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Potluri, Ravi C.

0000-0002-0509-2659

Mayo Clinic

SmartAnalyst, Inc, New York, NY, USA

Citations 16

Real-world treatment patterns, costs, and outcomes in patients with AL amyloidosis: analysis of the Optum EHR and commercial claims databases
Zonder, Jeffrey A. , Hoffman, James E. , Wong, Sandra W., Liedtke, Michaela , Abonour, Rafat , D’Souza, Anita , Lee, Charlene, Côté, Sarah, Ammann, Eric M. , Tran, NamPhuong, Lam, Annette , Nair, Sandhya, Dispenzieri, Angela , Ammann, Eric , Lam, Annette , D'Souza, Anita , Dispenzieri, Angela , Potluri, Ravi C.

Amyloid | October 25, 2022 | Volume: 30 | Issue: 2 | Pages: 161-168

10.1080/13506129.2022.2137400 Get It

Real-World Treatment Patterns in Patients with Light Chain (AL) Amyloidosis: Analysis of the Optum US Electronic Health Records and Commercial Claims Database
Zonder, Jeff, Hoffman, James E. , Wong, Sandy W. , Liedtke, Michaela , Abonour, Rafat , Lee, Charlene, Nair, Sandhya, Weiss, Brendan M. , Vermeulen, Jessica, Lam, Annette , Mehra, Maneesha, Dispenzieri, Angela , D’Souza, Anita , Potluri, Ravi C. , Vermeulen, Jessica

Blood | February 8, 2021 | Volume: 136 | Issue: Supplement 1 | Pages: 4-5

10.1182/blood-2020-140405 Get It

Background: Light chain (AL) amyloidosis is a rare disease in which deposits of insoluble amyloid derived from immunoglobulin light chains accumulate and cause dysfunction of organs including the heart and kidneys. In order to reverse organ damage and improve overall survival, treatment must provide rapid, deep, and sustained hematologic responses. Although therapies approved for the treatment of multiple myeloma have demonstrated some efficacy, there are currently no health authority-approved treatments for AL amyloidosis. A retrospective observational study was undertaken to characterize patients and describe treatment patterns in patients with AL amyloidosis from real-world data in the US. Methods: Data were extracted from Optum Electronic Health Records (EHR) and Optum Clinformatics Data Mart (claims) databases. Eligible patients had (1) a diagnosis of AL amyloidosis (ICD-10 code E85.81) on or after January 1, 2008 or (2) a diagnosis of amyloidosis (ICD-9 codes 277.30, 277.39; ICD-10 codes E85.89, E85.9) on or after January 1, 2008 and at least one line of therapy (LOT) comprising one or more of the following treatments: bendamustine bortezomib, carfilzomib, cyclophosphamide, daratumumab, dexamethasone, doxorubicin, elotuzumab, etoposide, interferon alfa-2a, interferon alfa-2b, ixazomib, lenalidomide, melphalan, panobinostat, pomalidomide, prednisone/prednisolone, thalidomide, vincristine, or autologous stem cell transplant. Patients were required to have continuous medical enrollment during the 365 days prior to the index amyloidosis diagnosis date (claims data) or have first active date at least 365 days prior to index amyloidosis date (EHR data), must not have had prior cancer in the 365-day period prior to the index amyloidosis diagnosis date, and must have been age ≥18 years at time of amyloidosis diagnosis. Patients treated with dexamethasone only or dexamethasone and prednisolone only for ≤90 days and those treated with prednisone/prednisolone only irrespective of duration were excluded. LOTs were defined by a start date, an end date, and a distinct regimen made up of ≥1 drugs. Patients may have multiple sequential LOTs during the available follow-up period. Comorbidities were scored according to the Charlson Comorbidity Index (CCI). A score of 0 reflects no comorbidities; higher scores reflect increased mortality risk and the maximum score is 24. Descriptive statistics are provided for patient characteristics at index diagnosis date for patients who had ≥1 LOT, distribution of regimens in each LOT, treatment attrition, and duration of treatment in each line of therapy and by regimen. Results: Data from 1688 patients (Optum claims, n=624; Optum EHR, n=1064) were included in the analysis (Figure). Median age at diagnosis was 67 years and 55.7% of patients were male. Almost 70% of patients had an index diagnosis date between 2013 and 2019. The median CCI score at index diagnosis date (based on comorbidities in the 365-day pre-index diagnosis period) was 1 and 10.9% of patients had a stem cell transplant on or after the index diagnosis date. The three most common comorbidities were hypertension (50.8%), renal failure (26.2%), and congestive heart failure (24.6%). Median follow-up period was 28 months. Treatment information for regimens used by ≥5% of patients for LOT1 is summarized in the Table. The most common treatment regimen for LOT1 was a proteasome inhibitor (PI), an alkylating agent, and a steroid (n=392, 23.2%); this combination was used for an average of 111 days. Of patients treated with this combination, the most common regimen was bortezomib, cyclophosphamide, and dexamethasone (VCd), used by 358 patients. Steroid only (dexamethasone for ≥90 days) regimens accounted for 16.4% and a PI ± steroid for 13.2% of LOT1. A limitation of the study is that assumptions were used to classify AL amyloidosis vs other types of amyloidosis. Conclusions: VCd is the most commonly used regimen in patients with newly-diagnosed AL amyloidosis. This is consistent with clinical guidelines and real world data from Europe (Palladini et al, EHA 2020), supporting this regimen as the current standard of care for treatment of patients with newly-diagnosed AL amyloidosis. Disclosures Dispenzieri: Celgene: Research Funding; Pfizer: Research Funding; Alnylam: Research Funding; Intellia: Research Funding; Janssen: Research Funding; Takeda: Research Funding. Zonder:Intellia, Amgen, Takeda, Janssen, Regeneron, Alnylam, Caelum, Oncopeptides: Consultancy; BMS, Celgene: Research Funding. Hoffman:Loxo: Current equity holder in publicly-traded company; Celgene: Honoraria, Speakers Bureau. Wong:Sanofi: Membership on an entity's Board of Directors or advisory committees; Janssen: Research Funding; Fortis: Research Funding; Roche: Research Funding; GSK: Research Funding; Amgen: Consultancy; Bristol Myers Squibb: Research Funding. Liedtke:Adaptive: Membership on an entity's Board of Directors or advisory committees; Caelum: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria. Abonour:BMS: Consultancy, Research Funding; Takeda: Consultancy; Janssen: Honoraria, Research Funding; Celgene: Consultancy. D'Souza:Amgen, Merck, TenoBio: Research Funding; Akcea, Imbrium, Janssen, Pfizer: Consultancy. Lee:Janssen: Current Employment. Nair:Janssen: Current Employment. Potluri:SmartAnalyst Inc.: Current Employment. Weiss:Janssen: Current Employment, Current equity holder in publicly-traded company. Vermeulen:Janssen: Current Employment, Current equity holder in publicly-traded company. Lam:Janssen: Current Employment. Mehra:Janssen: Current Employment.
Avoidable Acute Care Use Associated with Nausea and Vomiting Among Patients Receiving Highly Emetogenic Chemotherapy or Oxaliplatin
Navari, Rudolph M. , Ruddy, Kathryn J. , LeBlanc, Thomas W. , Clark-Snow, Rebecca, Binder, G. , Bailey, William L., Schmerold, Luke, Papademetriou, Eros , Roeland, Eric , Schmerold, Luke M , Leblanc, Thomas , Roeland, Eric J , Nipp, Ryan David , Schwartzberg, Lee Steven , Potluri, Ravi C.

The Oncologist | December 2, 2020 | Volume: 26 | Issue: 4 | Pages: 325-331

10.1002/onco.13620 Get It

Abstract Purpose Chemotherapy-induced nausea and vomiting (CINV) contributes to avoidable acute care, a metric now tracked in Medicare's oncology outcome measure. CINV is preventable, yet guidelines are often not followed. We sought to quantify acute care involving CINV and other avoidable toxicities after highly emetogenic chemotherapy (HEC) to identify excess risk and assess clinician adherence to antiemesis guidelines for HEC. Materials and Methods We retrospectively evaluated U.S. electronic health records (2012-2018) using Medicare's OP-35 outcome measure to identify avoidable acute care involving any of 10 toxicities, including CINV, after HEC regimens relative to non-HEC. Antiemetic guideline adherence was defined as use ofneurokinin-1 (NKl) receptor antagonists Q5 (RAs) plus 5-hydroxytryptamine type 3 RA+ dexamethasone at HEC initiation. Results Among 17,609 patients receiving HEC, acute care rates associated with HEC chemotherapy included 32% cisplatin, 31% carboplatin, and 21% anthracycline/cyclosphospharnide (AC), with 76% meeting the criteria as avoidable events. Oxaliplatin rates were 29%. Avoidable acute care occurred 1.83 times (95% confidence interval, 1.76-1.91, p < .0001) as often after HEC versus non-HEC excluding oxaliplatin; CINV-related acute care occurred 2.29 times as often. Nonadherence to antiemesis guidelines occurred in 34% and 24% of cisplatin and AC courses, respectively, because of omission of a NKl RA. Conclusions Patients treated with HEC regimens experienced high avoidable acute care use, 1.8 times the risk seen for other chemotherapy. Nonadherence to guideline-directed antiemetic prophylaxis highlights the need to ensure adherence to antiemetic guidelines, including the use of NKl RA in HEC. Implications for Practice After survival, perhaps the most important goal in oncology is limiting avoidable acute care, a goal now used by Medicare to impact cancer reimbursement. This study found that patients treated with highly emetogenic chemotherapy (HEC) regimens had high rates of avoidable acute care use, 1.8 times the risk seen for other chemotherapy. A substantial proportion of the avoidable acute care involved chemotherapy-induced nausea and vomiting. Results showed that incomplete adherence to national antiemetic guidelines for HEC regimens primarily driven by omission of upfront neurokinin-1 receptor antagonist use, suggesting that improved adherence can meaningfully resolve this gap in quality and cost of care.
What the HEC? Clinician Adherence to Evidence-Based Antiemetic Prophylaxis for Highly Emetogenic Chemotherapy
Roeland, Eric , Ruddy, Kathryn J. , LeBlanc, Thomas W. , Binder, G. , Sebastiani, Silvia , Schmerold, Luke, Papademetriou, Eros , Navari, Rudolph M. , Leblanc, Thomas , Roeland, Eric J , Nipp, Ryan David , Sebastiani, Silvia, Potluri, Ravi C. , Schwartzberg, Lee Steven

Journal of the National Comprehensive Cancer Network | June 5, 2020 | Volume: 18 | Issue: 6 | Pages: 676-681

10.6004/jnccn.2019.7526 Get It

Background: Clinician adherence to antiemetic guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC) remains poorly characterized. The primary aim of this study was to evaluate individual clinician adherence to HEC antiemetic guidelines. Patients and Methods: A retrospective analysis of patients receiving HEC was conducted using the IBM Watson Explorys Electronic Health Record Database (2012–2018). HEC antiemetic guideline adherence was defined as prescription of triple prophylaxis (neurokinin-1 receptor antagonist [NK1 RA], serotonin type-3 receptor antagonist, dexamethasone) at initiation of cisplatin or anthracycline + cyclophosphamide (AC). Clinicians who prescribed ≥5 HEC courses were included and individual guideline adherence was assessed, noting the number of prescribing clinicians with >90% adherence. Results: A total of 217 clinicians were identified who prescribed 2,543 cisplatin and 1,490 AC courses. Patients (N=4,033) were primarily women (63.3%) and chemotherapy-naïve (92%) with a mean age of 58.6 years. Breast (36%) and thoracic (19%) cancers were the most common tumor types. Guideline adherence rates of >90% were achieved by 35% and 58% of clinicians using cisplatin or AC, respectively. Omission of an NK1 RA was the most common practice of nonadherence. Variation in prophylaxis guideline adherence was considerable for cisplatin (mean, 71%; SD, 29%; coefficient of variation [CV], 0.40) and AC (mean, 84%; SD, 26%; CV, 0.31). Conclusions: Findings showed substantial gaps in clinician adherence to HEC CINV guidelines, including a high variability across clinicians. Clinicians should review their individual clinical practices and ensure adherence to evidence-based CINV guidelines to optimize patient care.
Work loss and activity impairment due to duration of nausea and vomiting in patients with breast cancer receiving CINV prophylaxis.
Navari, Rudolph M. , Ruddy, Kathryn J. , Clark-Snow, Rebecca, Wickham, Rita S., Binder, G. , Bailey, William L., Turini, Marco, Schmerold, Luke, Schwartzberg, Lee Steven , LeBlanc, Thomas W. , Potluri, Ravi C. , Roeland, Eric

Journal of Clinical Oncology | May 25, 2020 | Volume: 38 | Issue: 15_suppl | Pages: e24133-e24133

10.1200/jco.2020.38.15_suppl.e24133 Get It

e24133 Background: The impact of chemotherapy-induced nausea and vomiting (CINV) on work loss and activity impairment is important to patients yet not well described in literature. We sought to evaluate CINV-related work loss and activity impairment and their associations with CINV duration. Methods: In a prospective CINV prophylaxis trial of oral or intravenous netupitant/palonestron (NEPA) + dexamethasone (DEX) (12mg day 1 only) for patients with breast cancer receiving anthracycline + cyclophosphamide (AC), we defined CINV as vomiting or use of rescue medication during days 1-5 after AC. Pre-specified endpoints included CINV duration (0-5 days), patient reported CINV-associated work loss (Work Productivity and Activity Impairment survey), and CINV-related impaired activity [0 (none) - (worst) Likert scale] for chemotherapy cycles 1 and 2. CINV-related work loss and activity impairment could involve nausea with or without vomiting or rescue medication use. We categorized CINV duration as 1-2 days (d) or ≥3 d, and compared results using the chi-squared test. We report here on the first 2 cycles. Results: Survey data was captured for 792 cycles in 402 female patients including 132 (32.8%) employed patients. Mean age was 55.4. CINV was observed in 173 (21.8%) of total cycles. CINV-related work loss was reported in 26 (3.3% of all cycles, 15.0% of cycles with CINV, 38.2% of employed patient cycles with CINV) while 142 had related activity impairment. When we categorized cycles by CINV duration, CINV-related work loss was seen in 25.9% of 81 cycles with ≥3 d CINV duration vs. 5.4% for 92 cycles of 1-2 d of CINV (p < 0.001); mean scores of CINV-related impaired activity were 5.0 for ≥3 d CINV vs 3.0 for 1-2 d CINV (p < 0.001). Conclusions: Despite guideline recommended prophylaxis, CINV occurred in > 20% of AC cycles. In cycles with CINV, CINV-related work loss occurred in 38.2% for employed patients while activity impairment occurred in 82.1% for all patient cycles. The majority of CINV lasted 1-2 d. Notably, ≥3 d of CINV was associated with considerably higher levels of work loss and activity impairment suggesting that duration may be a meaningful measure of CINV impact. Clinical trial information: NCT03403712 . [Table: see text]
Abstract P5-14-07: Avoidable acute care involving chemotherapy-induced nausea and vomiting (CINV) among patients with breast cancer receiving anthracycline + cyclophosphamide (AC) with NEPA prophylaxis relative to other antiemetics: An external control arm
Ruddy, Kathryn J. , Navari, Rudolph M. , LeBlanc, Thomas W. , Clark-Snow, Rebecca, Wickham, Rita , Binder, G. , Bailey, William L., Schmerold, Luke, Papademetriou, Eros , Roeland, Eric , Leblanc, Thomas , Roeland, Eric J , Schwartzberg, Lee Steven , Potluri, Ravi C.

Cancer Research | March 26, 2020 | Volume: 80 | Issue: 4_Supplement | Pages: P5-14-07-P5-14-07

10.1158/1538-7445.sabcs19-p5-14-07 Get It

Abstract Background: Anthracycline and cyclophosphamide (AC) is a highly emetogenic chemotherapy (HEC) regimen. Combination netupitant/palonosetron (NEPA) + dexamethasone (DEX) is guideline-recommended for prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in HEC and moderately emetogenic chemotherapy. CMS’ OP-35 measure deems 30-day post-chemotherapy acute care as avoidable if involving nausea and emesis (NV) or any of 8 other toxicities. Results will be publicly reported and impact Medicare reimbursement. CMS (2017) found that 10% of &gt;58,000 patients with avoidable acute care after chemotherapy involved NV. Because NEPA is new, insufficient real world data exist to assess its CINV resource use. CINV-related acute-care after NEPA prophylaxis in AC has been reported in a prospective clinical trial. Our aim was to compare these rates to those seen after prophylaxis with other antiemetics for AC outside of a clinical trial. Methods: Pre-specified endpoints in a prospective trial of oral or IV NEPA + DEX in AC included acute-care use (emergency [ED] visits or inpatient admissions [IP]) involving CINV, defined as emesis or rescue drug use ≤5 days after AC, and concomitant ED/IP in the same period. We also evaluated CINV-related acute care after non-NEPA prophylaxis for AC in breast cancer from 10/2012-8/2018 in IBM Explorys electronic health records. We age-matched patients 3:1 to the NEPA trial. We further adjusted the event rate to address under-reporting of a) CINV rates (vs. 49.2% for aprepitant in AC in a clinical trial [Warr 2005]) and b) acute-care use, projected at 17-50% at sites external to the dataset. To compare the resulting adjusted event rate to the NEPA study, we conducted 10,000 Monte Carlo simulations, using random probabilities from 5.2-8.7% for Explorys patients, and from 0-2% for NEPA patients to address potential reporting variability, despite the trial including daily patient diaries. Analysis of data was limited to the first two cycles, the median duration in the NEPA trial. Results: In the NEPA trial, 402 patients received ≥1 cycle; 391 completed two cycles. Nine patients had IP admissions; none involved CINV. Five patients had 6 total ED visits; one met criteria for involving CINV; the resulting rate of acute care rate involving CINV was 0.25 per 100 patients. For other antiemetics, 2598 patients received AC (excluding NEPA prophylaxis). Among 1206 age-matched to the NEPA trial, 15 patients had acute-care events in the first 2 cycles, (1.24 per 100 patients), an odds ratio of 1:5.1 (CI 0.7-38.5) in favor of NEPA. After adjusting via the simulation, the odds ratio was 1:8.3 (CI: 2.43-24.21) in favor of NEPA. Conclusions: Comparing CINV-related acute care seen in a large prospective trial relative to real-world evidence in patients with breast cancer treated with AC, &lt;1% of patients receiving NEPA prophylaxis required acute care for CINV; the CINV-related acute-care risks seen with other antiemetic prophylaxis were 5 times (unadjusted) to 8 times (adjusted) the levels for NEPA. A similar comparison using only real world data should be conducted as data permit. Citation Format: Lee Schwartzberg, Kathryn J Ruddy, Rudolph M Navari, Thomas W LeBlanc, Rebecca Clark-Snow, Rita Wickham, Gary Binder, William L. Bailey, Ravi Potluri, Luke M Schmerold, Eros Papademetriou, Eric J Roeland. Avoidable acute care involving chemotherapy-induced nausea and vomiting (CINV) among patients with breast cancer receiving anthracycline + cyclophosphamide (AC) with NEPA prophylaxis relative to other antiemetics: An external control arm analysis [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-14-07.
Physician concordance with update to ASCO guidelines for antiemetic use with carboplatin AUC ≥ 4.
Navari, Rudolph M. , Ruddy, Kathryn J. , Clark-Snow, Rebecca, Wickham, Rita S., Binder, G. , Coberly, Tammy Bratton, Schmerold, Luke, LeBlanc, Thomas W. , Potluri, Ravi C. , Roeland, Eric

Journal of Clinical Oncology | March 12, 2020 | Volume: 37 | Issue: 15_suppl | Pages: 11595-11595

10.1200/jco.2019.37.15_suppl.11595 Get It

11595 Background: In 2017, NCCN (2/2017) and ASCO (8/2017) each amended antiemetic guidelines to classify carboplatin AUC ≥4 as highly emetogenic chemotherapy (HEC), recommending upfront triple prophylaxis with an NK1 receptor antagonist (RA) + 5HT3 RA + dexamethasone. Physician concordance with the new recommendations, and the consequences for avoidable post-chemotherapy acute care, merit study. Methods: In a large electronic health record database (IBM Explorys), we identified carboplatin courses of therapy (≥14-day cycles as a proxy for AUC ≥4) and courses with ≥7-day cycles of other HEC and non-HEC therapy from 4Q 2012 through August 2018. Guideline concordance, defined as triple prophylaxis at HEC initiation, was evaluated. We also assessed 30-day post-chemotherapy acute care (inpatient or emergency department) associated with nausea or vomiting (NV) or eight other toxicities deemed avoidable in the US Centers for Medicare & Medicaid’s new oncology outcome measure OP-35. Results: 11,554 carboplatin courses were identified. Before the guideline change, rates of upfront triple prophylaxis grew from 14% in 2013 to 16% in mid-2017. Rates then rose to 26% by 1Q 2018 before dropping to 21% by 3Q 2018; quarterly rates averaged 20% (range 15%-26%) following the guideline change. In 31% of carboplatin courses we noted 30-day acute care use, of which 75% involved ≥1 of the ten OP-35 toxicities. NV (with or without acute care use) was reported in 24% of courses, and 27% of total OP-35 acute care events involved NV. Rates for NV, and for OP-35-related and NV-related acute care after carboplatin, were similar to rates after other HEC chemotherapy, and higher than rates after other non-HEC IV chemotherapy or oral HEC/MEC agents. Conclusions: Use of upfront triple antiemetic prophylaxis has increased only marginally for carboplatin AUC ≥ 4 since its 2017 re-classification as HEC in national guidelines, perhaps due to low awareness of the change. Patients receiving carboplatin had similar rates of NV and related 30-day acute care events as seen for other HEC, confirming that the new HEC definition fits clinical experience. More triple prophylaxis use is needed to reduce NV and NV-related avoidable acute care seen with carboplatin AUC ≥ 4.
Impact of Addition of Carboplatin AUC ≥ 4 to Antiemetic Guidelines for Triple Antiemetic Prophylaxis: A Gap in Quality of Care, Guideline Adoption, and Avoiding Acute Care
Navari, Rudolph M. , Ruddy, Kathryn J. , LeBlanc, Thomas W. , Clark-Snow, Rebecca, Wickham, Rita , Binder, G. , Coberly, Tammy Bratton, Schmerold, Luke, Roeland, Eric , Leblanc, Thomas , Roeland, Eric J , Potluri, Ravi C.

JCO Oncology Practice | December 4, 2019 | Volume: 16 | Issue: 2 | Pages: e132-e138

10.1200/jop.19.00457 Get It

PURPOSE: After ASCO and National Comprehensive Cancer Network guideline recommendations for triple antiemetic prophylaxis for carboplatin area under the curve (AUC) ≥ 4, and the publication of studies documenting avoidable acute care after chemotherapy involving nausea and vomiting (NV) and other toxicities, we studied clinician adherence to the guideline change and assessed avoidable acute-care use. METHODS: Using a large electronic health record database, we evaluated antiemetic prophylaxis as recommended in the guidelines and post-chemotherapy avoidable acute-care use (defined as involving any of NV or 8 other toxicities) for patients initiating carboplatin or other chemotherapy from October 2012 to August 2018. RESULTS: We identified 11,554 carboplatin courses. After the guideline change adding neurokinin-1 receptor antagonists (RAs) for carboplatin AUC ≥ 4, its use rose to 20% of courses from the prior average of 16%; virtually all courses also included a 5-HT3 RA plus dexamethasone. We found avoidable acute care in 23% of courses; one quarter of these events were associated with NV. Acute care rates after carboplatin mirrored those after other highly emetogenic chemotherapy or oxaliplatin and exceeded those after other chemotherapy regimens. The > 80% shortfall in adherence may have been caused by low awareness or acceptance of the guideline change and/or by poor awareness of avoidable acute-care use after carboplatin. CONCLUSION: Neurokinin-1 RA prophylaxis for carboplatin AUC ≥ 4 remains low and largely unchanged despite National Comprehensive Cancer Network and ASCO 2017 recommendations for inclusion. NV and avoidable acute care involving NV seen after carboplatin were consistent with other highly emetogenic chemotherapy. Clinician action is required to remediate incomplete prophylaxis and to no longer place patient outcomes, resources for cancer treatment, and clinician reimbursement at risk.
Characterization of Frontline Treatment Patterns and Attrition Rates According to Subsequent Lines of Therapy in Non-Transplant Patients with Newly Diagnosed Multiple Myeloma
Mehra, Maneesha, Slavcev, Mary, Ukropec, Jon, Lam, Annette , Fonseca, Rafaël , Usmani, Saad Z. , Potluri, Ravi C.

Blood | October 14, 2019 | Volume: 132 | Issue: Supplement 1 | Pages: 3291-3291

10.1182/blood-2018-99-113125 Get It

Abstract Background: Each additional line of therapy is associated with lower rates of deeper responses, shorter durations of treatment-free intervals, and increased rates of toxicities/comorbidities in patients with multiple myeloma (MM; Yong K, et al. Br J Haematol 2016. 175[2]:252-264), all of which are factors that contribute to treatment discontinuation. In order to characterize the newly diagnosed MM (NDMM) patient population in the United States not treated with a stem-cell transplant based on the number of subsequent lines of therapy (LOT) received, we examined baseline patient characteristics and pre-existing comorbidities, frontline treatment patterns, and attrition rates for these patients according to whether subsequent LOT was received or not received. Methods: NDMM patients were identified from 3 US patient-level data sources: the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked database (from January 2007 through December 2014), the OPTUM™ Commercial Claims database (from January 2000 through March 2017), and the OPTUM™ Electronic Medical Records (EMR) database (from January 2007 through March 2016). Patients included in the assessment had 1) an index diagnosis of MM on or after 1 January 2007, 2) known gender, 3) medical prescription coverage in place at diagnosis, 4) a 1-year look-back period prior to the index diagnosis, 5) no prior malignancies in the 1-year period prior to index diagnosis, and 6) received ≥1 LOT. The analysis was limited to patients who did not receive stem cell transplantation at any time during their follow-up. Descriptive and logistic regression analyses were conducted to characterize and compare patients who received or did not receive a subsequent LOT. Results: The analysis included a total of 7,724 patients (1 LOT only: n = 3,906; 2+ LOT: n = 3,818). A summary of baseline patient characteristics and pre-existing comorbidities by LOT is summarized in Table 1. Patients who received a subsequent LOT vs those that did not were significantly younger (median age 72.0 vs 74.0 years; P <0.0001) and had significantly lower mean Charleston Comorbidity Index (CCI) score due to lower occurrence of renal, cardiac, and hepatic comorbidities (Table 1). Older age at diagnosis and presence of renal, congestive heart failure (CHF), hepatic, and pulmonary comorbidities were associated with higher attrition. The regimens used in frontline treatment included bortezomib/dexamethasone (26%), lenalidomide/dexamethasone (21%), bortezomib/lenalidomide/dexamethasone (11%), a bortezomib/alkylator ± steroid combination (6%), bortezomib monotherapy (10%), lenalidomide monotherapy (6%), thalidomide monotherapy (4%), and other (17%). The proportions of patients progressing to each subsequent line of therapy are shown in Table 2. In total, 49% of patients went on to receive a second line of therapy, and 55% of patients receiving a second line of therapy went on to receive a third line of therapy. The incidence of patients not receiving subsequent lines of therapy due to death or being lost to follow up by LOT is summarized in Table 2. Conclusions: A majority of non-transplant patients with NDMM in the study did not progress to subsequent lines of therapy, with attrition as high as 50% per line of therapy and only <8% of patients reaching LOT 5. This high level of attrition is associated with older age and poor comorbidity status of non-transplant patients with NDMM. Therefore, utilizing the most optimal regimens upfront (rather than reserving them for later lines) is warranted. Disclosures Fonseca: Mayo Clinic: Employment; Amgen: Consultancy. Usmani:Abbvie, Amgen, Celgene, Genmab, Merck, MundiPharma, Janssen, Seattle Genetics: Consultancy; Amgen, BMS, Celgene, Janssen, Merck, Pharmacyclics,Sanofi, Seattle Genetics, Takeda: Research Funding. Mehra:Janssen Global Services, LLC: Employment. Slavcev:Janssen Global Services, LLC: Employment. Ukropec:Janssen Scientific Affairs, LLC: Employment. Lam:Janssen Global Services, LLC: Employment. Potluri:SmartAnalyst Inc.: Employment.
PF643 CHARACTERIZATION OF FRONTLINE TREATMENT PATTERNS AND THE PROPORTION OF PATIENTS REACHING SUBSEQUENT LINES OF THERAPY IN TRANSPLANT ELIGIBLE PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Voorhees, Peter M. , Côté, Sarah, Lam, Annette , Ukropec, Jon, Maiese, Eric M., Nair, S. , Fonseca, Rafaël , Potluri, Ravi C. , Mehra, Mandeep R.

HemaSphere | June 17, 2019 | Volume: 3 | Issue: S1 | Pages: 274-275

10.1097/01.hs9.0000560856.29321.96 Get It

Background:It has been well documented that each additional line of treatment is associated with lower rates of deeper responses, shorter duration of treatment, and increased rates of toxicities/comorbidities in patients with multiple myeloma (MM; Yong K, et al. Br J Haematol 2016. 175[2]:252–264). These factors contribute to treatment discontinuation and impact the proportion of patients reaching subsequent lines of therapy.Aims:To characterize the rate of therapy attrition at relapse for patients with newly diagnosed MM (NDMM) who are transplant eligible in the United States.Methods:Patients with NDMM were identified from 3 US patient‐level data sources: the OPTUM™ Commercial Claims database (period: January 2000–March 2017), the OPTUM™ Electronic Medical Records (EMR) database (period: January 2007–March 2016), and the Surveillance, Epidemiology, and End Results (SEER)‐Medicare Linked database (period: January 2007–December 2014). Patients had 1) an index MM diagnosis on or after 1 January 2007, 2) medical prescription coverage in place at diagnosis, 3) no prior malignancies in the one‐year period prior to index diagnosis, 4) a one‐year look‐back period prior to index diagnosis, and 5) received ≥1 lines of therapy. Patients were considered transplant eligible if they received stem cell transplantation anytime during the follow‐up period. Baseline characteristics including comorbidities, index age, frontline treatment regimens and attrition rates at each subsequent line of therapy were characterized. Attrition was defined as the percentage of patients who did not have any recorded subsequent MM treatments as a result of death or lost to follow‐up in the database for any reason, including end of the database.Results:A total of 1,599 patients were included in this analysis. Baseline patient characteristics and pre‐existing comorbidities are summarized in Table 1. The induction regimens used as frontline treatments included bortezomib/dexamethasone (22%), lenalidomide/dexamethasone (13%), bortezomib/lenalidomide/dexamethasone (25%), all other bortezomib combinations (20%), and other (20%). The proportions of patients observed to progress to each subsequent line of therapy are summarized in Table 2. In total, 77% of patients received a second line of therapy, and only 55% received a third line treatment. The proportion of patients not receiving a subsequent line of therapy due to death is also summarized by lines of therapy in Table 2.Summary/Conclusion:A substantial number of patients with NDMM who are transplant eligible did not receive subsequent lines of therapy, with attrition by lines of therapy ranging from 23–40%. The increase in attrition rates with each additional line of therapy underscores the need to utilize upfront therapy associated with optimal progression‐free survival. Further studies evaluating the etiologic basis for this unexpectedly high attrition rate are warranted.image