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)

• Published in: Breast cancer research and treatment 2010-01, Vol.119 (1), p.169-176
• Main Authors: Tomova, Antoaneta, Bartsch, Rupert, Brodowicz, Thomas, Tzekova, Valentina, Timcheva, Constanta, Wiltschke, Christoph, Gerges, Dany Abi, Pawlega, Jan, Spanik, Stanislav, Inbar, Moshe, Zielinski, Christoph C.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anthracyclines; Anthracyclines - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Cancer; Cancer patients; Cancer research; Cancer therapies; Care and treatment; Chemotherapy; Clinical Trial; Clinical trials; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease Progression; Diseases; Docetaxel; Drug Administration Schedule; Female; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Medical sciences; Medicine; Medicine & Public Health; Metastasis; Middle Aged; Neoplasm Metastasis; Oncology; Recurrence; Relapse; Taxoids - administration & dosage; Time Factors; Tumors
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-009-0553-4

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 2 on days 1 + 8 plus docetaxel 75 mg/m 2 on day 8, or 4 cycles of docetaxel 100 mg/m 2 on day 1, followed by four cycles of gemcitabine 1,250 mg/m 2 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