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New Study Shows PCR and FCR Have Significant Activity in B-cell Chronic Lymphocytic Leukemia
Date:12/8/2008

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:

  • Nicholas Di Bella, M.D., Rocky Mountain Cancer Centers-Parker: Results of a Phase II study of Bortezomib in patients with relapsed or refractory indolent lymphoma
  • Robert Rifkin, M.D., Rocky Mountain Cancer Centers-Midtown: Phase II open label-trial of Bortezomib in patients with multiple myeloma who have undergone high-dose melphalan therapy followed by autologous peripheral blood stem cell transplantation and failed to achieve a complete response.

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)

  • Roger Lyons, M.D., Cancer Care Centers of South Texas-Medical Center: Phase II study of single agent Clofarabine in previously untreated older adult patients with acute myelogeneous leukemia (AML) unlikely to benefit from standard induction chemotherapy
  • Michael Maris, M.D., M.D., Rocky Mountain Cancer Centers-Midtown: Phase II study of Voreloxin (formerly known as SNS-595) as single agent therapy for elderly patients with newly diagnosed acute myeloid leukemia (AML): preliminary safety and clinical responses (The REVEAL-1 study)

Hematologic Malignancies

  • Jeffrey Matous, M.D., Rocky Mountain Cancer Centers-Midtown: Superiority of Rasuburicase vs. Allopurinol on serum uric acid control in adult patients with hematologic malignancies at risk of developing Tumor Lysis Syndrome

Multiple Myeloma

  • Jeffrey Matous, M.D., Rocky Mountain Cancer Centers-Midtown: Phase II study of oral Panobinostat in adult patients with advanced refractory multiple myeloma

Waldenstrom Macroglobulinemia

  • Jeffrey Matous, M.D., Rocky Mountain Cancer Centers-Midtown: Phase II trial of combination of Bortezomib and Rituximab in relapsed and/or refractory Waldenstrom Macroblobulinemia; Long-term responses to Fludarabine and Rituximab in Waldenstrom Macroblobulinemia

Chronic LymphocyticLeukemia

  • Jeff Sharman, M.D., Willamette Valley Cancer Center-Springfield: Fostamatinib Disodium (FosD), an oral inhibitor of Syk, is well-tolerated and has significant clinical activity in diffuse large B-cell lymphoma (DLBCL) and Chronic Lymphocytic Leukemia (CLL)

AboutUSOncologyResearch

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 USOncology

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.


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