1 months (ET) (95% CI: 10.9-12.3 months), (p = ns) in patients > 60 years. Conclusions: The introduction of Paclitaxel into clinical practice, and its administration in aggressive CT regimens with anthracyclines is not of benefit for patients age > 60 years, in whom less aggressive treatments and palliation may represent the right choice.