Comparative Study of Vinorelbine Monotherapy Versus Vinorelbine-Cisplatin in Metastatic Breast Cancer Patients Previously Treated with Anthracyclines and Taxanes
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- Category: Vol. 78, December 2010
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Comparative Study of Vinorelbine Monotherapy Versus Vinorelbine-Cisplatin in Metastatic Breast Cancer Patients Previously Treated with Anthracyclines and Taxanes,AZZA M. ADEL
Abstract
Background: There are few proved standards of care in metastatic breast cancer patients previously treated with anthracyclines and taxanes. This prospective randomized study was carried out to compare vinorelbine/cisplatin and vinorelbine single agent regarding efficacy, toxicity, PFS and overall survival after progression on anthracyclin and/or taxanes in patients with metastatic cancer breast.
Methods: This study included 2 groups of patients: Group I: Received Vinorelbine and cisplatin. Vinorelbine at a dose of 25mg/m2 intravenously on days 1 and 8 and cisplatin at the dose of 75mg/m2 on day 1 of a 3 week cycle. And Group II received only Vinorelbine in the previously mentioned dose on days 1 and 8 of a 3 week cycle. Treatment was repeated every three weeks for a maximum of 8 cycles or until evidence of disease progression or unacceptable toxicity.
Results: Thirty patients were treated in each group, overall response rate (CR+PR) in group 1 was 36.6% (11 patients) compared to 23.3% of patients in group 2 (7 patients); SD in 46.7% Vs. 53.3% of patients in both groups respectively; and PD in 16.7% and 23.3% of patients in both groups respectively. Response rate was statistically non significant between both groups (p:0.573). There were no differences in overall survival between the 2 treatment arms with median OS (Overall survival) 12.4 (95% Confidence interval 10.65-16.31) months for group I patients and 12 (95% confidence interval 10.19- 13.98) months for group II patients (p:0.564). Progression free survival (PFS) was significantly better for group I patients with median PFS of 8 months (95% confidence interval 6.67- 10.2) compared to 6.5 months (95% confidence interval 4.05- 7.03) for group II (p:0.04). More patients in group I had grade 3 and 4 nausea and vomiting (33.3% Vs. 10% of patients in both groups respectively, p:0.022), and sensory neuropathy (46.7% compared to 26.7% of patients in both groups respec-tively had grade 2-3 sensory neuropathy, p-value:0.043).
Conclusion: Adding cisplatin to vinorelbine for the salvage treatment of metastatic breast cancer did not improve the overall survival but was associated with better PFS on the expense of higher toxicity.