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 (1) , Rupert Bartsch (2) , Thomas Brodowicz (2) , Valentina Tzekova (3) , Constanta Timcheva (4) , Christoph Wiltschke (2) , Dany Abi Gerges (5) , Jan Pawlega (6) , Stanislav Spanik (7) , Moshe Inbar (8) , Christoph C. Zielinski (2)

1 Plovdiv Cancer Centre
2 Department of Medicine 1 and Cancer Centre, Clinical Division of Oncology
3 University Hospital “Queen Joanna”
4 SBALO National Oncology Centre
5 Rizk Hospital
6 Klinika Onkologii CmuJ
7 Onkol. Ustav Sv. Alzbety
8 Division of Oncology

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/m on days 1 + 8 plus docetaxel 75 mg/m on day 8, or 4 cycles of docetaxel 100 mg/m on day 1, followed by four cycles of gemcitabine 1,250 mg/m 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%,  < 0.001), neutropoenia (49 vs. 83%,  < 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.

Mots clés: Metastatic breast cancer; Chemotherapy; Sequential versus concomitant; Gemcitabine; Docetaxel

Antoaneta Tomova, Rupert Bartsch, Thomas Brodowicz, Valentina Tzekova, Constanta Timcheva, 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 Research and Treatment, 2009, 119 (1), pp.169-176. ⟨10.1007/s10549-009-0553-4⟩. ⟨hal-00535397⟩