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Annals of Oncology Advance Access originally published online on March 6, 2006
Annals of Oncology 2006 17(4):623-629; doi:10.1093/annonc/mdj130
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© 2006 European Society for Medical Oncology

Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients ≥65 years of age: an NCCTG study

M. Baweja1, V. J. Suman2, T. R. Fitch3, J. A. Mailliard4, A. Bernath5, K. M. Rowland6, S. R. Alberts2, J. S. Kaur2 and E. A. Perez1,*

1 Mayo Clinic, Jacksonville, FL; 2 Mayo Clinic, Rochester, MN; 3 Mayo Clinic, Scottsdale, AZ; 4 Missouri Valley Cancer Consortium CCOP, Omaha, NE; 5 Geisinger Medical Center, Danville, PA; 6 Carle Cancer Center, Urbana, IL, USA

* Correspondence to: Dr E. A. Perez, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224, USA. Tel: +1904-953-7283; Fax: +1904-953-2315; E-mail: perez.edith{at}mayo.edu

Background: A one-stage phase II trial was conducted to assess the tumor response rate and toxicity profile of single agent oral vinorelbine as first or second-line chemotherapy for women at least 65 years of age with metastatic breast cancer.

Patients and methods: Twenty-five patients with metastatic breast cancer aged ≥65 years of age were enrolled to receive oral vinorelbine on a weekly basis. The oral vinorelbine was given at 60 mg/m2 weekly for the first four doses and was increased to 70 mg/m2 for the subsequent administrations if there was no grade 4 neutropenia or no more than one episode of grade 3 neutropenia. Therapy was continued until progression or intolerable toxicity.

Results: Twenty-five patients were included and evaluable for analysis. One patient (4%) achieved a partial response (PR) that lasted for more than 13 months. Two additional patients remained stable for at least 6 months for a clinical benefit rate (PR + stable disease) of 12%. The 1-year survival rate was estimated to be 48% (95% CI 30% to 74.5%). Median time to progression was estimated to be 4.7 months (95% CI 2.0–5.5 months) and the 9-month disease progression-free rate was estimated to be 8% (95% CI 30.9% to 74.5%). The treatment was fairly well tolerated with grade 3 neutropenia in 12.5%, fatigue in 12.5% of the patients, and grade 2 neuromotor and neurosensory toxicities in 12.5% and 8.3%, respectively.

Conclusion: Oral vinorelbine as a single agent at these dose and schedule in this population of women ≥65 years is well tolerated but has a low level of objective efficacy for the treatment of metastatic breast cancer.

Key words: elderly, metastatic breast cancer, vinorelbine


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M. Findlay, G. von Minckwitz, and A. Wardley
Effective oral chemotherapy for breast cancer: pillars of strength
Ann. Onc., February 1, 2008; 19(2): 212 - 222.
[Abstract] [Full Text] [PDF]


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