Treatment initiation with bone-targeting agents among patients with bone metastasis secondary to solid tumors or patients with multiple myeloma.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 309-309
Author(s):  
Oth Tran ◽  
Mark Hatfield ◽  
Meghan Moynihan ◽  
Neel Shah ◽  
Laurie A. Costa ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Bone Metastasis ◽  
Solid Tumors ◽  
Index Date ◽  
Cord Compression ◽  
Tumor Type ◽  
Bone Targeting ◽  
Real World Evidence ◽  
Medicare Patients ◽  
Insured Patients

309 Background: Recent real-world evidence is lacking regarding the initiation of bone-targeting agents (BTAs), and time to treatment with BTAs after a diagnosis of bone metastasis secondary to solid tumors (BM-ST) or multiple myeloma (MM), in both the commercially insured and Medicare Supplemental populations. Methods: Patients aged >18 and newly diagnosed with BM-ST or MM during 11/1/2016-6/30/2019 (earliest diagnosis = index date) were selected from the IBM MarketScan Commercial and Medicare Databases. Patients were continuously enrolled in the 12 months before and 6 months after the index date and had no prior evidence of BTA use, skeletal-related events (SREs), osteoporosis or Paget’s disease. Initiation of and time to BTA treatment (i.e., denosumab, zoledronic acid, ibandronate or pamidronate) were reported during the variable follow-up period. SREs prior to BTA use were reported and included spinal cord compression, pathological fractures, surgery and radiation to bone. Results were stratified by tumor type (BM-ST and MM) and payer (commercial and Medicare). Results: The analysis included 8,769 commercially insured patients (70% BM-ST and 30% MM [mean age 55 and 54]) and 4,100 Medicare patients (74% BM-ST and 26% MM [mean age 76 and 75]). Across payers, the most common comorbidities were pain and hypertension. BTA initiation for BM-ST and MM patients was 46% and 24% among the commercial cohort, and 33% and 18% among the Medicare cohort. Among BM-ST commercial and Medicare cohorts, respectively, the proportion initiating BTA varied by solid tumor type: 64% and 45% of breast, 43% and 37% of prostate, and 47% and 34% of lung. Mean (SD) time to BTA initiation for BM-ST and MM patients was 3.0 (4.2) and 3.7 (5.2) months for the commercial cohort, and 3.1 (4.7) and 2.9 (3.3) months for the Medicare cohort. Among patients with BTA initiation, the proportion of BM-ST and MM patients with SREs prior to BTA treatment was 33% and 31% for the commercial cohort and 23% and 26% for the Medicare cohort. Across payers, the majority of first SREs were radiation to bone for BM-ST patients and pathological fracture for MM patients. Conclusions: For commercial patients, about one-half of BM-ST patients and a quarter of MM patients initiated BTA treatment; for Medicare patients, these proportions decreased to a third and a fifth, respectively. On average, BTA initiation occurred within about 3 to 4 months from first diagnosis. The proportion of commercial and Medicare patients with SREs prior to BTA initiation was a third and a quarter, respectively. Results generated from this study should be supplemented by the evaluation of the relationship between bone protection treatment patterns and outcomes associated with BM-ST and MM.

scholarly journals The Effectiveness of Zoledronic Acid and Ibandronic Acid in Delaying Skeletal-Related Events in Multiple Myeloma in Indonesia

2020 ◽  
Vol 10 (3) ◽  
pp. 195
Author(s):  
Nutrisia Aquariushinta Sayuti ◽  
Tri Murti Andayani ◽  
Dwi Endarti ◽  
Kartika Widayati
Keyword(s):  
Multiple Myeloma ◽  
Zoledronic Acid ◽  
Bone Metastasis ◽  
Acid Group ◽  
Cord Compression ◽  
Osteonecrosis Of The Jaw ◽  
Survival Times ◽  
Ibandronic Acid ◽  
Free Survival ◽  
Skeletal Related Events

Zoledronic acid and ibandronic acid are listed in the Indonesian national formulary to prevent skeletal-related events (SRE) in patients diagnosed with bone metastasis in multiple myeloma (MM), with limited evidence to compare their effectiveness. This study aimed to investigate the effectiveness and safety of zoledronic acid and ibandronic acid in delaying SRE. The method was the retrospective, with data obtained from the multicenter study for MM patients with bone metastasis (aged over 18 years), based on medical records between January 2016 and December 2018. Patients were assigned to zoledronic acid and ibandronic acid groups. The clinical outcome was the next SRE which consists of vertebral/bone fracture, spinal cord compression leading to the need for surgery or radiation, and adverse event (AE) due to 2 years of drugs usage. Result of this research was made up of a total of seventy (70) patients with  40  in the zoledronic acid group, and 30 in ibandronic acid. At median treatment duration of 8 months (range: 2 – 24 month), SRE incident in zoledronic acid and ibandronic acid were 20.0 % and 23.3 % respectively. Furthermore, their mean SRE free survival times were 21 months [95% confidence interval (CI) 19 - 23 months], and 19 months [95% CI, 16 – 22 months], respectively. Also, their time intervals were not significantly different (p>0.05). The osteonecrosis of the jaw (ONJ) was AE which occurred more in zoledronic acid than ibandronic acid. The conclusion was zoledronic acid tends to delay SRE time compared to ibandronic acid, although more ONJ occur.

scholarly journals Effect of denosumab versus zoledronic acid on calcium levels in cancer patients with bone metastasis: A retrospective cohort study

2019 ◽  
Vol 25 (8) ◽  
pp. 1846-1852 ◽  
Author(s):  
Sahar M Nasser ◽  
Arwa Sahal ◽  
Anas Hamad ◽  
Shereen Elazzazy
Keyword(s):  
Multiple Myeloma ◽  
Cohort Study ◽  
Zoledronic Acid ◽  
Bone Metastasis ◽  
Cancer Patients ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Calcium Supplementation ◽  
Level Control ◽  
Bone Targeting

Objective To identify the incidence of hypercalcemia and hypocalcemia in zoledronic acid and denosumab groups. Secondary objective was to determine the correlation between calcium supplement and calcium level control. Methods An observational retrospective cohort study was conducted by reviewing patient electronic records, laboratory results, and medication charts from 1 August 2015 to 31 July 2016. Adult cancer patients who were diagnosed with bone metastasis secondary to a solid tumor or multiple myeloma and who received either zoledronic acid or denosumab were included. Other indications for bone targeting agents were excluded. Data of bone targeting agents administration encounters were collected, evaluated, and analyzed. Results A total of 1141 encounters (for 271 patients) were included. The incidence of hypocalcemia was higher in denosumab compared to zoledronic acid group (5.5% vs. 3.1%, OR = 0.55, 95% CI [0.3–1.0]; P = 0.05). Hypercalcemia incidence was also higher in denosumab group (8.5% vs. 3.1%, OR = 2.9, 95% CI [1.68–5.03]; P < 0.0001). Breast cancer was the most common malignancy associated with hypocalcemia (27.3%) followed by ovarian cancer (25%) and multiple myeloma (22.7%). The risk of developing hypocalcemia was reduced by 16% in patients receiving calcium supplementation (RR = 0.84, 95% CI [0.55–1.20]; P = 0.39). Conclusion Denosumab use was associated with higher rates of both hypercalcemia and hypocalcemia compared to zoledronic acid. Adequate supplementation with calcium substantially reduced the risk of hypocalcemia. Our results highlight the importance of taking preventative measures upon bone targeting agents initiation and during treatment including regular monitoring of calcium levels and providing supplements accordingly.

Burden of hospitalizations associated with skeletal related events in patients with breast cancer or lung cancer and bone metastases or multiple myeloma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17083-17083 ◽  
Author(s):  
M. Lage ◽  
D. J. Harrison ◽  
B. Barber ◽  
S. Jun
Keyword(s):  
Breast Cancer ◽  
Lung Cancer ◽  
Multiple Myeloma ◽  
Bone Metastases ◽  
Index Date ◽  
Opioid Analgesic ◽  
Cord Compression ◽  
Continuous Coverage ◽  
Diagnosis Of Cancer ◽  
Skeletal Related Events

17083 Background: Patients with bone metastases secondary to cancer often experience skeletal related events (SREs) including pathological fracture, spinal cord compression, hypercalcemia, bone surgery or radiotherapy, or initiation of opioid analgesic use. These SREs result in major morbidity and reduced quality of life. This research examines hospitalizations associated with SREs. Methods: Data for this study were obtained from i3 LabRx Database (05/01/2000 to 03/31/2005). Individuals were included in the analyses if they had at least two diagnoses of breast cancer (based upon an ICD-9 code of 174.xx), lung cancer (162.xx), or multiple myeloma (203.0x) and had at least two diagnoses of bone metastases (198.5x) after the first diagnosis of cancer. In addition, individuals were required to have at least one SRE (based upon a previously published algorithm) on or after their initial diagnosis of bone metastases (their index date). Individuals were required to be continuously insured for at least 6 months prior to, and at least one month post their index date. Data were analyzed until 03/31/2005 or until the end of their continuous coverage, whichever occurred first. Descriptive statistics for each of these cohorts are provided. Results: A total of 1,204 individuals with breast cancer, 1,094 with lung cancer, and 258 with multiple myeloma were included in the study. The vast majority of individuals with breast cancer (96.5%), lung cancer (95.9%), or multiple myeloma (96.8%) were hospitalized. All three patient groups were likely to have SRE-related hospitalizations; multiple myeloma 43.4%, breast cancer 36.2% and lung cancer 35.6%. The average number of days per patient year that patients were hospitalized related to a diagnosis or procedure for a SRE was 6.75 days for patients with lung cancer, 6.56 days for patients with multiple myeloma, and 3.75 days for patients with breast cancer. Conclusion: Hospitalizations related to SREs are common and the number of days per year is substantial. No significant financial relationships to disclose.

Treatment Sequencing Patterns in Medicare-Enrolled Patients with Multiple Myeloma

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2120-2120 ◽  
Author(s):  
Shuling Li ◽  
Tanya Natwick ◽  
Akeem Yusuf ◽  
Irena Sarah Vidito ◽  
Khalid Mezzi ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Index Date ◽  
Employment Equity ◽  
Drug Regimens ◽  
Medicare Patients ◽  
Equity Ownership ◽  
Treatment Sequencing ◽  
Line Of Therapy ◽  
The Impact ◽  
Treatment Sequences

Abstract Introduction: Over the last decade, several novel therapies have been approved for multiple myeloma (MM) leading to significant improvement in the prognosis of MM patients. MM patients are often treated with multiple lines of therapy as relapse occurs. With the numerous options of therapeutic agents and novel combinations of regimens, the treatment for MM has become more complicated. However, little is known regarding the treatment sequencing patterns for Medicare patients with MM. In this study, we described the use of drug regimens by lines of therapy and characterized treatment sequences in Medicare patients with MM. Methods: Using a validated algorithm (Princic et al. Blood 2015;126:4521), we identified adult MM patients (≥ 18 years old) in 2008-2011 from the Centers for Medicare & Medicaid Services 100% Hematologic Cancer file (2007-2012) who began first-line (1L) treatment. Patients who advanced to second-line (2L), third-line (3L), and fourth-line (4L) were identified if a 90 day gap in all treatments was observed or when a drug was added to a regimen >90 days after the line index date. Drug regimens were based on National Comprehensive Cancer Network MM treatment guidelines and were identified using National Drug Code and Healthcare Common Procedure Coding System codes. Patients were included in the study if they received monotherapy, doublets, or triplets at 1L. The study period was from the 1L initiation date to the earliest of death, disenrollment from Medicare Parts A, B, and D coverage, receipt of treatments other than the above-mentioned drug regimens, or December, 31, 2012. We described the distribution of type of drug regimens by lines of therapy, overall and by age defined at MM index date, and characterized treatment sequencing patterns for patients who advanced to 2L, 3L, and 4L by type of drug regimens in the prior line of therapy, respectively. Results: In total, 12563 MM patients initiated 1L therapy. Of these, 9% were aged 18-64 years (enrolled in Medicare due to disabilities), 42% aged 65-74 years, and 49% aged ≥ 75 years. Most patients were white (78%) and more than half were female (53%). We identified 5647 (45%), 2243 (18%), and 773 (6%) patients who advanced to 2L, 3L, and 4L, respectively. Overall, doublets were the most common 1L regimen (62%), followed by monotherapy (21%) and triplets (17%). Most common treatments for monotherapy in 1L were dexamethasone (52%), lenalidomide (21%), and bortezomib (17%). The pattern was similar among patients who advanced to a 2L, 3L, or 4L, respectively, though more triplets were used at advanced lines. For 1L therapy, only 12% of patients aged ≥ 75 years received triplets, in contrast to >20% of triplet use in 3L and 4L respectively (Table). Of patients who received monotherapy in 1L and advanced to 2L, 37% continued monotherapy and 63% switched to more dense regimens (doublets, 53%; triplets 10%). Of patients who received doublets in 1L and advanced to 2L, 58% continued doublets, 22% switched to triplets, and 20% to monotherapy. Of patients who received triplets in 1L and advanced to 2L, 26% continued triplets and 74% switched to less dense regimens (doublets, 47%; monotherapy, 27%). Treatment sequencing patterns were similar for patients who advanced to 3L and 4L with monotherapy or doublets in prior lines, while the proportion of patients who repeated triplets increased to about 32% in 3L and 37% in 4L (Figure). Conclusions: Among Medicare patients with MM, doublets were the most frequently used regimens across all lines of therapy, while triplets were used in more advanced lines. Patients on monotherapy or doublets were more likely to retain their treatment pattern when they advance to the next line of therapy, while those on triplet regimen were more likely to switch to a less dense regimen when they advance to their next line of therapy. Fewer patients of older age (75+ years) were prescribed triplet therapies, however triplet use in this patient group increases in more advanced lines. These results provide a baseline description of treatment patterns from which we will be able to benchmark the impact of the recent introduction of novel agents and their use in elderly MM patients. Further studies assessing the comparative effectiveness and benefit-risk of treatment sequences are warranted. Figure Figure. Disclosures Yusuf: Amgen Inc.: Employment, Equity Ownership. Vidito:Amgen Inc.: Employment, Equity Ownership. Mezzi:Amgen Inc.: Employment, Equity Ownership. Werther:Amgen Inc.: Employment, Equity Ownership.

Health resource utilization and patient burden associated with SREs in a randomized controlled trial setting.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19514-e19514
Author(s):  
Jean-Jacques Body ◽  
Roger Von Moos ◽  
Fred Saad ◽  
Gary Edward Richardson ◽  
Janet Elizabeth Brown ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Solid Tumors ◽  
Resource Utilization ◽  
Index Date ◽  
Controlled Trial ◽  
Pathologic Fracture ◽  
Cord Compression ◽  
Health Resource ◽  
Health Resource Utilization ◽  
Medical Visits

e19514 Background: Bone metastases (BM) are common in patients (pts) with solid tumors and may result in skeletal related events (SREs) such as spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiation to bone (RT). SREs result in significant morbidity, debilitating pain, decreased health-related quality of life and increased health resource utilization (HRU). Data from 3 registrational phase 3 trials that showed superiority of denosumab over zoledronic acid in patients with solid tumors and BM were combined to assess HRU associated with different SRE types. Methods: Data through 41 weeks for pts with solid tumors and ≥ 1 BM enrolled in these randomized, active-controlled trials were included in this posthoc analysis. HRU were evaluated by SRE type and data were compared between pts with ≥ 1 on-study SRE and those not experiencing an on-study SRE. The index date for pts with on-study SREs was defined as the date that the first SRE was reported. The median time from randomization to incidence of first SRE for each SRE type was used to establish an index date for the control (no SRE) group. The HRU window encompassed a 3-month period (i.e.1 month before and 2 months after the index date) and was assessed by mean number of various types of medical visits during this window. Results: Data from 5,543 pts were included. PF was the most common type of first SRE (n=1,017), followed by RT (n=940), SCC (n=156), and SB (n=74). 3,618 pts did not have an on-study SRE. For all types of medical visits, HRU was higher for pts with an on-study SRE than those without (Table). Conclusions: SREs are associated with increased health resource utilization, reflecting an increased burden for patients with solid tumors and bone metastases. [Table: see text]

scholarly journals Socioeconomic Factors and Survival of Multiple Myeloma Patients

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 590
Author(s):  
Kamal Chamoun ◽  
Amin Firoozmand ◽  
Paolo Caimi ◽  
Pingfu Fu ◽  
Shufen Cao ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Socioeconomic Factors ◽  
Hematopoietic Cell Transplantation ◽  
Financial Burden ◽  
Private Insurance ◽  
Median Income ◽  
The Us ◽  
Medicare Patients ◽  
Insured Patients ◽  
Privately Insured

Background: Outcome of Multiple Myeloma (MM) patients has improved as the result of the introduction of novel medications and use of autologous hematopoietic cell transplantation. However, this improvement comes at the expense of increased financial burden. It is largely unknown if socioeconomic factors influence MM survival. Methods: We used the National Cancer Database, a database that houses data on 70% of cancer patients in the US, to evaluate the effect of socioeconomic factors on the survival of 117,926 MM patients diagnosed between 2005 and 2014. Results: Patients aged ≥65 years who were privately insured lived longer than patients with Medicare (42 months vs. 31 months, respectively, p < 0.0001). Treatment in academic institutions led to better survival (HR: 1.49, 95% CI: 1.39, 1.59). Younger age, fewer comorbidities, treatment in academic centers, and living in a higher median income area were significantly associated with improved survival. After adjusting for confounders, survival of Medicare patients was similar to those with private insurance. However, the hazard of death remained higher for patients with Medicaid (HR: 1.59, 95% CI: 1.36, 1.87) or without insurance (HR: 1.62, 95% CI: 1.32, 1.99), compared to privately insured patients. Conclusion: Economic factors and treatment facility type play an important role in the survival of MM patients.

scholarly journals Extrapolation of pharmacokinetics and pharmacodynamics of sunitinib in children with gastrointestinal stromal tumors

2021 ◽  
Author(s):  
Reza Khosravan ◽  
Steven G. DuBois ◽  
Katherine Janeway ◽  
Erjian Wang
Keyword(s):  
Body Size ◽  
Solid Tumors ◽  
Gastrointestinal Stromal Tumors ◽  
Drug Exposure ◽  
Tumor Type ◽  
Plasma Drug ◽  
Safety And Efficacy ◽  
Stromal Tumors ◽  
Mixed Effects Modeling ◽  
Starting Dose

Abstract Purpose The starting dose of sunitinib in children with gastrointestinal stromal tumors (GIST) was extrapolated based on data in adults with GIST or solid tumors and children with solid tumors. Methods Integrated population pharmacokinetics (PK), PK/pharmacodynamics (PD), and exposure–response analyses using nonlinear mixed-effects modeling approaches were performed to extrapolate PK and PD of sunitinib in children with GIST at projected dose(s) with plasma drug exposures comparable to 50-mg/day in adults with GIST. The analysis datasets included PK/PD data in adults with GIST and adults and children with solid tumors. The effect of covariates on PK and safety/efficacy endpoints were explored. Results Two-compartment models with lag time were successfully used to describe the PK of sunitinib and its active metabolite SU012662. PK/PD models were successfully built to describe key continuous safety and efficacy endpoints. The effect of age on sunitinib apparent clearance (CL/F) and body surface area on SU012662 CL/F was statistically significant (P ≤ 0.001): children who were younger or of smaller body size had lower CL/F; however, age and body size did not appear to negatively affect safety or efficacy response to plasma drug exposure. Conclusion Based on PK, safety, and efficacy trial simulations, a sunitinib starting dose of ~ 25 mg/m2/day was predicted to provide comparable plasma drug exposures in children with GIST as in adults with GIST treated with 50 mg/day. However, in the absence of a tumor type effect of sunitinib on CL/F in children, the projected equivalent dose for this population would be ~ 20 mg/m2/day.

Real-world treatment patterns in relapsed/refractory multiple myeloma: Clinical and economic outcomes in patients treated with pomalidomide or daratumumab

2021 ◽  
pp. 107815522199553
Author(s):  
Joshua Richter ◽  
Vamshi Ruthwik Anupindi ◽  
Jason Yeaw ◽  
Suneel Kudaravalli ◽  
Stojan Zavisic ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Treatment Options ◽  
Proteasome Inhibitors ◽  
Economic Outcomes ◽  
Office Visits ◽  
Refractory Multiple Myeloma ◽  
Kaplan Meier ◽  
Real World Evidence ◽  
New Treatment

Introduction Real-world evidence on later line treatment of relapsed/refractory multiple myeloma (RRMM) is sparse. We evaluated clinical outcomes among RRMM patients in the 1-year following treatment with pomalidomide or daratumumab and compared economic outcomes between RRMM patients and non-MM patients. Patient and Methods Adult patients with ≥1 claim of pomalidomide or daratumumab were identified between January 2012 and February 2018 using IQVIA PharMetrics® Plus US claims database. Patients were required to have a diagnosis or treatment for MM and a claim of any immunomodulatory drugs and proteasome inhibitors before the index date. Mean time to new therapy, overall survival (OS) using Kaplan-Meier curve and adverse events (AEs) were reported over the 1-year post-index period. RRMM patients were also matched to a non-MM comparator cohort and economic outcomes were compared between the two cohorts. Results 289 RRMM patients were matched to 1,445 patients without MM. Most prevalent hematological AE was anemia (72.0%) and non-hematological AE was infections (75.4%). Mean (SD) time to a new treatment was 4.7 (5.3) months and median OS was 14.6 months. RRMM patients had significantly higher hospitalizations and physician office visits (Both P < .0001) compared to non-MM patients. Adjusting for baseline characteristics, patients with RRMM had 4.9 times (95% CI 3.8-6.4, P < .0001) the total healthcare costs compared with patients without MM. The major driver of total costs among RRMM patients was pharmacy costs (67.3%). Conclusion RRMM patients showed a high frequency of AEs, low OS, and a substantial economic burden suggesting need for effective treatment options.

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