San Antonio, December 17, 2007— A leading cancer physician and researcher affiliated with US Oncology Research, an established community-based research network specializing in Phase I – Phase IV cancer clinical trials, presented findings on a Phase II trial conducted to increase pathologic complete response (pCR) and discover a baseline tumor gene expression profile associated with subsequent pCR for patients with stage 2 and 3 breast cancer.
The study results were presented in a poster session by Frankie Ann Holmes, M.D., of Texas Oncology, P.A.-Houston, associate chair of US Oncology’s Breast Cancer Research Committee and a member of the US Oncology Network.

Dr. Holmes’ was one of two poster presentations presented December 13-16 at the 30th annual San Antonio Breast Cancer Symposium by physicians affiliated with US Oncology, Inc., which supports one of the nation’s largest oncology treatment and research networks.

“The future is now,” said Dr. Frankie Ann Holmes, lead investigator for the trial. “The future of breast cancer is identification of the molecular mistakes in the tumor, then tailoring treatment to attack those mistakes. In the past, this could only be done at academic medical centers. Our trial showed that this can be done in a local oncologist’s office.”

The study, titled “Development of a genomic tool to predict pathologic complete remission in a community-based, preoperative, Phase II trial of 5-fluorouracil, epirubicin, cyclophosphamide followed by docetaxel-capecitabine for stage 2, 3 breast cancer,” was conducted among women with stage 2-3 breast cancer who underwent pretreatment fine needle aspiration (FNA) preserved in RNAlater® and shipped to Lajos Pusztai, M.D., Associate Professor at M.D. Anderson Cancer Center. 

Tissue from 34 patients was sent for chemoresponse testing with ChemoFx®. After FNA, FEC100 given as 5-FU 500 mg/m2, epirubicin 100 mg/m2 (75 mg/m2 if HER2+: “FEC75 +H”), and cyclophosphamide 500 mg/m2 all IV every 21 D x 4 cycles. Post ASCO ‘05, HER2+ pts received H (4 mg/kg on Day 1, then 2 mg/kg wkly x 12 wks).

After FEC, weekly docetaxel with capecitabine (wTX), both given every 21 D x 4 as: docetaxel 35 mg/m2 on D1 & D8, capecitabine 825 mg/m2 PO BID D1-14; and, if HER2+, H given as in part I. After CT, definitive local therapy (mastectomy or lumpectomy & axillary dissection) was done.  

The research findings indicated that 185 patients with a median age of 50 years (range, 24-84) were treated; 179 underwent definitive surgery. Results are summarized in the table below: