Phase II study of R-CHOP with GM-CSF cytokine support for elderly patients with untreated diffuse large B-cell lymphoma (DLBCL): A Wisconsin Oncology Network study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7566-7566
Author(s):  
B. S. Kahl ◽  
R. S. Go ◽  
G. Rodrigues ◽  
F. A. Sanchez ◽  
T. J. Saphner ◽  
...  
Keyword(s):  
Elderly Patients ◽  
B Cell Lymphoma ◽  
The Elderly ◽  
Difficult Problem ◽  
Gm Csf ◽  
Cd20 Expression ◽  
Secondary Endpoints ◽  
Adequate Organ Function ◽  
Intent To Treat

7566 Background: According to mature data from the GELA study, approximately 55% of elderly patients with DLBCL will be cured with R-CHOP. We hypothesized that sargramostim (GM-CSF), added to R-CHOP may potentiate the efficacy of rituximab by upregulating tumor cell CD20 expression and by augmenting antibody dependent cellular cytotoxicity (ADCC). Methods: Patients > 60 years old with untreated stage I-IV DLBCL were eligible if they had PS ≤ 2, measurable disease, adequate organ function, and provided informed consent. R-CHOP for 6–8 cycles was given every 21 days with GM-CSF given subcutaneously at a dose of 250 mg/m2 days 3–10 of each cycle. The primary endpoint was to estimate the CR/CRu rate. Secondary endpoints included estimates of the ORR, EFS, and OS. Results: Thirty-eight/forty patients have been enrolled to date and data are available for 36. One patient is too early and another was deemed ineligible after centralized pathology review. Baseline characteristics include median age 72 (range 61–86), 25% PS 0, 44% PS 1, 31% PS 2, 80% stage III/IV, 56% elevated LDH, 8% IPI 0–1, 25% IPI 2, 36% IPI 3, 31% IPI 4–5. Thirteen/thirty-six (36%) patients did not complete 6 cycles of protocol therapy, 8 due to intolerance of R-CHOP and 5 due to intolerance of GM-CSF. By intent-to-treat analysis, 17/36 patients achieved CR/CRu (47%) and 9/36 achieved PR (25%) for an ORR of 72%. No patients progressed while on study and all non-responders were deemed so secondary to inability to complete protocol therapy. The median follow-up time for surviving patients is 19 months. Considering inability to complete protocol therapy as an event, the 2-year EFS is 38%, the 2-year PFS is 56%, and the 2-year OS is 74%. Conclusions: Any benefit that may be conferred by GM-CSF is likely to be offset by toxicity and intolerance, with 14% of patients in this series unable to complete GM-CSF therapy. Additionally, R-CHOP is more toxic in elderly patients than is commonly appreciated with, 22% of patients unable to complete 6 cycles. Despite recent advances, DLBCL in the elderly remains a difficult problem and new approaches to therapy must be developed. [Table: see text]

Evaluation of R-CHOP and R-CVP in the treatment of elderly patient with non-Hodgkin lymphoma

MedPharmRes ◽  
2019 ◽  
Vol 3 (3) ◽  
pp. 1-6
Author(s):  
Truc Phan ◽  
Tram Huynh ◽  
Tuan Q. Tran ◽  
Dung Co ◽  
Khoi M. Tran
Keyword(s):  
Elderly Patients ◽  
Hodgkin Lymphoma ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
The Elderly ◽  
Free Survival ◽  
Non Hodgkin Lymphoma ◽  
Common Sign ◽  
Related Mortality

Introduction: Little information is available on the outcomes of R-CHOP (rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone) and R-CVP (rituximab with cyclophosphamide, vincristine and prednisone) in treatment of the elderly patients with non-Hodgkin lymphoma (NHL), especially in Vietnam. Material and methods: All patients were newly diagnosed with CD20-positive non-Hodgkin lymphoma (NHL) at Blood Transfusion and Hematology Hospital, Ho Chi Minh city (BTH) between 01/2013 and 01/2018 who were age 60 years or older at diagnosis. A retrospective analysis of these patients was perfomed. Results: Twenty-one Vietnamese patients (6 males and 15 females) were identified and the median age was 68.9 (range 60-80). Most of patients have comorbidities and intermediate-risk. The most common sign was lymphadenopathy (over 95%). The proportion of diffuse large B cell lymphoma (DLBCL) was highest (71%). The percentage of patients reaching complete response (CR) after six cycle of chemotherapy was 76.2%. The median follow-up was 26 months, event-free survival (EFS) was 60% and overall survival (OS) was 75%. Adverse effects of rituximab were unremarkable, treatment-related mortality accounted for less than 10%. There was no difference in drug toxicity between two regimens. Conclusions: R-CHOP, R-CVP yielded a good result and acceptable toxicity in treatment of elderly patients with non-Hodgkin lymphoma. In patients with known cardiac history, omission of anthracyclines is reasonable and R-CVP provides a competitive complete response rate.

scholarly journals Safety of High-Dose Dabigatran in Elderly and Younger Patients with a Low Bleeding Risk: A Prospective Observational Study

Cardiology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Aharon Erez ◽  
Gregory Golovchiner ◽  
Robert Klempfner ◽  
Ehud Kadmon ◽  
Gustavo Ruben Goldenberg ◽  
...  
Keyword(s):  
Observational Study ◽  
Elderly Patients ◽  
Prospective Observational Study ◽  
Bleeding Risk ◽  
The Elderly ◽  
High Dose ◽  
World Population ◽  
Younger Patients ◽  
End Point

<b><i>Introduction:</i></b> In patients with atrial fibrillation (AF) at risk for stroke, dabigatran 150 mg twice a day (DE150) is superior to warfarin for stroke prevention. However, there is paucity of data with respect to bleeding risk at this dose in elderly patients (≥75 years). We aimed to evaluate the safety of DE150 in comparison to warfarin in a real-world population with AF and low bleeding risk (HAS-BLED score ≤2). <b><i>Methods:</i></b> In this prospective observational study, 754 consecutive patients with AF and HAS-BLED score ≤2 were included. We compared outcome of elderly patients (age ≥75 tears) to younger patients (age &#x3c;75 years). The primary end point was the combined incidence of all-cause mortality, stroke, systemic emboli, and major bleeding event during a mean follow-up of 1 year. <b><i>Results:</i></b> There were 230 (30%) elderly patients, 151 patients were treated with warfarin, and 79 were treated with DE150. Fifty-two patients experienced the primary endpoint during the 1-year follow-up. Among the elderly, at 1-year of follow-up, the cumulative event rate of the combined endpoint in the DE150 and warfarin was 8.9 and 15.9% respectively (<i>p</i> = 0.14). After adjustment for age and gender, patients who were treated with DE150 had a nonsignificant difference in the risk for the combined end point as patients treated with warfarin both among the elderly and among the younger population (HR 0.58, 95% C.I = 0.25–1.39 and HR = 1.12, 95% C.I 0.62–2.00, respectively [<i>p</i> for age-group-by-treatment interaction = 0.83). <b><i>Conclusions:</i></b> Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

Cochlear implantation in elderly patients: stability of outcome over time

2016 ◽  
Vol 130 (8) ◽  
pp. 706-711 ◽  
Author(s):  
O Hilly ◽  
E Hwang ◽  
L Smith ◽  
D Shipp ◽  
J M Nedzelski ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Cochlear Implantation ◽  
Short Form ◽  
Age Groups ◽  
The Elderly ◽  
Long Term Results ◽  
Profound Hearing Loss ◽  
Younger Patients ◽  
Over Time

AbstractBackground:Cochlear implantation is the standard of care for treating severe to profound hearing loss in all age groups. There is limited data on long-term results in elderly implantees and the effect of ageing on outcomes. This study compared the stability of cochlear implantation outcome in elderly and younger patients.Methods:A retrospective chart review of cochlear implant patients with a minimum follow up of five years was conducted.Results:The study included 87 patients with a mean follow up of 6.8 years. Of these, 22 patients were older than 70 years at the time of implantation. Hearing in Noise Test scores at one year after implantation were worse in the elderly: 85.3 (aged under 61 years), 80.5 (61–70 years) and 73.6 (aged over 70 years;p= 0.039). The respective scores at the last follow up were 84.8, 85.1 and 76.5 (p= 0.054). Most patients had a stable outcome during follow up. Of the elderly patients, 13.6 per cent improved and none had a reduction in score of more than 20 per cent. Similar to younger patients, elderly patients had improved Short Form 36 Health Survey scores during follow up.Conclusion:Cochlear implantation improves both audiometric outcome and quality of life in elderly patients. These benefits are stable over time.

Age, Age of Onset and Course of Primary Depressive Illness in the Elderly*

1983 ◽  
Vol 28 (2) ◽  
pp. 102-104 ◽  
Author(s):  
Martin G. Cole
Keyword(s):  
Elderly Patients ◽  
Depressive Episode ◽  
Early Onset ◽  
Age Of Onset ◽  
Late Onset ◽  
The Elderly ◽  
Depressive Illness ◽  
Physical Illness ◽  
Course Of Illness

Thirty-eight elderly patients with primary depressive illness (Feighner criteria) were followed up for 7–31 months. In the absence of persistent organic signs and severe physical illness, age of onset (first depressive episode after 60) but not age was significantly related to course of illness. Compared to early onset depressives, late onset depressives were more likely to remain completely well during the follow-up period and less likely to have frequent or disabling relapses.

scholarly journals Geriatric Assessment for the Elderly Patients with Diffuse Large B Cell Lymphoma (DLBCL) and Treatment Outcomes

2013 ◽  
Vol 24 ◽  
pp. ix36
Author(s):  
Y. Takamatsu ◽  
Y. Naito ◽  
E. Sato ◽  
Y. Ikari ◽  
H. Katsuya ◽  
...  
Keyword(s):  
Elderly Patients ◽  
B Cell ◽  
Treatment Outcomes ◽  
Geriatric Assessment ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
The Elderly ◽  
Large B Cell Lymphoma ◽  
Large B Cell

scholarly journals Feasibility and Safety of Left Bundle Branch Pacing for Advance Aged Patients: A Multicenter Comparative Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhongyuan Ren ◽  
Binni Cai ◽  
Songyun Wang ◽  
Peng Jia ◽  
Yang Chen ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Effective Means ◽  
The Elderly ◽  
Elderly Group ◽  
Complication Rates ◽  
Related Complication ◽  
Aged Patients ◽  
Fluoroscopic Time ◽  
Symptomatic Bradycardia

Background: Left bundle branch pacing (LBBP) has been shown to be a safe and effective means to achieve physiological pacing. However, elderly patients have increased risks from invasive procedures and the risk of LBBP in elderly patients is not known. We aimed to investigate the safety and efficacy of LBBP in elderly patients &gt;80 years of age.Methods: From December 2017 to June 2019, 346 consecutive patients with symptomatic bradycardia, 184 patients under 80 years of age and 162 over 80 years, were included and underwent LBBP. The safety and prognosis of LBBP were comparatively evaluated by measured pacing parameters, periprocedural complications, and follow-up clinical events.Results: Compared with the younger, the elderly group had worse baseline cardiac and renal function. LBBP was achieved successfully in both groups with comparable fluoroscopic time and paced QRS duration (110.0 [102.0, 118.0] ms for the young vs. 110.0 [100.0, 120.0] ms for the elderly, P = 0.874). Through a follow-up of 20.0 ± 6.1 months, pacing parameters were stable while higher threshold and impedance were observed in the elderly group. In the evaluation of safety, overall procedure-related complication rates were comparable (4.4 vs. 3.8%, young vs. elderly). For prognosis, similar rates of major adverse cardiocerebrovascular events (7.1 vs. 11.9%, young vs. elderly) were observed.Conclusions: Compared to younger patients, LBBP could achieve physiological pacing in patients over 80 with comparable midterm safety and prognosis. Long-term safety and benefits of LBBP, however, necessitate further evaluation.

Long-Term Follow-Up of a Phase II Trial of Six Cycles of Dose-Dense R-CHOP-14 for First-Line Treatment of Diffuse Large B-Cell Lymphoma in Young and Elderly Patients

2016 ◽  
Vol 136 (2) ◽  
pp. 76-84 ◽  
Author(s):  
Eva González-Barca ◽  
Miguel A. Canales ◽  
Antonio Salar ◽  
Secundino Ferrer ◽  
Eva Domingo-Domenech ◽  
...  
Keyword(s):  
Survival Rate ◽  
Elderly Patients ◽  
B Cell ◽  
Phase Ii ◽  
Cell Lymphoma ◽  
International Prognostic Index ◽  
B Cell Lymphoma ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Background/Aims: Rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) every 14 days seems to achieve better outcomes than R-CHOP every 21 days in diffuse large B-cell lymphoma (DLBCL) patients. Currently, the standard regimen is R-CHOP every 21 days. Methods: This is a phase II clinical trial of treatment with 6 cycles of R-CHOP-14 with pegfilgrastim support in 2 populations of previously untreated DLBCL patients aged ≥65 years (n = 73) or <65 years (n = 51) with low-risk International Prognostic Index scores (0-2). Results: With a median follow-up of 63.7 months, the 5-year event-free survival rate was 53.8% in patients aged ≥65 years and 71.0% in patients aged <65 years. The 5-year overall survival rate was 71.4 and 89.8%, respectively. The complete remission rate was 69.9% for older and 80.4% for younger patients. The median relative dose intensity of cytotoxic drugs was 143.2% in the elderly and 149.1% in the young patients. Febrile neutropenia was the most common grade 3-4 adverse event, being higher in elderly patients (21.3 vs. 9.3%). Eight deaths (7 in elderly patients) were considered treatment related. Conclusion: In conclusion, the R-CHOP-14 regimen is feasible and very active, though it is more toxic in elderly patients mainly due to an increased incidence of infections. New strategies, such as new monoclonal antibodies or new targeted therapies, are needed to improve the outcomes of DLBCL patients.

scholarly journals Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial

2020 ◽  
Author(s):  
George R Thompson ◽  
Alex Soriano ◽  
Athanasios Skoutelis ◽  
Jose A Vazquez ◽  
Patrick M Honore ◽  
...  
Keyword(s):  
Invasive Candidiasis ◽  
Double Blind Study ◽  
Phase 2 ◽  
Double Blind ◽  
Once Daily ◽  
Secondary Endpoints ◽  
Intent To Treat ◽  
Cure Rates ◽  
Treat Population

Abstract Background Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC). Methods Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up. Results Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS. Conclusions RZF was safe and efficacious in the treatment of candidemia and/or IC.

P1339ARTERIOVENOUS FISTULA AND BASILIC VEIN TRANSPOSITION IN ELDERLY PATIENTS ON HEMODIALYSIS: AN OBSERVATIONAL STUDY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Vinant Bhargava ◽  
Priti Meena ◽  
Ambrish Satwik ◽  
Apurv Srivastava ◽  
A K Bhalla ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Vascular Access ◽  
Elderly Population ◽  
The Elderly ◽  
Primary Patency ◽  
New Delhi ◽  
Secondary Patency ◽  
Basilic Vein ◽  
The Mean

Abstract Background and Aims With the increase in the line expectancy of chronic kidney disease in the older population (&gt;60 years), the numbers requiring haemodialysis is progressively rising. The elderly population may be different from the younger in terms of non-suitable vessels for access creation, non-maturation, and vascular calcifications, and this may alter the outcomes of use of arteriovenous fistula (AVF). This study was conducted to analyse the outcomes of AVF in elderly patients (&gt;60 years). Method Retrospective study was conducted in the Department of Nephrology at Sir Ganga Ram Hospital, New Delhi. Patients of more than 60 years of age in whom AVF was created from 1st January 2012 to 31st December 2016 were included in the study. Follow-up data of 3.5 years was analysed. The primary endpoint was to assess primary and secondary patency rates. Results A total of 300 patients were included in the study. The mean age was 63.8 years. Radiocephalic AVF (RCAVF) was the most common site of [69.8% (n = 210)], followed by brachiocephalic (BCAVF) in 25.2% (n = 75) and basilic vein transposition (BVT) in 5% (n = 15). At 12 months, overall survival of the AVF was 66.8%. At 42 months, the primary patency rate of RCAVF, BCAVF, and BVT was 50.6%, 52.6%, and 50.4% respectively. The commonest cause of access failure was thrombosis (20.4%) followed by non-maturation (9%). Vascular access abandonment was found least in BCAVF. Conclusion AVF remains the preferred vascular access for haemodialysis in the elderly population. Brachiocephalic AVF has higher primary and secondary patency rates. Thrombosis and failure of maturation are major concerns in the elderly AVF.

scholarly journals Effect of Montelukast 10 mg in Elderly Patients with Mild and Moderate Asthma Compared with Young Adults. Results of a Cohort Study

2018 ◽  
Vol 12 (1) ◽  
pp. 67-74
Author(s):  
Guillermo Sánchez ◽  
Diana Buitrago
Keyword(s):  
Older Adults ◽  
Young Adults ◽  
Cohort Study ◽  
Elderly Patients ◽  
Inhaled Corticosteroids ◽  
Age Groups ◽  
The Elderly ◽  
Moderate Asthma ◽  
Beta 2

Background: The clinical characteristics and physio-pathogenic mechanisms of asthma in patients older than 60 years appear to differ from the behavior described for other age groups. Therefore, the effectiveness of medications for elderly patients with asthma should not be extrapolated from studies conducted on teenagers or young adults. Objective: The study aimed to establish the clinical effect of montelukast 10 mg in elderly patients with mild and moderate asthma compared to its effect on young adults. Method: A prospective cohort study was conducted during 12 weeks of follow-up, which consecutively included the total population of adult patients attended by a group of 21 general practitioners, between July and December 2016. Young adults (18-59 years) and older adults were included (60 years or older) with mild or moderate asthma, which, according to the criteria of his treating physician, had been prescribed montelukast 10 mg/day. The variables of interest were: use of inhaled corticosteroids during the last month, use of inhaled beta-2 adrenergic agonists as a rescue in the last month, having attended the emergency service during the last month due to an asthma attack, presence of wheezing in the physical examination, the number of attacks in the last month and the number of days without symptoms in the last month. Results: A total of 126 patients entered the cohort and 104 completed the follow-up, of which 29% were older adults. On admission, 65.4% of patients (68/104) had used rescue inhaled beta2 in the last month and had been using schemes with corticosteroids. After 12 weeks of follow-up, 58.1% (43/74) of the young adults required treatment schedules with corticosteroids, while in the elderly, only 36.7% of the patients (11/30) required this treatment scheme (p-value: 0.047). Regarding the use of rescue inhaled beta-2 at 12 weeks, 55% of young adults reported using them, compared to 33.3% of older adults (p-value: 0.041). Conclusion: In this cohort of patients, treated with montelukast 10 mg/day for 12 weeks, there was a reduction of broncho-obstructive symptoms and exacerbations of the disease. In older adults compared to young adults, a greater reduction in the use of beta2 agonists rescue medications and in the concomitant use of inhaled corticosteroid schemes was documented.

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