Sanofi Canada Research Articles

Once Weekly Oral Selinexor, Pomalidomide, and Dexamethasone in Relapsed Refractory Multiple Myeloma

Once Weekly Oral Selinexor, Pomalidomide, and Dexamethasone in Relapsed Refractory Multiple Myeloma

Efficacy and Safety of Selinexor-Containing Regimens in Patients with Multiple Myeloma Previously Treated with Anti-CD38 Monoclonal Antibodies (αCD38 mAb)

Efficacy and Safety of Selinexor-Containing Regimens in Patients with Multiple Myeloma Previously Treated with Anti-CD38 Monoclonal Antibodies (αCD38 mAb)

CC-92480, a Potent, Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, in Combination with Dexamethasone (DEX) and Bortezomib (BORT) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results from the Phase 1/2 Study CC-92480-MM-002

CC-92480, a Potent, Novel Cereblon E3 Ligase Modulator (CELMoD) Agent, in Combination with Dexamethasone (DEX) and Bortezomib (BORT) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results from the Phase 1/2 Study CC-92480-MM-002

Lenalidomide Dosing and Outcomes in Transplant-Ineligible Patients with Newly-Diagnosed Multiple Myeloma: A Multi-Institutional Report from the Canadian Myeloma Research Group (CMRG) Database

Lenalidomide Dosing and Outcomes in Transplant-Ineligible Patients with Newly-Diagnosed Multiple Myeloma: A Multi-Institutional Report from the Canadian Myeloma Research Group (CMRG) Database

Selinexor-Based Regimens in Patients with Multiple Myeloma after Prior Anti-B-Cell Maturation Antigen Treatment

Selinexor-Based Regimens in Patients with Multiple Myeloma after Prior Anti-B-Cell Maturation Antigen Treatment

95-LB: LixilanONE CAN: Randomized Trial Comparing a Daily vs. Weekly Titration Algorithm for Switching from Basal Insulin to iGlarLixi Fixed-Ratio Combination in People with T2DM in Canada

The combination of basal insulin with a GLP-1 RA may be helpful for people with T2DM to achieve and maintain HbA1c targets compared with each used individually. This randomized, 26-week, multicenter Phase 3 study (NCT03767543) in people with T2DM included participants with HbA1c ≥7.5% and ≤10.5%, and on basal insulin for ≥6 months (dose of ≤40 units/day). In addition to background oral glucose lowering medications, all participants received once-daily iGlarLixi, a fixed-ratio combination given within 1 hour prior to their first meal of the day, and were randomized 1:1 with instructions to titrate daily using a 1 unit per day algorithm or the traditional once-weekly titration (2 or 4 units per week) with target FPG of 4.4 to 5.6 mmol/L (79.2 to 100.8 mg/dL). Daily titration of iGlarLixi was superior to a weekly titration for the primary endpoint of change from baseline in HbA1c at week 26. The proportion of participants experiencing ≥1 gastrointestinal event(s) (27.9% daily vs. 27.8% weekly titration) and incidence of hypoglycemic events (84% daily vs. 81% weekly titration) were similar between the two arms. In this randomized trial, a daily titration algorithm for iGlarLixi was demonstrated as a safe alternative to the traditional weekly titration, while allowing patients to reach their maintenance dose earlier. Disclosure I. Hramiak: Advisory Panel; Self; AstraZeneca, Bayer Inc., BI-Lilly Joint Venture (Boehringer Ingelheim and Eli Lilly), Dexcom, Inc., Insulet Corporation, Medtronic, Research Support; Self; Eli Lilly and Company, Novo Nordisk, Sanofi. H. C. Gerstein: Advisory Panel; Self; Novo Nordisk Inc., Pfizer Inc., Sanofi, Consultant; Self; Abbott, Covance Inc., Eli Lilly and Company, Kowa Company, Ltd., Sanofi, Other Relationship; Self; Boehringer Ingelheim (Canada) Ltd., DKSH, Eli Lilly and Company, Sanofi, Zuellig, Research Support; Self; AstraZeneca, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. L. A. Leiter: Advisory Panel; Self; Abbott Diabetes, Amgen Inc., AstraZeneca, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Esperion, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi, Other Relationship; Self; Applied Therapeutics, Research Support; Self; Amgen Inc., AstraZeneca, Esperion, Kowa Company, Ltd., Lexicon Pharmaceuticals, Inc., Medicines Company, Novartis Pharmaceuticals Corporation, Speaker’s Bureau; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk Inc. J. Yale: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Novo Nordisk Canada Inc., Sanofi, Research Support; Self; Bayer Inc., Speaker’s Bureau; Self; Dexcom, Inc., Medtronic, Merck & Co., Inc., Omnipod. H. S. Bajaj: Other Relationship; Self; Eli Lilly and Company, Novo Nordisk, Research Support; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Kowa Pharmaceuticals America, Inc., Merck & Co., Inc., Sanofi, Tricida, Inc. J. A. Stewart: Employee; Self; Sanofi. M. Toutounji: Employee; Self; Sanofi. S. B. Harris: Advisory Panel; Self; Abbott Diabetes, Abvance Therapeutics, HLS Therapeutics Inc., Lilly Diabetes, Novo Nordisk A/S, Consultant; Self; Boehringer Ingelheim (Canada) Ltd., mdBriefCase, Other Relationship; Self; American Diabetes Association, AstraZeneca, Novo Nordisk Canada Inc., Sanofi. Funding Sanofi Canada

Patient Satisfaction with Quality of Care of a New Multidisciplinary Thrombosis Service

INTRODUCTION As patient centered healthcare is becoming increasingly popular, it is important to assess patient satisfaction with this approach. We started a new multidisciplinary Adult Outpatient Thrombosis Service (TS) in October 2017 in a Canadian health authority servicing over 300 000 people. The TS is a comprehensive thrombosis and anticoagulation management program with unique, interrelated clinics providing the spectrum of care required for this patient group. The TS includes an Emergency Thrombosis Clinic for care after an acute episode of venous thromboembolism; Thrombosis Clinics addressing non-urgent thrombosis questions and follow up; Anticoagulation Management Clinics for patients on extended duration anticoagulation; and a Perioperative Anticoagulation Management Clinic for patients on anticoagulation requiring surgery or procedures. The TS is staffed by Pharmacists, a Thrombosis Physician/Hematologist, and Clerical staff. The objective of this study was to assess patient satisfaction with the TS. METHODS We conducted a cross sectional survey of patients attending at least one appointment at the TS between October 2017 and May 2019 and who had a valid mailing address available in the hospital records. Eligible patients (n=1058) were mailed an anonymous survey with a cover letter and self-addressed, return stamped envelope. Patient satisfaction with the TS was measured using the seven item Short Assessment of Patient Satisfaction (SAPS), a validated, convenient satisfaction survey tool. The SAPS assesses the core satisfaction domains including treatment satisfaction, explanation of treatment results, clinician care, participation in decision-making, respect by the clinician, time with the clinician, and satisfaction with clinic care. The SAPS utilizes 5-point responses (0-4), with the continuous score range from 0 (extremely dissatisfied) to 28 (extremely satisfied), and categorical responses (0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied). Additionally, five patient characteristic questions were included. Patients were also given the opportunity to respond to an open-ended question regarding the care they received. Participant characteristics and responses are presented using descriptive statistics; linear regression was used to explore variations across characteristics. Qualitative content analysis of open-ended question comments was used to further our understanding of the patient experience and perceived quality of care. RESULTS A total of 563 surveys were returned for a response rate of 53%. Nine were excluded due to more than 2 missing SAPS item answers. Most respondents (87%, n=481) were 50 years of age or older, and 51% (n=285) were male. About two-thirds (67%, n=368) had post-secondary education. About half (54%, n=296) were taking a direct oral anticoagulant (DOAC), about one fifth taking warfarin (19%, n=102), or on no anticoagulant (19%, n=104) at the time of survey response. Almost half had taken the anticoagulant for 1 to 5 years at the time of survey response (47%, n=255), with the remainder split between less than 1 year (28%, n=152), and greater than 5 years (25%, n=137). The mean score for the SAPS was 22.1 (SD 4.1, range 8 to 28). Based on the categorical response, 85% were satisfied or very satisfied with the TS. Multivariate analysis showed that patients with post-secondary education were more satisfied with the TS (β=16.153, p=0.024), and patients taking warfarin were less satisfied with the TS (β= -15.832, p=0.039). The SAPS tool demonstrated a high internal consistency when assessed for reliability using Composite reliability tests (0.86). Forty percent (n=223) provided written responses to the open-ended question. The majority of responses described positive patient experiences and perceptions regarding the TS and quality of care received. Four major themes emerged: service organization and coordination of care, patient-provider relationship, pharmacist-led medication therapy management, and patient-centered delivery and communication of health information. CONCLUSION To our knowledge, this is the first survey to assess patient satisfaction with a multidisciplinary TS. We found a high proportion (85%) of respondents were satisfied with the care provided. Disclosures Young: Sanofi Canada: Honoraria, Research Funding; Bayer: Research Funding; Pfizer: Honoraria. Chitsike:Sanofi Canada: Honoraria, Research Funding; Bayer Canada: Research Funding.

Patient Adherence to Medication within a New Multidisciplinary Thrombosis Service

BACKGROUND Poor medication adherence puts patients who require thrombosis care at greater risk of complications. Little is known about the impact of multidisciplinary care models on medication adherence in patients requiring anticoagulation management. It is also unclear from the literature whether adherence varies in clinical practice with the advent of direct oral anticoagulants (DOACs) which have shorter half-lives and require limited or no laboratory monitoring compared to vitamin-K antagonists. We started a new multidisciplinary Adult Outpatient Thrombosis Service (TS) in October 2017 in a Canadian health authority servicing over 300 000 people. The TS is a comprehensive thrombosis and anticoagulation management program with unique, interrelated clinics providing the spectrum of care required for this patient group. The TS includes an Emergency Thrombosis Clinic for care after an acute episode of venous thromboembolism; Thrombosis Clinics addressing non-urgent thrombosis and anticoagulation questions and follow up; Anticoagulation Management Clinics for long term follow up of patients on anticoagulation; and a Perioperative Anticoagulation Management Clinic for patients on anticoagulation requiring surgery or procedures. The TS is staffed by Pharmacists, a Thrombosis Physician/Hematologist, and Clerical staff. The objective of the survey was to assess self-reported medication adherence of patients within the TS. PATIENTS/METHODS We conducted a cross-sectional survey of patients who were consulted to the TS between October 2017 and May 2019. Eligible patients were mailed an anonymous survey with a cover letter and self-addressed, return stamped envelope. Adherence to medication was assessed using the 12-item validated Adherence to Refills and Medications Scale (ARMS). The ARMS utilizes a 4 point scale (1-4), with the continuous score range of 12 to 48, and lower scores indicating better adherence. Baseline characteristics and patient satisfaction with the TS were evaluated for association with medication adherence. Linear regression analysis was used to examine the associations between patient's characteristics, their satisfaction with TS and medication adherence. RESULTS Of 1058 eligible patients, 563 responded to the survey representing a response rate of 53%. Seventeen were excluded who had more than 6 missing responses to the ARMS items. Out of remaining 546 patients with complete responses 55% (n=297) were on DOACs, 19% (n=102) on warfarin, 5.0% (n=27) on low molecular weight heparin (LMWH), 3.3% (n=18) on antiplatelet therapy and 18% (n=96) were not receiving anticoagulation therapy at the time of completing the survey. Nearly half had taken anticoagulant for 1 to 5 years (47%, n=253) while 28% (n=150) and 25% (n=137) had been on an anticoagulant for less than 1 year and more than 5 years respectively. Most patients (87%, n=475) were 50 years of age or older and half (51%, n=277) were male. About two-thirds (67%, n=360) had at least post-secondary education. The mean score for the ARMS was 13.9 (SD 2.2, range 12 to 25). Most patients (88%, n = 481) reported high adherence to medication (ARMS score = 12-16). In univariate analysis, post-secondary education (β = 0.0052, p = 0.006) and patient satisfaction with the TS (β = 0.0004; p = 0.019) significantly predicted medication adherence among participants. In multivariate analyses education (β = 0.0039, p = 0.048) and duration of anticoagulant use (β = 0.0047, p = 0.0244) were significantly associated with medication adherence. The internal consistency reliability for the ARMS tool was acceptable (Cronbach's alpha = 0.70). CONCLUSIONS Self-reported medication adherence was high (88%) in patients seen at a multidisciplinary TS. Post-secondary education and duration of anticoagulant use were important predictors of medication adherence. Disclosures Young: Sanofi Canada: Honoraria, Research Funding; Bayer: Research Funding; Pfizer: Honoraria. Chitsike:Bayer Canada: Research Funding; Sanofi Canada: Honoraria, Research Funding.

Risk Factors for the Development of Skin Cancers in Patients with Chronic Lymphocytic Leukemia: A Retrospective Cohort Study

Introduction: Individuals with chronic lymphocytic leukemia (CLL) are often immunosuppressed and at increased risk of infection and secondary malignancies. The primary aim of this study was to determine the incidence of skin cancer amongst the CLL population at Kingston Health Sciences Centre (KHSC), Ontario, Canada. Secondly, we sought to identify the risk factors associated with the development of skin cancer in CLL patients. Methods: Consecutive patients seen at KHSC with a diagnosis of CLL between 2014 January 1 and 2019 December 31 formed the primary study cohort. KHSC serves a region of ~ 550,000 including a high proportion of older individuals and those living in rural areas. Approval was provided by Queen's University Research Ethics Board. Four independent reviewers conducted retrospective electronic chart review, initially in duplicate with review of any areas of discrepancy to ensure a standardized approach. Data collected included age, sex, CLL date of diagnosis, stage, genetics and treatment; histological diagnoses of other cancers (skin and other), smoking status (ever/never) and date of last follow up or death. The primary outcome was the development of the first skin cancer (squamous cell carcinoma, basal cell carcinoma, melanoma, or sarcoma) confirmed via pathology reports that are available in our local institution. All statistical analysis was performed using SAS Enterprise v. 7.15. Categorical variables were compared using chi-square or Fisher exact tests, medians using Wilcoxon and Mann-Whitney tests, and continuous variables using t-tests. Risk factors for development of skin cancer were assessed using multivarable Cox-proportional hazard models. Results: Of the total cohort of 377 individuals with CLL, 251 (67%) were male. Median age at diagnosis of CLL was 65 years (range 36 - 93 years of age). Median follow-up from the time of CLL diagnosis was 6.5 years (range 0.27 - 30.98). Of these, 80 individuals (21.2%) developed at least one skin cancer after their diagnosis of CLL, with an age-adjusted incidence of 16.96/1000 patient years (95% CI 12.5 - 23). Among the 297 who did not develop skin cancer post-CLL diagnosis, 13 individuals who had documented skin cancer pre-CLL diagnosis only, are included in the non-skin cancer group (Figure 1). Females had a lower incidence of skin cancer compared with males (63 males versus 17 females, p=0.009). There was no difference between the groups based on Rai stage at diagnosis, smoking history, or IGHV /p53 status. Individuals treated with ibrutinib had a lower incidence of skin cancer (3 versus 49, p=0.002). Development of skin cancer was associated with development of other invasive tumours including CLL transformation (p=0.001) (Table 1). Conclusion: Limitations of this study include its small size, and single institution setting. Our data likely reflect a conservative estimate as skin cancers may be diagnosed outside of the institution, and not all CLL is treated at tertiary care centres. Consistent with other studies we found that males with CLL are at increased risk of developing skin cancer, as compared to females. Individuals with CLL and skin cancer were more likely to develop another malignancy or Richter's transformation. The finding of lower incidence of skin cancer with ibrutinib treatment is novel; further investigation in larger populations is needed to determine if it may offer a protective effect. Disclosures Asai: Sanofi Canada: Honoraria, Research Funding; AllerGen NCE: Research Funding; Pfizer: Honoraria, Research Funding; Janssen: Honoraria; Leo Pharma: Honoraria; Eli Lilly: Honoraria; Novartis: Honoraria; Abbvie: Honoraria, Research Funding; Canadian Institutes of Health Research: Research Funding. Hay:Roche: Research Funding; Janssen: Research Funding.

One-Year Outcomes with Once or Twice Daily Enoxaparin

Background: Enoxaparin given once daily (QD) for thrombotic disorders is less burdensome than twice-daily (BID) dosing. However, long-term outcomes when enoxaparin given as QD monotherapy are unknown. Methods: We did a population-based cohort study. New users of enoxaparin alone (2005-2014) were identified in the linked healthcare databases of Quebec, Canada, and followed up for up to one year. The number of dispensed syringes divided by prescription length determined QD or BID enoxaparin by intention to treat. Cumulative rates of major bleeding and re-treatment with anticoagulants at one year were compared between enoxaparin groups. Re-treatment was initiation of anticoagulation after at least 30 days of no dispensed anticoagulants. The duration of enoxaparin monotherapy was the sum of prescriptions until discontinuation. Results: The cohort included 504 patients; QD and BID enoxaparin users were 445 and 59, respectively. Mean (SD) age was 78.0 (6.6) years, 43.8% were males, and 61.9% had cancer. At 12 months, major bleeding occurred in 21 (4.7%) and 4 (6.8%) among QD and BID enoxaparin users, respectively (Figure 1A, P = 0.49). Re-treatment with anticoagulants occurred in 37 (9.6%) and 5 (9.4%) of QD and BID users, respectively (Figure 1B, P = 0.98). The duration of enoxaparin monotherapy was on average 13.9 (95% CI, 4.4-23.4, P = 0.005) days longer with QD vs BID use. Conclusions: Monotherapy with QD enoxaparin was common and longer than BID enoxaparin with no apparent differences in bleeding or re-treatment with anticoagulants. Figure 1 Disclosures Klil-Drori: Sanofi Canada: Research Funding. Nazha:Sanofi Canada: Employment. Gharib:Sanofi Canada: Employment. Perreault:Sanofi Canada: Research Funding. Tagalakis:Servier: Other: participated on ad boards; Bayer: Other: participated on ad boards; Pfizer: Other: participated on ad boards; Sanofi Aventis: Other: investigator initiated grant;participated on ad boards; BMS-Pfizer: Other: participated on ad boards.

Less Chronic Graft-Versus-Host Disease, Immunosuppressive Therapy and Better Survival after Anti-Thymocyte Globulin in Unrelated Donor Stem Cell Transplant Recipients: Longer Follow-up of a Multicentre Cell Therapy Transplant Canada Randomized Trial

Less Chronic Graft-Versus-Host Disease, Immunosuppressive Therapy and Better Survival after Anti-Thymocyte Globulin in Unrelated Donor Stem Cell Transplant Recipients: Longer Follow-up of a Multicentre Cell Therapy Transplant Canada Randomized Trial

Persistent Red Blood Cell (RBC) Transfusion Is Associated with Increased Mortality Risk in Transfusion-Dependent (TD) Patients with Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS+)

Persistent Red Blood Cell (RBC) Transfusion Is Associated with Increased Mortality Risk in Transfusion-Dependent (TD) Patients with Myelodysplastic Syndromes (MDS) with Ring Sideroblasts (RS+)

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine

Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial

Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial

Intermediate Vs High Dose Busulfan-Based Conditioning for Allogeneic Cell Transplantation in Patients with Acute Leukemia or Myelodysplastic Syndromes from HLA Matched Related or Unrelated Donors: Achieving the Same with Less

Intermediate Vs High Dose Busulfan-Based Conditioning for Allogeneic Cell Transplantation in Patients with Acute Leukemia or Myelodysplastic Syndromes from HLA Matched Related or Unrelated Donors: Achieving the Same with Less

Prognostic Performance of Frailty Measures in MDS Patients Treated with Hypomethylating Agents

Prognostic Performance of Frailty Measures in MDS Patients Treated with Hypomethylating Agents

Acute Myeloid Leukemia (AML) Treated with Azacitidine: Survival Outcomes for Patients Who Complete More Than Six Cycles Are Similar to High-Risk Myelodysplastic Syndrome/Low Blast Count AML

INTRODUCTION: Despite accumulating evidence supporting the efficacy of hypomethylating agents in patients with AML and > 30% bone marrow blasts as well as in relapsed/refractory AML, this therapy is not yet funded by National Health Plans / Healthcare Funding Agencies in a number of countries including Canada. The assistance of an industry-sponsored compassionate program has enabled provision of azacitidine for this group of patients at The Ottawa Hospital. We report here our local "real-world" experience of azacitidine efficacy in this diverse group of AML patients and identify a sub-group whose outcomes are equivalent to that of patients with higher-risk Myelodysplastic Syndrome (MDS) and AML with 20-30% blasts for whom azacitidine therapy has funding approval in Canada. METHODS: All patients who received azacitidine at The Ottawa Hospital between 2009 and 2016 were included in this single-center, retrospective analysis. Azacitidine was administered at a dose of 75mg/m2 subcutaneously daily for 7 consecutive days every 28 days. Response was evaluated with a repeat bone marrow aspirate and trephine biopsy after the 6th cycle. In those patients confirmed to have stable or responsive disease, azacitidine was continued until progression of disease, intolerable side-effects of the drug or the patient chose to discontinue therapy. Overall survival curves were generated using the Kaplan-Meier method and log-rank tests were used to compare subgroups of patients. Actuarial median survival months were calculated with 95% confidence intervals (CI). P-values less than 0.05 were considered statistically significant. RESULTS: During the study period, 109 patients received azacitidine: 54 had MDS /AML with 20-30% blasts (the 'funded' group) and 55 had either AML with > 30 % blasts (n=23), AML relapsed post-intensive chemotherapy (n=14), AML relapsed post-allogeneic stem cell transplant (n=10) or primary refractory AML (n=8) (the 'unfunded' group). Median survival of the 'funded' group was 12.2 months while median survival of the 'unfunded' group was 5.6 months (95% CI 3.3-7.7; p=0.0058). Of the AML patients in the 'unfunded' group, 24% completed more than 6 cycles of azacitidine compared to 52% of patients in the 'funded' group. In both the 'funded' and 'unfunded' groups, patients who completed more than 6 cycles of azacitidine had similar survival outcomes (p=0.7277): the 'funded' group had a median survival of 19 months (95% CI 14.4-25.3) while the median survival of this sub-population of the 'unfunded' AML group was 22 months (95% CI 11.7-24.9). Patients in both groups who failed to complete more than 6 cycles of azacitidine also had a similar outcome (p=0.39), with a median survival of 5.7 months (95% CI 4.0-6.3) for patients with MDS/AML 20-30% blasts and 3.6 months (95% CI 2.2-5.1) for AML patients with > 30% blasts or relapsed/refractory disease. Reasons for patients not completing at least 6 cycles of azacitidine included progression of disease (25%), bacterial infections most commonly pneumonia (53%) and patient preference (7%). CONCLUSION: A significant sub-population of AML patients with > 30% blasts or refractory/relapsed AML can achieve a meaningful survival benefit with the hypomethylating agent, azacitidine. A higher proportion of this AML patient population discontinued azacitidine as a result of infective complications. The provision of routine prophylactic antibiotics may enable more patients with AML to receive an adequate amount of azacitidine to achieve therapeutic benefit and warrants further investigation. Our results add to the growing body of 'real-world' evidence that supports healthcare funding agencies to provide coverage of azacitidine for patients with AML who in some countries at present do not fulfill government funding criteria. Disclosures Bredeson: Otsuka: Research Funding. Maze:Pfizer Inc: Consultancy; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees. Sabloff:Novartis Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; ASTX: Membership on an entity's Board of Directors or advisory committees, Research Funding; Actinium Pharmaceuticals, Inc: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer Canada: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Astellas Pharma Canada: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi Canada: Research Funding.

Intermittent Transfusion Independence Is Associated with Improved Overall Survival in Patients with Transfusion Dependent MDS

Intermittent Transfusion Independence Is Associated with Improved Overall Survival in Patients with Transfusion Dependent MDS

UM171 Modified Cord Blood Achieves Excellent Survival and Disease Control after 2 Years of Follow-up in High and Very High Risk Malignancies

UM171 Modified Cord Blood Achieves Excellent Survival and Disease Control after 2 Years of Follow-up in High and Very High Risk Malignancies

Bortezomib-Based Induction, Augmented Conditioning with Busulfan and Melphalan + ASCT and Lenalidomide Maintenance for Newly Diagnosed Multiple Myeloma: Long-Term Results of the National Canadian Mcrn-001 Study

Bortezomib-Based Induction, Augmented Conditioning with Busulfan and Melphalan + ASCT and Lenalidomide Maintenance for Newly Diagnosed Multiple Myeloma: Long-Term Results of the National Canadian Mcrn-001 Study