Treatment Patterns and Clinical Outcomes Across Consecutive Treatment Lines in Multiple Myeloma Patients: Single-Center Real World Experience.

2019 ◽  
Vol 19 (10) ◽  
pp. e251-e252
Author(s):  
Svetlana Trestman ◽  
Irit Avivi ◽  
Moshe Mittelman ◽  
shai levi ◽  
Yael Cohen
2018 ◽  
Vol 24 ◽  
pp. 5887-5893
Author(s):  
Xifeng Qian ◽  
Heng Chen ◽  
Jun Xia ◽  
Jing Wang ◽  
Xin Zhou ◽  
...  

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 25-26
Author(s):  
Eric M. Ammann ◽  
Annette Lam ◽  
Wenze Tang ◽  
Tobias Kampfenkel ◽  
Mohit Sharma ◽  
...  

Background: In patients with newly-diagnosed multiple myeloma (NDMM) who receive frontline autologous stem cell transplantation (ASCT), maintenance therapy (MT) following ASCT has been shown to delay disease progression and death. Current National Comprehensive Cancer Network (NCCN) guidelines also recommend MT for patients with MM, including the use of lenalidomide, bortezomib-based regimens, or ixazomib. However, there is limited evidence on the use and outcomes associated with MT in contemporary real-world patients. The present study assessed MT treatment patterns and clinical outcomes in a real-world US cohort of patients with NDMM following ASCT. Methods: This retrospective, observational cohort study included NDMM patients initially diagnosed from 2011-2018 who received frontline ASCT. Patients were selected from the US Flatiron Health (FH) deidentified electronic health record (EHR)-derived database, which includes longitudinal patient-level data from over 265 community-based and academic cancer clinics across the US. To ensure capture of post-ASCT consolidation and MT, the study sample was restricted to patients who resumed contact within the FH network within 60 days following ASCT. Patients were excluded if they received treatment within the context of a clinical trial or had a second transplant within 180 days of their initial ASCT. Patients were classified as receiving MT if (during the 180-day post-transplant period) they initiated treatment with an NCCN-recommended MT regimen or continued to receive a subset of the antimyeloma agents used as induction regimen following ASCT and consolidation (if any). Key measures included baseline demographic and clinical characteristics, antimyeloma treatments (frontline induction, consolidation, and MT, if any), and clinical outcomes (time to next myeloma treatment [TTNT] and overall survival [OS]). Treatment duration and clinical outcomes were analyzed using Kaplan-Meier estimators and Cox regression to account for right-censoring. For TTNT and OS, follow-up began on the earlier of the ASCT date + 90 days or start of MT and continued through the dataset cut-off date (May 30, 2020) or loss to follow-up; TTNT and OS were estimated for patients receiving lenalidomide maintenance [R-MT], bortezomib maintenance [V-MT], or no MT, but was not estimated for other MT regimens due to sample size considerations. Results: 528 NDMM patients (median age 61 years, interquartile range [IQR]: 55, 68; 45.3% female) underwent ASCT and met study inclusion criteria. The most common induction regimens were bortezomib-lenalidomide-dexamethasone (VRd; 60.0%), lenalidomide-dexamethasone (Rd; 16.3%), and cyclophosphamide-bortezomib-dexamethasone (CyBorD; 10.2%). Following ASCT, 7.2% of patients received consolidation therapy and 74.2% received MT (lenalidomide monotherapy [R-MT]: 58.7%; bortezomib monotherapy [V-MT]: 7.6%; other MT: 7.8%). Median duration of MT was 18.0 months (IQR: 8.7, 29.1), and was similar for R-MT and V-MT (median 18.9 and 18.6 months, respectively). MT use increased from 69.3% to 79.0% from 2011-2013 to 2017-2018 (P=0.04); in addition, patients were more likely to have received VRd as induction across different MT (Table 1). R-MT and V-MT were both associated with longer TTNT relative to no MT (unadjusted hazard ratios [HRs]: 0.29 [95% CI: 0.22, 0.38] and 0.39 [95% CI: 0.25, 0.61], respectively) (Figure 1A). Improvements in OS were marginally significant with R-MT (HR: 0.58 [95% CI: 0.33, 1.00]) and nonsignificant with V-MT (HR: 0.86 [95% CI: 0.35, 2.11]) relative to no MT (Figure 1B); however, the OS estimates are characterized by low precision due to the relatively small number of events observed. Limitations included lack of documentation of reasons for treatment in the FH database, and use of consolidation and MT were inferred from observed treatment patterns; therefore, misclassification of MT was possible. Conclusions: This analysis demonstrates that MT use following ASCT has increased in routine clinical practice in the US since 2011-2013, with R-MT being the most common regimen followed by V-MT. However, a substantial proportion of patients did not receive MT. MT use in real-world settings was associated with longer TTNT and a trend toward longer OS. Exploration of additional maintenance regimens to improve clinical outcomes is warranted in this patient population. Disclosures Ammann: Janssen Scientific Affairs: Current Employment, Current equity holder in publicly-traded company. Lam:Janssen: Current Employment. Tang:Janssen: Current Employment. Kampfenkel:Janssen: Current Employment. Sharma:Mu Sigma: Current Employment; Janssen: Other: Contractor. Lee:Janssen: Current Employment. Kaila:Janssen Scientific Affairs: Current Employment. Fu:Janssen: Current Employment. Gray:Janssen: Current Employment. He:Janssen: Current Employment.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shebli ATRASH ◽  
Philippe THOMPSON-LEDUC ◽  
Ming-Hui TAI ◽  
Shuchita KAILA ◽  
Kathleen GRAY ◽  
...  

Abstract Background Daratumumab, a CD38 monoclonal antibody, has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly-diagnosed and refractory patients with multiple myeloma (MM). However, there is limited evidence on treatment patterns and effectiveness of daratumumab in the real-world setting, particularly in first line (1 L). This study aimed to describe real-world treatment patterns and clinical outcomes among patients initiating daratumumab across different lines of therapy. Methods A retrospective chart review of adult patients with MM initiating daratumumab between November 2015 and March 2021 was conducted at two clinical sites in the United States. De-identified patient-level data were abstracted in an electronic case report form. Patient characteristics and treatment patterns were described. Clinical outcomes including overall response rate (ORR), progression-free survival, and time to next line of therapy were reported using descriptive statistics and stratified by line of therapy (1 L, second line [2 L] or third line or later [3 L+]). A sub-group analysis evaluated treatment patterns and ORR among patients re-treated with daratumumab. Results A total of 299 patients were included in the study (mean age: 68 years; 55% male). Among them, 26 were 1 L patients, 66 were 2 L patients, and 207 were 3 L+ patients; 110 patients (36.8%) received a stem cell transplant prior to daratumumab initiation. The mean duration of follow-up was 10 months among 1 L patients and 19 months among 2 L and 3 L+ patients. Patients who initiated daratumumab in 1 L had a 100% ORR, while those initiating in 2 L and 3 L+ had an ORR of 78.8 and 65.2%, respectively. Among re-treated patients, ORR was 66.7% during the first treatment segment, and 52.9% during the second treatment segment. Kaplan-Meier rates of progression-free survival at 12 months were 89.9, 75.2, and 53.1% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Kaplan-Meier rates of time to next line of therapy at 12 months were 94.1, 73.4, and 50.0% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Conclusions These findings suggest that daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1 L.


2018 ◽  
Vol 19 (5) ◽  
pp. 521-525 ◽  
Author(s):  
Rik Rozemeijer ◽  
Daniela Benedetto ◽  
Adriaan O. Kraaijeveld ◽  
Michiel Voskuil ◽  
Mèra Stein ◽  
...  

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18727-e18727
Author(s):  
Robert Smith ◽  
Mei Xue ◽  
Natalie Dorrow ◽  
Prateesh Varughese ◽  
Cosima Hogea ◽  
...  

e18727 Background: Treatment for multiple myeloma (MM) over the past decade has significantly improved survival. In particular, 3 drug classes have altered the treatment paradigm for MM patients: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and CD38 monoclonal antibodies (anti-CD38s). Despite these advances, the majority of patients with MM will become refractory to PIs, IMiDs, and anti-CD38s, and limited evidence indicates these patients have poor outcomes. A retrospective study in the US showed that 275 patients treated at 14 academic institutions with prior exposure to a PI, IMiD, and anti-CD38 had median overall survival of 9.2 months. The aim of this study was to evaluate real-world treatment patterns and outcomes (duration of therapy and overall survival) of patients who had been treated with a PI, IMiD, and anti-CD38 in community practices in the US. Methods: This retrospective observational study was conducted using the Integra Connect (IC) database. The IC database includes electronic health data from structured and unstructured fields from 12 community practices on the East and West Coast of the US. Adult patients with ≥2 ICD-9/ICD-10 codes for MM on at least 2 separate dates, who received MM treatment between Jan 1, 2016, and Dec 31, 2019, with treatment history that included at least one PI, one IMiD, and one anti-CD38 (triple exposed), and initiated a subsequent line of therapy (s-LOT) after becoming triple exposed, were included. Duration of length of s-LOT was defined as number of days from start of s-LOT to last-day supply of s-LOT. Overall survival was defined as the length of time from start of s-LOT through death or the date of the last office visit. Results: A total of 501 patients were included in this analysis. The median age of patients was 64.9 years; 50% were male; 50% had commercial insurance. 82.8% of patients had ECOG 0 or 1 at diagnosis and had received a median of 3 prior lines of therapy (LOTs) before initiating s-LOT. Prior to initiating s-LOT, 91% had been exposed to bortezomib, 81% to carfilzomib, 94% to lenalidomide, 82% to pomalidomide, and 100% to daratumumab. In s-LOT, 95% received treatment that included same drug or same drug class (30% received bortezomib, 48% carfilzomib, 31% lenalidomide, 47% pomalidomide, and 31% daratumumab). The median duration of s-LOT was 78 days and median survival was 10.3 months (308 days) from initiation of s-LOT. Conclusions: For triple-class exposed patients, there is a lack of consensus on the most efficacious approach to subsequent treatment. The present study shows a significant amount of retreatment with previously used agents or classes among these patients with short duration of therapy and poor survival. As has been previously noted, new strategies and agents targeting novel aspects of MM are needed to improve outcomes for these patients. Disclosures: This study (213286) was sponsored by GlaxoSmithKline.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 17-18
Author(s):  
Parameswaran Hari ◽  
Lita Araujo ◽  
Dominick Latremouille-Viau ◽  
Peggy Lin ◽  
Mikhail Davidson ◽  
...  

Background: Renal impairment (RI) is associated with substantial clinical and economic burden in patients with multiple myeloma (MM), but real-world data reporting on healthcare resource utilization (HRU) and outcomes in these patients are lacking. We assessed treatment patterns, overall survival (OS), HRU and associated costs across lines of therapy (LoT) in patients with MM who had baseline RI. Methods: We identified patients (aged ≥18 years) with continuous Part A, B and D coverage who initiated pharmacologic therapy for MM between January 1, 2012 and December 31, 2016. Baseline demographics, disease characteristics, and treatment patterns from first-line to fourth-line (1L-4L) were reported for all eligible patients (main cohort). Within this cohort, a subgroup of patients diagnosed with RI at baseline (RI subgroup) were identified using appropriate International Classification of Diseases (ICD)-9 and ICD-10 codes. Treatment regimens were identified during the first 60 days following start of each LoT; stem cell transplantation (SCT) in 1L was considered part of the 1L regimen. The end of each LoT was indicated by treatment augmentation, treatment switching (after >60 days), discontinuation of all agents (for >90 days), or death. Overall survival (Kaplan-Meier analysis) was defined as time from start of each LoT until death or censoring (end of data/Medicare coverage). All-cause HRU categories were identified during each LoT and reported as incidence rate per patient per month (PPPM); associated all-cause healthcare costs during LoT were reported in 2017 US$. Results are presented using standard descriptive statistics. Results: A main cohort of 10,026 patients was identified; of these, a RI subgroup of 714 patients with baseline RI was identified (7.1% of main cohort). At 1L initiation, the RI subgroup was generally younger (71.9 vs. 74.6 years), had a lower proportion of females (47.8% vs. 53.1%) and had a higher proportion of Medicare coverage for end-stage renal disease (62.9% vs. 6.3%) than the main cohort. Patients with RI had a higher mean Charlson Comorbidity Index score (excluding MM; 4.8 vs. 3.3) and a higher proportion of patients with comorbidities (anemia: 72.5% vs. 57.9%; diabetes with chronic complications: 38.7% vs. 27.1%; cardiovascular diseases: 97.2% vs. 82.5%) than the main cohort. In the RI subgroup, among patients who received SCT in 1L (n=76), bortezomib-dexamethasone (Vd) was the most frequent 1L regimen (39.5%), followed by bortezomib-lenalidomide-dexamethasone (VRd; 17.1%) and bortezomib-cyclophosphamide-dexamethasone (VCd; 15.8%). In patients who had no SCT in 1L, Vd was the most frequent 1L regimen (59.5%), followed by VCd (12.7%) and lenalidomide-dexamethasone (Rd; 12.1%). Among patients in the RI subgroup who progressed to 2L therapy, 61.7% received lenalidomide-based regimens in 1L. Newer MM therapies such as carfilzomib, pomalidomide, ixazomib, daratumumab, and elotuzumab were used more frequently in later LoTs (2L: 25.6%; 3L: 50.0%; 4L: 68.8%). Median OS from start of 1L was shorter in the RI subgroup than in the main cohort (29.9 vs. 46.5 months; Table), and this difference was consistent across each subsequent LoT. Incidence of HRU during 1L (Table) was generally higher in the RI subgroup than the main cohort, particularly for inpatient days (1.3 vs. 0.7 PPPM) and home health services (0.9 vs. 0.5 PPPM); this pattern was consistent between cohorts across each subsequent LoT. Total costs in the 1L RI subgroup vs. main cohort (Table) were $14,782 vs. $12,451; the cost differential was maintained across each subsequent LoT. The key driver of this difference was the additional medical service costs ($12,047 vs. $7,459 in 1L) incurred by patients with RI. Conclusion: Patients with MM who had baseline RI were shown to experience higher clinical and economic burden in real-world clinical practice than the overall MM population. This burden was maintained across LoTs. Efficacious regimens that help improve renal function with minimal toxicity would enable patients with MM and RI to persist with treatment and may help address unmet need in this subgroup of patients. Table Disclosures Hari: BMS: Consultancy; GSK: Consultancy; Janssen: Consultancy; Amgen: Consultancy; Takeda: Consultancy; Incyte Corporation: Consultancy. Araujo:Sanofi Genzyme: Current Employment. Latremouille-Viau:Sanofi Genzyme: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Novartis Pharmaceutical Corporation: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Lin:Sanofi Genzyme: Current Employment. Davidson:Sanofi Genzyme: Other: Mikhail Davidson is an employee of Analysis Group, Inc which received consultancy fees from Sanofi Genzyme.. Guerin:Sanofi Genzyme: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Abbvie: Consultancy, Other; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Sasane:Sanofi Genzyme: Current Employment.


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