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US Oncology Research Network Presents Clinical Studies at San Antonio Breast Cancer Symposium
Date:12/17/2007

SAN ANTONIO, Dec. 17 /PRNewswire/ -- 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(R) 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(R). 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:

Subset Number of Patients Percentage pCR

Breast/Ax

All patients with surgery

post CT 179 34 (27-41)

ER or PR+ HER2- 80 24 (16-34)

FR-, PR-, HER2- 63 23 (31-55)

HER2-, no H 143 32 (25-40)

HER2+, received FEC 75+H 36 39 (25-55)

The most frequent Grade 3-4 toxicities were neutropenia (77 percent), diarrhea (9 percent), hand-foot syndrome (8 percent), and stomatitis (7 percent).

Decreased left ventricular ejection fraction (LVEF) <50 percent occurred in 4 of 40 pts receiving FEC75+H but there was no heart failure & repeat LVEFs were >50 percent in all 4 patients.

Of 143 non-H treated patients, two had LVEFs <50 percent (one each: 25 percent, 44 percent). Microarray: 107/192 specimens generated less than or equal to 10 mcg cRNA, median 35 mcg, which was hybridized to Affymetrix HG- U133A gene chips successfully in 101 specimens. The success rate was 35 percent in the first 80 cases and 65 percent in the last 112 cases. Sample attrition precluded separate discovery/validation cohorts so data combined with two MDACC trials (T-->FAC and FEC-->docetaxel). The pCR predictive algorithm was similar, though not identical, to the T-->FAC and will be presented separately.

The study concluded that : 1) FEC100 (FEC75H)-->wXT(H) is a safe, effective preoperative chemotherapy regimen; 2) pCR was dependent on genomic subtype; 3) Microarray studies are possible in the community; and, 4) A unique microarray signature associated with pCR to FEC100-->wTX was NOT discovered but gene set enrichment analysis (GSEA) is ongoing to identify biological pathways and functionally related genes that are associated with pCR.

In addition, Joyce O'Shaughnessy, M.D., Texas Oncology, PA, Baylor-Sammons Cancer Center in Dallas, associate director for clinical research and co-chair of breast cancer research for US Oncology, delivered the following presentation at the conference:

Preliminary results of a randomized Phase II study of weekly irinotecan/carboplatin with or without cetuximab in patients with metastatic breast cancer

Joyce O'Shaughnessy, Weckstein DJ, Vukelja SJ, McIntyre K, Krekow L, Holmes FA, Asmar L, Blum JL, US Oncology Research, Inc., Houston, TX; Baylor-Charles A. Sammons Cancer Center, Dallas, TX; Texas Oncology, P.A. -- Dallas Presbyterian, Dallas, TX; New Hampshire Oncology-Hematology, Hookset, NH; Tyler Cancer Center, Tyler, TX; The Breast Care Center of North Texas, Bedford, TX; Texas Oncology, P.A., Houston, TX.

About US Oncology Research

The US Oncology Research Network is an established community-based research operation specializing in all phases of cancer clinical trials. The research network currently has 500 physicians actively enrolling patients, 77 research sites, and is currently involved in more than 60 open research trials. The network has contributed to the development of 24 of 30 of the latest cancer-fighting drugs approved by the Food and Drug Administration for use. Since 1993, more than 32,000 patients have participated in clinical trials managed by US Oncology network practices. For more information, visit the "Research" section under "Our Services" on the company's Web site, http://www.usoncology.com.

About US Oncology

US Oncology, headquartered in Houston, supports one of the nation's largest cancer treatment and research networks with services that help participating oncologists advance integrated cancer care in the community setting through shared best practices and research.

The company's expertise in every aspect of the cancer care delivery system-from drug development to treatment and outcomes measurement-enables US Oncology to help increase the efficiency and safety of cancer care. According to the company's last quarterly earnings report, US Oncology is affiliated with 1,164 physicians operating in 443 locations, including 91 radiation oncology facilities in 39 states. For more information, visit the company's Web site, http://www.usoncology.com.


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