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A multicenter phase II trial of docetaxel plus gemcitabine as salvage treatment in anthracycline- and taxane-pretreated patients with metastatic breast cancer

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Abstract

Objective

To evaluate the docetaxel–gemcitabine (DG) combination administered every 2 weeks as salvage therapy in anthracycline- and taxane-pretreated patients with metastatic breast cancer (MBC).

Patients and treatment

Thirty women with MBC who had disease progression after chemotherapy with anthracyclines, or anthracyclines and taxanes were treated with docetaxel 50 mg/m² and gemcitabine 1,500 mg/m² on days 1 and 14 in cycles of 28 days. All patients had received prior anthracyclines, and fourteen (46.6%) had also received prior taxanes. All patients were evaluable for toxicity and 24 for response to treatment.

Results

Complete response occurred in four (13.3%) patients and partial response in 10 (33.3%) for an overall response rate of 46.7% (95% CI 28.8–64.5). Seven patients (23.3%) had stable disease and nine (30%) progressive disease. Of the 14 patients previously treated with both anthracyclines and taxanes, seven (50%) responded. The median duration of response was 4.8 months (range 1.9–15.3), the median time to disease progression 6.6 months (range 0.5–16.9) and the median overall survival 16.8 months (range 1.3–53.2). There was no treatment-related toxic death. Neutropenia was the only grade 4 toxicity occurring in three (10%) patients. None of them developed neutropenic fever. Grade 3 thrombocytopenia occurred in two (6.7%) patients. Non-hematological toxicities were manageable.

Conclusion

The DG combination administered biweekly is very well tolerated and effective in anthracycline- and taxane-pretreated patients with MBC. A previous treatment with taxanes does not preclude a good clinical response to this regimen.

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Acknowledgments

This work was partially supported by the Hellenic Oncology Research Group (HORG).

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Authors and Affiliations

  1. Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11470, Athens, Greece

    N. Karachaliou, Ch. Kouroussis, P. Papakotoulas, K. Kalbakis, K. Tryfonidis, N. Vardakis, E. Poppis, V. Georgoulias & D. Mavroudis

  2. Department of Medical Oncology, University General Hospital of Heraklion, Voutes, 71110, Heraklion, Crete, Greece

    D. Mavroudis

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  1. N. Karachaliou
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  2. Ch. Kouroussis
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  4. K. Kalbakis
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Correspondence to D. Mavroudis.

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Karachaliou, N., Kouroussis, C., Papakotoulas, P. et al. A multicenter phase II trial of docetaxel plus gemcitabine as salvage treatment in anthracycline- and taxane-pretreated patients with metastatic breast cancer. Cancer Chemother Pharmacol 69, 1345–1352 (2012). https://doi.org/10.1007/s00280-012-1824-z

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  • DOI: https://doi.org/10.1007/s00280-012-1824-z

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