scholarly journals Stem Cell Transplant Minimizes Insurance Coverage-Driven Outcomes Disparities for Multiple Myeloma Patients

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 424-424
Author(s):  
Gayathri Ravi ◽  
Kamal Chamoun ◽  
Kirsten M Boughan ◽  
Shufen Cao ◽  
Pingfu Fu ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplant ◽  
Private Insurance ◽  
Cell Transplant ◽  
Proportional Hazard ◽  
Cox Proportional Hazard ◽  
Insurance Type ◽  
Insured Patients

Advent of novel anti-myeloma agents and broader use of stem cell transplant has led to significant improvement in survival of patients (pts) with Multiple Myeloma (MM). However, there are well-described issues with affordability of novel drugs and rapidly escalating price of these agents (Shih et al. JCO 2017), leading to significant disparity among different sociodemographic groups. Hereby, we interrogated the National Cancer Database (NCDB) (which covers 70% of MM patient diagnosed nationwide) to assess impact of insurance type on survival. We also sought to investigate if autologous transplant may overcome socioeconomic effects on survival, by potentially minimizing the need for chronic use of expensive drugs. Methods: Data from 117,926 MM pts diagnosed with MM (ICD-O 9732) between year 2005 and 2014 were analyzed.. The comparison of patient characteristics among insurance types was done using ANOVA for continuous measurements and Chi-square test for categorical factors. OS was measured from the date of diagnosis to the date of death, censored at the date of last follow-up for survivors. Survivor distribution was estimated using Kaplan-Meier methods and difference of OS between groups was examined by log-rank test. The effect of continuous measurements including age, distance to medical facility and facility volume on OS was estimated using Cox proportional hazard model. The effect of insurance type on OS was estimated using multivariable Cox proportional hazard regression after adjusting the effects of confounding factors. Results: Median age at diagnosis was 67 years (19-90); 55% were males. 57% of pts lived in areas where the median income was < $46k/year (individual income data was not available); Primary insurance was Medicare (52%), private insurance (35%) or Medicaid (5%), and 3% were uninsured. 40% were treated in academic institutions. Median follow up was 30.2 (range, 0-145.2) months. By univariate analysis, better OS was observed in pts with primary MM, lower Charlson Comorbidity Index (CCI), treatment in academic institutions, higher median regional income, or private insurance (p<0.001 for all) (Table-1). Ninety six percent of patients were treated in facilities located ≤ 120 miles from area of residence. More patients with private insurance (5.7%) travelled > 120 miles to the treatment facility than patients with Medicare (3%).Amongst patients younger than 65 years, 33% of patients with private insurance received transplant compared to 20% of those on Medicare (p<0.001). For those 65 years and older, 11% of privately insured patients were transplanted compared to only 6 % for those on Medicare (p<0.001). Median age of pts on Medicare and private insurance, was 74 and 57 years old, respectively. When restricting the analysis to pts ≥ 65 years old, pts with private insurance had longer OS compared to Medicare pts (p<0.0001). Table-2 shows the results of multivariate analysis. There was a statistically significant difference in survival between patients with private insurance and those with Medicare in favor of the private insurance among patients older than 65 years old (41.9 vs. 30.8 months, p<0.001 (Figure-1)). Similarly insurance type was a significant predictor of survival among patients who received therapies other than transplant among pts younger or older than 65 years old (Figure-2), however when considering patients who received transplant, there was no difference in survival between privately insured patients and Medicare in both age group (Figure-3). Conclusions: Although insurance type and regional income are associated with MM survival among patients who relied on non-transplant modalities, there was no significant impact of these socioeconomic factors on survival of patients that received an autologous transplant in this large database. This finding merits further investigation. Disclosures Malek: Janssen: Speakers Bureau; Amgen: Speakers Bureau; Adaptive: Consultancy; Celgene: Consultancy; Medpacto: Research Funding; Takeda: Consultancy; Sanofi: Consultancy.

Tandem Autologous Stem Cell Transplantation in Chemorefractory Multiple Myeloma

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4554-4554
Author(s):  
Catherine Garnett ◽  
Chrissy Giles ◽  
Osman Ahmed ◽  
Maialen Lasa ◽  
Holger W. Auner ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Stem Cell Transplant ◽  
Progression Free Survival ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Free Survival

Abstract Abstract 4554 High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is currently standard treatment for younger patients with multiple myeloma, resulting in improved survival and response rate compared to conventional chemotherapy. Disease relapse, however, remains almost inevitable and thus the role of two successive (tandem) autologous stem cell transplants has been evaluated in chemorefractory patients as a means of prolonging duration of disease response. We retrospectively analysed the results of nine patients with chemorefractory disease treated at a single UK institution who received tandem ASCT between January 1998 and February 2009. There were six men and three women. Median age at diagnosis was 56 years (range, 42–65 years). Paraprotein isotype was IgG in eight patients and IgA in one patient. Median serum paraprotein level was 41g/L (range 12–73g/L) at presentation. At time of 1st transplant six patients were in stable disease (SD) and three had evidence of progressive disease. Conditioning melphalan dose was 140mg/m2 in all but two patients who received 110mg/m2 and 200mg/m2. Median time between transplants was 3.7 months (range 2.3–6.4 months) with PR and SD being observed in 2/9 and 7/9 patients at time of 2nd transplant. None of the patients reached complete response (CR). One patient received melphalan 140mg/m2 prior to 2nd transplant. The remaining patients received melphalan 200mg/m2. Median follow up after tandem transplant was 54.3 months (range 15.6 –143.6 months). No treatment related mortality was reported. At the time of analysis, six patients were still alive and under follow up with an overall survival (OS) figure for the group of 52% at 10 years from diagnosis (Figure 1). Median progression free survival (PFS) was 20 months from 2nd transplant (range 6.7–62.6 months) (Figure 2). Tandem autologous stem cell transplant in chemorefractory patients has resulted in overall survival similar to autologous stem cell transplant in chemosensitive patients and should be considered in patients with chemorefractory disease. Figure 1: Overall survival from diagnosis in patients receiving tandem autologous stem cell transplant for multiple myeloma Figure 1:. Overall survival from diagnosis in patients receiving tandem autologous stem cell transplant for multiple myeloma Figure 2: Progression free survival following tandem transplant Figure 2:. Progression free survival following tandem transplant Disclosures: No relevant conflicts of interest to declare.

Allogeneic Hematopoietic Stem Cell Transplant in Advanced Multiple Myeloma: Experience from a Single Center

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5536-5536
Author(s):  
Yizel Elena Paz Nuñez ◽  
Beatriz Aguado Bueno ◽  
Isabel vicuña Andrés ◽  
Ángela Figuera Álvarez ◽  
Miriam González-Pardo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Board Of Directors ◽  
Hematopoietic Stem Cell ◽  
Hematopoietic Stem Cell Transplant ◽  
Stem Cell Transplant ◽  
Cell Transplant ◽  
Advisory Committees ◽  
Hematopoietic Stem

Abstract Introduction The prognosis of patients with multiple myeloma (MM) has improved in the last years due to the important advances in the knowledge of the biology of the disease, the implementation of new drugs and the incorporation of autologous hematopoietic stem cell transplant (autoHSCT). The allogenic hematopoietic stem cell transplant (alloHSCT) continues to be controversial: it offers a curative potential but with the cost of high toxicity, limiting the procedure to those young patients with a high-risk disease. This procedure shall be performed in expert centers and, whenever possible, in the context of a clinical trial. In the following we describe the experience of our center with alloHSCT in advance multiple myeloma patients. Patients and methods A total of 18 patients were diagnosed with multiple myeloma received an alloHSCT during a 13 year period (1996-2013), with a median age of 46 ± 5.9 years. All of our patients received an allogenic HLA matched sibling donor with reduced-intensity conditioning. The majority of patients were transplanted because of advanced disease, relapse after an autologous transplant or as part of a sequential transplant in patient with a high risk disease. One patient received, in two occasions, an alloHSCT. Around 70% of patients had received more than 3 previous lines of treatment including, in nearly 95%, an autoHSCT. Patient's characteristics can be found on table 1, characteristics of the procedure can be found in table 2.Table 1.Patient«s CharacteristicsN (%)GenderMale Female10 (55,5%) 9 (44,4%)Secreted ProteinIgGκ IgG λ IgA κ BJ Plasmocitoma8 (44,4%) 4 (22,2%) 2 (11,1%) 3 (16,7%) 1 (5,6%)Debut DS stageII-A II-B III-A III-B Plasmocitoma5 (27,8%) 1 (5,6%) 8 (44,4%) 3 (16,7%) 1 (5,6%)Cytogentics at diagnosisMissing Unfavorable Favorable10 (55,5%) 6 (33,3%) 2 (11,1%)Previous lines of treatment²2 3-4 ³56 (33,3%) 10 (55,5%) 2 (11,1%)Previous autoHSCTYes No17 (94,5%) 1 (5,6%)Previous radiotherapyYes No8 (44,4%) 10 (55,6%)Disease status at transplantComplete remission Partial remission Relapse9 (50,0%) 3 (16,7%) 6 (33,3%)Table 2.Treatment characteristicsN (%)Conditioning regimenMyeloablative Reduced-intensity6 (33,3%) 12 (66.7%)Stem cell sourceBone marrow Peripheral blood4 (22.2%) 14 (77.8%)GVHD prophylaxisCsA+MTXCsA+CSCsA+MMF10 (55.6%) 3 (16.7%) 5 (27.8%)InfectionsYes No16 (88.9%) 2 (11.1%)MucositisYes No12 (66.7%) 6 (33.3%)Acute GVHDYes II-IV III-IV No4 (22.3%) 3 (16.7%) 1 (5.6%) 14 (77.8%)Chronic GVHDNo Limited Extensive8 (44.3%) 5 (27.8%) 5 (27.8%) Results: Transplant related mortality (TRM) before day 100th was one case due to a thromboembolic event. Global TRM was 16.6% (3 cases). The incidence of acute graft versus host disease (aGVHD) was 22%, controlled on most cases when corticosteroids were initiated. More than half of the patients developed chronic graft versus host disease (cGVHD), with an equal distribution on either presentation as limited or extensive. (Table 2) The total number of patients eligible for analysis was 17 (one patient was lost on follow-up). With a median follow up of 11 years, the overall survival (OS) was of 8.06 years [IC 95% 4,33-11,78] (figure 1.) and the estimated progression free survival (PFS) was of 25.83 months [IC 95% 8.87-42.79](figure 2). A total of 5 (29,4%) patients are still alive and 2 (11,7%) of them are in complete remission, of these 1 patient did not have a previous autoHSCT with a follow up of almost 15 years. Conclusions: Our results are similar to those reflected on the literature1-2. However we have to point out that our population is homogenous with advanced MM with more than 3 previous lines of treatment including in most cases auto-HSCT. In spite of this, morbility and mortality in our cohort was acceptable with the limitation of a high rate of cGVHD. There is a need of more studies including more patients to evaluate the role of alloHSCT in the era of new drugs for MM. References 1. Rosi-ol L et al. Allogeneic hematopoietic SCT in multiple myeloma: long-term results from a single institution. Bone Marrow Transplant. 2015. 2. Beaussant Y et al. Hematopoietic Stem Cell Transplantation in Multiple Myeloma: A Retrospective Study of the Société Française de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC). Biol Blood Marrow Transplant. 2015 Disclosures Alegre: Celgene Corporation: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees.

Evaluating results from the multiple myeloma subset of patients treated with denosumab or zoledronic acid (ZA) in a randomized phase III study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8589-8589 ◽  
Author(s):  
Noopur S. Raje ◽  
Wolfgang Willenbacher ◽  
Vania Hungria ◽  
Andrew Spencer ◽  
Yulia Alexeeva ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Multiple Myeloma ◽  
Stem Cell ◽  
Solid Tumors ◽  
Primary Endpoint ◽  
Stem Cell Transplant ◽  
Phase Iii ◽  
Cell Transplant ◽  
Phase 3

8589 Background: Denosumab (dmab) is a fully human monoclonal antibody against RANKL and is superior to ZA in preventing skeletal-related events (SREs) as shown in 3 identically designed phase 3 trials (N=5723). Overall survival (OS) was balanced between treatment groups in the overall study populations of these trials. In the trial of patients (pts) with solid tumors (excluding breast and prostate) and multiple myeloma (MM), OS was longer for dmab pts with lung cancer, shorter for pts with MM, and balanced for pts with other solid tumors. This analysis further characterizes the results from the MM subset of this trial. Methods: Pts with solid tumors or MM were randomized (1:1) to receive 120 mg of SC dmab or 4 mg of IV ZA Q4W. Daily calcium and vit D supplements were strongly recommended. The primary endpoint was the time to first on-study SRE; results from the primary endpoint and lung cancer subset were previously reported. Results: Of 1776 randomized pts, 10% had MM (93 ZA, 87 dmab). OS favored ZA (hazard ratio: 2.26; 10 subject difference in deaths). 1-year OS was 83% dmab, 97% ZA. Imbalances in baseline prognostic characteristics were observed. More pts in the dmab arm had low baseline renal function (CrCl < 40 mL/min) (ZA 2 [2%], dmab 9 [10%]) and more ZA pts underwent stem cell transplant (ZA 23 [25%], dmab 15 [17%]). Additionally, more ZA pts had stage I tumors at diagnosis (ZA 13 [14%], dmab 9 [10%]) and better performance status (ECOG = 0; ZA 30 [32%], dmab 21 [24%]). Study discontinuations due to consent withdrawal or lost to follow-up were also higher in the ZA group (ZA 17 [18%], dmab 11 [13%]) and occurred earlier in the ZA arm (ZA 59%, dmab 45% within 9 months of randomization). Conclusions: In this SRE study of dmab vs ZA, pts were stratified by baseline characteristics known to affect SRE outcomes, but not by prognostic factors or concurrent anticancer therapy that may impact survival in MM. OS results in the MM cohort are difficult to interpret due to small sample size and imbalances in baseline disease characteristics, stem cell transplant therapy, and consent withdrawal or loss of follow-up that favored ZA. A phase 3 trial is currently underway, which controls for these factors in pts with MM. Clinical trial information: NCT00330759.

Rituximab Administration Following Autologous Stem Cell Transplant for Multiple Myeloma Is Associated with Severe IgM Deficiency.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4897-4897
Author(s):  
Seah H. Lim ◽  
Yana Zhang ◽  
Zhiqing Wang ◽  
Rupa Varadarajan ◽  
Phillip O. Periman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
B Cells ◽  
Stem Cell Transplant ◽  
Autologous Stem Cell Transplant ◽  
Control Group ◽  
Cell Transplant ◽  
Increased Risk ◽  
Igm Deficiency

Abstract Clonotypic B cells are frequently isolated from the peripheral blood of patients with multiple myeloma (MM). These clonotypic B cells may be clonogenic cells of MM. We hypothesized that rituximab may be a useful maintenance therapy in MM after autologous stem cell transplant (ASCT). The rationale was that CD20 antibody would deplete the clonotypic and, hence, clonogenic B cells to reduce the risk of disease relapse. ASC were mobilized with Cytoxan (3g/m2) and G-CSF from patients with MM. Two weeks after ASC collection, high dose IV melphalan (200 mg/m2) was administered followed 24 hours later by the infusion of at least 2x106/kg CD34+ cryopreserved ASC. Rituximab infusion (375 mg/m2) was started on day +30. Each patient received one antibody infusion every 3 months for 2 years or until disease progressed. All patients continued on monthly zoledronate and did not receive any other antimyeloma treatment. A total of 10 patients have been treated. Seven patients who have had post-transplant follow-up periods of &gt;12 months were evaluated. The immunoglobulin recovery and incidence of infections in this group of patients were compared to 6 patients with MM who have undergone an ASCT without rituximab maintenance. The total normal IgM level in all 7 patients was severely depressed following rituximab administration. IgG and IgA were variably affected in these patients. The IgM immunosuppression was prolonged and consistent, being seen in all patients, regardless of the disease status after transplantation. In contrast, the control group showed normalization of the total IgM levels by 3 months after transplant. Two patients treated with rituximab received pneumococcal vaccines 12 months after transplant and neither developed any IgG response to the vaccines. The data indicate that rituximab infusion following ASCT for MM severely impaired B-cell immune reconstitution. Six of the 7 patients developed moderate to severe infections during the first 12 months after initiation of rituximab infusion. There were a total of 23 episodes of infections: 21 pneumonia and 2 septicemia (one pneumococcus and one Pseudomonas). A patient died in CR due to pneumonia. In contrast, only one episode of pneumonia was observed in the control group during the same follow-up period. Therefore, the IgM deficiency probably predisposed the patients to infection. Of the 7 patients who have had more than 12 months of follow-up periods, 4 had disease refractory to standard induction chemotherapy. Of all the 10 patients treated, 6 achieved CR (2 were in CR before treatment, 2 achieved CR 3 months and 2 achieved CR 6 months after starting rituximab). All 4 patients with refractory MM (all had a follow-up of more than 12 months) achieved CR, one before and 3 after starting rituximab. One of the refractory patients has since relapsed, one died of pneumonia in CR 12 months and the other 2 have remained in CR 12+ and 18+ months after ASCT. With a follow-up of 29 months after transplant, the progression-free survival was 56.5% and the overall survival 71.4%. Rituximab infusion after ASCT for MM is therefore associated with severe IgM deficiency and an increased risk of infection. Further works are needed to determine the antitumor activities of rituximab in MM in the setting of minimal residual disease, but this should only be carried out with special attention to the prevention of infection.

scholarly journals Racial and Socioeconomic Disparities in the Utilization of Autologous Stem Cell Transplant for Treatment of Multiple Myeloma in the Era of Novel Agents

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 423-423 ◽  
Author(s):  
Victoria A. Vardell ◽  
Daniel Ermann ◽  
Maryam Gbadamosi-Akindele ◽  
Funmi Badejo ◽  
Peter T. Silberstein ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplant ◽  
Private Insurance ◽  
Autologous Stem Cell Transplant ◽  
Rate Of Change ◽  
Socioeconomic Disparities ◽  
Novel Agents ◽  
Cell Transplant ◽  
To Receive

INTRODUCTION: The prognosis of multiple myeloma (MM) has improved drastically in the last 20 years with the advent of novel agents, specifically with the introduction of bortezomib in late 2003. Novel agents in combination with autologous stem cell transplant (ASCT), have led to the achievement of high response rates in many patients. ASCT is now considered standard of care for all eligible patients, and previous studies have found increasing rates of ASCT in all age groups since the introduction of novel agents. Studies have also revealed disparities with decreased ASCT utilization in racial and socioeconomic minorities. This study utilizes the National Cancer Database (NCDB) to determine how the use of ASCT has changed for MM in the bortezomib era. METHODS:The NCDB was used to identify 157,443 patients diagnosed between 2004-2016 with Multiple Myeloma. Only patients with information on ASCT were included, and demographic characteristics between those patients that received and did not receive ASCT were compared. Race, insurance type, facility type, average income, education, and Charleson-Deyo comorbidity score, among other factors, were included in this analysis (Table 1). To determine the trends in ASCT over the era of novel agents, the proportion of patients receiving ASCT within these groups was trended over each year, and linear models to determine the rate of change in each group was compared. Bivariate and Multivariate regression analysis for each characteristic was used to determines odds ratios (OR) for receiving ASCT by demographic factors. RESULTS: Between 2004 to 2016 the proportion of all patients receiving ASCT as part of initial therapy more than doubled from 10.1% to 22.0%; increasing by approximately 1.06% per year on a linear regression model (R20.98) (Table 2). The greatest proportional increases were seen in Blacks, Hispanics, patients over 65 years of age, patients with higher comorbidity scores, Medicare, and patients treated at community centers. On multivariate analysis the patients that were most likely to receive ASCT (p&lt;0.05) had private insurance (OR 5.4), were treated at academic centers (OR 7.3) and were highly educated (OR 1.7) (Table 3). For each increased year of diagnosis patients were significantly more likely (OR 1.1) to receive ASCT. Patients with a decreased chance of receiving transplant (p&lt;0.05) were black (OR 0.6) or other non-white race (OR 0.7), Hispanic (OR 0.8), or had increased comorbidities (OR 0.4 for Charleson-Deyo score of 3 or greater). For every year of increased age, the likelihood of ASCT decreased (OR 0.92) (Table 3). DISCUSSION: In the era of novel agents, the rate of ASCT has rapidly increased each year, with the greatest increases seen in elderly patients, those with higher comorbidity indexes, and in patients who are racially and socioeconomically disadvantaged. However, significant racial and socioeconomic disparities still exist in the treatment of MM, and must be considered as treatment continues to advance. Disclosures No relevant conflicts of interest to declare.

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