Background: The introduction of daratumumab into the treatment of multiple myeloma has improved outcomes in patients; however, community oncologists often dose more frequently than the US FDA-approved label. Materials and methods: Integra analyzed its database to elucidate daratumumab treatment patterns and the impact of increased utilization on the cost of care for multiple myeloma. Results: Following week 24, 671 (65%) of 1037 patients remained on daratumumab-containing regimens, with 330 patients continuing more frequent treatments than the expected once-every-4-weeks dosing described in the standard dosing schedule. Patients received an average of 14% more daratumumab doses than the FDA-approved label indicates, increasing the 1-year daratumumab costs by an estimated US$31,353. Conclusion: Daratumumab is utilized more frequently than the FDA-recommended dosing, leading to higher multiple myeloma treatment costs.
The care of patients with HIV and Burkitt lymphoma poses a challenge to clinicians. Due to the limited treatment options that exist for relapsed/refractory Burkitt lymphoma, there is a need for the development of new therapies. This review aims to discuss evidence for current management strategies including chemotherapy and stem cell transplant, and highlight gaps in knowledge that will need to be addressed in the future.
Addressing these challenges with HIT has the potential to increase care delivery and coordination, and ensure positive outcomes. The purpose of this study was to examine the use of a user-centered HIT app "BMT Roadmap" in a sample of adult and pediatric HCT patient-caregiver dyads. Methods: We used a mixed methods approach to collect quantitative and qualitative person-reported outcome measures (PROs) longitudinally upon admission, discharge, and day 100 post-HCT. Adult and pediatric patient caregivers (n = 39) completed encrypted psychometric surveys and inperson semi-structured interviews. Qualitative data were derived from multiple-reviewer thematic analysis. Results: Adult caregivers logged on fewer days than pediatric caregivers (M = 10.09 + 10.67 versus M = 18.26 + 14.35 respectively; t = -1.82, p = .07), reflecting differences in lengths of stay and thus access to the app. After statistical correction for differing access, we found caregivers used the app mostly for viewing patient laboratory values, and adult caregivers devoted more time to the medication and phases of care modules (t = 2.52, p = .02; t = 1.87, p = .07 respectively). Most adult and pediatric caregivers identified separate educational, organizational, and psychosocial needs during the phase of the transplant. However, both found BMT Roadmap informative and valuable for the caregiving experience. Conclusion: Caregivers of adult and pediatric patients receiving first-time allogeneic HCT report different caregiving experiences. Thus, they desire different interventions to learn best practices of caregiving. Clearly delineating differences in caregiving for adult and pediatric patients helps with customizable HIT design and may improve long-term patient outcomes.
BACKGROUND Since the FDA's initial indication for the use of daratumumab in relapsed/refractory multiple myeloma (RRMM) in November 2015, usage has been expanded by subsequent approvals in newly diagnosed, transplant-ineligible MM patients, and more recently in newly diagnosed transplant-eligible patients. Real World Data (RWD) has been published demonstrating daratumumab's efficacy in RRMM settings[1]and its utility of split dosing for the initial dose[2]. However, no study has been published to examine the real-world dosing patterns of daratumumab compared to the FDA standard dosing schedule. While there are minimal variations in the approved dosing schedule of daratumumab, generally accepted dosing is weekly in week 1 through week 8, q 2 Wks in week 9 through week 24, and q 4 Wks after week 24, all at the standard 16 mg/kg dosage[3]. In its approved dosing schedule, adjustments are made in the frequency of administration, but not in the standard weight-based dosing. METHODS Utilizing the Integra Connect database which contains 17 community oncology network accounts and over 1,900 providers in US, we collected all MM patients treated with daratumumab between January 1, 2016 and March 31, 2020. We then excluded any patient whose first line of therapy (LOT) was ambiguous, in order to correctly identify the daratumumab-containing LOTs. We also excluded LOT 1 daratumumab transplant induction due to the wide variation in daratumumab dosing schedules in clinical trials in the transplant eligible patient[4]. LOTs were determined based on International Myeloma Working Group guidelines[5]. Data were collected on the date of each individual daratumumab administration, counting initial split dose, if utilized, as 1 dose. The duration of daratumumab and number of doses administered were calculated and corrected for any time on treatment breaks. The study was conducted per individual patient by LOT cohorts, and for the entire cohort of patients. We utilized the standard dose schedule for daratumumab noted above to establish the expected doses of daratumumab and calculated the compliance dose ratio (ratio of actual doses to expected doses per time on therapy) to evaluate how closely real-world treatment adhered to the standard dosing schedule. RESULTS 1037 MM patients were included with at least 6 doses of daratumumab administration and without stem cell transplant or uncertain LOT. Across all LOTs, the mean duration of daratumumab treatment was 5.6 months with a median duration of 9.8 months. After week twenty-four, 671 (65%) patients remained on daratumumab-containing regimens, with 330 patients continuing q 1 Wk or q 2 Wks dosing, whereas the standard would employ a switch to q 4 Wks dosing (Figure 1). Overall compliance dose ratio was consistently above 100%, implying a significant proportion of patients were receiving more frequent dosing than expected under the standard dosing schedule (Figure 2). We carefully evaluated patients in various LOTs and combination therapies. Drug combination was not found to exert a significant impact on the daratumumab dosing pattern. Compliance dose ratio of daratumumab is slightly higher in RRMM compared to the dose ratio in LOT 1 newly diagnosed MM, but even LOT 1 has a ratio greater than 1 (Figure 3). It should be noted that this increased compliance dose ratio is present in all LOT cohorts despite 25% of patients being started on doses less frequent than weekly (Figure 1). CONCLUSIONS In real-world community oncology practices, daratumumab is utilized in a more frequent dosing schedule than the FDA approved standard dosing. With standard dosing there are 23 daratumumab doses in the first 52 weeks. The compliance dose ratio found in our RWD implies 27.3 doses in the first year for the entire cohort and 26.9 and 28.3 doses in LOTs 2 and 3 respectively. Thus, significantly increased drug and administrative costs are incurred over those anticipated in respect to daratumumab dosing utilization. This study is limited to the EMR and administrative claims data of those individuals who are being treated in a community oncology setting. Residual confounding and bias may exist due to entry error and unobserved patient characteristics. References [1] Gergely Varga, et al; Blood 2018; 132:3257 [2] Rifkin R, et al; Clin Ther. 2019;41(5):866-881 [3] DARZALEX® [Prescribing Information] [4] Abdallah N, et al. Ther Adv Hematol. 2019 Dec 23 [5] Rajkumar SV, et al Blood. 2015;126(7):921-922 Disclosures Smith: Integra Connect: Current Employment; Sanofi: Research Funding. Xue:Sanofi: Research Funding; Integra Connect: Current Employment. Marks:Sanofi: Research Funding. Scott:Integra Connect: Current Employment; Sanofi: Research Funding. Blanc:Sanofi: Research Funding. Nagovski:Sanofi: Research Funding. Lambert:Sanofi: Research Funding; Integra Connect: Current Employment. Varughese:Integra Connect: Current Employment; Sanofi: Research Funding.
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