Impact of FDA approval of lenalidomide maintenance therapy in the first-line treatment of multiple myeloma after autologous stem cell transplant on total healthcare costs.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19509-e19509 ◽  
Author(s):  
Jipan Xie ◽  
Kejal Parikh ◽  
Christina Chen ◽  
Chelsey Yang ◽  
Adina Farrukh ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Maintenance Therapy ◽  
Healthcare Costs ◽  
Stem Cell Transplant ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Line Treatment ◽  
First Line ◽  
Fda Approval ◽  
First Line Treatment

e19509 Background: Lenalidomide maintenance therapy after autologous stem cell transplant (ASCT) in the first-line treatment has been shown to improve progression-free survival (PFS) and overall survival (OS) in multiple myeloma (MM) patients (pts). This study assessed the impact of FDA approval of lenalidomide maintenance therapy on total healthcare costs of a US health plan. Methods: A model was developed to estimate the incremental (additional) total plan costs (in 2016 USD) for maintenance therapy in each year for the first 3 years after lenalidomide monotherapy (R) maintenance therapy approval. The number of post-ASCT adult MM pts eligible for initiating maintenance therapy was estimated from published epidemiological data and an analysis of Connect MM Registry data. Clinical endpoints for R-maintenance, including time on treatment, PFS and OS, were obtained from a meta-analysis of published clinical trials (CALGB, IFM, and GIMEMA). The use of common off-label maintenance therapies was considered. Types of costs included in the model were drug, drug administration, adverse events (AE), AE monitoring, one-time progression and terminal care costs. Results: In a hypothetical health plan with 1 million members, the number of adult MM pts eligible to initiate post-ASCT maintenance therapy was estimated to be 28. Among them, 14.8 pts initiated R-maintenance in Year 1, 15.2 in Year 2, and 15.3 in Year 3, representing an incremental increase of 2.9%, 4.2% and 4.4% after R-maintenance therapy approval, respectively. After considering additional costs of maintenance, as well as potential offsets resulting from delayed progression the incremental total healthcare costs by year are listed in the table. Conclusions: Approval of lenalidomide monotherapy for maintenance after ASCT in the first-line treatment of MM has minimal impact on total plan costs, primarily due to the small incident population and the already common use of lenalidomide in post-ASCT maintenance. [Table: see text]

scholarly journals FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

2018 ◽  
Vol 23 (6) ◽  
pp. 734-739 ◽  
Author(s):  
Elizabeth Dianne Pulte ◽  
Andrew Dmytrijuk ◽  
Lei Nie ◽  
Kirsten B. Goldberg ◽  
Amy E. McKee ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Maintenance Therapy ◽  
Stem Cell Transplant ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Newly Diagnosed ◽  
Fda Approval

Single Centre Analysis Of Autologous Stem Cell Transplant Outcomes In Multiple Myeloma In 338 Consecutive Patients: Maintenance/Consolidation Is Associated With Superior Survival, But Early Relapse Is The Single Most Important Predictor Of Survival and May Override Genetic Risk

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2159-2159
Author(s):  
Paul M Maciocia ◽  
Nicholas Counsell ◽  
Antonia Bird ◽  
Laura Percy ◽  
Sally Moore ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell Transplant ◽  
Autologous Stem Cell Transplant ◽  
Important Predictor ◽  
Novel Agents ◽  
Cell Transplant ◽  
Consolidation Therapy ◽  
First Line ◽  
Disease Response ◽  
Early Relapse

Abstract Introduction High dose therapy with autologous stem cell transplant (ASCT) represents the standard of care for untreated patients with multiple myeloma (MM) who are young and fit. Novel agents are changing the landscape of pre- and post-ASCT therapies, but benefits may not apply to all patients. We report 338 MM patients treated with up-front ASCT at University College Hospital London from September 1993 - December 2010. Results Patient characteristics are described in Table 1. 90 (27%) received novel agents (thalidomide, bortezomib or lenalidomide) prior to transplant, and the remainder had VAD (vincristine, doxorubicin, dexamethasone)-based regimens. Most patients (64%) had 1 line of therapy prior to ASCT, 26% had 2 lines and 11% >/=3 lines. Responses to first line therapy were 24% >/= VGPR, 45% PR, ORR 69%. Best response prior to ASCT was: 27% >/= VGPR, 59% PR, ORR of 86%. 42 patients (12%) had stable disease or worse pre-ASCT. Transplant-related mortality at 100 days was 3.3%, 166 patients (49%) attained >/= VGPR at 3 months and 126 (37%) PR. Maintenance/consolidation regimens were interferon or thalidomide-based. Median follow-up was 6.1 yrs, progression-free survival (PFS) 2.0 yrs and overall survival was (OS) 5.8 yrs from ASCT and 6.8 yrs from diagnosis. 266 patients have relapsed, and 169 have died. On multivariate analysis, international staging system (ISS) stage 1, female gender, use of novel agents first-line and disease response (>/=VGPR pre- and 3 months post-ASCT) predicted longer PFS (p's < 0.05). Timing of relapse was the most important predictor of survival (median OS 1.6yrs if relapse within 12 months vs 7.2yrs if not, HR = 6.7, p<0.001. Shorter OS was also associated with male gender, advanced ISS, non-IgG isotype, CD56-negativity, older age at ASCT, <PR post ASCT (p's < 0.05) and later year of ASCT (median OS 6.2 yrs 2005-10 v 4.9 yrs 1993-2004, HR = 0.8, p = 0.006). Use of novel agents at first line predicted longer OS on univariate but not multivariate analysis. Prior lines of therapy and time from diagnosis to ASCT did not impact PFS or OS. Post-ASCT maintenance/ consolidation therapy was associated with prolonged PFS (adj HR 0.6, [95% CI 0.4-0.8] and OS (adj HR 0.5 [0.3-0.7]. Adverse cytogenetics (CGN) was associated with reduced PFS (HR 1.7 [1.1 – 2.7]) and OS (HR 2.2 [1.2-4.0]). In patients with adverse CGN who did not relapse early, OS was similar to patients with standard risk CGN (OS 5.6 yrs v 7.2 yrs, p = NS, Fig 1). Outcomes for those relapsing early were similar in pre-2005 and later (>/= 2005) cohorts (OS 1.6 v 1.7 yrs, p = NS, Fig 2). Median post-relapse survival (PRS) was 2.6 yrs. Factors predicting longer PRS included IgG isotype, CD56-positivity, later year of ASCT and of relapse, younger age at ASCT, longer PFS from ASCT and the use of novel agents at relapse. Patients relapsing in 2005 and later had longer PRS (3.6 v 1.3 yrs, HR = 0.4, p = 0.0001). Prior treatment with maintenance/consolidation did not impact PRS (PRS 3.1 v 2.4 yrs, p = NS). Conclusions These data indicate that post-ASCT strategies and choice of agent at relapse may be as important determinants of outcome as disease response pre-ASCT. Early relapse was the most important predictor of death following ASCT and may outweigh the impact of adverse CGN. The adverse outcome of patients relapsing early is not salvaged using contemporary treatment strategies at relapse. The benefit of CD56 expression on OS, but not on PFS suggests this denotes disease that remains chemo-responsive disease through relapses. Maintenance or consolidation therapy following ASCT appears to prolong PFS and OS without impacting post-relapse survival. Disclosures: No relevant conflicts of interest to declare.

Sufficient and Timely Autologous Stem Cell Harvest After Chemoimmunotherapy with Alemtuzumab In Combination with Bi-Weekly CHOP as First Line Treatment In Systemic Peripheral T-Cell Lymphomas (PTCL): a Feasibility Analysis From the First Randomized Trial In Systemic PTCL (ACT trial)

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2395-2395
Author(s):  
Francesco d'Amore ◽  
Maria Gomes da Silva ◽  
Sirpa Leppa ◽  
Antonio Pezzutto ◽  
Thomas Relander ◽  
...  
Keyword(s):  
Body Weight ◽  
Stem Cell ◽  
T Cell ◽  
Stem Cell Transplant ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
First Line ◽  
Cd34 Cells ◽  
Cell Harvest ◽  
First Line Treatment

Abstract Abstract 2395 While already tested in T-PLL, the impact of chemo-immunotherapy with alemtuzumab in combination with bi-weekly CHOP on autologous stem cell harvest (ASCH) has not yet been analysed in the context of first line treatment of primary systemic peripheral T-cell lymphoma (PTCL). We therefore evaluated the feasibility of ASCH in the first 23 patients of the ongoing international multicenter ACT-1 study, the first, and so far only, randomized trial in primary systemic PTCL. The ACT trials (ACT-1 + ACT-2) test the addition of alemtuzumab to CHOP followed, in younger patients (ACT-1), by high-dose therapy with autologous stem cell transplant (HDT+ASCT). The aims of the analysis were: (i) feasibility of ASCH in alemtuzumab + CHOP (A-CHOP) treated patients as compared to patients not receiving the antibody, but otherwise treated and managed in the same way, and (ii) comparison of ASCH counts in the two treatment arms. By July 2010, 20 patients, 11 in the standard treatment (arm A) and 9 in the experimental treatment (arm B) cohort, had undergone induction therapy and had been primed for subsequent ASCH according to local guidelines. Histological subtype distribution in the two treatment groups showed: PTCL not otherwise specified N=4 (arm A) and N=5 (arm B), angioimmunoblastic N=5 (arm A) and N=4 (arm B), extranodal NK/T-cell, nasal type N=1 (arm A), hepatosplenic N=1 (arm A). Pre-therapeutic evidence of bone marrow involvement was present in 4 (arm A) and 2 (arm B) patients, respectively. Of the original 23 patients, three did not undergo stem-cell harvest due to progressive disease (1 pt), patient's decision (1 pt), and pre-therapeutic CNS involvement (1 pt). Among the 20 harvested patients, ASCH failure was experienced in three patients (standard arm N=1 and experimental arm N=2; p=0.57). In two patients (one in each treatment cohort) a suboptimal stem cell yield could be optimized by the use of plerixafor according to local guidelines. A comparison of stem cell counts (CD34+ cells × 106/kg body weight) from the two treatment cohorts showed a trend towards moderately lower stem cell yields in alemtuzumab-treated patients (3.34 CD34+ cells × 106/kg body weight in arm B vs 6.54 CD34+ cells × 106/kg body weight in arm A, p=0.03). In conclusion, the addition of alemtuzumab to bi-weekly CHOP in the setting of first-line therapy of primary systemic PTCL does not significantly impair ASCH prior to upfront autologous stem cell transplant. Disclosures: No relevant conflicts of interest to declare.

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