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Bi-weekly docetaxel and gemcitabine regimen in her-2-negative and anthracycline-pretreated metastatic breast cancer patients: a multicenter phase II trial

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Abstract

Purpose

Bi-weekly gemcitabine (G) in combination with docetaxel (D) is an effective treatment for metastatic breast cancer (MBC) previously treated with adjuvant/neoadjuvant anthracyclines containing regimens with a good toxicity profile. In the present phase II study, we investigated the activity of the same regimen as first-line treatment.

Methods

Women with breast cancer pretreated in adjuvant/neoadjuvant setting with anthracyclines received bi-weekly G (1,250 mg/m² days 1, 15) and D (50 mg/m² days 1, 15) every 28 days with restaging after 3 and 6 cycles.

Results

Overall 42 patients were enrolled. Median age is 48 years (range, 31–71 years). Eight patients (19%) achieved complete responses, 18 (43%) partial responses for an overall response rate (ORR) of 62%; five patients (12%) obtained stable disease (SD), and 8 (19%) patients had progressive disease (PD). After a median 17-month follow-up, the median time to disease progression was 12 months (95% CI, 3–26 months) and the median survival time was 27 months (95% CI, 4–57 months). No grade 4 toxicity was seen except in one patient who developed a grade 4 neutropenia. Grade 3 toxicities were leukopenia (2%), neutropenia (14%), anemia (2%), nausea and vomiting (2%), diarrhea (2%), asthenia (2%), and skin toxicity (12%).

Conclusion

The GD bi-weekly regimen is well tolerated and active as first line in anthracyclines-pretreated women with MBC. It appears as an interesting alternative compared to a 3-week schedule whenever hematological toxicity is the main clinical concern.

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Conflict of interest

The Authors indicated no potential conflicts of interest.

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Authors and Affiliations

  1. Department of Internal Medicine, “S. Martino” Hospital, Viale Benedetto XV 6, 16132, Genoa, Italy

    R. Murialdo & Alberto Ballestrero

  2. Department of Oncology, “S. Paolo” Hospital, Savona, Italy

    F. Bertolotti, G. Pastorino & Fulvio Brema

  3. Oncology Unit, Villa Scassi Hospital, Genoa, Italy

    M. Mencoboni & M. Bergaglio

  4. Oncology Department, Azienda Ospedaliera Santa Corona, Pietra Ligure, Savona, Italy

    U. Folco & N. Cinzia

  5. Department of Medical Oncology, “S. Andrea” Hospital, La Spezia, Italy

    F. Vaira

  6. Department of Oncology, “SS Antonio e Margherita” Hospital, Tortona, Italy

    C. Simoni

  7. Departement of Medical Oncology, ASL3 Genovese, Genoa, Italy

    L. Canobbio & M. Parodi

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  1. R. Murialdo
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  2. F. Bertolotti
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Correspondence to R. Murialdo.

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Murialdo, R., Bertolotti, F., Pastorino, G. et al. Bi-weekly docetaxel and gemcitabine regimen in her-2-negative and anthracycline-pretreated metastatic breast cancer patients: a multicenter phase II trial. Cancer Chemother Pharmacol 68, 1009–1016 (2011). https://doi.org/10.1007/s00280-011-1570-7

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  • DOI: https://doi.org/10.1007/s00280-011-1570-7

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