Blood Transfusion and Erythropoiesis Stimulating Agents (ESAs) Use In Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

The national coverage decision regarding reimbursement for usage of ESAs for chemotherapy-induced anemia (CIA) from the Centers for Medicare & Medicaid Services (CMS) underwent changes in early 2007. This study examines the rates of packed red blood cell (PRBC) transfusions and usage of ESAs before and after the changes of these health care regulations in patients with DLBCL treated with standard Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) chemotherapy.

We retrospectively reviewed from records of patients seen at our center from March 2007 to January 2009 with previously untreated DLBCL, identified from a prospective database of the lymphoma registry at UT-MDACC. Eligibility for inclusion in this evaluation required treatment with at least 4 cycles of standard R-CHOP chemotherapy, one cycle given every three weeks, and adequate information regarding ESA and blood transfusion administration. Three time periods were identified based on 3 successive changes in billing coverage guidelines for ESAs. These changes were based upon reimbursement of ESAs for hemoglobin levels of ≤ 12 g/dl (Period 1), ≤ 11 g/dl (Period 2) and ≤ 10 g/dl (Period 3). The number of PRBC transfusions and number, dose, and type of ESA injections were reported per patient. We also evaluated the overall survival (OS) rates for patients in these three time intervals. Chi-square and Kruskal-Wallis tests were used to analyze categorical and continuous variables, respectively. The Kaplan-Meier and log-rank tests were used to estimate OS rates and evaluate the associations of PRBC transfusions and use of ESAs with OS, respectively.

160 records were available for review, and 129 were included in this analysis. There were 77 patients in Period 1, 31 in Period 2, and 21 in Period 3. With a median follow-up time of 24.7 months (range 1 – 38), PRBCs and ESAs were administered to 43 and 34 patients, respectively. PRBC transfusion rates in each time period were: 29 (37.7%) for Period 1, 8 (25.8%) for Period 2, and 6 (28.6%) for Period 3 (p = 0.43). Patients receiving ESAs in each time period were 25 (33.3%), 5 (16.7%), and 4 (19%), respectively (p = 0.16). There were no differences in the rates of PRBC transfusions (p = 0.88) or use of ESAs (p = 0.36) for these patients over these time periods, although the latter observation may be due to small numbers of patients in each period group. The 2-year OS rate was 68% for those 43 who received transfusions compared to 94% for the 86 patients who did not require transfusions (p=0.001), while there was no statistical difference between OS rates for those 34 who did and the 95 patients who did not receive ESAs (87% vs 84%, p=0.97).

The changes of CMS reimbursement for ESAs in patients with CIA may have decreased the use of ESAs, but in this study have not made any changes in the rates of PRBC transfusions in patients with DLBCL receiving standard R-CHOP chemotherapy. Furthermore, OS rates were lower in those requiring transfusions than in those who did not, but the use of ESAs appeared to have no effects on these results.

Wang:Celgene: Research Funding; Onyx: Research Funding; Millenium: Research Funding; Novartis: Research Funding. Fowler:Millennium Pharmaceuticals, Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding.