Clinical Breast Cancer February 2006 • 505 Introduction Ongoing clinical evaluations of new combination chemotherapy regimens are being conducted to improve effi- cacy, disease palliation, and overall survival among patients with metastatic breast cancer. Docetaxel, a semisynthetic taxane, and the ribonucleotide reductase and nucleoside analogue gemcitabine are cytotoxic agents with significant clinical activity against a broad spectrum of solid tumors, in- cluding advanced-stage breast cancer. 1-6 In an initial phase II study, weekly gemcitabine given for 3 of 4 weeks was as- sociated with an objective response rate (ORR) of 25% in pa- tients who received ≥ 1 chemotherapy regimen for metasta- tic breast cancer, with a median survival duration of 11.5 months in the overall population. 1 The recently presented results of a phase III trial suggest that administering gemc- itabine/paclitaxel as first-line chemotherapy for metastatic breast cancer leads to a significant survival advantage com- pared with paclitaxel alone. 7 In an earlier phase III trial, do- cetaxel 100 mg/m 2 every 3 weeks produced a combined ORR Phase II Trial of Weekly Docetaxel/ Gemcitabine as First-Line Chemotherapy in Patients with Locally Recurrent or Metastatic Breast Cancer Purpose: A phase II study evaluated weekly docetaxel/gemcitabine as first-line chemotherapy for locally recurrent or metastatic breast cancer in a multicenter community oncology practice setting. Patients and Methods: Eligible patients who had not received chemotherapy for metastatic disease received docetaxel 30 mg/m 2 followed by gemcitabine 800 mg/m 2 , each administered weekly for 3 weeks (days 1, 8, and 15), followed by a 1-week rest period (28-day cycle). Patients also received oral dexamethasone to reduce the incidence/severity of fluid reten- tion and hypersensitivity reactions. Of the 46 enrolled patients, 45 were treated as part of the intent-to-treat (ITT) population and were evaluable for safety. Results: There were 3 complete responses and 12 partial responses among the 39 evaluable patients, for an objective response rate (ORR) of 39% (95% confidence interval [CI], 24%-54%). The ORR in the ITT population was 33% (95% CI, 18%-48%). Median time to response was 3.4 months, with a median response duration of 6.7 months. Median survival was 15.8 months, and median time to progression was 5.8 months. The most common grade 3/4 hematologic toxicity was neutropenia (13.3%); there was a low incidence of other grade 3/4 hematologic toxicities. Grade 3 fatigue (15.6%) was the most com- mon grade 3/4 nonhematologic toxicity, and grade 2 alopecia occurred in 47% of patients. One patient who had been receiving chronic corticosteroid therapy died from treatment-related neutropenia and acute respirato- ry distress syndrome. Conclusion: These phase II results suggest that weekly docetaxel/gemcitabine is moder- ately active and well tolerated as first-line therapy for locally recurrent or metastatic breast cancer. No clear ad- vantage for combined weekly docetaxel/gemcitabine was observed compared with published results on the effi- cacy of docetaxel and gemcitabine given as single agents. Clinical Breast Cancer, Vol. 6, No. 5, 505-510, 2005 Key words: Cytotoxic agents, Dose-dense therapy, Neutropenia, Taxanes contribution Abstract original Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Cancer Information Group, ISSN #1526-8209, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400. Joyce A. O’Shaughnessy, Robert Pluenneke, Jack Sternberg, Pankaj Khandelwal, Des Ilegbodu, Lina Asmar Submitted: Nov 16, 2005; Revised: Apr 22, 2005 Accepted: Apr 22, 2005 Address for correspondence: Joyce A. O’Shaughnessy, MD, Baylor Sam- mons Cancer Center, Texas Oncology, PA, US Oncology, 3535 Worth St, 5th Floor, Collins Bldg, Dallas, TX 75246 Fax: 214-370-1850; e-mail: joyce.o’shaughnessy@usoncology.com US Oncology, Dallas, TX