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Utilization of Rituximab Therapy in Patients (pts) with Newly Diagnosed Follicular (FL) and Diffuse Large B Cell (DLCL) Non-Hodgkins Lymphoma (NHL) in the United States: An Analysis from the National Comprehensive Cancer Network (NCCN)

[1800] Utilization of Rituximab Therapy in Patients (pts) with Newly Diagnosed Follicular (FL) and Diffuse Large B Cell (DLCL) Non-Hodgkins Lymphoma (NHL) in the United States: An Analysis from the National Comprehensive Cancer Network (NCCN) [abstract]. NHL Outcomes Project [abstract]. American Society of Hematology: Session Type: Poster Session 912-I

Jonathan W. Friedberg, Eva Lepisto, Maria Alma Rodriguez, Rebecca Ottensen, Ann S. LaCasce, Auayporn P. Nademanee, Michael Millenson, Myron Czuczman, Joyce Niland, Andrew D. Zelenetz, Jane Weeks James P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA; National Comprehensive Cancer Network, Rockledge, PA, USA; MD Anderson Cancer Center, Houston, TX, USA; Dana-Farber Cancer Institute, Boston, MA, USA; City of Hope Medical Center, Duarte, CA, USA; Fox Chase Cancer Center, Philadelphia, PA, USA; Roswell Park Cancer Institute, Buffalo, NY, USA; Memorial Sloan-Kettering Cancer Center, New York, NY, USA

Rituximab, an anti-CD20 monoclonal antibody, was approved by the FDA in 1997 for treatment of pts with relapsed or refractory indolent B-cell NHL. Sales of this agent in the United States now exceed $1 billion annually, suggesting utilization in settings other than the approved indication. Phase III data on the benefit of rituximab for pts with previously untreated NHL include a single published randomized trial which was limited to the population of pts > 60 years of age with advanced stage DLCL. Using the NCCN NHL outcomes database, we analyzed the evolution of rituximab utilization in the treatment of newly diagnosed FL and DLCL, and the economic implications of these choices. The NCCN NHL outcomes database project collects demographic, staging, treatment and outcome information on consecutive pts with NHL seen at five NCCN institutions (Dana-Farber Cancer Institute, Roswell Park Cancer Institute, City of Hope, Fox Chase Cancer Center and MD Anderson Cancer Center). Since 7/2000, 853 pts have been enrolled. Of 396 pts with newly diagnosed FL or DLCL, and a median follow-up of 224 days (range 91-730), 343 (FL: n=122; DLCL: n=221) were treated with systemic therapy. 281 (82%) received rituximab as part of the initial treatment regimen, either as a single agent (n=10) or with chemotherapy. Rituximab use did not significantly differ between pts with FL compared with DLCL (78% vs. 84%, p=0.18). In patients with DLCL, there was no significant difference in rituximab use for patients with early stage vs. advanced stage disease (83% vs. 87%, p=0.45), or for patients > 60 vs. < age 60 (88% vs. 82%, p=0.25). Similarly, in patients with FL, there was no association between rituximab use and patient stage (76% vs. 79%, p=0.78), or age (83% vs. 76%, p=0.48). Using logistic regression, there was an increasing pattern of rituximab useage across 6-month time intervals since the year 2000 (p<0.01), controlling for histology and institution. Only 28% of these patients were enrolled on a clinical trial. Therefore, despite the absence of confirmatory clinical trials, the vast majority of patients seen in these NCCN institutions with FL and DLCL receive rituximab as part of their initial treatment regimen. If this experience reflects national trends, a potential expenditure of $0.5 billion annually is associated with the use of rituximab for de novo B cell NHL. Clinical trials, and follow-up from the NCCN NHL database project, are clearly warranted to establish which pts benefit from rituximab, the optimal timing and schedule of this therapy, and the incorporation of other antibody-based approaches, including radioimmunotherapy, into treatment algorithms for NHL. Abstract #1800 appears in Blood, Volume 102, issue 11, November 16, 2003