Time Spent at Home Among Older Adults with AML Treated with Hypomethylating Agents and Venetoclax

Abstract Introduction The prognosis for older adults with acute myeloid leukemia (AML) is poor. Of approximately 12,000 adults age ≥ 60 diagnosed with AML in the U.S. annually, less than 40% survive 1 year from diagnosis. Prior research has shown that adults with AML feel time at home is a critical consideration in treatment selection. However, to date, no study has adequately described the amount of time older adults can expect to spend at home following initiation of AML therapy. In this study, we aimed to (1) quantify this time and (2) assess the impact of venetoclax (VEN) combination therapy on time at home for older adults with AML. Methods We queried records from University of North Carolina Health to identify individuals age ≥ 60 newly diagnosed with AML from 2015 to 2020. First-line AML therapy was identified, and those receiving azacitidine (AZA) and/or VEN were included. Dates of diagnosis, first remission, death, last follow up, and all oncology clinic / emergency department (ED) / inpatient encounters were captured. Patients with incomplete records were excluded. The primary outcome was proportion of days at home (PDH). PDH was calculated for each patient by subtracting the number of care days (days hospitalized or seen in an ED / oncology clinic / infusion center) from the total days of follow up, divided by total days of follow up. Overall survival (OS) was calculated via the Kaplan-Meier method. Covariates including demographics and disease risk (per European Leukemia Net 2017) were captured. PDH was evaluated via summary statistics for the full cohort and stratified by each categorical variable, both for the full follow up period and on a month-by-month basis among survivors. Associations between PDH and covariates were further assessed via linear regression with adjustment for length of follow up, with significance assessed via Wald Chi-square test. Results From 2015-2020, 137 older adults receiving first-line AZA and/or VEN were identified. 24 were excluded due to incomplete records. Among the remaining 113, mean age was 76 (range 60-99), 80.4% were white, and 43.4% were female. Most received AZA+VEN (51.3%) followed by AZA monotherapy (39.0%) and other VEN-containing combinations (9.7%). The majority had adverse-risk AML (61.3%). Baseline covariates including age and ELN risk were similar across therapy groups. Over the full follow up period, mean PDH was 0.58 (95% confidence interval 0.54-0.63) with a median of 0.63. PDH was similar among those with adverse-risk (mean 0.55, CI 0.49-0.61) and intermediate-risk AML (0.64, CI 0.56-0.72). PDH did not differ among therapy groups: AZA+VEN (0.60, CI 0.54-0.66), AZA alone (0.57, CI 0.49-0.66), and other VEN-containing regimens (0.54, CI 0.40-0.69). When adjusted for length of follow up, no covariate had a significant association with PDH (all p > 0.05). When evaluated month-by-month, the proportion of days at home rose over time among survivors. For example, of patients who survived the full month, mean PDH was 0.51 (CI 0.47-54, n = 105) in month 1 following diagnosis and 0.77 (CI 0.72-0.82, n = 57) in month 6. Figure 1 summarizes person-days at home or engaged in care for 12 months following diagnosis (including contributions from those who did not survive the full month). 34.5% of patients achieved composite complete remission, with higher rates among those receiving AZA+VEN (51.7%) than AZA alone (13.6%) (OR 6.8, p = 0.0002). Median OS was 0.64 years (CI 0.32 - 0.91) and was similar across therapy groups. Conclusion Burden of care for older adults with AML treated with first-line AZA or VEN is high. These individuals spend nearly half (cohort mean 42%) of days following diagnosis engaged in oncology care. In randomized studies, the addition of VEN to AZA improves OS and increases remission rates though results in higher rates of neutropenic fever. Although this study may be underpowered to detect small differences, the superior remission rates with AZA+VEN did not translate to more days at home, perhaps due to increased admissions for neutropenic fever and office/infusion visits. Given the importance of time at home to older adults with AML identified in prior research, these data provide new information to support shared decision making regarding treatment options. Future prospective trials should evaluate burden of care, including time at home, as an endpoint. While awaiting these data, larger analyses of the impact of treatment regimen on burden of care would be useful. Figure 1 Figure 1. Disclosures Bryant: Carevive: Consultancy, Research Funding; Jazz Pharmaceuticals: Consultancy, Research Funding; Servier Pharmaceuticals: Honoraria, Speakers Bureau. Coombs: Alexion Pharmaceuticals: Research Funding; Machaon Diagnostics: Research Funding. Foster: Macrogenics: Research Funding; Rafael Pharmaceuticals: Research Funding; Macrogenics: Consultancy; Daiichi Sankyo: Consultancy; Agios: Consultancy; Bellicum Pharmaceuticals: Research Funding.

Download Full-text

The Outcome of Treatment-Free Remission after First-Line Nilotinib or Dasatinib in Chronic Phase Chronic Myeloid Leukemia Patients Is Different

Blood ◽

10.1182/blood-2021-146722 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 2552-2552

Author(s):

Franck E. Nicolini ◽

Vincent Alcazer ◽

Stephanie Dulucq ◽

Sandrine Hayette ◽

Jean-Michel Cayuela ◽

...

Keyword(s):

Board Of Directors ◽

Research Funding ◽

Chronic Phase ◽

Median Dose ◽

First Line ◽

Advisory Committees ◽

French Group ◽

Treatment Free Remission ◽

The Impact

Abstract Aims: The absolute number of chronic phase CML patients (pts) reaching the treatment-free remission (TFR) criteria has been substantially increased by the use of second-generation TKI (TKI2), initiated since diagnosis, comparing to Imatinib first-line. However, the relative rate of unsuccessful TFR (i. e. pts loosing their MMR after TKI2 cessation) still remains around 50% at 2 years and beyond, whatever the TKI2 was. The aim of this study is to analyse the rate of successful TFR in pts receiving Nilotinib (Nilo) or Dasatinib (Dasa) first-line obtaining the appropriate criteria. Methods: Observational retrospective study in 3 reference centers of the French group of CML lead between 2010 and 2021. Eligible pts were CP CML pts initiating either Nilo 300 mg BID or Dasa 100 mg daily since diagnosis, until cessation for sustained MR4.5 (i.e. ≥2 years on ≥4 datapoints). Data were retrospectively collected according to the national regulations with pts' information. All pts were assessed and followed according to ELN recommendations 2009, 2013 and 2020 along treatment and to the recommendations from the French group of CML (D. Rea et al., Cancer 2018) for TFR. In this regard, the TKI2 was resumed in case of loss of MMR. All BCR-ABL1 assessments were performed in the 3 reference laboratories, standardised and expressed in % (IS) with ≥32,000 copies of ABL1 as control. All patients were harbouring major BCR-ABL1 transcripts. The primary endpoint was the survival without loss of MMR after TKI2 cessation. The secondary endpoints were the kinetics of MMR loss, and the identification of factors influencing MMR loss. Results: Seventy-two pts were reported (47 Nilo, 25 Dasa) with 57% females with a median age at diagnosis of 48 (36.75-61.25) years. The median follow-up since diagnosis was 9.26 (3.75-13.75) years (8.8 for Nilo and 9.47 for Dasa p=ns) and after TKI2 cessation 3.94 (0.7-8.8) years (3.92 for Nilo and 3.90 for Dasa p=ns). Sokal scores were 42% Low, 41% Intermediate, 17% High in Nilo and 39% L, 25% I and 35% H in Dasa pts (p=ns). ELTS scores were 50% L, 22% I, 9.5% H (18.5% Uk) in Nilo and 46.5% L, 28.5% I and 3.5% H (21.5% Uk) in Dasa pts (p=0.95). Five (9%) pts harboured ACA at diagnosis in the Nilo group and 2 (7%) in the Dasa group (p=1.00). The median time from TKI2 initiation to sustained MR4.5 was 19 (3.12-36) months in the Nilo group and 16 (6.3-39) months in the Dasa group (p=0.644). The duration of sustained MR4.5 until cessation was 3.04 (1.5-9.3) years for Nilo and 2.65 (1.11-7.95) for Dasa (p=0.96). The median dosing of Nilo was 600 (300-800) mg daily and 80 (20-100) mg at TKI2 cessation. None of these patients switched to another TKI during the follow-up. TKI2 cessation occurred after 60.5 (43-74.5) months in the Nilo group and 68 (39-90) months in the Dasa group (p=0.581). Thirty-seven pts out of 47 (79%) were BCR-ABL1 undetectable at Nilo cessation 18/25 (72%) at Dasa cessation (p=0.60). At M3 after discontinuation, 58% of pts remained undetectable after Nilo cessation and 30.4% after Dasa cessation (p=0.05).The median survival of pts without loss of MMR was not reached in the Nilo group, and was 14 (4.73-NR) months in the Dasa group, (p=0.042) as analysed by the KM method (Figure 1.). Two patients died (1 Nilo, 1 Dasa) from competing events (solid tumours) after unsuccessful TFR. Twenty-eight pts (14 Dasa, 14 Nilo) restarted their TKI2 after MMR loss and all regained ≥ MMR after 3 months of Dasa at a median dose of 75 (40-100) mg daily and all except one (who regained MMR at M12) after resumption of Nilo at a median dose of 350 (300-600) mg daily. Univariate analysis identified pts with H+I Sokal (as compared to low) as an unfavourable factor for successful TKI2 cessation [HR=0.35 (0.15-0.83), p=0.017] and type of TKI2 (Nilo as reference vs Dasa) was discriminant [HR=2.1 (1.01-4.35), p=0.047]. Multivariate analysis identified the type of TKI2 as a significant factor impacting on TFR outcome [HR 2.11 (0.97-4.55], p=0.05]. Conclusions: As it is likely that no prospective head-to-head comparison will be performed in this setting, on this limited series of pts, we conclude that the outcome of TFR seems to be different according to the TKI2 used since diagnosis, suggesting the impact of distinct biological variables modified by the type of TKI2 on the long run (such as immunological system, BM micro-environment, others) on TFR outcome. Figure 1 Figure 1. Disclosures Nicolini: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel, accommodations, expenses, Research Funding; Kartos Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sun Pharma Ltd.: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria; Incyte Biosciences: Honoraria, Other: travel, accommodations, expenses, Research Funding, Speakers Bureau. Etienne: Incyte: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau. Rea: Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees.

Download Full-text

Chemoimmunotherapy for Patients with Chronic Lymphocytic Leukemia: MD Anderson Experience Beyond FCR300

Blood ◽

10.1182/blood.v128.22.2047.2047 ◽

2016 ◽

Vol 128 (22) ◽

pp. 2047-2047 ◽

Cited By ~ 1

Author(s):

Dai Chihara ◽

Philip A Thompson ◽

Hagop M. Kantarjian ◽

Susan M. O'Brien ◽

Alessandra Ferrajoli ◽

...

Keyword(s):

Cumulative Incidence ◽

Research Funding ◽

Risk Model ◽

Lymphocytic Leukemia ◽

Cox Proportional Hazards Model ◽

High Dose ◽

First Line ◽

Ighv Gene ◽

The Impact

Abstract Background: Novel, targeted therapies, such as ibrutinib, have transformed outcomes for patients with relapsed CLL and for older and unfit patients in the first-line setting. However, chemoimmunotherapy (CIT) remains the standard-of-care in fit patients. We reported that a subgroup of patients with IGHV mutated CLL experience prolonged PFS and potential cure after first-line CIT withfludarabine, cyclophosphamide and rituximab (FCR). However, FISH data was not available for this cohort of patients. Accurate knowledge of which patients are likely to experience prolonged PFS after FCR is essential to better select patients who may benefit from CIT in the era of novel therapies. Patients and Methods: We analyzed 492 patients who were treated on six clinical trials of first-line CIT between 2004 and 2015. Treatments were FCR, (n=277) FCR with high dose rituximab (n=65), FCR plusmitoxantrone (n=30), FCR plusalemtuzumab (n=60) and FCR with GM-CSF (n=60). Progression-free survival (PFS) and overall survival (OS) were calculated and pretreatment characteristics were evaluated for association with survival outcomes using a Cox Proportional Hazards model. Cumulative incidence was calculated by competing risk (death without event) regression analysis. Results: The median age of patients was 59 (range 28-84). Sixty-seven percent of the patients were male, 33% of the patients had mutated IGHV gene. Thirty percent of patients had del(13q), 19% had Trisomy12, 21% had del(11q), 8% had del(17p) and 21% were negative by FISH. Fifty-nine percent of patients received six cycles of CIT. With a median follow up duration of 6.2 years, the median PFS and OS were 6.3 years and not reached, respectively. Recently reported risk model by Rossi and colleagues using IGHV mutation status and FISH results (Blood 2015) discriminated PFS very well; 5-year PFS for low risk {mutated without del(11q)}, intermediate risk {unmutated or del(11q)} and high risk group {del(17p)} were 81%, 45% and 22%, respectively. Of note, there was a plateau in PFS after 8 years in patients with mutated IGHV gene, with 10-year PFS of 63% (Figure A). There was a significantly improved OS after relapse by the time. Three-year OS in patients who started salvage chemotherapy in 2004 to 2012 and 2012 to 2016 were 59% and 83%, respectively, suggesting the impact of improved salvage treatment options, particularly B cell signaling pathway inhibitors (Figure B). Five-year cumulative incidence of Richter transformation (RT) and AML/MDS was 4.8% and 4.2%, respectively (Figure C, D). There was a difference in onset for these two complications; 52% of RT occurred within 2 years, while 62% of AML/MDS occurred in 2-4 years after CIT. Overall, 110 patients (22.4%) died during the follow-up; the three major causes of death were CLL progression (4.9%), Richter transformation (3.7%) and AML/MDS (3.3%). Conclusion: Patients with mutated IGHV gene and who do not have del(11q) or del(17p) have favorable outcomes and demonstrate a plateau on the PFS curve, consistent with prior studies. Effective salvage therapy has improved outcomes at relapse, but the development of RT and AML/MDS remain major causes of mortality in CLL patients. Given favorable outcomes for patients with mutated IGHV gene treated with FCR, further studies are warranted to identify predictors of non-response among the mutated patients, risk factors for development of AML/MDS and RT and whether choice of first-line therapy can modulate this risk. Disclosures Thompson: Pharmacyclics: Consultancy, Honoraria. O'Brien:Janssen: Consultancy, Honoraria; Pharmacyclics, LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding. Jain:Servier: Consultancy, Honoraria; Novimmune: Consultancy, Honoraria; Incyte: Research Funding; Celgene: Research Funding; ADC Therapeutics: Consultancy, Honoraria, Research Funding; Genentech: Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Seattle Genetics: Research Funding; Novartis: Consultancy, Honoraria; Abbvie: Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding; BMS: Research Funding; Infinity: Research Funding. Wierda:Abbvie: Research Funding; Novartis: Research Funding; Acerta: Research Funding; Gilead: Research Funding; Genentech: Research Funding.

Download Full-text

A Single-Institution Retrospective Cohort Study of Patients Treated with R-EPOCH for Richter's Transformation of Chronic Lymphocytic Leukemia

Blood ◽

10.1182/blood.v126.23.2951.2951 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2951-2951 ◽

Cited By ~ 3

Author(s):

Kerry A. Rogers ◽

Galena Salem ◽

Deborah M. Stephens ◽

Leslie A. Andritsos ◽

Farrukh T. Awan ◽

...

Keyword(s):

B Cell ◽

Research Funding ◽

Performance Status ◽

B Cell Lymphoma ◽

Neutropenic Fever ◽

Lymphocytic Leukemia ◽

Aggressive Lymphoma ◽

First Line ◽

Ecog Performance Status

Abstract Background: Richter's transformation (RT), the occurrence of an aggressive lymphoma in patients with prior chronic lymphocytic leukemia (CLL), occurs in up to 10% of CLL patients. Anthracycline-based chemoimmunotherapy remains standard, but outcomes are poor (median survival approximately 12 months). R-EPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) has demonstrated superior efficacy to R-CHOP in HIV-associated diffuse large B-cell lymphoma, Burkitt's lymphoma, and primary mediastinal B-cell lymphoma. We conducted a single-institution retrospective cohort study to characterize efficacy and toxicity of R-EPOCH as first-line treatment for RT. Methods: The study included patients treated with R-EPOCH as first-line therapy for histologically confirmed RT at the Ohio State University between January 1st 2006 and May 31st 2014. Characteristics of the CLL and RT, ECOG performance status, and laboratory assessment of bone marrow and organ function were abstracted from medical records. Toxicity of R-EPOCH was assessed by reviewing the frequency of adverse events (AE). R-EPOCH treatment outcomes were assessed as documented by the treating physician and not secondarily verified. Progression free survival (PFS) and overall survival (OS) durations were calculated from date of Richter's biopsy until date of event (PFS: relapse/death; OS: death), censoring patients without event at last follow-up. PFS and OS estimates were obtained using the Kaplan-Meier method. Univariable proportional hazards models were used to model PFS and OS as a function of each clinical variable. Results: The study included 46 patients. Median age at RT diagnosis was 67 (range 38-83). Median number of months from CLL to RT diagnosis was 53 (range 0.4-198). A median of 3 (range 0-13) prior CLL treatments had been given with 10 (22%) patients receiving ibrutinib as the most recent. The majority of patients where CLL risk was evaluable demonstrated poor-risk disease: 24/43 (56%) complex karyotype, 20/41 (49%) del(17)(p13.1), 27/32 (84%) unmutated IGHV. The majority of evaluable patients had an ECOG performance status of 0 or 1 (18/28, 64%). Table 1 shows RT characteristics for these patients. Treatment with R-EPOCH was started a median of 5 days after RT diagnosis (range 0-110). The majority of patients did not complete 6 cycles: 16 (35%) completed 1 cycle, 10 (22%) 2 cycles, 5 (11%) 3 cycles, 4 (9%) 4 cycles, 2 (4%) 5 cycles, and 9 (19%) 6 cycles. Of 131 cycles given, 114 (87%) were fully evaluable for AE with results in table 2. Outcome of R-EPOCH treatment was known for 44 patients: 9 (20%) achieved complete response, 8 (18%) clinical response documented by the treating physician, 14 (32%) progressive disease, and 13 (30%) died without (known) lymphoma progression. With a median follow up of 39 (range 13-54) months, 9 (20%) patients were alive without lymphoma progression. All patients with lymphoma progression died. Median PFS was 3.5 months (95% CI: 2.0-7.6) and median OS was 5.9 months (95% CI: 3.2-10.3) (Figure 1). In univariable analysis, risk of death was higher for patients with complex CLL karyotype (HR 4.38, p=0.0002), del(17)(p13.1) (HR 3.04, p=0.003), higher number of CLL treatments (HR 1.16, p=0.004), higher bilirubin (HR 1.68, p=0.04), and higher serum creatinine (HR 1.65, p=0.05). Conclusions: Patients with RT treated with first-line R-EPOCH had poor PFS (median 3.5 months) and OS (median 5.9 months) with only 20% of patients alive at last follow up. Characteristics of underlying CLL influenced outcomes of R-EPOCH with worse PFS and OS in deletion 17p and complex karyotype patients. Better therapies for RT are urgently needed, especially in patients with poor risk CLL. Table 1. Characteristics of Aggressive Lymphoma n=46 Histology, no. (%)- Large Cell- Early large-cell/Prolymphocytic- Plasmablastic (EBV+)- High-grade B-cell 42 (91) 2 (4) 1 (2) 1 (2) Extranodal Disease- Yes- No 20 (43) 26 (57) Bulky Disease, no. (%)- Yes ≥5, <10 cm- Yes ≥10 cm- No- Unknown 16 (42) 8 (21) 14 (37) 8 Table 2. Adverse Events by Cycle Cycle 1 (n=40) Cycle 2 (n=29) Cycle 3 (n=15) Cycle 4 (n=12) Cycle 5 (n=11) Cycle 6 (n=7) Any AE* Infection Neutropenic Fever Hospitalization ICU Stay 29 (72%) 14 14 14 4 17 (59%) 7 4 7 0 7 (47%) 1 0 1 0 4 (33%) 1 0 1 0 2 (18%) 1 1 1 0 1 (14%) 0 0 1 0 *Hospitalization, infection, neutropenic fever, non-neutropenic fever, ICU stay, transfusion, mucositis, fatigue requiring treatment delay, and ileus. Disclosures Stephens: Immunomedics: Research Funding; Acerta Pharma BV: Research Funding. Byrd:Acerta Pharma BV: Research Funding. Maddocks:Janssen: Research Funding; Novartis: Research Funding; Pharmacyclics: Consultancy, Research Funding. Jones:AbbVie: Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Research Funding.

Download Full-text

Use of Statins, Survival and Incidence of Thrombosis Among Older Adults with Polycythemia Vera: A Population-Based Study

Blood ◽

10.1182/blood-2018-99-119272 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 3580-3580

Author(s):

Nikolai Podoltsev ◽

Mengxin Zhu ◽

Rong Wang ◽

Amer M. Zeidan ◽

Xiaoyi Wang ◽

...

Keyword(s):

Older Adults ◽

Overall Survival ◽

Research Funding ◽

Jak2 V617f ◽

Population Based ◽

Competing Risk ◽

Rank Test ◽

Part D ◽

The Impact

Abstract Introduction: Patients with myeloproliferative neoplasms (MPN) are at increased risk for cardiovascular morbidity and mortality with the highest risk among polycythemia vera (PV) patients. MPN guidelines recommend aggressive management of cardiovascular risk factors which may include statin administration. Statins can induce apoptosis and inhibit JAK2-V617F-dependent cell growth in vitro, as well as inhibit erythropoietin-independent erythroid colony formation of primary cells from patients with MPN. JAK2-V617F mutation is a common somatic event occurring in over 95% of PV patients. There is no published data regarding the impact of statins on the outcomes of PV patients. Methods: Using the Surveillance, Epidemiology, and End Results-Medicare linked database, we assembled a population-based cohort of older adults who were diagnosed with PV during 2007-2013 and fulfilled the following eligibility criteria: 1) aged 66-99 years at diagnosis; 2) had continuous Medicare Parts A and B coverage and not enrolled in health maintenance organizations from 12 months before diagnosis to death or the end of study (12/31/2014), whichever was earlier (i.e., the end of follow up); and 3) continuously enrolled in Medicare Part D from 6 months before diagnosis to end of follow up. Patients were identified as statin users if they had any prescription for statins in Part D claims from their PV diagnosis to the end of follow up. For both statins and hydroxyurea (HU, a common treatment of PV), percentage of days covered (PDC) was defined as the percentage of days from diagnosis to the end of follow-up covered by respective prescriptions. We further classifed statins as lipophilic or hydrophilic. Therapeutic phlebotomy intensity was defined based on the number of phlebotomies per year (>0 but < 3: low intensity, ≥3: high intensity). Log-rank tests were used to compare Kaplan-Meier (K-M) curves between statin users and non-users with regard to overall survival and risk of thrombosis after PV diagnosis. Multivariate Cox proportional hazards models were used to assess the impact of statins use on overall survival. Multivariate competing risk models with death as a competing risk were utilized to evaluate the relationship between statin PDC and thrombosis risk. All multivariate models adjusted for HU PDC, phlebotomy intensity, age, sex, race, state buy-in, influenza vaccination 12 months prior to PV diagnosis (a marker for healthcare access), disability status, modified Elixhauser score for comorbidities, and previous thrombosis. All statistical tests were two-sided and conducted with SAS (Version 9.4). Results: Of the 721 PV patients included in this study (median age = 77 years, interquartile range: 71-83 years), a majority were female (56.7%) and white (91.4%) (Table 1). About 55% of patients used statins, and 72.9% of the 395 users (n=288) started before PV diagnosis. The median statin PDC was 67% among statin users, and most patients (n=361, 91.4%) used only one type of statins (lipophilic: n=295; hydrophilic: n=65). With a median follow-up of 2.75 years, 26.1% (n=103) of statin users and 47.9% (n=156) of statin non-users died; users (median: 6.65 years) had a significantly better overall survival than non-users (median: 3.86 years Log rank test, p<.01) (Figure 1). Adjusting for covariates, every 10% of statin PDC after PV diagnosis was associated with an 18% lower risk of all cause mortality (95% confidence interval [CI]: 0.78-0.86; p<.01). The magnitude of association was very similar for lipophilic and hydrophilic statins. Thrombosis after PV diagnosis was recorded in 257 (35.6%) patients, 177 of whom had arterial thrombosis. One hundred and eighteen (33.4%) statin users and 139 (37.8%) non-users had thrombosis after PV diagnosis. The risk of thrombosis was significantly lower in statin users than in non-users based on Log-rank test (p=.04) (Figure 2) and multivariable competing risk model (every 10% of statin PDC was associated with a 5% lower risk of thrombosis (95% CI: 0.92-0.99; p<.01). Subgroup analyses for lipophilic and hydrophilic statins generated almost identifical results. Sensitivity analyses that only included patients who started using statins after PV diagnosis revealed similar findings pertaining to both survival and thrombosis. Conclusions: In this large population-based cohort study of older adults with PV, use of statins was associated with improved survival and decreased risk of thrombosis. Disclosures Podoltsev: Alexion: Consultancy, Honoraria; Astellas Pharma: Research Funding; Sunesis Pharmaceuticals: Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Astex Pharmaceuticals: Research Funding; Daiichi Sankyo: Research Funding; Celgene: Research Funding; CTI biopharma: Research Funding; Boehringer Ingelheim: Research Funding; Celator: Research Funding. Zeidan:Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Otsuka: Consultancy, Honoraria; Takeda: Honoraria, Speakers Bureau; Celgene: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Agios: Consultancy, Honoraria. Davidoff:Celgene: Research Funding. Huntington:Janssen: Consultancy; Bayer: Consultancy; Celgene: Consultancy. Gore:Celgene: Consultancy, Research Funding. Ma:Incyte: Consultancy; Celgene: Consultancy, Research Funding.

Download Full-text

Role of Neutrophil Lymphocyte Ratio [NLR] As a Biomarker of Frailty and Predictor of Survival Among Older Adults with Multiple Myeloma (MM)

Blood ◽

10.1182/blood-2020-143290 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 6-6

Author(s):

Smith Giri ◽

Susan Bal ◽

Kelly N. Godby ◽

Joshua Richman ◽

Adam J Olszewski ◽

...

Keyword(s):

Older Adults ◽

Overall Survival ◽

Research Funding ◽

First Line ◽

Targeted Interventions ◽

First Line Therapy ◽

Systems Research ◽

Line Therapy ◽

Race Ethnicity ◽

The Impact

Introduction: NLR combines a marker of inflammation (neutrophilia) and immune senescence (lymphopenia) to reflect aging related alterations in the immune systems. Prior studies have shown that NLR can serve as a marker of frailty and predict survival among older adults with solid tumors and lymphomas, its role among older adults with MM remains unclear. Methods: We used the Flatiron Health electronic health record-derived de-identified database to source older adults (age ≥60y) with incident MM diagnosed between 1/1/2011 and 2/1/2020. We limited our study cohort with known first line therapy and absolute neutrophil and lymphocyte count (cells//µL) up to 90 days before the start of treatment. We constructed a modified frailty index (Facon et al Leukemia 2020) at MM diagnosis combining age, comorbidity and ECOG performance status, captured within 90 days from the start of first line therapy categorizing patients into frail vs nonfrail. We examined the association between NLR (stratified into quartiles, Q1-Q4) and frailty using logistic regression model adjusted for age, sex and race/ethnicity. We used Kaplan Meier methods and multivariable Cox regression to assess the impact of NLR on overall survival adjusting for age, sex, race/ethnicity, international staging system (ISS) stage, high-risk cytogenetics (HRCA; del17p, t4;14 or t14;16), and first-line therapy. Results: Of 2792 eligible patients, the median age at MM diagnosis was 73y (IQR: 67-78y), with 53% males and 61% non-Hispanic whites. Of these, 56% had IgG isotype, 22% ISS stage-III and 13% had HRCA. The median NLR was 2.29 (IQR: 1.5 to 3.59). Of the 1,743 evaluable for frailty, 1042 patients (59.8%) were frail. Overall, 45% received proteasome inhibitor (PI) + Immunomodulatory agent (Imid) based first line therapy and 19% received autologous stem cell transplantation. Patients in the highest NLR quartile were at a 2.1-fold higher odds of being frail (95% CI 1.52-2.86; p <0.001) when compared with those in the lowest NLR quartile (after adjusting for age, sex and race/ethnicity). NLR was poorly correlated with age (Pearson's r= 0.02). Patients in the highest NLR quartile had an inferior overall survival vs those in the lowest quartile (median OS/3y-OS in Q4 3.3y/53% vs 4.7y/69% in Q1; log-rank p <0.01). Similar results were seen when limiting to patients receiving first line PI & Imid triplet and PI or Imid based doublet regimens (Fig 1). In a multivariable analysis, patients in the highest NLR quartile had a 1.5 times increased hazards of death (95% CI 1.28-1.85, p <0.001) when compared with those in the lowest NLR quartile, after adjusting for potential confounders (Table 1). Conclusion: NLR is an easily available laboratory biomarker associated with frailty as well as inferior overall survival among older adults with MM. Future studies should explore its value as a screening tool to identify frail older adults with MM and guide appropriate treatment selection and targeted interventions to prevent excess toxicities and improve outcomes. Table 1 Disclosures Giri: Pack Health: Research Funding; Carevive Systems: Research Funding; Carevive Systems: Honoraria. Olszewski:Genentech, Inc.: Research Funding; Spectrum Pharmaceuticals: Research Funding; TG Therapeutics: Research Funding; Adaptive Biotechnologies: Research Funding. Costa:Amgen: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria; AbbVie: Consultancy; Celgene: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Genentech: Consultancy.

Download Full-text

Oral Fludarabine and Intravenous Rituximab (FR) for Chronic Lymphocytic Leukemia (CLL): Long Term Outcomes and Secondary Malignancies in 673 Patients Treated in British Columbia (BC)

Blood ◽

10.1182/blood-2019-125189 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 4300-4300

Author(s):

Elysha Vanderveer ◽

Steven J.T. Huang ◽

Helene Bruyere ◽

Tanya Gillan ◽

Charles H. Li ◽

...

Keyword(s):

Median Time ◽

Research Funding ◽

Secondary Malignancies ◽

Long Term Outcomes ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

The Impact

Background: Oral fludarabine and intravenous rituximab (FR) was the standard first-line therapy for CLL or small lymphocytic lymphoma (SLL) patients (pts) in BC from 2003-2015. Ibrutinib for relapsed/refractory (R/R) CLL was introduced and publicly funded in 2015. Our aim was to review long term outcomes of all CLL/SLL pts treated with FR in BC, including the impact of 2nd line therapy with ibrutinib versus chemoimmunotherapy and to report the risk of secondary malignancies in this population based cohort. Methods: The BC Provincial CLL Database was used to identify all CLL/SLL pts who received first-line FR from 2003-2017. The BC Cancer Registry was used to identify secondary malignancies occurring after FR. Primary outcomes were overall survival (OS) and treatment free survival (TFS), defined as start of FR to next-line therapy or death/last follow-up. Variables examined for impact on OS/TFS included age at FR, gender, primary diagnosis (CLL vs SLL), B symptoms, advanced stage (Rai stage 3-4 CLL, Ann Arbor 1-2 SLL), baseline hemoglobin, lymphocyte count, platelets, LDH and FISH abnormalities. All variables significant on univariate analyses (P<.1) were included in multivariate Cox proportional hazard regression models to identify significant predictors of OS/TFS. Results: 673 pts were identified as receiving FR as first-line therapy for CLL (86%) or SLL (14%). Median time from CLL/SLL diagnosis to FR was 2.5 years (y) (range 0.1-27.3). Median age at FR was 67 y (range 26-91) with 73% ≥ 60 y and 39% ≥ 70 y. Most pts were male (66.1%), had early stage disease (84.2%) with no B symptoms (89.7%) and normal LDH (81.1%). Of 411 pts with pre-treatment FISH testing, prevalence of FISH abnormalities were: 48.5% del13q, 25.7% trisomy 12, 12.9% del11q, 8.0% del17p. Median number of FR cycles was 6 (range 1-10). Median follow-up of living pts from FR was 6.4 y (range 0.2-12.7). 2 y and 5 y OS were 89.4% (95% CI: 86.8-91.6) and 73% (95% CI: 69.0-76.6) respectively; median OS 11.6 y (95% CI: 4.6-13.7 y). 2 y and 5 y TFS were 72% (95% CI: 68-75%) and 37% (95% CI: 33 - 41) respectively, median TFS 3.8 y (95% CI: 1.78-7.09). Those with del17p had significantly worse OS and TFS compared to those without (median OS 5.7 vs 13.7 y, P<.001; median TFS 1.4 vs 3.9 y, P<.001), Fig. 1. Multivariate analysis identified only del17p (HR 4.35, 95%CI: 2.10-9.01, P<.001) and age at FR (HR 1.04, 95% CI: 1.01-1.07, P=.007) as significant predictors of OS, and del17p (HR 4.3, 95% CI: 2.5-7.5, P<.001) as a significant predictor of TFS. During the follow up period, 351 pts (52%) went on to 2nd-line therapy: ibrutinib 87 (including 2 with BR and 1+R), cyclophosphamide-based (CVP/CHOP) +/- R 102, repeat FR 71, FCR 6, F alone 21, bendamustine +/-R 13, chlorambucil+/-R 38, steroids 3, R alone 3, alemtuzumab 2, other chemotherapy 3 and allotransplant 2. Median follow-up after 2nd-line therapy was 2.8 y (range 0.1-10.8). Median OS and TFS from 2nd-line treatment (TFS2) for ibrutinib (n=87) vs. for other treatments (n=264) was: OS not reached vs 5.3 y, P<.001; TFS2 not reached vs 1.2 y, P<.001. These significant differences persisted when analyses were restricted to those who received ibrutinib vs. chemoimmunotherapy (n=169): median OS not reached vs. 6.3 y (P=.002); median TFS not reached vs. 1.7 y (P<.001), Fig. 2. 2 y OS and TFS2 after ibrutinib were 91% (95% CI: 80-96%) and 78% (95% CI: 65-87%), respectively. A total of 202 malignancies were recorded after initiation of FR in 166 pts (24.7%), Table 1. The median time from FR to 2nd malignancy was 2.3 y (range 0.1-13.5). Richter's transformation (RT) occurred in 36 pts (5.3%) at median 1.9 y (range 0.1-13.2) from FR. Most frequent 2nd malignancies were: non-melanoma skin cancer (11.7%), lung (2.5%), colon (2.1%), other heme (1.9%), and prostate (1.8%). There were 4 cases of acute myeloid leukemia (AML), 2 of which received alkylator therapy after FR prior to AML diagnosis. Conclusions: In this large, homogeneous cohort of CLL/SLL pts treated with first-line FR, including nearly 40% of pts ≥ age 70, we demonstrate a short median TFS of 3.8 y; however, a long OS of 11.6 y. Rates of 2nd malignancies are low after this non-alkylator based chemoimmunotherapy regimen. Ibrutinib for R/R CLL/SLL after FR resulted in significantly improved survival over alternate therapy, with excellent 2 yr OS 91% and TFS 78%. These data demonstrate the efficacy of FR and the benefit of ibrutinib over chemoimmunotherapy as second-line therapy for CLL/SLL in the real-world. Disclosures Bruyere: Jenssen: Other: Travel Grant; Celgene: Honoraria. Villa:Roche, Abbvie, Celgene, Seattle Genetics, Lundbeck, AstraZeneca, Nanostring, Janssen, Gilead: Consultancy, Honoraria. Scott:Celgene: Consultancy; Roche/Genentech: Research Funding; Janssen: Consultancy, Research Funding; NanoString: Patents & Royalties: Named inventor on a patent licensed to NanoSting [Institution], Research Funding. Savage:BMS, Merck, Novartis, Verastem, Abbvie, Servier, and Seattle Genetics: Consultancy, Honoraria; Seattle Genetics, Inc.: Consultancy, Honoraria, Research Funding. Connors:Takeda Pharmaceuticals: Honoraria; Seattle Genetics: Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy. Sehn:TEVA Pharmaceuticals Industries: Consultancy, Honoraria; Acerta: Consultancy, Honoraria; Morphosys: Consultancy, Honoraria; F. Hoffmann-La Roche/Genentech: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Astra Zeneca: Consultancy, Honoraria; F. Hoffmann-La Roche/Genentech: Consultancy, Honoraria, Research Funding; Kite Pharma: Consultancy, Honoraria; Kite Pharma: Consultancy, Honoraria; Morphosys: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; TEVA Pharmaceuticals Industries: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Acerta: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Astra Zeneca: Consultancy, Honoraria. Gerrie:Lundbeck, Seattle Genetics: Consultancy, Honoraria.

Download Full-text

Restoring Functional Deficits in Older Adults with Hematologic Malignancy

Blood ◽

10.1182/blood-2019-130531 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 4776-4776

Author(s):

Ashley E. Rosko ◽

Sarah A Wall ◽

Robert A Baiocchi ◽

Don M. Benson ◽

Jonathan E. Brammer ◽

...

Keyword(s):

Older Adults ◽

Physical Function ◽

Board Of Directors ◽

Clinical Outcomes ◽

Research Funding ◽

Hematologic Malignancy ◽

Exercise Program ◽

Advisory Committees ◽

The Impact

Background: Geriatric deficits in patients with malignancy are predictive of morbidity and mortality. Measuring geriatric deficits provides additional prognostic information not otherwise captured in routine oncology care. Currently, the gap in geriatric-care delivery is the paucity of data demonstrating effective interventions once geriatric deficits are identified. Older adults with hematologic malignancy are understudied and evaluating both the impact of geriatric factors and interventions to improve upon geriatric deficits are warranted. Here we demonstrate the impact of identifying functional impairment and an exercise program among older adults with hematologic malignancy. Methods: This was a single center prospective study of older patients (≥60 years) with hematologic malignancy. Patients actively receiving any therapeutic treatment (chemotherapy, immunotherapy, targeted agents) were enrolled in a six-month exercise program to attenuate functional decline. The Otago Exercise Program (OEP) has been found to be an effective exercise regimen to improve functional balance, muscle strength, and prevent fall-related injury and mortality.1 The OEP is a structured combination of physical therapist prescribed individualized exercise plans with home-based exercise targeted to improve balance and functional decline. Patients enrolled had mild or moderate impairments in physical function, as defined by a score ≤9 on the Short Physical Performance Battery (SPPB). Patients were evaluated at baseline for geriatric deficits (Visit 1), after four months of OEP training (Visit 2), and following two months of self-directed exercise (Visit 3 - end of study) using a standardized Geriatric Assessmpent (GA) tool (CARG GA). The relationship between geriatric deficits and mortality and hospital utilization were analyzed. The change in GA factors over 3 visits were evaluated through a linear mixed model. The proportional hazards model was built to assess the association between Visit 1 GA and overall survival (OS), where OS was defined as time from date of V1 to death, censoring patients who were still alive at time of last follow-up. The generalized linear models were used to link Visit 1 GA with other clinical outcomes such as hospital length of stay (LOS) and the probability of emergency room (ER) visit. Results: Older adults (median age: 75.5; range 62-83) actively receiving chemotherapy for hematologic malignancy were enrolled (n=30). Physical health scores as measured by the MOS-PFS increased significantly at the second visit. [Median MOS-PFS: V1=55 (0-100); V2=70 (30-100), p<.01; V3=57.5 (0-90), p=0.43], where patient reported KPS increased significantly and the improvement was sustainable [Median KPS: V1=80 (40-100); V2=90 (60-100), p=0.02; V3=90 (50-100), p=0.04]. Objective measures of physical function improved to normal scores by visit 2 and were sustained [Median SPPB: V1=7 (0-11); V2=11 (2-12), p<.01; V3=9 (2-12), p<0.01]. With a median follow-up of 21.4 months, 9 patients had died. Half of patients were hospitalized either once or multiple times with a median of 3 admissions (range 1-7).The total LOS ranged from 2 to 41 days with a median of 13 days. During the study period and 1-year follow up, 67% (20/30) patients had ER visits with a median count of 1.5 visits (range 1-6). The SPPB was the only tool that was associated with all three clinical outcomes; OS with a hazard ratio (HR) of 0.80 (95% confidence interval (CI) 0.65-0.97, p=0.03), LOS [Incidence Rate Ratio=0.86 (95% CI 0.75-0.98), p=0.02], and the odds of ER visit [odds ratio = 0.77 (95% CI 0.62-0.94), p=0.01]. Chronologic age had no relationship with OS, LOS, or ER utilization. Conclusions: Functional deficits of older patients with hematologic malignancy on active chemotherapy, both subjective and objective metrics, improved with the OEP exercise program. Objective markers of physical function (SPPB) correlated with mortality and hospital utilizations among this population. There was no significant relationship between age and clinical outcomes. Mitigating functional impairment among older adults with hematologic malignancy is important to improve clinical outcomes in this high-risk population. Disclosures Rosko: Vyxeos: Other: Travel support. Baiocchi:Prelude: Consultancy. Brammer:Celgene: Research Funding; Seatlle Genetics: Honoraria, Speakers Bureau. Byrd:Novartis: Other: Travel Expenses, Speakers Bureau; Pharmacyclics LLC, an AbbVie Company: Other: Travel Expenses, Research Funding, Speakers Bureau; Genentech: Research Funding; TG Therapeutics: Other: Travel Expenses, Research Funding, Speakers Bureau; Acerta: Research Funding; Ohio State University: Patents & Royalties: OSU-2S; Gilead: Other: Travel Expenses, Research Funding, Speakers Bureau; BeiGene: Research Funding; Janssen: Consultancy, Other: Travel Expenses, Research Funding, Speakers Bureau. Efebera:Takeda: Honoraria; Akcea: Other: Advisory board, Speakers Bureau; Janssen: Speakers Bureau. Maddocks:Pharmacyclics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Merck: Research Funding; Teva: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding. Rogers:Acerta Pharma: Consultancy; AbbVie: Research Funding; Genentech: Research Funding; Janssen: Research Funding.

Download Full-text

Haploidentical Transplant with Peripheral Blood Hematopoietic Cell Grafts in Older Adults with AML or MDS

Blood ◽

10.1182/blood.v128.22.4658.4658 ◽

2016 ◽

Vol 128 (22) ◽

pp. 4658-4658

Author(s):

Michael Slade ◽

John F DiPersio ◽

Peter Westervelt ◽

Ravi Vij ◽

Geoffrey L. Uy ◽

...

Keyword(s):

Older Adults ◽

Overall Survival ◽

Cumulative Incidence ◽

Older Patients ◽

Research Funding ◽

Disease Risk ◽

Risk Index ◽

Hematopoietic Cell ◽

Comorbidity Index

Background: Modern post-transplant cyclophosphamide (PTCy) protocols with haploidentical (haplo) donors have dramatically expanded the donor pool for patients requiring hematopoietic cell transplantation (HCT). Initial studies were performed with bone marrow grafts, which require the donor to undergo anesthesia during harvest. Consequently, the use of mobilized peripheral blood hematopoietic cells (PBHC) may be desirable, especially with older donors. However, data on PBHC haplo-HCT in older adults is lacking. Objectives: To report the impact of age on transplant-related outcomes in a large cohort of patients undergoing haplo-HCT with PTCy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Methods: We retrospectively identified all adult patients undergoing T cell replete haplo-HCT with PTCy for AML or MDS at our institution from January 2009 to June 2016. Patients were grouped into three cohorts: Age1 (<55), Age2 (55-65) and Age3 (>65). Patients were scored for disease risk and underlying comorbidities using the Disease Risk Index (DRI) and HCT Comorbidity Index (HCT-CI). Overall survival (OS) was analyzed using a Cox Proportional Hazards (CPH) model, with all variables pre-specified. Results: We identified 107 patients, 92 with AML and 15 with MDS. Median follow up was 8.0 months in all patients and 18.3 months in patients surviving at last follow-up. Median donor age was 39, 34 and 49 in Age1, Age2 and Age3, respectively (p = 0.02). Donor relationship was also significantly different among Age1 (child: 25%, sibling: 53%, parent, 22%), Age2 (62%, 38%, 0%) and Age3 (64%, 36%, 0%) (p < 0.001). Younger patients were significantly more likely to receive myeloablative conditioning (55% vs. 35% vs. 27%, p = 0.04). Median OS was 448, 417 and 147 days in Age1, Age2 and Age3 patients. Actuarial 2-year OS was 40%, 34% and 11%, respectively. The 2-year cumulative incidence of relapse was 34%, 30% and 56%. The 2-year cumulative incidence of treatment-related mortality was 30%, 45% and 35%. There was a trend towards a lower 100-day cumulative incidence grade II-IV acute graft-versus host-disease (aGVHD) in older patients (44% vs. 35% vs. 15%, p = 0.07) but not in grade III-IV aGVHD (16% vs. 7% vs. 5%, p = 0.42). Similarly, there was a trend towards a lower 1-year cumulative incidence of cGVHD in older patients (37% vs. 36% vs. 10%, p = 0.07), but not severe cGVHD (5% vs. 0% vs. 0%, p = 0.16). No significant difference was seen in median time to neutrophil engraftment (17 vs. 18 vs. 17 days, p = 0.14) or platelet engraftment (28 vs. 30.5 vs. 32 days, p = 0.93). Univariate and multivariate CPH model of OS is summarized in table 1. Age > 65 and prior allogeneic HCT were associated with significantly worse survival. Conclusions: The use of PBHC haplo-HCT in older adults with AML or MDS is a feasible treatment option. However, a careful pre-transplant evaluation and analysis of risks and benefits is warranted when offering this transplant modality to older adults. Even after adjusting for pre-transplant comorbidity and disease risk, older age is associated with inferior survival in this cohort. Cox Proportional Hazard Analysis of Overall Survival. Abbreviations: Hematopoietic Cell Transplant Comorbidity Index (HCT-CI), Disease Risk Index (DRI) Figure 1 Overall survival by age Figure 1. Overall survival by age Disclosures DiPersio: Incyte Corporation: Research Funding. Vij:Takeda: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Novartis: Honoraria; Celgene: Consultancy; Bristol-Myers Squibb: Honoraria; Janssen: Honoraria; Karyopharm: Honoraria. Schroeder:Incyte Corporation: Honoraria, Research Funding.

Download Full-text

Impact of Malnutrition Status on Muscle Parameter Changes over a 5-Year Follow-Up of Community-Dwelling Older Adults from the SarcoPhAge Cohort

Nutrients ◽

10.3390/nu13020407 ◽

2021 ◽

Vol 13 (2) ◽

pp. 407

Author(s):

Laetitia Lengelé ◽

Olivier Bruyère ◽

Charlotte Beaudart ◽

Jean-Yves Reginster ◽

Médéa Locquet

Keyword(s):

Older Adults ◽

Muscle Strength ◽

Physical Performance ◽

Community Dwelling ◽

Timed Up And Go ◽

P Values ◽

Student’S T ◽

The Impact ◽

Community Dwelling Older Adults

This study aimed to assess the impact of malnutrition on the 5-year evolution of physical performance, muscle mass and muscle strength in participants from the SarcoPhAge cohort, consisting of community-dwelling older adults. The malnutrition status was assessed at baseline (T0) according to the “Global Leadership Initiatives on Malnutrition” (GLIM) criteria, and the muscle parameters were evaluated both at T0 and after five years of follow-up (T5). Lean mass, muscle strength and physical performance were assessed using dual X-ray absorptiometry, handgrip dynamometry, the short physical performance battery test and the timed up and go test, respectively. Differences in muscle outcomes according to nutritional status were tested using Student’s t-test. The association between malnutrition and the relative 5-year change in the muscle parameters was tested using multiple linear regressions adjusted for several covariates. A total of 411 participants (mean age of 72.3 ± 6.1 years, 56% women) were included. Of them, 96 individuals (23%) were diagnosed with malnutrition at baseline. Their muscle parameters were significantly lower than those of the well-nourished patients both at baseline and after five years of follow-up (all p-values < 0.05), except for muscle strength in women at T5, which was not significantly lower in the presence of malnutrition. However, the 5-year changes in muscle parameters of malnourished individuals were not significantly different than those of well-nourished individuals (all p-values > 0.05).

Download Full-text

Cohort study of ageing from Bagé (SIGa-Bagé), Brazil: profile and methodology

BMC Public Health ◽

10.1186/s12889-021-11078-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Elaine Thumé ◽

Marciane Kessler ◽

Karla P. Machado ◽

Bruno P. Nunes ◽

Pamela M. Volz ◽

...

Keyword(s):

Older Adults ◽

Health Care ◽

Cohort Study ◽

Primary Health Care ◽

Rio Grande ◽

Cognitive Testing ◽

Rio Grande Do Sul ◽

Primary Health ◽

The Impact

Abstract Background The Bagé Cohort Study of Ageing is a population-based cohort study that has recently completed the first follow-up of a representative sample of older adults from Bagé, a city with more than 100,000 inhabitants located in the state of Rio Grande do Sul, Brazil. This is one of the first longitudinal studies to assess the impact of primary health care coverage on health conditions and inequalities. Our aim is to investigate the prevalence, incidence and trends of risk factors, health behaviours, social relationships, non-communicable diseases, geriatric diseases and disorders, hospitalisation, self-perceived health, and all-cause and specific-cause mortality. In addition, we aim to evaluate socioeconomic and health inequalities and the impact of primary health care on the outcomes under study. Methods/design The study covers participants aged 60 or over, selected by probabilistic (representative) sampling of the urban area of the city of Bagé, which is covered by Primary Health Care Services. The baseline examination included 1593 older adults and was conducted from July 2008 to November 2008. After eight to nine years (2016/2017), the first follow-up was conducted from September 2016 to August 2017. All participants underwent an extensive core assessment programme including structured interviews, questionnaires, cognitive testing (baseline and follow-up), physical examinations and anthropometric measurements (follow-up). Results Of the original participants, 1395 (87.6%) were located for follow-up: 757 elderly individuals (47.5%) were re-interviewed, but losses in data transfer occurred for 22. The remaining 638 (40.1%) had died. In addition, we had 81 (5.1%) refusals and 117 (7.3%) losses. Among the 1373 older adults who were followed down, there was a higher proportion of female interviewees (p=0.042) and a higher proportion of male deaths (p=0.001) in 2016/2017. There were no differences in losses and refusals according to gender (p=0.102). There was a difference in average age between the interviewees (68.8 years; SD ±6.5) and non-interviewees (73.2 years; SD ±9.0) (p<0.001). Data are available at the Department of Social Medicine in Federal University of Pelotas, Rio Grande do Sul, Brazil, for any collaboration.

Download Full-text