The observation of single-agent gemcitabine maintenance therapy in patients with metastatic breast cancer

Objective: The aim of the study was to evaluate the efficacy and tolerability of single-agent gemcitabine in the maintenance treatment of histologically confirmed metastatic breast cancer cases. Methods: The 45 patients carried efficacious chemotherapy were divided into maintenance therapy group (n = 23) and control group (n = 22) according to the different treatment methods. Patients in the maintenance therapy group received gemcitabine therapy until 6 cycles, disease progression or adverse effect intolerance. Within the control group, the patients were given best supportive care. Follow-up was made until disease progression, death or 2 years. The short-term clinical efficacy and adverse effects, progression-free survival (PFS) and median survival of recurrence (MSR) of these two groups were compared and analyzed. Results: Compared with the control group, the experiment group had higher response rate (RR; 73.9% vs 31.8%; P < 0.05), and significantly progress of median PFS (13.1 vs 9.6 months; P < 0.05). However, the progression of MSR had no statistically difference with the control group (23.3 vs 21.1 months; P > 0.05). Most of the treatment-related adverse events were mild, and the most common adverse event was hematologic toxicity. The 3 cases occurred grades 3-4 neutropenia and 3 cases occurred grades 3-4 thrombocytopenia. The 1 patient stopped treatment because of grade 3 allergic reaction, and 4 patients required dose reduction for grade 4 adverse events. Other adverse effects were grades 1-2, and all were recovered after symptomatic treatment. There was no significant side effect which threatened the life. Conclusion: In the extension maintenance treatment, gemcitabine can consolidate the therapeutic effect in advance and significantly prolong median PFS of metastatic breast cancer patients. In conclusion, gemcitabine monotherapy with a favorable safety profile is an effective maintenance treatment in metastatic breast cancer patients.