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Open Access Research article

A phase II trial of a biweekly combination of paclitaxel and gemcitabine in metastatic breast cancer

Silverio Tomao12*, Adriana Romiti3, Federica Tomao2, Marisa Di Seri2, Giuliana Caprio2, Gian Paolo Spinelli2, Edmondo Terzoli1 and Luigi Frati2

Author Affiliations

1 Department of Clinical Oncology, "Regina Elena" Cancer Institute of Rome, Via Chianesi, 53, 00100 Rome, Italy

2 Department of Experimental Medicine and Pathology, University of Rome "La Sapienza", Viale Regina Elena 324, 00161 Rome, Italy

3 Department of Medical Oncology, S.Andrea General Hospital, Via di Grottarossa, Rome, Italy

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BMC Cancer 2006, 6:137  doi:10.1186/1471-2407-6-137

Published: 24 May 2006

Abstract

Background

Many emerging new drugs have recently been trialled for treatment of early and advanced breast cancer. Among these new agents paclitaxel and gemcitabine play a crucial role, mostly in patients with relapsed and metastatic disease after failure of chemotherapy with antracyclines.

Methods

A phase II study was started in order to evaluate the activity and toxicity of a combination of paclitaxel and gemcitabine in a biweekly schedule on metastatic breast cancer patients previously treated with antracyclines.

Results

Twenty-five patients received paclitaxel (150 mg/mq) by 3-hours infusion, followed by gemcitabine (2000 mg/mq) given as a 60 min i.v. infusion (day 1–14) for a maximum of eight cycles. In all patients treatment was evaluated for toxicity and efficacy; four patients (16%) achieved a complete response, 12 (48%) a partial response giving an overall objective response rate of 64%. Stable disease was documented in 5 patients (20%) and progressive disease occurred in 4 patients (16%).

Conclusion

The schedule of treatment was safe and tolerable from a haematological and non-haematological point of view. These data confirm that the combination of gemcitabine and paclitaxel on a biweekly basis is an effective and well-tolerated regimen in breast cancer patients with prior therapeutic exposure to antracyclines.