Combined doxorubicin/vinorelbine (Navelbine) therapy in the treatment of advanced breast cancer.

A multicenter US study of the combination of doxorubicin (50 mg/m2 day 1) and vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) (25 mg/m2 days 1 and 8) every 21 days examined the effects of this regimen as first-line chemotherapy in advanced breast cancer patients. Of the 62 patients enrolled in the study, 41 were completely evaluable for response and toxicity at the time of this analysis. The median patient age was 59 years. Prior therapy included hormone therapy (55%), adjuvant chemotherapy (40%), and radiotherapy (28%). Two hundred twelve courses of combined therapy were given. Toxicities included granulocytopenia (grade 4, 83%; grade 3, 12%), febrile neutropenia requiring hospitalization (three patients, 8%), septic death (one patient, 3%), thrombocytopenia (grade 3, 5%), stomatitis (grade 4, 5%), alopecia (grade 3, 15%), and nausea/vomiting (grade 3, 12%). One patient developed clinical congestive heart failure due to doxorubicin. The overall response rate for 58 patients evaluable for response was 57% (95% confidence interval: 45% to 69%): 16% of patients had complete responses (9 patients) and 41% had partial responses (24 patients). Twenty-seven percent of patients had stable disease (16 patients). This regimen was well tolerated and had excellent patient acceptance.