scholarly journals Burden of Treatment-Induced Peripheral Neuropathy in Patients with Multiple Myeloma in Sweden

2021 ◽  
pp. 1-9
Author(s):  
Hareth Nahi ◽  
Göran Walinder ◽  
Vishal Patel ◽  
Ying Qu ◽  
Aaron Levine ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Peripheral Neuropathy ◽  
Healthcare Resource Utilization ◽  
Line Treatment ◽  
Swedish Cancer Registry ◽  
Treatment Objective ◽  
Baseline Characteristics ◽  
Mean Differences ◽  
Line Of Therapy

Introduction: Treatment-induced peripheral neuropathy (TIPN) is a complication of multiple myeloma (MM) treatment. Objective: This real-world, retrospective study used electronic medical record (EMR) data from 3 Swedish clinics to assess the occurrence and economic burden of TIPN in patients with MM. Methods: Eligible patients had an MM diagnosis in the Swedish Cancer Registry between 2006 and 2015 and initiated treatment during that period. Follow-up was until last EMR visit, death, or study end (April 2017). The current analyses included patients receiving bortezomib, lenalidomide, carfilzomib, or thalidomide at any treatment line. To discern healthcare resource utilization (HCRU) and costs associated with TIPN from other causes, patients with TIPN were matched with those without on baseline characteristics, treatment, and line of therapy. All analyses were descriptive. Results: Overall, 457 patients were included; 102 (22%) experienced TIPN. Patients experiencing TIPN during first-line treatment mostly received bortezomib-based regimens (n = 48/57 [84%]); those with TIPN during second- and third/fourth-line treatment mostly received lenalidomide/thalidomide-based regimens (19/31 [61%], 8/14 [57%], respectively). Patients with TIPN had higher HCRU/costs than those without TIPN (mean differences in hospital outpatient visits: 5.2, p = 0.0031; total costs per patient-year: EUR 17,183, p = 0.0007). Conclusions: Effective MM treatments associated with a reduced incidence of TIPN could result in decreased healthcare expenditure.

scholarly journals Real-world treatment patterns, healthcare use and costs in triple-class exposed relapsed and refractory multiple myeloma patients in the United States

2020 ◽  
Author(s):  
Deepu Madduri ◽  
May Hagiwara ◽  
Kejal Parikh ◽  
Corey Pelletier ◽  
Thomas E Delea ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Median Time ◽  
Proteasome Inhibitors ◽  
The United States ◽  
Healthcare Resource Utilization ◽  
Treatment Patterns ◽  
Refractory Multiple Myeloma ◽  
Kaplan Meier ◽  
Line Of Therapy

Aim: To estimate treatment patterns and healthcare costs among triple-class exposed relapsed and refractory multiple myeloma (RRMM) patients. Materials & methods: Eligible patients had ≥1 line of therapy (LOT) each of proteasome inhibitors, immunomodulatory drugs and daratumumab in December 2015–September 2018 and received a new LOT. Results: A total of 154 patients were included with a median follow-up of 6.2 months. Median time from diagnosis to new LOT was 41.0 months. Kaplan–Meier estimate of median time to therapy discontinuation was 4.2 months. Mean per-patient, per-month MM-related costs were 35,657 US dollars. Most frequently observed regimens were lenalidomide or pomalidomide + daratumumab (18.2%), lenalidomide or pomalidomide + proteasome inhibitors (15.6%) and lenalidomide or pomalidomide monotherapy (11.0%). Conclusion: Triple-class exposed RRMM patients receive heterogeneous treatments for a short duration with high healthcare resource utilization and costs.

Evolving Unmet Need in Patients Refractory to Lenalidomide: Overview of the Clinical Trials in Relapsed/Refractory Multiple Myeloma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 22-23
Author(s):  
Maria-Victoria Mateos ◽  
Rohan Medhekar ◽  
Istvan Majer ◽  
Mehmet Turgut
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Literature Review ◽  
Board Of Directors ◽  
Unmet Need ◽  
Publicly Traded ◽  
First Line ◽  
Advisory Committees ◽  
Line Of Therapy

Introduction: The majority of newly diagnosed multiple myeloma (NDMM) patients are currently treated with lenalidomide-based regimens as their first line of therapy. This trend is likely to continue in the coming years. Typically, lenalidomide is administered until disease progression and has significantly contributed to better outcomes in these patients. However, most patients relapse, and prognosis worsens with each relapse. The choice of optimal treatment for patients who relapse while receiving lenalidomide as first line of therapy is unclear. Moreau et al (Blood Cancer J. 9, 38 [2019]) concluded that there is limited data on approved combinations for treating these patients and are restricted by the low number of lenalidomide-refractory patients enrolled in the pivotal trials. Results from the ongoing clinical trials of the combination of carfilzomib and anti-CD38 antibodies were not available at the time of the Moreau et al publication. The aim of this targeted literature review was to include this new data and to summarize currently available evidence on progression-free survival (PFS) for the treatment of RRMM patients who progressed on lenalidomide-based regimens. Methods: A targeted literature review was conducted to identify registrational clinical trials in patients with RRMM reporting PFS outcomes. PubMed, congress proceedings, and product labels were searched between Jan 2014 to July 2020. In addition to PFS, demographic, disease characteristics and treatment history were extracted for the trial populations to contextualize potential variations in study outcomes. The regimens studied in these trials were classified as lenalidomide-based, proteasome inhibitor (PI)-based and pomalidomide-based. Number of prior lines of therapy, prior exposure and refractoriness to lenalidomide and bortezomib were reported. Results: Twelve registrational trials were identified based on the search criteria (Table 1). Most pivotal trials assessing lenalidomide-based regimens (POLLUX, ELOQUENT-II, TOURMALINE-MM1) except the ASPIRE trial excluded patients who were refractory to lenalidomide. Trials evaluating PI-based regimens (e.g., CANDOR) or pomalidomide-based regimens (e.g., OPTIMISMM) included these patients, with more recent studies enrolling a larger proportion. Percentage of lenalidomide-exposed (and lenalidomide refractory) ranged from 40% (32%) in CANDOR to 98% (90%) in ELOQUENT III. These studies also enrolled a larger proportion of patients who were bortezomib-exposed, although most of these patients were at first relapse, with the exception of ELOQUENT III and ICARIA where most patients were at third relapse. Among lenalidomide-refractory patients, the median-PFS (mPFS) observed for the pomalidomide-based regimens ranged from 9.5 to 10.1 months and that observed for PI-based regimens ranged from 4.9 to 25.7 months. PFS in the lenalidomide-refractory subgroup was considerably shorter than in the ITT population. The mPFS for patients receiving carfilzomib/daratumumab/dexamethasone (KDd; CANDOR) and isatuximab/carfilzomib/dexamethasone (IsaKd; IKEMA) was not reached at median follow-up of 16.9 and 20.7 months respectively. While the mPFS for (KDd) for lenalidomide-refractory patients in CANDOR trial was not yet reached at median follow up of 16.9 months; the mPFS of 25.7 months for KDd in the MMY-1001 trial appears to be the longest among the assessed regimens. Conclusion: Patients refractory to lenalidomide have shorter PFS and represent a population with high unmet need. This targeted literature review suggests that the PI-based KDd regimen provides longer PFS compared to other lenalidomide-sparing regimens in lenalidomide-refractory populations. Heterogeneity across trial populations may limit the comparability of these treatments. Disclosures Mateos: Regeneron: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Consultancy, Honoraria; Adaptive Biotechnologies: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie/Genentech: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; PharmaMar-Zeltia: Consultancy; GlaxoSmithKline: Consultancy. Medhekar:Amgen Inc.: Current Employment, Current equity holder in publicly-traded company. Majer:Amgen (Europe) GmbH: Current Employment, Current equity holder in publicly-traded company.

scholarly journals Bortezomib, doxorubicin and dexamethasone (PAD) front-line treatment of multiple myeloma: updated results after long-term follow-up

2008 ◽  
Vol 141 (4) ◽  
pp. 512-516 ◽  
Author(s):  
Rakesh Popat ◽  
Heather E. Oakervee ◽  
Simon Hallam ◽  
Nicola Curry ◽  
Liz Odeh ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Line Treatment ◽  
Front Line ◽  
Long Term Follow Up

Healthcare Resource Utilization and Sickness Absence in Newly Diagnosed Multiple Myeloma Patients in Sweden: Trends in a Changing Treatment Landscape

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 17-18
Author(s):  
Fredrik Borgsten ◽  
Xenia Gatopoulou ◽  
Marta Pisini ◽  
Magnus Tambour ◽  
Frida Schain ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Sickness Absence ◽  
Healthcare Resource ◽  
Productivity Loss ◽  
Healthcare Resource Utilization ◽  
Publicly Traded ◽  
The Third ◽  
The Past ◽  
Over Time

Background In the last decades the introduction of novel drugs has greatly improved the prognosis of multiple myeloma (MM) patients. We have investigated healthcare resource utilization and sickness absence-associated productivity loss over time in a population-wide, retrospective registry study in Sweden. Methods 8,693 patients were identified in the National Cancer Register with a MM diagnosis from July 2001 to December 2015 and followed until 2016. Specialized healthcare usage (inpatient admissions and outpatient visits) were obtained from the Patient Register and costs were estimated by weighted DRG codes. For patients under 66 years of age, sickness absence and salary information were obtained by linkage to the LISA Register. Analyses were performed separately on patients who underwent autologous stem cell transplantation (ASCT) (n=1,425) and on non-transplanted patients (n=7,012) and stratified by diagnosis periods 2001-2005, 2006-2010 and 2011-2015 to reflect increased introduction of effective drugs into clinical care. Median age was 60 years in the ASCT group and 75 years in the non-ASCT group. Results The number of MM patients that underwent ASCT increased over time (n= 282 in 2001-2006 to n= 592 in 2011-2015). MM patients diagnosed most recently had improved overall survival (OS), with five-year OS rate increasing from 52% to 58% to 62% for patients diagnosed in 2001-2005, 2006-2010 and 2011-2015, respectively (p<0.0001). Patients diagnosed during 2011-2015 spent on average 20% and 9% less total time in specialized healthcare than patients diagnosed during 2001-2005 and 2006-2010, respectively (adjusting for sex, age at ASCT, weighted comorbidity score at ASCT and per follow-up year and education at ASCT). This decrease was driven by less usage and time in both inpatient and outpatient care. Adjusted sickness absence time decreased by 41% and 38% in the third follow-up year for patients diagnosed during 2011-2015 compared to patients diagnosed during 2001-2005 and 2006-2010, respectively. Productivity loss costs represented about 45% of total costs (healthcare resource costs ~55%) in the first two follow-up years, but decreased over time. The cumulative median per person cost (healthcare- and productivity-related) over the three follow-up years post-diagnosis decreased by 21% in 2011-2015 (€52,273) compared to 2001-2005 (€66,182), despite an 8% increase in three-year OS over the same period. The number of non-ASCT MM patients also increased over time (n=2,053 in 2001-2005 to n= 2,587 in 2011-2015). Median survival increased from 2.5 years to 3.4 years for patients diagnosed during 2001-2005 compared to 2011-2015. Average total time spent in specialized healthcare was reduced by 29% and 12% for patients diagnosed during 2011-2015, compared to patients diagnosed during 2001-2005 and 2006-2010, respectively (adjusting for sex, age at diagnosis, weighted CCS at diagnosis, weighted CCS per follow-up year and education at diagnosis). This was associated with decreased need for inpatient care and a shift towards more outpatient usage. By the third follow-up year, the adjusted sickness absence time in patients diagnosed during 2011-2015 was reduced by 44% and 23% compared to patients diagnosed in 2001-2005 and 2006-2010, respectively. Productivity loss accounted for approximately 15% of total costs (healthcare resource costs ~85%) and was stable over follow-up years. The cumulative median per-person cost (healthcare- and productivity-related) over three follow-up years was similar for patients diagnosed in 2001-2005 (€25,621) and 2011-2015 (€26,592), despite a 12% increase in three-year OS over the same period. Conclusion The availability of new treatment options for MM patients in Sweden over time was associated with less healthcare usage, less time spent in healthcare and lower productivity loss due to sickness absence for both ASCT and non-ASCT-treated patients. These improved clinical and economic outcomes provide policy makers, healthcare providers and physicians with invaluable real-world insights for cost-benefit considerations in the continued development and introduction of effective treatments for MM. Figure 1 Disclosures Borgsten: Janssen: Current Employment. Gatopoulou:Janssen: Current Employment. Pisini:Janssen: Current Employment. Tambour:Janssen: Current Employment, Current equity holder in publicly-traded company. Schain:Schain Research: Current Employment, Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Divested equity in a private or publicly-traded company in the past 24 months, Ended employment in the past 24 months. Jones:Schain Research: Current Employment. Kwok:Schain Research: Other: Internship . Hjortsberg:Janssen: Current Employment.

scholarly journals Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study

Leukemia ◽  
2020 ◽  
Vol 34 (7) ◽  
pp. 1875-1884 ◽  
Author(s):  
Nizar J. Bahlis ◽  
Meletios A. Dimopoulos ◽  
Darrell J. White ◽  
Lotfi Benboubker ◽  
Gordon Cook ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Residual Disease ◽  
Progression Free Survival ◽  
Complete Response ◽  
Open Label ◽  
Refractory Multiple Myeloma ◽  
Open Label Phase ◽  
Intent To Treat ◽  
Line Of Therapy

Abstract In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1–21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35–0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10–5; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31–0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42–0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.

Lenalidomide Therapy Is Associated with Improvement of Peripheral Neuropathy in Patient with Relapsed/Refractory Multiple Myeloma: Preliminary Results From a Single-Centre Prospective Non Interventional Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4949-4949
Author(s):  
Renato Zambello ◽  
Tamara Berno ◽  
Laura Candiotto ◽  
Chiara Dalla Torre ◽  
Marta Campagnolo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Peripheral Neuropathy ◽  
Prospective Study ◽  
Eastern Cooperative Oncology Group ◽  
Single Centre ◽  
Preliminary Results ◽  
Neurological Evaluation ◽  
Neurophysiological Studies ◽  
Previously Treated

Abstract Abstract 4949 In recent years, proteasome inhibitors and immunomodulatory drugs (IMIDs) have provided invaluable advantage in the therapy of multiple myeloma (MM) in terms of disease free survival and often overall survival. However the benefits have sometimes been blunted by the occurrence of adverse effects which strongly impact quality of life. Among them, peripheral neuropathy (PN) represents one of the most disabling and often dose-limiting side effect. Lenalidomide, a second generation IMID and a structural analogue of thalidomide, has been claimed to have low toxicity on peripheral nervous system. In a single-centre prospective study we evaluated the natural history of chemotherapy-induced PN in consecutive patients previously treated with bortezomib and/or thalidomide, who shifted to lenalidomide for relapsed or refractory MM. The aim was to evaluate the clinical course of PN during lenalidomide therapy. Patients and methods 34 consecutive patients previously treated with bortezomib and/or thalidomide were treated with lenalidomide (25 mg daily for 21 day cycle) alone or associated with low dose dexametasone for relapsed/refractory MM. Patients previously treated with bortezomib and/or thalidomide, who developed a chemotherapy-induced PN and whose MM was still in remission, were used as control. Neurological evaluation was planned at baseline, after 6 and 12 months from the beginning of lenalidomide therapy. Patients were assessed with the Total Neuropathy Score clinical version (TNSc), which has been previously validated against the most common neurotoxicity scales used by oncologists (NCI-CTC 2.0, ECOG); pain was assessed with the visual analogue score (VAS). The Eastern Cooperative Oncology Group (ECOG) performance status was also assessed. Nerve conduction studies were performed at the beginning of the treatment and regularly during follow up. Lack of chemotherapy-induced PN at baseline was not an exclusion criteria, as well as progression of myeloma during lenalidomide treatment. Results Of the 34 patient in lenalidomide therapy, sixteen (mean age 66 yrs ± 8) were available for evaluation with at least six months follow up. Fourteen patients presented chemotherapy-induced PN at baseline, confirmed also by neurophysiological studies. Two patients had no PN at baseline (TNSc: 0) despite previous exposure to bortezomib in one case, and bortezomib and thalidomide in the other case. The majority of evaluable patients (75%) had a TNSc >2 at baseline (median = 6.7, SD ±3.6, range 3-15). Two patients had a baseline TNSc ' 2 (median 1,5). After 6 months of follow up, hematological response was documented in 14 patients (4 patients were in VGPR, 10 in PR) whereas 2 patients were in progression after initial response. Neurological evaluation after 6 months revealed improvement or stability of symptoms and neurological scale in 12 out of 14 patients (TNSc 5.5, SD ±3.9 at baseline vs 3.8, SD ±2.2 post 6 months therapy, respectively). The improvement of symptoms was generally more evident in those patients with the highest baseline TNSc. One patient with bortezomib and thalidomide-induced PN, while presenting a subjective and neurophysiologic improvement, had a worse TNSc score due only to a worse vibration sensibility score alone. However, this patient was also on antituberculosis treatment with isoniazid, which is known to be neurotoxic. Two patients without PN at baseline, still remained with score 0 at 6 months follow up. As expected, clinical improvement not always correlated with electrophysiological improvement. In two cases evaluation at one year was possible, and data showed a continuous improvement of PN. Conclusions Using validated clinical and instrumental tools, the preliminary results of our prospective study suggest that during lenalidomide therapy PN improves, regardless of myeloma response. Updated results of the study will be presented at the meeting. The results of the on-going follow up study on a wider population of patients will help confirm these data and define appropriate timing for the detection of electrophysiological improvement. Disclosures No relevant conflicts of interest to declare.

Healthcare Resource Utilization Trends over Time with Continuous Lenalidomide Treatment (Tx) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1326-1326
Author(s):  
Katja Weisel ◽  
Dan T. Vogl ◽  
Michel Delforge ◽  
Kevin Song ◽  
Meletios Dimopoulos ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Resource Utilization ◽  
Research Funding ◽  
Healthcare Resource ◽  
Healthcare Resource Utilization ◽  
Medical Utilization ◽  
Fixed Duration ◽  
Advisory Committees ◽  
Over Time

Abstract Introduction: Multiple myeloma (MM) is an incurable hematologic condition that is associated with high Tx costs. Resource consumption is driven by hospitalization and medical utilization, which is highest during periods of uncontrolled disease, such as after diagnosis and during relapses (De Portu 2013). In the pivotal phase 3 FIRST trial, continuous Tx with lenalidomide plus low-dose dexamethasone (Rd) was compared with fixed-duration Rd (Rd18) or fixed-duration combination Tx with melphalan, prednisone, and thalidomide (MPT), each for 18 months (mos), in NDMM pts who were ineligible for stem cell transplantation. Continuous Rd extended progression-free survival (PFS) and overall survival (interim analysis) vs. MPT. However, it is still unclear whether extending Tx duration with Rd adversely affects healthcare resource utilization. This analysis quantifies the rates of hospitalizations and medical utilization with continuous Rd over time based on data collected in the FIRST trial. Methods: The FIRST trial (N = 1,623) was a pivotal multinational, randomized, open-label study with a median follow up of 37 mos. Non-protocol-driven resource-use data was collected until subjects discontinued study Tx. To assess whether continuous Rd increases healthcare resource utilization over time, the rates of resource utilization for subjects treated with continuous Rd (N = 535) were plotted for up to 48 mos. In addition, hospitalization and medical utilization rates during the Tx period (18 mos) were estimated and compared between the 2 fixed-duration Tx arms. Results: Resource utilization amongst pts treated with continuous Rd declined over time (Figure). The annualized hospitalization rate in the first 3 mos was 3.2 times higher than the average rate for the remaining 45 mos of follow-up (2.02 vs. 0.62), and 4.2 times higher for medical utilization (5.66 vs. 1.34). After 4 years (yrs) of continuous Rd Tx, hospitalization and medical utilization rates were estimated to be 83% and 84% lower than those observed in the first 3 mos of Tx, reflecting the long-term disease control observed with continuous Rd in the FIRST trial. The highest hospitalization rates were associated with infections (0.20 per patient year), cardiovascular disorders (0.06), and respiratory and thoracic disorders (0.05). The mean (standard deviation) length of stay per admission was 14.08 (21.19) days. The highest medical utilization rates were associated with blood transfusions (0.76 interventions per patient year), general imaging procedures (0.21), respiratory and thoracic imaging procedures (0.20), and therapeutic interventions (0.09).The hospitalization rates for the fixed dose Tx arms were 0.91 (Rd18) and 0.79 (MPT) per patient year of follow-up during the Tx period of 18 mos, resulting in a rate ratio (RR) of 1.15 (1.01–1.30). The equivalent rates for medical utilization were 3.00 (Rd18) and 2.86 (MPT) medical interventions per patient year (RR = 1.05 [0.98–1.12]). Conclusions: The rates of resource utilization among pts treated with continuous Rd dropped substantially after the first 3 mos of Tx, and then gradually declined as Tx duration increased. The findings suggest that continuous Tx with Rd does not further increase resource utilization in hospitalizations and medical utilization compared to fixed-duration Tx. A comparison between the 2 fixed arms showed a 15% increase in hospitalization with Rd18 vs. MPT, and no differences in medical utilization between the 2 arms. A limitation of this analysis is that the resources were collected only while pts were receiving their respective Txs. Future analysis should include all costs generated by healthcare resources throughout pts Tx, including Tx-free intervals, and the costs associated with relapses. Figure 1: Hospitalization and medical utilization rates per patient year for patients treated with continuous Rd Figure 1:. Hospitalization and medical utilization rates per patient year for patients treated with continuous Rd Disclosures Weisel: BMS: Consultancy; Onyx: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Celgene Corporation: Consultancy, Honoraria; Noxxon: Consultancy. Off Label Use: Lenalidomide used in newly diagnosed multiple myeloma patients. Vogl:Amgen: Consultancy; Millennium/Takeda: Research Funding; GSK: Research Funding; Acetylon: Research Funding; Celgene Corporation: Consultancy. Delforge:Janssen: Honoraria; Celgene Corporation: Honoraria. Song:Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Dimopoulos:Celgene Corporation: Consultancy, Honoraria. Cavenagh:Celgene Corporation: Honoraria. Hulin:Celgene Corporation: Honoraria. Foá:Celgene Corporation: Consultancy. Oriol:Janssen: Consultancy, Speakers Bureau; Celgene Corporation: Consultancy, Speakers Bureau. Guo:Celgene Corporation: Consultancy. Monzini:Celgene Corporation: Employment, Equity Ownership. Van Oostendorp:Celgene: Employment. Ervin-Haynes:Celgene: Employment. Facon:Celgene Corporation: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

VTD (Bortezomib Plus Thalidomide Plus Dexamethasone) Followed By Autologous Stem Cell Transplantation As First Line Treatment for Multiple Myeloma: Real Life Results from a Single Institution

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5380-5380
Author(s):  
Salvatore Palmieri ◽  
Angela Gravetti ◽  
Stefano Rocco ◽  
Antonella Carbone ◽  
Carolina Copia ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Salvage Therapy ◽  
Partial Remission ◽  
Response Rate ◽  
Real Life ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Abstract BACKGROUND. In recent years, new classes of drugs have been introduced for the treatment of Multiple myeloma (MM). Several randomized trials have investigated, in the setting of first line treatment of patients eligible for autologous transplant (ASCT), the efficacy of the combination of two to four new and old drugs given as induction. Among these, VTD combination (bortezomib plus thalidomide plus dexamethasone) provided impressive results, so that it is now considered at different Institutions the standard of care as pretransplant therapy. However, data of VTD derive from clinical trials and should be verified in the "real life" setting, in terms of either efficacy or toxicity. AIMS. Here we present our experience in 76 MM patients treated between 2008 and 2014 with VTD as part of a first line treatment including also mobilization, single or double ASCT, and consolidation with two additional VD courses. No patient had been enrolled into a clinical trial. CHARACTERISTICS OF PATIENTS/METHODS. There were 39 males and 37 females, with a median age of 57 years (range 38-67). MM subtype was IgG=44 cases, IgA=15, IgD=1, micromolecular=13, non secreting=2, and solitary plasmocytoma=1. Stage according to Durie & Salmon was II-A=29, II-B=2, III-A=34 and III-B=10. In 8 cases single or multiple vertebroplasty was also necessary, while 7 patients had concomitant extramedullary plasmocytoma. In absence of CRAB criteria, patients were treated when progressive increase of M-component was observed. Treatment was given according to GIMEMA-MM-BO2005 protocol (Cavo et al, Lancet 2010) except for the following: from September 2012, bortezomib was given subcutaneously (in a total of 37 patients) and 4 instead of 3 induction cycles were given; mobilization therapy consisted of vinorelbine 30mg/sqm day 1 plus cyclophosphamyde 1500 mg/sqm day 2 (for further details, Annunziata et al, Ann Hematol 2006); consolidation did not include thalidomide and was given only from 2011; no maintenance therapy with dexamethasone was administered. RESULTS. Overall response rate after induction was 92% (70/76 patients), with 35 complete remission (CR), 25 very good partial remission (VGPR), 9 partial remission (PR) and one minimal response (MR). One patient was considered as stable disease and continued with the therapeutic program, 3 patients were refractory and were switched to salvage therapy, and 2 patients died during induction (due to fatal sepsis from H1N1 virus infection and multiorgan failure in a severely ill subject, respectively). After successful mobilization in 70/71 patients, single (n=34) or double (n=36) ASCT were given, depending on quantity of CD34+ cell collection, toxicity of first ASCT and response achieved. High dose melphalan was the conditioning regimen in all cases. After ASCT, response was upgraded in 24 cases (in 17 cases VGPR to CR, 4 PR to VGPR, 2 PR to CR, 1 MR to PR). Consolidation was given in all 47 programmed cases. Hematologic toxicity of VTD was negligible. Reduction of thalidomide schedule was necessary in 60 patients, while only 16 patients (21%) were able to complete the programmed days of therapy at 200 mg/day. In the remaining cases, 39 completed the therapy at 100 mg, 2 at 50 mg, while 19 had to definitely discontinue therapy after a median of 33 days (15-68). More frequent reasons of discontinuation or reduction were neuropathy, constipation, fatigue and skin rash; only 1 case of thrombosis was recorded in a non responding patient. Reduction of bortezomib dose was necessary only in 5 patients (all ev cases), all because of neuropathy. At the time of writing 57/76 patients (75%) are alive, with a median follow up of 27 months. The median duration of response was 38 months, 25/70 patients (36%) having progressed or relapsed. Depending on time to relapse (> or < 18 months), bortezomib or lenalidomide based salvage therapy was used. Overall and progression free survival (OS and PFS) are shown in figure 1. DISCUSSION. Our data demonstrate that the VTD combination in the real life is an extremely effective regimen in terms of response rate. Most patients after VTD are able to mobilize CD34+ cells as well as to receive ASCT. In a considerable proportion of cases reduction of thalidomide dose is required and in 25% of cases the drug needed to be discontinued. As compared to data from clinical trials, PFS in our series seems to be shorter, however our patients were unselected and in this series follow up is significantly longer. Disclosures No relevant conflicts of interest to declare.

Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma for Long-Term Follow-up: Single Center Results

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5836-5836
Author(s):  
Weiwei Sui ◽  
Dehui Zou ◽  
Gang An ◽  
Shuhui Deng ◽  
Yan Xu ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Autologous Transplantation ◽  
First Line ◽  
Hematopoietic Stem ◽  
Agent Based ◽  
Total Treatment ◽  
Long Term Follow Up ◽  
Baseline Characteristics

Abstract Objective: To evaluate the efficacy and long-term outcome of the total treatment of induction therapy, ASCT and consolidation and maintenance therapy. Methods: A retrospective analysis was made on in multiple myeloma patients in our center between April 1, 2003 and February 1, 2016. The 157 patietns received autologous hematopoietic stem cell transplantation and review the autologous transplantation of long-term follow-up results. Analysis of the effect of transplantation efficacy, the impact on survival remission of different transplantation depth, transplantation in first line or not, salvage transplantation, prognosis of different staging system and other factors. Results: The baseline characteristics of the patients were shown in table 1. Overall patient ASCT before total effective rate (ORR) was 93.6%, in which the complete remission (CR) ratio was 33.1%. After ASCT, the best treatment response rate of PR was 80.3%, and the rate of CR was 58.6%. 91.69 months of median follow-up, patients with an overall survival (OS) and progression free survival (PFS) respectively 91.69 and 50.76 months; in 2005 before the median OS and PFS 39.0m and 23.0m. In 2005 after respectively and 56.41m 120.90m, P = 0.000. The median OS and PFS in the first line transplantation group and salvage transplantation group were vs 54.21m 39.0m and vs 7.09m 119.0m (P value was 0). 136 cases of patients with R-ISS stage, I, II, III of the patients with the median survival time were 120.90m (n=46), 86.43m (n=69), 35.65m (n=21), there were significant differences between groups, p=0.000. Each period of PFS were 72.11m, 51.84m, 28.09m, I and II, III,, p=0.001 and p=0.03, while there was no significant difference between II and III, p=0.122. The received autologous transplantation as first-line and salvage treatment of patients with subgroup survival analysis, median OS of the R-ISS stage III patients and different 15.84m 35.65m, P = 0.031; two groups of patients the median PFS (phase I: 91.69m vs18.92m; II: vs 16.69m 53.42m; phase III: vs 5.91m 28.52m) have difference (P = 0.000). In the first-line transplantation group, transplantation is more than or equal to PR and did not get effective PR group between OS were significantly different; before transplantation achieved CR, PR but did not obtain Cr and did not get effective PR group between PFS were significantly different; after transplantation and achieved CR CR did not get the patients had a median PFS were 65.57m 48.13m, P = 0.039 and median OS no difference. Accept any kind of noval agent- based chemotherapy were significantly longer OS and PFS than traditional chemotherapy (P = 0.001, P = 0.004) .There was no obvious difference on median OS between based regimen (bortezomib group median OS: NR; thalidomide group:120.90m); PFS in thalidomide group (median PFS : NR vs 54.21m) significantly prolonged (P = 0.010). By comparing the baseline characteristics of the two groups, it was found that the PFS was significantly shorter in the bortezomib group with an extra medullary lesion. Multivariate analysis showed that only R-ISS and the depth of remission before transplantation had effect on OS (p=0.003) and PFS (p=0.036) respectively. Conclusion: The total treatment of novel agent-based chemotherapy and ASCT for transplantation-eligible multiple myeloma patients is effective, further improve the remission rate and remission depth, prolong PFS and OS, the overall median survival up to 120.9m. First line transplantation can significantly prolong the OS and PFS compared with salvage transplantation. R-ISS and pre-transplant remission depth are prognostic factors influencing survival of patients. The total treatment to thalidomide based without extramedullary perhaps makes patients get long-term survival. Disclosures No relevant conflicts of interest to declare.

Differences in survival for advanced-stage colorectal cancer (CRC) patients by lines of therapy received in a U.S. local oncology practice.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14106-e14106
Author(s):  
Susan H Foltz Boklage ◽  
Charles Kreilick ◽  
Carl V Asche ◽  
Sally Haislip ◽  
James W. Gilmore ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Proportional Hazards ◽  
Survival Rates ◽  
Cox Proportional Hazards ◽  
Advanced Stage ◽  
Line Treatment ◽  
Chemotherapy Drugs ◽  
Line Of Therapy ◽  
Oncology Practice

e14106 Background: Improvements in survival for advanced-stage colorectal cancer (CRC) patients who receive chemotherapy have been reported. We compared survival rates for patients with 3+ vs. <3 lines of therapy using electronic medical records of a local oncology practice in Georgia, USA. Methods: The Georgia Cancer Specialist (GCS) EMR Database (1/1/2005–07/ 31/2010) was used. The database contains data on patient demographics, cancer diagnostic information, chemotherapy and non-chemotherapy drugs administered written prescriptions, chemotherapy/radiation protocols, chemotherapy protocol changes, office visit information, and hospitalizations. Patients newly diagnosed with CRC between 01/01/05 and 06/31/10 treated with systemic therapy for CRC were identified. Patients were followed from initial CRC diagnosis to death, loss to follow-up, or end of study. Patients were categorized by number of lines of therapy received (1, 2, 3+) and original stage at diagnosis (III b/c, IV, unknown). Survival following initial line of therapy was evaluated using Cox proportional hazards models controlling forstage at diagnosis, type of 1st line treatment, and other patient characteristics. Results: The study included 704 patients with a median age of 63 years (age range 26-85 years) at diagnosis and 49% (n=345) female. 45% (n=317) and 42% (n=296) had stage IV and III b/c CRC at diagnosis, respectively. 53% (n=373) received only 1st line treatment, 27% (n=190) received 1st and 2nd line treatment and 20% (n=141) received 3rd line and beyond. The median follow up was 431 days and death was reported in 27%(n=190) of subjects. The multivariate Cox proportional hazard analysis indicated that there was no statistical difference in survival between patients who received 2nd line of therapy vs. 3 plus lines of therapy (HR=1.42; p<0.067). Conclusions: A non-statistical significant association between 2nd and more than 3 total lines of therapy in survival was found in subjects diagnosed with stage III B/C and IV. However the trend towards survival was present, indicating that some patients could benefit from the addition of 3rd line but it would require additional studies to confirm this.

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