Progression-Free Survival of Daratumumab Versus Bortezomib Triplet Combination With Lenalidomide and Dexamethasone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma: TAURUS Chart Review Study.

BACKGROUND: Daratumumab, lenalidomide and dexamethasone (DRd) and bortezomib, lenalidomide and dexamethasone (VRd) are preferred regimens for transplant ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM). Both DRd and VRd demonstrated superior efficacy versus Rd in the MAIA and SWOG S0777 trials, respectively, but there is no head-to-head (H2H) clinical trial comparing their efficacy. Differing populations in the MAIA and S0777 trials make an unadjusted comparison of outcomes challenging and biased. The current TAURUS study is the first real-world H2H study comparing progression-free survival (PFS) among TIE NDMM patients treated with DRd or VRd as first-line (1L) in similar clinical settings. MATERIALS AND METHODS: A multicenter chart review study was conducted at nine sites across the United States. All TIE patients treated with DRd and a randomly selected population of VRd patients were included. TIE NDMM patients aged ≥65 were included if they initiated 1L DRd/VRd between January 2019 and September 2021. PFS was defined as the time from DRd/VRd initiation until disease progression or death. A doubly-robust multivariable Cox regression model combined with inverse probability of treatment weighting (IPTW) methodology was used to compare PFS between cohorts. RESULTS: Weighted cohorts comprised 91 DRd and 87 VRd patients. Thirteen DRd and 24 VRd patients experienced progression/death. Patients treated with DRd had a lower risk of progression/death versus VRd (adjusted hazard ratio: 0.35, 95% confidence interval: [0.17; 0.73]). CONCLUSION: DRd is associated with a significantly lower risk of disease progression or death compared to VRd as 1L treatment for TIE NDMM patients.

Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis.

BACKGROUND: The present study evaluated the relative survival benefits associated with enasidenib and current standard of care (SoC) therapies for patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and an isocitrate dehydrogenase 2 (IDH2) mutation who are ineligible for hematopoietic stem cell transplantation (HSCT). METHODS: Propensity score matching (PSM) analysis compared survival outcomes observed with enasidenib 100 mg daily in the phase I/II AG221-C-001 trial and SoC outcomes obtained from a real-world chart review of patients in France. RESULTS: Before matching, enasidenib (n = 195) was associated with numerically improved overall survival (OS) relative to SoC (n = 80; hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.61-1.11). After matching and adjusting for covariates (n = 78 per group), mortality risk was significantly lower with enasidenib than with SoC (HR, 0.67; 95% CI, 0.47-0.97). The median OS was 9.26 months for enasidenib (95% CI, 7.72-13.24) and 4.76 months for SoC (95% CI, 3.81-8.21). Results remained robust across all sensitivity analyses conducted. CONCLUSIONS: PSM analyses indicate that enasidenib significantly prolongs survival relative to SoC among patients with R/R AML and an IDH2 mutation who are ineligible for HSCT. Future prospective studies are needed to validate these findings using other data sources and to assess the comparative efficacy of enasidenib for other treatment outcomes.

Plerixafor in non-Hodgkin's lymphoma patients: a German analysis of time, effort and costs.

Mobilization and collection of peripheral blood stem cells is part of the standard treatment procedure for non-Hodgkin's lymphoma patients eligible for high-dose chemotherapy with autologous stem cell transplantation. Mobilization is usually achieved with chemotherapy and/or cytokines, but plerixafor might be added in case of poor mobilization. Due to the high cost several institutions have developed their own management pathway to optimize use of plerixafor. Such models are however rarely generalizable; in a multi-center, European, non-interventional study, evaluating the impact of plerixafor in poor mobilizers, country specific differences in patient treatment and cost structure were obvious. For German centers, there was a non-significant reduction in the number of apheresis sessions carried out and in apheresis costs. In contrast to other European countries the majority of German Plerixafor patients were very poor mobilizing patients with initial CD34+ cell count ≤ 10/µl (40/51). In this group the number of apheresis sessions decreased from 2.1 to 1.6 sessions per patient (p = 0.01) and costs decreased from €6246 to €4758 (p = 0.01). Our results show that preemptive plerixafor use has a strong effect in poor mobilizers with an initial CD34+ cell count ≤ 10 cells/µl.

Plerixafor in poor mobilizers with non-Hodgkin's lymphoma: a multi-center time-motion analysis.

High-dose chemotherapy alongside peripheral blood stem cell (PBSC) infusion has become the standard of care in different hematologic malignancies. The goal of PBSC mobilization is to allow collection of sufficient CD34+ cells to proceed to transplantation. The current mobilization regimen with granulocyte colony-stimulating factor (G-CSF), alone or in combination with chemotherapy, still fails in 10-25% of patients. Plerixafor is able to rescue most of these patients from mobilization failure. In this study, we investigated the impact of plerixafor on the cost and time spent on apheresis in patients who were considered poor mobilizers, with <20 × 106/µl peripheral CD34+ cells after mobilization but prior to apheresis. Patient hospital records from ten centers in three European countries were reviewed and compared during two time periods, namely prior and after plerixafor introduction to the market. During the plerixafor period, patients spent less time on apheresis (350 vs. 461 min). Poor mobilizers given plerixafor collected more CD34+ cells during the first apheresis session, leading to a decrease in the average number of apheresis sessions needed. The total apheresis yield was unaffected. This analysis shows that the use of plerixafor lessens the time-effort associated with the management of poor mobilizers and reduces apheresis costs.

Impact of long-acting growth factors on practice dynamics and patient satisfaction.

OBJECTIVE: To quantify time expended, patient satisfaction, and econometrics associated with short-acting (sargramostim, epoetin alfa) and long-acting (darbepoetin alfa, pegfilgrastim) growth factors. DESIGN: Retrospective resource utilization and prospective two-phase observational study. METHODS: During week 1, time-motion measurements related to patient treatment and drug preparation were collected for scheduling; check-in; phlebotomy; laboratory; and drug preparation, administration, and recording. Drug utilization for one chemotherapy cycle during weeks 2 and 3 was assessed for sargramostim, pegfilgrastim, epoetin alfa, darbepoetin alfa, sargramostim plus epoetin alfa, and pegfilgrastim plus darbepoetin alfa. Patients completed a satisfaction survey. RESULTS: Among 140 patients (mean age 58 yrs), mean chemotherapy cycle duration was 19 days. A total of 268 events were observed. Mean total staff time/patient visit for drug administration was 22.1 minutes, with most time spent on scheduling (5.5 min) and drug preparation, administration, recording (5.2 min). For sargramostim only versus pegfilgrastim only, pegfilgrastim resulted in a 37% reduction (p < 0.01) in all visits and an 85% reduction (p < 0.01) in mean number of doses. For epoetin alfa only versus darbepoetin alfa only, darbepoetin alfa resulted in a 48% reduction (p < 0.01) in mean number of doses. The most common dosage of epoetin alfa was 40,000 U/week (63.6%) and that of darbepoetin alfa was 200 microg every other week (92%), but complete blood counts were obtained weekly. For pegfilgrastim plus darbepoetin alfa versus sargramostim plus epoetin alfa, a 45% reduction (p < 0.01) in total visits and a 77% reduction (p < 0.01) in mean number of doses were noted in the former group. In 69 patients converted to long-acting drugs, 65 actual hours for a single treatment cycle were saved. For patients receiving pegfilgrastim plus darbepoetin alfa, there was a 45% reduction in total clinic visits, 77% reduction in doses, and staff time savings of 1.9 hours/patient/cycle of chemotherapy. Fifty-four patients completed the survey and trended toward neutral in their responses, with moderate disagreement that receiving injections is painful. CONCLUSION: Long-acting growth factors resulted in significant time savings for staff and providers by reducing the number of necessary office visits for drug administration. These time savings can significantly improve the quality of life for patients, as well as nurses, physicians, and caregivers.