Elderly CML Patients On Early Applied High Dose Imatinib Achieve Molecular Remissions As Fast As Younger Patients In Contrast To Patients On Standard Dose Imatinib: A Subanalysis Of The German CML-Study IV

Abstract Introduction The outcome of elderly patients with chronic myeloid leukemia (CML) treated with imatinib has been studied in several trials. However, there are no reports on the effects of different imatinib dosages in older vs. younger CML patients. Methods To evaluate the efficacy of imatinib in the elderly, we analyzed data from the German CML-Study IV, a randomized 5-arm trial designed to optimize imatinib therapy alone or in combination. There was no upper age limit for inclusion. Patients with BCR-ABL positive CML in chronic phase randomized to imatinib 400 mg/d (IM400) or imatinib 800 mg/d (IM800) were compared, stratified according to median age at diagnosis in western populations ≥ 65 years vs. < 65 years, regarding effectively administered imatinib dose, time to hematologic, cytogenetic and molecular remissions, adverse events (AEs), rates of progression to accelerated phase (AP) and blast crisis (BC), survival, and causes of death. The full 800 mg dose was given after a 6 weeks run-in period with imatinib 400 mg/d to avoid excessive cytopenias. The dose could then be reduced according to tolerability for maximum patients' compliance. Results From July 2002 through March 2012, 1,551 patients were randomized, 828 of these to IM400 or IM800. Median age of these patients was 52 years (IM400: 53 years; IM800: 51 years). 784 patients were evaluable for follow-up (IM400: 382; IM800: 402). 193 patients were ≥ 65 years, 591 < 65 years. 110 patients (29%) on IM400 and 83 (21%) on IM800 were ≥ 65 years. Median observation time on IM400 was 63.0 months in the elderly and 67.6 months in the younger group, on IM800 50.9 months in the elderly and 50.1 months in the younger group. The median dose per day was lower for elderly patients on IM800 (421 mg/d for patients ≥ 65 years vs. 556 mg/d for patients < 65 years), with the highest median dose in the first year (466mg/d for patients ≥ 65 years vs. 630mg/d for patients < 65 years). The median dose for patients on IM400 was 400 mg/d for both age groups. There was no difference between age groups in achieving a complete hematologic remission or a complete cytogenetic remission, neither if IM400 and IM800 were combined, nor in an analysis according to treatment groups. Elderly patients on IM400 achieved major molecular remission (MMR) and deep molecular remission (MR4) significantly later than younger patients (18.1 vs. 15.9 months, p=0.013; 54.4 vs. 33.3 months, p=0.012, respectively) whereas no difference was detected for patients on IM800 (11.9 vs. 10.5 months; 24.2 vs. 26.1 months, respectively). Imatinib was well tolerated in elderly patients with only few WHO grade 3-4 AEs being more frequent in the elderly than in younger patients (dermatologic AEs on IM400: 5.4 vs. 0.4%; infections on IM800: 8.3 vs. 2.5%). There were no significant differences between age groups in probabilities of progression to AP or BC neither if IM400 and IM800 were combined, nor in an analysis according to treatment groups. Five-year age-adjusted relative survival for elderly patients was comparable to that of younger patients. Conclusion We could demonstrate that elderly patients achieved molecular remissions significantly later when treated with standard dose imatinib but not when treated with higher imatinib dosages. As the safety profile of IM800 in senior patients was favorable too we conclude, that the optimal dose for elderly patients could be higher than 400 mg/d. Disclosures: Müller: Ariad: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Hochhaus:Pfizer: Consultancy; ARIAD: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding, Travel Other. Hehlmann:BMS: Consultancy, Research Funding; Novartis: Research Funding. Saussele:BMS: Honoraria, Research Funding, Travel, Travel Other; Pfizer: Honoraria; Novartis: Honoraria, Research Funding, Travel Other.

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Therapy with Imatinib In Elderly CML Patients (>65years): Results of the German CML-Study IV.

Blood ◽

10.1182/blood.v116.21.3411.3411 ◽

2010 ◽

Vol 116 (21) ◽

pp. 3411-3411

Author(s):

Susanne Saussele ◽

Nadine Pletsch ◽

Michael Lauseker ◽

Armin Leitner ◽

Susanne Jung-Munkwitz ◽

...

Keyword(s):

Elderly Patients ◽

Older Patients ◽

Research Funding ◽

Gastrointestinal Symptoms ◽

Chronic Phase ◽

The Elderly ◽

Interferon Α ◽

Younger Patients ◽

Treatment Groups ◽

Grade 3

Abstract Abstract 3411 Background: Dose of therapy and time to response may be different in the elderly as compared to younger patients with CML. This has been reported previously for interferon α (Berger et al., Leukemia 2003). For imatinib, contradictory results have been presented (Rosti et al. Haematologica 2007, Guliotta et al. Blood 2009). Aims: An analysis comparing dose-response relationship in patients more or less than 65 years (y) of age is warranted. Methods: We analysed the German CML-Study IV, a randomized 5-arm trial to optimize imatinib therapy by combination, dose escalation and transplantation. Patients older and younger than 65y randomized to imatinib 400 mg (IM400) or 800 mg (IM800) were compared with regard to time to hematologic, cytogenetic and molecular remissions, imatinib dose, adverse events (AEs) and overall survival (OS). Results: From July 2002 to April 2009, 1311 patients with Ph+ CML in chronic phase were randomized, 623 patients were evaluable, 311 patients for treatment with IM400 and 312 for IM800. 84 (27%) and 66 (21%), respectively, were older than 65 years. All patients were evaluable for hematologic, 578 (140 >65y and 438 <65y) for cytogenetic, and 600 (143 and 457, respectively) for molecular responses. Median age was 70y vs. 49y for IM400 and 69y vs. 46y for IM800. The median dose per day was lower for elderly patients with IM800 (517mg vs. 666mg) and the same with IM400 (400mg each). Patients' characteristics at baseline were evenly distributed in all groups regarding gender, follow-up, hemoglobin, platelet count and spleen size. Leukocyte counts were significantly lower in elderly patients (IM400: 50/nl vs. 78/nl, IM800: 36/nl vs. 94/nl). EURO score was different due to age in elderly patients (low risk: IM400: 11% vs. 43%, IM800: 14% vs. 42%; intermediate risk: IM400: 79% vs. 44% and IM800: 73% and 43%). There was no difference in cytogenetic and molecular analyses between treatment groups. With regard to efficacy, there was no difference for older patients in achieving a complete cytogenetic remission (CCR) and major molecular remission (MMR) if IM400 and IM800 were compared together. If treatment groups were analyzed separately, older patients treated with IM400 reached CCR and MMR statistically significant slower than younger patients (CCR: median 14.2 months vs. 12.1 months, p=0.019; MMR: median 18.7 months vs. 17.5 months, p=0.006). There was no difference with IM800 (CCR: median 7.7 months vs. 8.9 months, MMR: median 9.9 months vs. 10.0 months). 3y-OS for older patients >65y was 94.7% and for patients <65y was 96.1%. Some differences were observed in the safety analyses. 530 patients (IM400: 278, IM800: 252) were evaluated on common toxicity criteria (WHO). Some hematologic AEs were documented slightly more often in the elderly than in the younger patients: for IM400 anemia grade 1–2 (60 vs. 42%) and leukopenia grade 3–4 (5.6 vs. 1.4%) and for IM800 anemia grade 1–4 (64 vs.47% and 7.2 vs. 5.7%) and thrombocytopenia grade 3–4 (9.3 vs. 7.1%). Non hematologic AEs were more prominent in IM800 and were mainly gastrointestinal symptoms (IM400: 33 vs. 31%, IM800: 48 and 44%) and edema (IM400: 28 vs. 29%, IM800: 35 vs. 50%). There was no difference for grade 3/4 non-hematological AEs in older patients in both groups. Conclusions: Imatinib 400 mg and 800 mg are well tolerated also in the elderly. The IM800 dosage was more tolerability-adapted for the elderly, but there was no difference in reaching a CCR and MMR in contrast to the IM400 where a significantly slower response was detected in the elderly. Whether this difference is clinically relevant has yet to be determined. Updated results will be presented. Disclosures: Haferlach: MLL Munich Leukemia Laboratory: Employment, Equity Ownership, Research Funding. German CML-Study Group:Deutsche Krebshilfe: Research Funding; Novartis: Research Funding; Roche: Research Funding; BMBF: Research Funding; Essex: Research Funding.

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ACUTE KIDNEY INJURY IN ELDERLY PATIENTS

Wiadomości Lekarskie ◽

10.36740/wlek201908109 ◽

2019 ◽

Vol 72 (8) ◽

pp. 1466-1472

Author(s):

Grażyna Kobus ◽

Jolanta Małyszko ◽

Hanna Bachórzewska-Gajewska

Keyword(s):

Acute Kidney Injury ◽

Renal Failure ◽

Acute Renal Failure ◽

Elderly Patients ◽

Older Patients ◽

Age Groups ◽

Kidney Injury ◽

The Elderly ◽

Younger Patients ◽

Common Cause

Introduction: In the elderly, impairment of kidney function occurs. Renal diseases overlap with anatomic and functional changes related to age-related involutionary processes. Mortality among patients with acute renal injury is approximately 50%, despite advances in treatment and diagnosis of AKI. The aim: To assess the incidence of acute kidney injury in elderly patients and to analyze the causes of acute renal failure depending on age. Materials and methods: A retrospective analysis included medical documentation of patients hospitalized in the Nephrology Clinic during the 6-month period. During this period 452 patients were hospitalized in the clinic. A group of 77 patients with acute renal failure as a reason for hospitalization was included in the study. Results: The prerenal form was the most common cause of AKI in both age groups. In both age groups, the most common cause was dehydration; in the group of patients up to 65 years of age, dehydration was 29.17%; in the group of people over 65 years - 43.39%. Renal replacement therapy in patients with AKI was used in 14.29% of patients. In the group of patients up to 65 years of age hemodialysis was 16.67% and above 65 years of age. -13.21% of patients. The average creatinine level in the group of younger patients at admission was 5.16 ± 3.71 mg / dl, in the group of older patients 3.14 ± 1.63 mg / dl. The size of glomerular filtration GFR in the group of younger patients at admission was 21.14 ± 19.54 ml / min, in the group of older patients 23.34 ± 13.33 ml / min. Conclusions: The main cause of acute kidney injury regardless of the age group was dehydration. Due to the high percentage of AKI in the elderly, this group requires more preventive action, not only in the hospital but also at home.

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Cochlear implantation in elderly patients: stability of outcome over time

The Journal of Laryngology & Otology ◽

10.1017/s0022215116008197 ◽

2016 ◽

Vol 130 (8) ◽

pp. 706-711 ◽

Cited By ~ 13

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.

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Adjuvant or Palliative Chemotherapy for Colorectal Cancer in Patients 70 Years or Older

Journal of Clinical Oncology ◽

10.1200/jco.1999.17.8.2412 ◽

1999 ◽

Vol 17 (8) ◽

pp. 2412-2412 ◽

Cited By ~ 193

Author(s):

R. A. Popescu ◽

A. Norman ◽

P. J. Ross ◽

B. Parikh ◽

D. Cunningham

Keyword(s):

Colorectal Cancer ◽

Elderly Patients ◽

Older Patients ◽

Palliative Chemotherapy ◽

Performance Status ◽

Age Groups ◽

Response Rates ◽

The Elderly ◽

Younger Patients ◽

Royal Marsden Hospital

PURPOSE: The surgical treatment of colorectal cancer (CRC) in elderly patients (age 70 years or older) has improved, but data on adjuvant and palliative chemotherapy tolerability and benefits in this growing population remain scarce. Elderly patients are underrepresented in clinical trials, and results for older patients are seldom reported separately. PATIENTS AND METHODS: Using a prospective database, we analyzed demographics, chemotherapy toxicity, response rates, failure-free survival (FFS), and overall survival (OS) of CRC patients receiving chemotherapy at the Royal Marsden Hospital. The cutoff age was 70 years. RESULTS: A total of 844 patients received first-line chemotherapy with various fluorouracil (5-FU)-containing regimens or raltitrexed for advanced disease, and 543 patients were administered adjuvant, protracted venous infusion 5-FU or bolus 5-FU/folinic acid (FA) chemotherapy. Of the 1,387 patients, 310 were 70 years or older. There was no difference in overall or severe (Common Toxicity Criteria III to IV) toxicity between the two age groups, with the exception of more frequent severe mucositis in older patients receiving adjuvant bolus 5-FU/FA. For patients receiving palliative chemotherapy, no difference in response rates (24% v 29%, P = .19) and median FFS (164 v 168 days) were detected when the elderly were compared with younger patients. Median OS was 292 days for the elderly group and 350 days for the younger patients (P = .04), and 1-year survival was 44% and 48%, respectively. The length of inpatient hospital stay was identical. CONCLUSION: Elderly patients with good performance status tolerated adjuvant and palliative chemotherapy for CRC as well as did younger patients and had similar benefits from palliative chemotherapy.

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Abstract P203: The Effect of Combination Evidence-Based Medical Therapy on Six-Month Mortality in Elderly Patients with ACS

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.4.suppl_1.ap203 ◽

2011 ◽

Vol 4 (suppl_1) ◽

Author(s):

Sibin Zacharias ◽

Michael Howe ◽

Dan Montgomery ◽

Elizabeth A Jackson

Keyword(s):

Elderly Patients ◽

Risk Score ◽

Beta Blockers ◽

Age Groups ◽

The Elderly ◽

Lipid Lowering ◽

Evidence Based ◽

Younger Patients ◽

Grace Risk Score ◽

Improve Compliance

Background Beta-blockers, anti-platelet agents, ACE-inhibitors, and lipid-lowering agents have been shown to reduce mortality in patients with acute coronary syndromes (ACS). Elderly patients often do not receive these medications due to provider concerns regarding potential for adverse events. We compared three age groups for receipt of cardiac medications after ACS and associated outcomes at six months. Methods Data on demographics, comorbidities, and management was collected on ACS patients discharged between January 1999 and December 2006. A composite appropriateness score, defined as the number of evidence-based medications received divided by the number indicated, was calculated for each patient. Patients were grouped by age. The primary outcome was six-month mortality across appropriateness level, after adjustment for the GRACE risk score. Results Of 3,058 patients followed, 175 died at six-months. Older age was associated with lower receipt of indicated medications upon discharge as compared to younger patients, identified by an appropriateness score of 0, 1, or 2 (p<0.0001). After adjustment for the GRACE risk score, ACS patients 65 years or greater who received appropriate cardiac medications had similar risk reductions to those less than 65. (Figure) Conclusions Older patients without contraindications to cardiac medications have similar survival benefits to younger patients. Efforts to improve compliance with current ACS guidelines for all patients including the elderly are warranted.

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Phase II Study of Sphingosomal Vincristine in CHOP+/ − Rituximab for Patients with Aggressive Non-Hodgkin’s Lymphoma (NHL): Promising 3 Year Follow-Up Results in Elderly Patients.

Blood ◽

10.1182/blood.v106.11.943.943 ◽

2005 ◽

Vol 106 (11) ◽

pp. 943-943

Author(s):

Maria Alma Rodriguez ◽

Nam H. Dang ◽

Luis Fayad ◽

Andre Goy ◽

Fredrick Hagemeister ◽

...

Keyword(s):

T Cell ◽

Elderly Patients ◽

Phase Ii ◽

Phase Ii Study ◽

Cell Lymphoma ◽

Standard Dose ◽

Age Groups ◽

B Cell Lymphoma ◽

Younger Patients

Abstract Background: Individuals older than 60 years have a worse prognosis than younger patients with aggressive NHL. Vincristine is an active drug in the treatment of malignant lymphomas. Sphingosomal vincristine (SV) was well tolerated with 45% ORR in patients with multiple relapses of aggressive NHL (ASH abst. 412, 1999). Based on these data, a phase II study of CHOP with rituximab (no rituximab for T-cell histology), and substituting SV for free vincristine, was undertaken in patients with previously untreated aggressive NHL. Methods: Aggressive NHL histologies eligible for study were diffuse large B-cell lymphoma (DLCL), peripheral T-cell lymphoma (PTCL), follicular lymphoma grade 3 (FL gr3), anaplastic large cell lymphoma (ALCL), and indolent lymphomas with aggressive transformation (TL). Patients were treated with standard dose CHOP that included SV 2.0 mg/m2 without dose capping, ± rituximab 375 mg/m2, given every 21 days for 6 to 8 courses (ASH abst. 338, 2002). Results: Of 73 patients enrolled on study, 68 were evaluable for response. Median age was 61 (range 22–80), 36 patients (53%) were >60 years old. Overall, 24 patients (23 elderly) had an IPI score ≥3. Patients received a median of 6 study treatments (range 1–8). Diagnoses were: DLCL = 56; FL gr 3 = 4; PTCL = 4; ALCL = 2 and TL = 2. ORR was 92.6% (63/68 pts) with 55 pts achieving CR (80.1%), 7 CRu (10.3%), and 1 PR (1.5%); 3 patients had PD (4.4%) and 2 were not assessed for response (2.9%). ORR was similar in both elderly (>60) and younger pts (≤60): 91.9% and 93.5% respectively. Neuropathy was generally mild (Gr.1–2). Hematological toxicities were as follows: 56% Gr.3–4 neutropenia, 6% Gr.3 anemia, and 13% Gr.3–4 thrombocytopenia. Toxicites were comparable in elderly and younger patients. The median follow up for the study is 39.6 months (mos), and overall survival 94%. There have been 9 relapses (5 DLCL, 3 T-cell, 1 FL gr3, 1 transformed) for elderly patients and 5 relapses (4 DLCL, 1 T-cell) for patients ≤60. The table below shows progression free survival (PFS) at 3 years, for all histologies, and DLCL by age. There is no difference between the age groups. Conclusions: This regimen, with sphingosomal vincristine in CHOP +/− Rituximab, has a high overall response rate. It is a well-tolerated therapy with mild neurotoxicity for all patients. At 3 years, the PFS in elderly patients with DLCL treated with RCHOP is comparable to that of younger patients, despite a larger fraction of high risk IPI in the older patients. This regimen merits randomized comparison to RCHOP in DLCL. Age (Yrs) All Histologies (n=68) DLCL (n=56) ≤60 84%, CI [66–93] 85%, CI [66–94] >60 83%, CI [66–92] 86%, CI [66–94]

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Treatment of Aggressive B-Cell Lymphoma in the Elderly: The Influence of SNPs Affecting Pharmacodynamics Is Different Compared to Younger Patient

Blood ◽

10.1182/blood.v120.21.1613.1613 ◽

2012 ◽

Vol 120 (21) ◽

pp. 1613-1613

Author(s):

Thomas Melchardt ◽

Lukas Weiss ◽

Clemens Hufnagl ◽

Daniel Neureiter ◽

Ralf Kemmerling ◽

...

Keyword(s):

Elderly Patients ◽

B Cell ◽

Research Funding ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

The Elderly ◽

Tissue Samples ◽

Younger Patients ◽

The Impact ◽

Aggressive B Cell Lymphoma

Abstract Abstract 1613 Background: Elderly patients with aggressive B-cell lymphoma are underrepresented in almost all clinical trials and treatment related toxicity mainly due to anthracycline treatment is a major concern. Individual pharmacogenetic settings may influence the prognosis due to altered efficacy and treatment related toxicity. Several single nucleotide polymorphisms (SNPs) involved in metabolization of chemotherapeutic agents have been proposed to influence the clinical course of disease in younger patients. However, no data are available in elderly patients. Methods: We retrospectively analyzed and characterized 83 consecutively diagnosed patients ≥75 years with aggressive B-cell lymphoma (78 cases of diffuse large B-cell lymphoma and 5 cases of follicular lymphoma grade 3) from January 2004 until December 2011 treated at our tertiary cancer center by chart-based review. DNA was extracted from diagnostic tissue samples and analysis for 10 SNPs with previously reported effect on pharmacodynamics of components of the CHOP regimen were performed with commercially available primers (rs1883112 NCF4, rs3957357 GSTA1, rs4673 CYBA, rs1799977 MLH1, rs1045642 ABCB1, rs9024 CBR1, rs1695 GSTP1, rs17222723 ABCC2, rs7853758 SLC28A3, rs1056892 CBR3). Results: The entire cohort of 83 patients had a median age of 80 years (range 75–97 years) and 43 of 83 patients were male. Based on clinical judgment of fitness 82% of all patients received a combination of anthracycline and rituximab based therapy. The median overall survival (OS) in all patients was 43 months. Unsurprisingly, patients deemed eligible for a treatment with an anthracycline and rituximab had a better median OS than patients not eligible for this approach (54 vs 6 months p< 0.0001). Patients not treated with this combination therapy were significantly older (p<0.0001), had a worse ECOG status (p<0.03) and a higher Charlson index of Comorbidity (CI) (p<0.02). The cohort treated with an anthracycline and rituximab (n=68) had a median age of 79 years and 50% had a CI ≥1. In this group there was no significant difference in the median OS in patients <80 or >80 years of age (54 vs 55 months, Figure A) or with a CI ≤ 1 or CI ≥1 (43 vs 59 months). Tissue samples were available for 97% of these patients, which were used for DNA extraction and SNP analyses. Pharmacogenetic testing of 10 SNPs was performed as described before. The AA genotype of CBR 3 suggesting lower risk for anthracycline related cardiomyopathy or the GG genotype of MLH 1, which influences the mismatch repair system and the promotion of apoptosis e.g. triggered by chemotherapy, was found in 15 of 65 (23%) patients. Patients with either of these genotypes had a better median OS (30 months vs not reached p=0.01, Figure B). In multivariate analysis this benefit remained significant. Additional significant factors were an age-adjusted IPI ≤ 1 and a cumulative dosage of doxorubicin higher than 200mg/m2. The latter is likely a surrogate for overall tolerability of chemotherapy and no early progression. Discussion: Given the encouraging OS data of our unselected cohort we think that elderly patients with aggressive B-cell lymphoma should be offered curative immunochemotherapy with an anthracycline regardless of age taking into account severe comorbidities. We could further show that CBR3 and MLH1 polymorphism had an impact on the OS of these patients. The favorable CBR3 A/A genotype suggests the generation of a lower level of the cardiotoxic compound doxorubicinol after doxorubicin treatment in these patients, who are likely to be more prone to anthracycline-caused toxicity than younger patients. The impact of the MLH1 genotype indeed seems to be changed in elderly compared to younger patients, where the A/A genotype is associated with a better OS in patients treated with R-CHOP. The favorable impact of the G/G phenotype in elderly patients may be caused by a lower susceptibility to apoptosis induction in the healthy tissue. Thus, the meaning of pharmacogenetic markers may be substantially different between the young and the elderly due to the different impact of toxicity and efficacy in these populations. Based on these results a subgroup with exceptionally good OS may be defined for this age. Disclosures: Melchardt: Roche: Honoraria, Speakers Bureau; GSK: Research Funding; Ratiopharm: Research Funding. Weiss:Roche: Honoraria. Greil:Roche: Honoraria, Research Funding, Speakers Bureau; GSK: Research Funding; Ratiopharm: Research Funding. Egle:Roche: Honoraria, Research Funding, Speakers Bureau; GSK: Research Funding; Ratiopharm: Honoraria, Research Funding.

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551 INCREASED POSTOPERATIVE MORBIDITY AFTER TOTALLY MINIMALLY INVASIVE ESOPHAGECTOMY FOR CANCER IN ELDERLY PATIENTS

Diseases of the Esophagus ◽

10.1093/dote/doab052.551 ◽

2021 ◽

Vol 34 (Supplement_1) ◽

Author(s):

Nikolaj Baranov ◽

Frans Van Workum ◽

Camiel Rosman

Keyword(s):

Minimally Invasive ◽

Elderly Patients ◽

Minimally Invasive Esophagectomy ◽

Age Groups ◽

The Elderly ◽

Elderly Group ◽

Younger Patients ◽

Invasive Esophagectomy ◽

Outcome Parameters ◽

Increased Risk

Abstract The incidence of elderly patients with esophageal cancer is increasing. The aim of this study is to compare postoperative outcomes after esophagectomy between elderly patients and younger patients and to compare outcomes after totally minimally invasive esophagectomy (TMIE) and open esophagectomy (OE) in these age groups. Methods Data was retrieved from the Dutch Upper Gastrointestinal Cancer Audit (DUCA), a national surgical outcome registry. The primary outcome parameter was severe complications, defined as Clavien Dindo ≥3. Secondary outcome parameters were postoperative complications, reintervention rate, length of hospital stay and mortality. Outcome parameters were compared between patients aged ≥75 years and < 75 years and between TMIE and OE in these age groups. We adjusted for the following casemix parameters: gender, Charlson Co-morbidity Index score ASA score and neoadjuvant therapy. A sensitivity analysis was performed with different age groups: <65, 65–69, 70–74, 75–79 and ≥ 80 years. Results Of all 5539 included patients 14.0% were aged ≥75 years and 86.0% were aged <75 years. Severe complications were observed more frequently in the elderly group compared to the younger group (RR = 1.15 [1.04–1.27], p = 0.007). Interestingly, there was an increased risk of severe complications after TMIE in both the elderly group (RR = 1.50 [1.19–1.90], p = 0.001) and the younger group (RR = 1.41 [1.28–1.56], p < 0.001). No difference in mortality between TMIE and OE was found. Sensitivity analyses of TMIE compared to OE across all age groups showed increased risk of severe complications. Adjustment for casemix for all analysis did not change the results. Conclusion Severe complications after esophagectomy occur more frequently in elderly compared to younger patients. TMIE in elderly patients did not result in less morbidity and was in fact associated with more severe complications compared to OE across all age groups, which may be due to a learning curve effect.

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Feasibility and Efficacy of ABVD In Elderly Hodgkin Lymphoma Patients: Analysis of Two Randomized Prospective Multicenter Trials of the German Hodgkin Study Group (HD10 and HD11)

Blood ◽

10.1182/blood.v116.21.418.418 ◽

2010 ◽

Vol 116 (21) ◽

pp. 418-418 ◽

Cited By ~ 2

Author(s):

Boris Böll ◽

Helen Görgen ◽

Michael Fuchs ◽

Bastian von Tresckow ◽

Andreas Engert ◽

...

Keyword(s):

Elderly Patients ◽

Hodgkin Lymphoma ◽

Conflicts Of Interest ◽

Dose Intensity ◽

The Elderly ◽

Observation Time ◽

High Rate ◽

Who Grade ◽

Younger Patients ◽

Chemotherapy Dose

Abstract Abstract 418 About 20% of all patients with first diagnosis of Hodgkin Lymphoma (HL) are older than 60 years. They have a poor prognosis mainly due to an increased toxicity of chemo- and radiotherapy. Although resulting in better disease control, aggressive regimens as BEACOPP are not feasible in this cohort of patients due to a treatment related mortality of up to 20%. Therefore, ABVD is considered treatment of choice for elderly HL patients, although prospective studies are lacking and current concepts mostly rely on cohort analyses. We therefore analyzed feasibility, safety and outcome of patients older than 60 years with early favorable- or early unfavorable-stage HL treated with 4 cycles of ABVD within the HD10 and HD11 trials of the GHSG. Sixty-eight and 49 elderly patients with a median age of 65 and 64 years were treated in HD10 and HD11, respectively. Early termination of protocol therapy was documented in 18% of HD10 patients, but only in 8% of HD11 patients, resulting in a lower relative total chemotherapy dose (RCD) in HD10. The relative dose intensity (RCD divided by total relative chemotherapy duration) was much lower in both studies compared to younger patients, due to more toxicity-related therapy delays and dose reductions, as 4 cycles of ABVD caused WHO grade III/IV toxicities in 67% (HD10) and 69% (HD11). Overall efficacy was significantly lower than in younger patients with an overall response rate of 90% in HD10 and 92% in HD11. The rate of relapsing patients was the same as in younger patients in HD11 (14%), whereas in HD10 it was much higher in the elderly (12%) which was mainly due to late relapses. Overall 22% and 37% of the patients died in HD10 and HD11, respectively (median observation time: 92 months). Besides other causes as cardiovascular disease (7%) or secondary neoplasia (5%), there was a high rate of deaths due to insufficient HL-control (5%) and treatment-related toxicities (5%). The 5-year PFS estimates for elderly patients were 79% (95% CI, 67% to 87%) in HD10 and 69% (95% CI, 54% to 80%) in HD11 compared to 96% (95% CI, 93% to 97%) and 86% (95% CI, 83% to 88%) for younger patients in HD10 and HD11, respectively. In conclusion, 4 cycles of ABVD are effective in elderly HL patients; however, treatment-related toxicity is high. Disclosures: No relevant conflicts of interest to declare.

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

Cardiology ◽

10.1159/000516368 ◽

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

Introduction: 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). Methods: 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 <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. Results: 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 (p = 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 [p for age-group-by-treatment interaction = 0.83). Conclusions: Our results suggest that Dabigatran 150 mg twice a day can be safely used among elderly AF patients with low bleeding risk.

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