US Oncology, Inc. New Study Shows PCR and FCR Have Significant Activity in B-cell Chronic Lymphocytic Leukemia

US Oncology Affiliated Physicians Participate in ASH Conference

SAN FRANCISCO, Dec. 8 /PRNewswire/ -- A leading cancer researcher affiliated with the US Oncology Research Network will present findings from a randomized, multicenter Phase III trial that compared FCR and PCR in patients with B-cell chronic lymphocytic leukemia (CLL).

The study results will be given in an oral presentation by Dr. Craig Reynolds of Ocala Oncology Center at the 50th Annual Meeting of the American Society of Hematology (ASH) held December 6-9, 2008 in San Francisco. Dr. Reynolds is the lead investigator and serves as co-chairman, and chairman for new protocol development, of US Oncology’s National Lung Cancer Research Committee.

Purine analog-based regimens have emerged as highly active regimens in the treatment of chronic lymphocytic lymphoma (CLL). Promising results have been reported with the combination of fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) by Keating and colleagues at the University of Texas M.D. Anderson Cancer Center. Previous US Oncology Research Network, as well as a Mayo Clinic and MSKCC trials, evaluated the combination of pentostatin (P), cyclophosphamide (C), and rituximab (R) (PCR); results suggested similar efficacy with less infectious complications than that seen with FCR.

The current multicenter, randomized, community-based trial was conducted to compare FCR and PCR in previously untreated or minimally treated B-cell chronic lymphocytic leukemia. The primary end point of the study was infectious complications with efficacy and safety as secondary endpoints. Correlative studies of immune function were conducted by Kay and colleagues at the Mayo Clinic and will be reported separately.

“This study establishes the role of these regimens in the treatment of CCL,” said Dr. Reynolds. “New therapies such as these offer hope for our patients.”

The research found that both PCR and FCR have significant activity in CLL and can be given safely in the community setting. Both regimens possess significant toxicity and response rates in this multi-institution, community-based randomized trial were lower than previous Phase II trials of previously untreated patients. This trial did not demonstrate a lower infection rate with PCR using pentostatin at the 4 mg/m2 dose level. In early follow-up, no statistically significant differences with respect to overall response rate or survival were observed between FCR and PCR, although the CR rate was significantly higher with FCR.

This research will be presented at the 50th Annual Meeting of the American Society of Hematology on December 8, 2008 at 11:30 a.m. PST.

Physician researchers affiliated with the US Oncology network will also present the following US Oncology Research network studies as posters at this year’s ASH conference:

The following physicians affiliated with the US Oncology network participated in the following studies that will be presented as oral and poster presentations and published studies at this year’s ASH conference:

Acute Myeloid Leukemia (AML)

Hematologic Malignancies

Multiple Myeloma

Waldenstrom Macroglobulinemia

Chronic Lymphocytic Leukemia

About US Oncology Research

The US Oncology Research network is an established community-based research operation specializing in comprehensive Phase I-IV trials and translational Phase I research. The research network is currently enrolling patients at 109 research sites, and is involved in 63 open trials.

Supported by US Oncology, the network has played a pivotal role in 24 of the last 30 cancer drugs approved by the Food and Drug Administration and more than 32,000 patients have participated in clinical trials. For more information, visit the “Research” section under “Our Services” on the company’s Web site, www.usoncology.com.

About US Oncology

US Oncology, headquartered in Houston, works closely with physicians, manufacturers and payers to identify and deliver innovative services that enhance patient access to advanced cancer care. US Oncology supports one of the nation’s foremost cancer treatment and research networks, accelerating the availability and use of evidence-based medicine and shared best practices.

US Oncology’s expertise in supporting every aspect of the cancer care delivery system--from drug development to treatment and outcomes measurement, enables the company to help increase the efficiency and safety of cancer care. According to the company’s last quarterly earnings report, US Oncology is affiliated with 1,227 physicians operating in 485 locations, including 92 radiation oncology facilities in 39 states. For more information, visit the company’s Web site, www.usoncology.com.

CONTACT: Jennifer Horspool of US Oncology, +1-832-601-6151,
Jennifer.Horspool@usoncology.com; or Lisa Henderson, +1-813-775-6208,
Lisa.Henderson@hillandknowlton.com, for US Oncology

Web site: http://www.usoncology.com/

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