Skip Navigation


Annals of Oncology Advance Access originally published online on October 6, 2006
Annals of Oncology 2007 18(1):58-63; doi:10.1093/annonc/mdl338
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
18/1/58    most recent
mdl338v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (6)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Basso, U
Right arrow Articles by Monfardini, S
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Basso, U
Right arrow Articles by Monfardini, S
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 2006 European Society for Medical Oncology

breast cancer

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

U Basso1,*, L Fratino3, A Brunello1, F Lumachi2, GL De Salvo4, S Lonardi1, C Ghiotto1, H Koussis1, LM Pasetto1 and S Monfardini1

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

* Correspondence to: Dr U. Basso, Divisione di Oncologia Medica, Istituto Oncologico Veneto, via Gattamelata 64, 35126 Padova, Italy. Tel: +39-049-8215931; Fax: +39-049-8215932. E-mail: u.basso{at}tin.it

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.

Key words: breast cancer, elderly, gemcitabine, geriatric assessment, metastatic, vinorelbine


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?




Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.