Safety signals raised in the recent oncology clinical trials have led to various regulatory restrictions including FDA black-box warning, National Coverage Determination (NCD), and updated ASCO/ASH guidelines in 2007. The purpose of this study was to determine the impact of these changes on the utilization of ESAs and on transfusion (Tx) of RBCs in 2006 (prior to changes) and 2007. We identified the total number of unique patients that received any treatment including chemotherapy, radiation, transfusions, or any treatment in the out-patient and in-patient settings during this 2 year time period. All the data on the ESA doses dispensed by the hospital pharmacy and all the RBC transfusions dispensed by the Blood bank were also analyzed. The ESA units were calculated by converting 40,000 units of epoetin alfa or 100 mcg of darbepoetin alfa to one unit of ESA. When comparing 2007 to 2006, the number of patients that received ESAs decreased by 26% and the total ESA units decreased by 30%. The overall usage of ESAs decreased by 55%, from 2398 units in 1/2006 to 1080 units in 12/2007. However, the number of pts that received RBC transfusions increased only by 6% and the total number of RBC units transfused by 2% (from 38,218 units in 2006 to 38,948 units in 2007). The median Hgb on the day of transfusion was same for each year (Hgb 8.2 g/dL for both 2006 and 2007), suggesting that the lack of impact on RBC Tx may not be due to a change in Tx threshold. The total number of unique patients referred and treated at MDACC during 2007 (24,356) increased by 13% from 2006 (21,619), not accounting for a lack of impact on transfusions. We therefore examined Hgb at the initiation of ESAs in a subset of pts (n=212) that had not received ESA for at least 3 months. The median Hgb/HCT values at the initiation of ESAs were 9.5 g/dL/27.4. The most frequent utilization of ESAs and transfusions was in patients with hematological malignancies. Conclusion: These findings indicate that the recent ESA safety concerns and related regulatory changes have significantly affected the ESA utilization. The lack of significant impact of reduced ESA usage on RBC transfusions may be related to a lower Hgb threshold used at initiation of ESAs and/or the targeted patient population (less likely to respond) treated with ESAs. Further research is needed to establish the factors contributing to the lack of correlation and to optimize the use of ESAs.
Patients (pts) with multiple myeloma (MM) have a high risk of venous thromboembolism (VTE) due to features of the disease or treatment, such as thalidomide (Thal), Lenalidomide (Len), steroids, and certain chemotherapeutic agents. Based on evidence showing the benefit of VTE pharmacological prophylaxis, it is recommended that VTE prophylaxis be prescribed for pts receiving these agents. However, the impact of these guidelines on patient outcomes is less well studied. The study aim was to evaluate the characteristics of MM pts with VTE in a comprehensive cancer center. This retrospective analysis included all MM pts diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) between July and December 2006. Medical records were examined for risk factors such as central venous catheter (CVC), functional status, history of VTE, MM treatment, and use of VTE prophylaxis. Twenty four VTE events (19 DVT, 3 PE, 2 DVT and PE concurrently) occurred in 21 pts, of whom 18 had a single event and 3 had 2 each. During 14 of the 24 events (58.3%), pts were receiving agents known to increase the risk of VTE, including 12 receiving Thal or Len + steroids. During 15 events, pts were anemic (Hgb ≤ 11gms/dL); 4 of these were on erythropoietic agents. Only 1 event occurred while the patient was receiving LMWH. Ten events occurred in pts on aspirin (3 at 81mg, 7 at 325mg). Fourteen events (58.3%) occurred in pts not receiving VTE prophylaxis; 7 occurred when platelet counts were between 18–76 × 103/mm3. The other 7 events were in pts on various myeloma regimens including 2 on melphalan/stem cell transplant and one each on bortezomib, Thal, dexamethasone (Dex), denosumab, and cyclophosphamide/Dex. None of the 3 with recurrent VTE were on anticoagulation at time of recurrence. All 3 were admitted and anticoagulation was held for thrombocytopenia (2) or renal failure (1). Of the 7 events occurring during treatment with Len + steroids occurred while on aspirin; 6 had additional risk factors. One was heterozygous for Factor V Leiden mutation; one had surgery prior to the event; four had neuropathy with 3 in wheelchairs. Of the nine pts with an upper extremity DVT, all but 2 were associated with a CVC (77.7%). Lower extremity DVT commonly occurred in pts with impaired mobility due to neuropathy or deconditioning (38%). In spite of increased awareness of the risk of thrombosis, VTE remains a significant cause of morbidity in MM pts. In this study, CVC, poor mobility, and treatment with Len/Dex were the most common risk factors. VTE events occurred during treatment with Len/Dex despite the concurrent use of aspirin. This suggests that aspirin alone may not be adequate as VTE prophylaxis in pts with MM and multiple risk factors for VTE. The role of aspirin and other interventions to prevent VTE deserve further investigation to optimize thromboprophylaxis in this population.
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