A novel metronomic schedule of oral vinorelbine for the treatment of metastatic breast cancer in elderly patients...............

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Sub-category: Metastatic Breast Cancer

Category: Breast Cancer--Metastatic Breast Cancer

Meeting: 2009 ASCO Annual Meeting


Citation: J Clin Oncol 27:15s, 2009 (suppl; abstr 1085)

Abstract No: 1085

Author(s): R. Addeo, V. Faiola, G. Cennamo, R. Guarrasi, L. Montella, P. Iodice, A. Sgambato, E. Capasso, M. Caraglia, S. Del Prete; ASLNA3, Frattamaggiore, Italy; Università Cattolica del Sacro Cuore, Roma, Italy; S.U.N., Napoli, Italy



Background: Oral vinorelbine (VNR) is particularly useful in elderly patients due to its favorable toxicity profile. Several studies demonstrated that this drug seems to represent an active treatment for metastatic breast cancer (MCB). We evaluated the clinical efficacy and tolerance of metronomic chemotherapy with oral VNR.


Methods: Women were eligible if they had a histologically proven untreated MBC and were > 70 years old. A two-staged Simon accrual design was adopted for this phase II trial. Patients were required to have negative estrogen receptor status, at least one bidimensionally measurable target lesion, Karnofsky performance status >70; life expectancy > 3 months. Each patient received oral vinorelbine 80 mg/m2 fractionated in days 1, 3, and 5, three week on-one week off, every 4 weeks, for a maximum of six cycles unless disease progression or unacceptable toxicity.


Results: Thirty-two patients with MBC were eligible, assessable for response, and toxicity. The median age was 75 years (range 70-84), sixteen patients (50%) had a Karnofsky performance status of 90-100. The main comorbidities recorded were: hypertension in 9 (28%) patients and diabetes mellitus in 6 (19%). The overall response rate (on an intent-to-treat basis) was 41% (13 of 32; 95% CI, 20%-54%). Two complete response and 11 partial responses were noted. In addition, other 10 patients (31%) had stable disease of > 4 months duration, and 9 patients (28 %) had disease progression. Median time to disease progression was 7.1 months and median overall survival was 12.7 months. The schedule was well tolerated, grade 3 toxicity was observed only in two patients.


Conclusions: Metronomic oral VNR can be safely administered to elderly patients with MBC and is active in this population. Final data analysis will be presented.