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)

Antoaneta Tomova, Rupert Bartsch, Thomas Brodowicz, Valentina Tzekova, Constanta Timcheva, Christoph Wiltschke, Dany Abi Gerges, Jan Pawlega, Stanislav Spanik, Moshe Inbar, Christoph C. Zielinski

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)169-176
Number of pages8
JournalBreast Cancer Research and Treatment
Volume119
Issue number1
DOIs
StatePublished - Jan 2010
Externally publishedYes

Keywords

  • Chemotherapy
  • Docetaxel
  • Gemcitabine
  • Metastatic breast cancer
  • Sequential versus concomitant

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