Real-world treatment patterns and outcomes of triple-exposed multiple myeloma patients treated in community oncology practices in the United States.

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.


Author(s):  
Faith Davies ◽  
Robert Rifkin ◽  
Caitlin Costello ◽  
Gareth Morgan ◽  
Saad Usmani ◽  
...  

AbstractMultiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) ≥ 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optum’s deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs ≥2 were identified. More patients ≥75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT ≥ 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT ≥ 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.


2021 ◽  
Vol 21 ◽  
pp. S419-S420
Author(s):  
Robert Smith ◽  
Mei Xue ◽  
Natalie Dorrow ◽  
Prateesh Varughese ◽  
Cosmina Hogea ◽  
...  

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4745-4745
Author(s):  
Humberto Martinez-Cordero ◽  
Virginia Abello ◽  
William Armando Mantilla Duran ◽  
Rigoberto Gomez ◽  
Jheremy Reyes ◽  
...  

Abstract Background Proteasome inhibitors (PIs) are approved for treating newly diagnosed and relapsed multiple myeloma (MM) in Colombia. This propensity score matching (PSM) analysis using data from the real-world, was designed to establish the role PIs (bortezomib or carfilzomib) at first relapsed or refractory MM. The primary endpoint was overall response rate (ORR) and secondary endpoint included was overall survival (OS). Moreover, an analysis of OS was done regarding response attained. On Behalf of RENEHOC-GRIMMCO (Colombian Registry for Hemato-Oncological Diseases and Colombian Mieloma Múltiple study group). Methods PSM by nearest neighbor analysis to evaluate the role of PIs used at first relapse in multiple myeloma of patients belonging to RENEHOC registry, between 2010 and 2020. Results 390 patients were identified in the first relapse of the Colombian registry, 269 patients with PI and 121 patients without PI. One hundred and ten patients were included in each group after PSM. Patients were matched for age, ISS, extramedullary disease, and use of lenalidomide to define the influence of this immunomodulatory drug in the PI group. A difference was found in the use of lenalidomide because only 1 patient was treated with PI and lenalidomide concomitantly (0.91%) compared to 31 patients in the group without PI (28.18%), (p <0, 0001). Regarding ORR, no differences were found between the 2 groups 38.18% in PIs vs 37.27% in non-PIs group (p = 0.801). A trend towards better OS was found in the PIs group with a median of 58 months versus 39 months (p = 0.179). Overall survival in patients who achieved at least PR was better compared to those who did not reach 79 months versus 32 months in non-responders (p = 0.0001). Conclusion In this study, we found that the use of PI has a tendency to improve overall survival in real-world in MM patients when used in the first relapse and that this effect could possibly be enhanced with the combination with lenalidomide. Regardless of the treatment used, better responses are associated with better survival. Figure 1 Figure 1. Disclosures Abello: Janssen: Honoraria; Amgen: Honoraria; Dr Reddy's: Research Funding. Sossa: Amgen: Research Funding.


2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A239-A239
Author(s):  
Wolfram Samlowski ◽  
Robert Nicholas ◽  
Tayla Poretta ◽  
Andriy Moshyk ◽  
Jonathan Rajkumar ◽  
...  

BackgroundNivolumab is approved in the US and EU for the adjuvant treatment of resected stage III-IV melanoma based on results from the CheckMate-238 clinical trial.1,2 However, the trial did not enroll any patients with Stage IIIA disease per the American Joint Committee on Cancer (AJCC) 7th edition criteria and included a limited number of patients with stage IIIA disease per the AJCC 8th edition.3,4,5Recognizing the need for real-world data to assess outcomes of patients with resected stage IIIA melanoma treated with adjuvant nivolumab, a non-interventional study was conducted to investigate treatment patterns and outcomes among patients receiving adjuvant nivolumab within the US community practice setting.MethodsA retrospective analysis of the US Oncology Network’s iKnowMed medical data was conducted to examine patients with resected stage IIIA melanoma treated with adjuvant nivolumab between 01-Jan-2018 and 31-Dec-2019 with a follow-up period through 31-Mar-2020. Patients were followed for up to 27 months after their sentinel lymph node biopsy. Baseline demographic/clinical characteristics and treatment patterns were examined descriptively. Duration of treatment (DOT) and overall survival were analyzed using the Kaplan-Meier method.ResultsA total of 58 patients with stage IIIA melanoma treated with adjuvant nivolumab were identified. Median age was 57.8 years (range 21.5–93.5), 62.1% were male, and 75.9% were Caucasian. Among patients with a documented Eastern Cooperative Oncology Group (ECOG) performance status (51.7%), all had an ECOG score of 0 or 1. Median follow-up time was 12.6 months (range 0.3–25.1). Median DOT was 10.6 months (range 6.8–12.0). Overall survival rates at 12 and 24 months were 97.7% (95% CI 84.6–99.7) and 92.2% (95% CI 69.6–98.2), respectively.ConclusionsThis real-world analysis of patients with stage IIIA melanoma treated with adjuvant nivolumab showed that a large proportion of patients were alive at the end of the study period, suggesting these patients have a favorable prognosis. Further investigation and follow-up is warranted to assess clinically relevant outcomes among patients with resected stage IIIA melanoma.Ethics ApprovalThe study was approved by US Oncology Inc’s Institutional Review Board, approval number 20-020E-2020-0224-01.ReferencesWeber J, Mandala M, Del Vecchio M, et al. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. NEJM 2017;377:1824–35.Weber J, Mandala M, Del Vecchio M, et al. Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: A randomized, double-blind, phase 3 trial (CheckMate 238). Ann Oncol 2017;28(5):632–33.Balch CM, Gershenwald JE, Soong SJ, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009;27(36):6199–6206.Gershenwald JE, Scolyer RA, Hess KR, et al. Melanoma staging: Evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin 2017;67(6):472–492.National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Cutaneous Melanoma Version 3.2020 - May 18, 2020. 2020.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5581-5581
Author(s):  
Shelby Corman ◽  
Sneha Kelkar ◽  
Shardul Odak ◽  
Jingchuan Zhang ◽  
Vimalanand S. Prabhu ◽  
...  

5581 Background: Traditional platinum-based systemic chemotherapy continue to be the SOC for aEC in the first line. Phase 2 clinical trials of chemotherapy (GOG 129 series) and some targeted therapies (229 series) for second line advanced endometrial cancer (aEC) have proved disappointing. Recently the treatment landscape for aEC patients has significantly changed with newer targeted therapies focusing on the microsatellite instability (MSI) status of endometrial tumors. The objective of the ECHO study was to describe real-world treatment patterns and outcomes in non-MSI-high or DNA mismatch repair proficient (pMMR) aEC patients in clinical practice in the United States (US) prior to 2019. Methods: The ECHO study is a multicenter, retrospective chart review study in women diagnosed with aEC in the US. Data were obtained from medical records of adult women (≥18 years) diagnosed with advanced or inoperable aEC (stages III or IV) with known MSI status, who had received at least one prior systemic therapy and progressed between July 1, 2016 – June 30, 2019. De-identified patient data extracted by treating oncologists included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed to estimate real-world progression-free survival (rwPFS) and overall survival (OS). Results: A total of 124 non-MSI-high or pMMR aEC patients who had progression following first line therapy were included in this interim analysis. Average age was 63 years, 62.9% White/Caucasian, 16.9% Hispanic/Latino, and 86% had ECOG ≤1. Metastases were observed in 70% of patients at diagnosis, with the most common metastatic sites being lung (47.6%), liver (32.3%), and distant lymph nodes (29%). As 2nd line therapy, 69% of patients received mono or combination chemotherapy (primarily with doxorubicin), 13% hormonal therapy, and 18% targeted therapy ± chemotherapy. Median duration of 2nd line therapy was 4 months. The majority (86.3%) discontinued 2nd line therapy, with disease progression the most common reason (66.4%). A quarter (26.6%) of patients initiated an additional line of therapy. Median rwPFS from initiation of 2nd line therapy was 5 months (95% confidence interval [CI]: 4-9). Median OS from initiation of 2nd line therapy was 12 months (95%CI: 9-18). Estimated OS rates from initiation of 2nd line therapy at 6, 12, and 24 months were 66%, 47%, and 30%, respectively. Conclusions: In this retrospective, chart review study, patients with non-MSI-high/pMMR aEC in the US who failed at least one systemic therapy had poor prognosis on subsequent therapies. There continues to be a significant unmet need in this group of women. Novel therapies are needed that delay progression and/or improve overall survival and further research is indicated to explore this.


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