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Daratumumab, a monoclonal antibody targeting CD38, is approved to treat multiple myeloma. Red blood cells express low levels of CD38, which can result in a false-positive antibody screen in daratumumab-treated patients. Educational materials were developed to inform healthcare professionals (HCPs) and blood transfusion management department personnel (BTMDP) about this risk and recommended measures to mitigate that risk. Materials were distributed in European countries where daratumumab was commercially available. This post-authorization safety study was designed to evaluate whether HCPs and BTMDP understood the materials. An anonymous, cross-sectional, non-interventional, web-based survey was distributed in 12 European countries. Four key questions were identified, for which a correct answer from at least 80% of respondents was considered indicative of satisfactory effectiveness. A total of 408 participants completed the questionnaires (62.3% (n = 254) HCPs and 37.7% (n = 154) BTMDP). Responses were consistent between groups. All respondents were aware of the educational materials (the first key question) and at least 80% correctly answered three of the four key questions. A key question regarding which blood typing test(s) daratumumab interferes with did not achieve satisfactory effectiveness (60% correct responses). In a weighted analysis, 79% of respondents correctly identified the recommended measures for daratumumab-treated patients requiring transfusion. This was attributed to an error in the survey’s German translation; in a sensitivity analysis, 90% of participants correctly responded to this question. Results suggest that participants were aware of the educational materials, the risk of daratumumab interference with blood testing, and recommended measures to mitigate that risk.

Introduction Treatment guidelines, including ESMO, emphasize the importance of testing KRAS status prior to selecting optimal therapy for mCRC patients and recommend the use of anti-EGFR antibodies only for KRAS wild-type patients. This study evaluates adherence to guidelines and describes the use of chemotherapy regimens and monoclonal antibodies (mabs) in 1st (1L) and 2nd line (2L) by KRAS status in Germany, Spain, Italy, France and United Kingdom (UK). Methods Using physician survey data from Oncology Analyzer databaseTM in five European countries, treatment regimens for 1L and 2L mCRC patients were assessed. Patients ≥21 years of age diagnosed with mCRC and treated between January 2009 and December 2010 undergoing chemotherapy and who were not in clinical trials were included in the study. Results 4919 patients were identified in 1L and 2L with median age category of 61-65 yrs. 3937 patients were identified in 1L with 42% known and 58% unknown KRAS status. Among those with KRAS status, 18% were mutant, and 24% were wild type. In 2L, 982 patients were identified, with 53.6% known and 46.4% unknown KRAS status. Among those with KRAS status, 21.5% were mutant, 32.1% were wild type. In 1L, 48.3% of KRAS mutant patients received a bevacizumab-containing regimen in comparison to 32.2% and 22.5% for KRAS wild type and unknown patients, respectively. Cetuximab-containing regimens were mainly used for wild-type patients in 1L (34.6% versus 1.3% and 2.1% for mutant and unknown, respectively). In 2L, 42.2% of KRAS mutant patients received bevacizumab-containing regimens versus 20.6% for wild type and 23.9% for unknown patients. KRAS wild-type patients were more likely to receive cetuximab-containing regimens in 2L (50.5% of patients versus 3.8% and 6.4% for mutant and unknown, respectively). Across 1L and 2L, 88.9% of patients in the UK were not tested for KRAS status, while the range for Germany, Spain Italy and France was 41-56%. The top 3 regimens by KRAS status are shown in the table below: Conclusion Mabs are routinely combined with chemotherapy in the treatment of mCRC, which is consistent with treatment guidelines. Bevacizumab containing regimens were common across all KRAS categories in both 1L and 2L. Overall, cetuximab use was observed only in KRAS wild-type patients across both lines. Continued KRAS testing should be implemented stringently in the EU, especially in the UK, to obtain more informed KRAS dependent data on current treatment patterns for mCRC patients. Table 1 .

Introduction Treatment patterns for mCRC vary across countries in Western Europe, which may influence patient outcomes. This study describes the latest use of chemotherapy regimens and monoclonal antibodies (mabs) in clinical practice in 1L and 2L across five countries. Methods Using physician survey data from Oncology Analyzer databaseTM in five European countries (Germany, Spain, Italy, France and United Kingdom (UK)), treatment patterns for 1L and 2L mCRC patients were assessed. Patients≥21 years with mCRC, treated between January 2009 and December 2010 undergoing chemotherapy and who were not in clinical trials were included. Results 4919 stage IV patients were identified in 1L and 2L (3937 and 982, respectively). Overall, median age category in 1L was 66-70yrs (59.2% male) and 61-65yrs in 2L (63.6% male). With regards to metastases, approximately 75% of patients had liver metastases and 35% had lung metastases. In 1L, patients in Germany, UK and Spain were more commonly administered an oxaliplatin containing regimen (47.8%, 58.7% and 47.5%, respectively), while in 2L, patients were more commonly administered an irinotecan containing regimen (55.3%, 50.8% and 46.2%, respectively). In France and Italy, the use of an irinotecan containing regimen was more common than an oxaliplatin containing regimen (France 1L: 46.5% vs. 34.7%, 2L: 49.3% vs. 26.5% and Italy 1L: 43.7% vs. 41.9%, 2L: 53.1% vs. 26.8%). The top 3 regimens are shown in the table by country: Conclusion Standard of care across Western EU for mCRC includes oxaliplatin and irinotecan containing chemotherapy regimens routinely combined with mabs. The preferred treatment regimens are different amongst the five European countries studied. In the UK, treatment with mabs is uncommon and capecitabine containing regimens are routinely used, which is consistent with NICE recommendations. Further research should be done to ascertain impact on patient outcomes for variation in treatment patterns across EU countries. Table 1 .