Purpose: No standard chemotherapy has been so far definitely settled for elderly patients with metastatic breast cancer (MBC). In order to identify a regimen with acceptable efficacy and low burden of non-overlapping toxic effects, a combination consisting of liposomal pegilated doxorubicin (PLD) with alternating oral and intravenous vinorelbine (NVB) has been investigated in a phase II study.
Methods: Thirty-four consecutive patients (median age 71 years; range 65-82) with MBC have been enrolled. Based on 4-weekly cycles, PLD 40 mg/m(2) plus NVB 25 mg/m(2) i.v., have been administered intravenously on day 1 and oral NVB 60 mg/m(2) on day 15.
Results: All patients were assessable for safety and efficacy. In all, 17 responses were documented with three complete responses (CR) and 14 partial responses, with an overall response rate of 50% (95% CI 36-66). Median overall survival time was 13 months and the median time to progression 8 months. Interestingly, all the patients with CR are still alive with a disease-free survival of more than 1 year. The main toxicity was neutropenia: grade 3 in 15% and grade 4 in 11% of patients, respectively. Febrile neutropenia was recorded in three patients not requiring dose reduction. Other frequently reported adverse events included: anemia, nausea, vomiting, stomatitis, all rarely severe. The evaluation of quality of life (QoL) did not show any significant change during the study.
Conclusions: Our data suggest that this combination is active and well tolerated in elderly patients with MBC and could represent another efficacious chance for the management of this population.