title: 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).
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.
authors.affiliation: Plovdiv Cancer Centre, Plovdiv, Bulgaria.
authors.forename: Antoaneta
authors.initials: A
authors.lastname: Tomova
authors.forename: Rupert
authors.initials: R
authors.lastname: Bartsch
authors.forename: Thomas
authors.initials: T
authors.lastname: Brodowicz
authors.forename: Valentina
authors.initials: V
authors.lastname: Tzekova
authors.forename: Constanta
authors.initials: C
authors.lastname: Timcheva
authors.forename: Christoph
authors.initials: C
authors.lastname: Wiltschke
authors.forename: Dany Abi
authors.initials: DA
authors.lastname: Gerges
authors.forename: Jan
authors.initials: J
authors.lastname: Pawlega
authors.forename: Stanislav
authors.initials: S
authors.lastname: Spanik
authors.forename: Moshe
authors.initials: M
authors.lastname: Inbar
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Zielinski
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D012008:Recurrence; D043823:Taxoids / Q000008:administration & dosage*; D013997:Time Factors; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine