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Annals of Oncology Advance Access published online on October 6, 2006
Annals of Oncology, doi:10.1093/annonc/mdl338
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© 2006 European Society for Medical Oncology
Received June 15, 2006
Revised August 2, 2006
Accepted August 14, 2006

original article

Which benefit from adding gemcitabine to vinorelbine in elderly (≥70 years) women with metastatic breast cancer? Early interruption of a phase II study

U. Basso 1 *, L. Fratino 2, A. Brunello 1, F. Lumachi 3, G. L. De Salvo 4, S. Lonardi 1, C. Ghiotto 1, H. Koussis 1, L. M. Pasetto 1, and S. Monfardini 1

1 Department of Medical Oncology, Istituto Oncologico Veneto-IOV, Padova
2 Department of Medical Oncology, Centro Riferimento Oncologico-CRO, Aviano
3 Department of Endocrine Surgery, University Hospital, Padova
4 Department of Clinical Epidemiology and Biostatistics, Istituto Oncologico Veneto-IOV, Italy

* To whom correspondence should be addressed.
U. Basso, E-mail: u.basso{at}tin.it


  Abstract

Background: Since vinorelbine and gemcitabine are both active in breast cancer with moderate toxicity, in 2002 we started a phase II trial with a combination regimen in elderly patients.

Patients and methods: To evaluate complete plus partial response rates and toxicity of first-line vinorelbine 25 mg/m2 plus gemcitabine 1000 mg/m2 on days 1 and 8, every 3 weeks, in women ≥70 years with advanced breast cancer and measurable lesions. All patients underwent multidimensional geriatric assessment before enrollment. A two-step design was applied, and the trial would be completed if an overall response rate ≥30% was obtained with a grade 3-grade 4 (G3-G4) toxicity rate ≤25% (excluding neutropenia) in the first step.

Results: Twelve eligible patients had a median age of 74 years. At MGA, eight patients were fit, three vulnerable, one frail due to major depression; only two patients had G3 comorbidities according to Cumulative Illness Rating Scale-Geriatric. Seventy-five percent of patients had visceral disease. We obtained only one partial remission (11.1%) and six stabilizations of disease in nine assessable patients, with a time to progression of 3 months. Three patients (25%) experienced G3 neutropenia, and three patients (25%) developed G3 anemia (one patient) and G3 gastrointestinal toxicity (two patients).

Conclusions: The promising response rates obtained with this combination by other authors could not be confirmed in our small cohort of older women with breast cancer, therefore the trial was prematurely terminated. We do not recommend the co-administration of gemcitabine to vinorelbine in women ≥70 years outside the setting of controlled clinical trials.

Keywords: breast cancer; elderly; gemcitabine; geriatric assessment; metastatic; vinorelbine.
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