Background:
A prospective, multicenter, randomized, phase iii trial comparing the efficacy of combination chemotherapy with 5-fluorouracil, doxorubicin, and cyclophosphamide (fac) with a combination of vinorelbine and doxorubicin (na) in the treatment of patients with advanced breast carcinoma was undertaken.
Methods:
One hundred and seventy-seven patients who previously were untreated for recurrent or metastatic breast carcinoma were entered into the study; 7 patients could not be assessed. the final analysis relates to 85 patients who were treated with fac and 85 patients who were treated with na, of whom 21 (25%) and 44 (52%), respectively, had received prior adjuvant chemotherapy.
Results:
The overall response rates were similar for the two treatments and were unaffected by prior exposure to adjuvant therapy; overall response rate (orr) for fac was 74% (95% confidence interval [95% ci], 65-83%), and the orr for na was 75% (95% ci, 66-84%). the activity of na in patients with liver involvement was greater than that of fac in terms of survival. overall survivals were similar, with a median of 17.3 months for patients receiving fac and 17.8 months for patients receiving na. severe toxicity was uncommon with world health organization grade 3-4 neutropenia affecting only 7% of patients in each arm of the study. na was associated with a higher incidence of mild to moderate constipation, neurotoxicity, and phlebitis, whereas fac produced a slight excess of mild cardiotoxicity.
Conclusions:
The efficacy of these two regimens is very similar, although na may be more active in a subset of patients with visceral metastatic disease, particularly liver involvement. it is clear that, in a direct comparison with an established three-drug regimen, the newer two-drug combination of na demonstrated equivalent activity with no significant excess of grade 3-4 toxicity.