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Concomitant docetaxel plus gemcitabine versus sequential docetaxel followed by gemcitabine in anthracycline-pretreated metastatic or locally recurrent inoperable breast cancer patients: a prospective multicentre trial of the Central European Cooperative Oncology Group (CECOG)

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Abstract

Docetaxel (D) plus gemcitabine (G) is an active combination in anthracycline pre-treated breast cancer. Impact of sequential administration of these drugs is unclear. This trial aimed to compare concomitant DG with sequential D → G. Patients were randomised to eight cycles of gemcitabine 1,000 mg/m2 on days 1 + 8 plus docetaxel 75 mg/m2 on day 8, or 4 cycles of docetaxel 100 mg/m2 on day 1, followed by four cycles of gemcitabine 1,250 mg/m2 on days 1 + 8, in a 21-day schedule. Time to progression (TTP) was defined as primary endpoint; secondary endpoints were overall response rate (ORR), response duration (RD), overall survival (OS) and toxicity. Due to poor recruitment, the trial was terminated after 100 of a pre-planned 430 patients. Patient characteristics were well balanced. No significant difference was observed in terms of TTP, ORR, RD and OS. Grade 3/4 adverse events encompassed leucopoenia (29 vs. 68%, P < 0.001), neutropoenia (49 vs. 83%, P < 0.001) and febrile neutropoenia (4 vs. 9%, n.s.), all favouring D → G. No difference in efficacy was observed between concomitant and sequential treatment. D → G produced significantly more episodes of haematological toxicity due to the administration of docetaxel at 100 mg/m² without GCSF-support.

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Authors and Affiliations

  1. Plovdiv Cancer Centre, Plovdiv, Bulgaria

    Antoaneta Tomova

  2. Department of Medicine 1 and Cancer Centre, Clinical Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, 1090, Vienna, Austria

    Rupert Bartsch, Thomas Brodowicz, Christoph Wiltschke & Christoph C. Zielinski

  3. University Hospital “Queen Joanna”, Sofia, Bulgaria

    Valentina Tzekova

  4. SBALO National Oncology Centre, Sofia, Bulgaria

    Constanta Timcheva

  5. Rizk Hospital, Beirut, Lebanon

    Dany Abi Gerges

  6. Klinika Onkologii CmuJ, Krakow, Poland

    Jan Pawlega

  7. Onkol. Ustav Sv. Alzbety, Bratislava, Slovakian Republic

    Stanislav Spanik

  8. Division of Oncology, Tel Aviv Sourasky Medical Centre, Tel Aviv, Israel

    Moshe Inbar

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  1. Antoaneta Tomova
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  2. Rupert Bartsch
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  3. Thomas Brodowicz
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  4. Valentina Tzekova
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  6. Christoph Wiltschke
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  11. Christoph C. Zielinski
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Correspondence to Christoph C. Zielinski.

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Tomova, A., Bartsch, R., Brodowicz, T. et al. Concomitant docetaxel plus gemcitabine versus sequential docetaxel followed by gemcitabine in anthracycline-pretreated metastatic or locally recurrent inoperable breast cancer patients: a prospective multicentre trial of the Central European Cooperative Oncology Group (CECOG). Breast Cancer Res Treat 119, 169–176 (2010). https://doi.org/10.1007/s10549-009-0553-4

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  • DOI: https://doi.org/10.1007/s10549-009-0553-4

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