Therapy In Elderly Patients Research Articles

Predictors of mortality and clinical outcomes following implantable cardioverter-defibrillator therapy in elderly patients: A retrospective single-center cohort study.

Implantable cardioverter-defibrillators (ICDs) are frequently used to prevent sudden cardiac death in patients with high-risk arrhythmias. However, the use of ICD therapy in elderly patients beyond the predicted age of life expectancy is still controversial. We aimed to evaluate the predictors of mortality and clinical outcomes following ICD implantation in elderly patients. We conducted a retrospective analysis of 145 elderly patients aged 72 years and older who received ICD implantation between January 2010 and August 2015. We collected and analyzed baseline data, including clinical, demographic, and medical history, the reason for ICD therapy, procedural data, and echocardiography results. Follow-up data included the development of complications and mortality. The predictors of mortality were identified using the univariate and multivariable Cox regression models. During the median follow-up duration of 30.5 [18.0-48.0] months, 141 cases completed follow-up (mean age = 76.0 ± 3.7 years). Forty-four patients experienced at least one episode of ICD therapy. Inappropriate shock, recurrent shock, and device-related infection were the most frequent complications observed in our study. Of the 145 patients, 42 died during the follow-up period, with an average survival time of 22.4 months after ICD implantation. Among these patients, 11 received ICD for primary prevention, and 31 received it for secondary prevention. Cardiovascular problems were the leading cause of death. We found that a low baseline ejection fraction (EF) was an independent predictor of mortality (hazard ratio = 0.93, 95% confidence interval: 0.90-0.98; p = 0.008). Our study suggests that ICD therapy is a valuable treatment option for elderly patients beyond their predicted age of life expectancy. The study highlights the importance of baseline EF as a significant predictor of mortality in these patients.

ПРИМЕНЕНИЕ ПРЯМЫХ ПЕРОРАЛЬНЫХ АНТИКОАГУЛЯНТОВ У ПОЖИЛЫХ ПАЦИЕНТОВ С ОНКОЛОГИЧЕСКИМИ ЗАБОЛЕВАНИЯМИ

Venous thromboembolism is a common complication in elderly patients, especially in the presence of cancer. Currently used for thromboprophylaxis, vitamin K antagonists and low molecular weight heparins are effective, but have a number of disadvantages, which leads to a rare prescription of anticoagulant therapy in elderly patients. Modern studies have shown that direct oral anticoagulants (DOACs) can also be effective and safe in this category of patients, and the convenience of their use increases patient adherence to treatment. However, elderly patients have a number of features that must be considered when prescribing anticoagulant therapy. So, in the presence of renal failure or impaired liver function, it is necessary to consider the possibility of adjusting the prescribed dose. And in connection with the polypharmacy common in old age and the drug interactions associated with it, it is necessary to carefully consider all the drugs taken by the patient for their compatibility and, if necessary, make replacements. This review presents data on the efficacy and safety of DOACs in elderly patients, as well as presents and systematizes various clinical situations when therapy correction or careful monitoring is required.

Defibrillator exchange in the elderly.

Implantable cardioverter-defibrillator (ICD) therapy in elderly patients is controversial because survival benefits might be attenuated by nonarrhythmic causes of death. The purpose of this study was to investigate the outcome of septuagenarians and octogenarians after ICD generator exchange (GE). A total of 506 patients undergoing elective GE were analyzed to determine the incidence of ICD shocks and/or survival after GE. Patients were divided into a septuagenarian group (age70-79 years) and an octogenarian group (age ≥80 years). The primary endpoint was death from any cause. Secondary endpoints were survival after appropriate ICD shock and death without experiencing ICD shocks after GE ("prior death"). The association of the ICD with all-cause mortality and arrhythmic death was determined for septuagenarians and octogenarians. Comparing both groups, similar left ventricular ejection fraction (35.6% ± 11.2% vs 32.4% ± 8.9%) and baseline prevalence of New York Heart Association functional class III or IV heart failure (17.1% vs 14.7%) were found. During the entire follow-up period of the study, 42.5% of patients in the septuagenarian group died compared to 79% in the octogenarian group (P<.01). Prior death was significantly more frequent in both age groups than were appropriate ICD shocks. Predictors of mortality were common in both groups and included advanced heart failure, peripheral arterial disease, and renal failure. In clinical practice, decision-making for ICD GE among the elderly should be considered carefully for individual patients.

THU-156 - Tolerability of first line systemic therapy in elderly patients with advanced hepatocellular carcinoma

THU-156 - Tolerability of first line systemic therapy in elderly patients with advanced hepatocellular carcinoma

Survival outcomes with observation or adjuvant therapy in elderly patients with biliary tract cancer.

e16230 Background: The impact of adjuvant therapy (AT) on overall survival (OS) for biliary tract cancer (BTC) is contested. The BILCAP study suggested an improvement in OS with adjuvant capecitabine compared to observation. This was not apparent in the intention to treat population. Importantly, none of the patients in the study was older than 70 years. Considering the toxicity of AT and conflicting results of efficacy, the role of AT in older adults with BTC needs to be thoroughly assessed. We hypothesized that AT is not associated with significant benefit in the elderly. Methods: We performed a retrospective review of patients with resected BTC; gall bladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC) using the National Cancer Database (NCDB) PUFs (2004-2019). We limited analysis to patients aged &gt;= 70 years. We compared clinical characteristics and outcomes in those who received AT (including chemotherapy and chemotherapy + radiation) within 6 months after resection, and those who did not (Obs). We performed propensity score matching analysis of both groups (matched for age, sex, race, Charleson-Deyo score, AJCC pathologic T stage among others) and assessed survival by Kaplan-Meier analysis. Results: We identified 8,091 elderly patients with T1-T3/N1-N2 resected BTC. The majority had GBC (76.7%), and 3, 041 (38%) were aged &gt;= 80 years (median 78 years). Only 2, 632 (32.5%) received AT. Of these, 1,304 (50%) received chemotherapy and radiation. Median OS was higher in the Obs vs the AT group (24.3 months, vs 20.2 months, P &lt; 0.0001) and the five-year survival was also higher in the Obs group (29.1% vs 22.6%, P&lt;0.001). Survival also favored the Obs group in a propensity score matched cohort of 835 patients per group (median OS 33.1 vs 19.5 months, P &lt;0.0001). On multivariable analysis AT was associated with a higher hazard of death (HR 1.21, CI 1.13-1.29, P &lt;0.001). Age &gt;=80 (HR 1.39, CI 1.32-1.47, P&lt;0.001), GBC ( HR 1.29, CI 1.20-1.39, P&lt;0.001) were also associated with worse survival. Compared to diagnosis between 2004-2009 diagnosis in 2010- 2015 (HR 0.83, CI 0.78- 0.89) and 2016- 2019 (HR 0.74 CI 0.67-0.8, P &lt;0.001) were associated with improved OS. Conclusions: In patients &gt;=70, AT for BTC was not associated with improved OS and was actually associated with a higher hazard of death compared Obs. Based on these results, the role of AT for BTC in the elderly needs to be examined prospectively.

P85 REAL WORLD EXPERIENCE ON THE USE OF SGLT2–I IN ELDERLY PATIENTS WITH HFREF

Abstract SGLT2–i have been shown to improve prognosis in patients with heart failure with reduced ejection fraction (HFrEF) in randomized clinical trials (RCTs). However, at the moment, we have little data on the use of these drugs in clinical practice, both in terms of safety and efficacy profile. Objectives To describe the characteristics of HFrEF outpatients who started SGLT2–i in clinical practice; evaluate tolerability and the effect on clinical and biohumoral parameters. Methods We prospectively analyzed patients who started SGLT2–i in our Heart Failure clinic. The baseline characteristics, the variations of bio–humoral and clinical parameters were recorded, as well as the onset of adverse effects leading to drug suspension after one month. Results We evaluated 37 patients, with a mean age of 77.7± 8.5 years (65% over 75). The baseline characteristics of the population compared to that of the treatment arms of the RCTs are shown in Fig.1. Most patients were in NYHA II (62%), with ischemic etiology (65%), with reduced EF (mean 34.7± 5.1%) and nearly half of the patients received ICD or CRT–D (43.2%). At the one month follow–up, there was a significant reduction in NYHA class (Fig. 2)and furosemide dose (36.3 vs 53.2 mg, p&amp;lt;0.001), without a significant change in NTproBNP values ​​(2499 vs 2431 pg /mL, p=0.804). Furthermore, there was a reduction in systolic blood pressure (115 vs 120 mmHg, p=0.029) with no significant increase in the incidence of orthostatic hypotension (27% vs 21%, p=0.48). In line with the trials, there was a slight, non–significant worsening of renal function (CKD–EPI 52.9 vs 55.9 mL/min, p=0.10). At one month, no patients experienced any adverse effects leading to SGLT2–i discontinuation. Conclusions In this preliminary analysis, after one month of SGLT2–i therapy in elderly patients, there was a clinical and hemodynamic improvement as demonstrated by the improvement of the NYHA class and the reduction of the diuretic therapy. SGLT2–i have been shown to be relatively safe, with no adverse effects and no increased risk of orthostatic hypotension or significant worsening of renal function.

Features of the treatment of arterial hypertension in elderly patients

Arterial hypertension (AH) is one of the most common problems in the elderly and one of the most important cardiovascular risk factors. AH in the elderly has features with a high incidence of ISAH and is characterized by a high level of SBP and a low level of DBP, which creates certain problems for the safety of treatment. The need for antihypertensive therapy in elderly patients has received convincing evidence of the effectiveness of reducing mortality and cardiovascular complications. The purpose of this scientific review was to raise awareness of the problem of treating hypertension in elderly patients, including those with low DBP. The results of studies and meta-analyzes evaluating the efficacy and safety of standard and intensive SBP reduction in elderly patients, as well as the results of the effect of antihypertensive therapy on DBP levels, especially at baseline low DBP (&lt;70 mmHg), are presented. The studies identified the main groups of antihypertensive drugs that provide an effective and safe reduction in blood pressure in elderly patients, have a cardioprotective effect and do not adversely affect comorbidities. These include: diuretics of the thiazide-like group, calcium channel blockers, as well as additional indications and concomitant conditions – ACE inhibitors and antigotensin II receptor blockers. Several meta-analyses have shown the benefit of intensively lowering SBP &lt; 120 mmHg before the standard target level SBP &lt; 140 mmHg. in elderly patients as a lower risk of fatal and non-fatal cardiovascular events and overall mortality. Thus, the impact of intensive SBP reduction was beneficial in preventing 1 case of MACE (NNT = 38) and in preventing 1 case of total mortality (NNT = 85); while the rate of harm in the form of arterial hypotension was significantly high (NNH = 778). With regard to the effect on the level of DBP in elderly patients with hypertension or ISAH, an inverse relationship between DBP and adverse coronary events was revealed and a J-curve was described, confirmed in a number of studies (INVEST, ARIC, SPRINT). Moreover, with an initially low DBP (&lt;70 mmHg), a significant increase in the frequency of outcomes and the relative risk of outcomes was noted. It is not easy to decide on antihypertensive therapy in such situations. The evidence base of studies suggests the benefit of lowering SBP for the prevention of cardiovascular events in elderly patients, but with caution and individual approach. It is important to take into account individual patient characteristics such as cognition, autonomy, and frailty/frailty when setting target BP.

Systemic Therapy in Elderly Patients With Her2/Neu-Positive Breast Cancer: A SEER Database Study.

The use of systemic therapy in elderly patients with Her2/neu-positive breast cancers has been questioned given the potential for cardiac side effects with several of the agents frequently used. This study aimed to evaluate trends in use of systemic therapy in patients 70years and older. The 2010-2016 SEER database was used to collect data on female patients with non-metastatic Her2/neu-positive breast cancer. Data was stratified to compare systemic therapy use in patients <70 vs ≥70. A total of 62,014 patients were included in the study. Of those, 79.0% (38,760) of patients <70years old received systemic therapy while only 45.2% (5844) of patients ≥70 received systemic therapy (P < .001). Of patients ≥70 with ER positive tumors, 42.1% received systemic therapy and those with ER negative tumors, 52.1% received systemic therapy. The mortality rate in patients ≥70 was 8.5% in those who received systemic therapy and 12.1% in those who did not (P < .001). There remains a significant difference in rates of systemic therapy administration in the elderly population with an associated increase in mortality due to their cancer. Continuing educational efforts could be of benefit.

An analysis of antithrombotic therapy in elderly patients with atrial fibrillation undergoing percutaneous coronary interventions.

As a result of large, randomized trials and updates to clinical guidelines, antithrombotic therapy following percutaneous coronary intervention (PCI) has changed in recent years for patients with nonvalvular atrial fibrillation (NVAF). The purpose of this study was to investigate the real-world data of antithrombotic regimens at discharge and their evolving trends, as well as compare the effect of different therapies on the incidence of major cardiovascular and cerebrovascular ischemic events (MACCEs) and bleeding events in elderly patients. An analysis of 6298 stent implantation patients from 2016-2018 was carried out retrospectively. AF patients aged 65 and older were divided into two groups according to the antithrombotic regimens prescribed at hospital discharge: dual antiplatelet aggregation treatment group (DAPT) and anticoagulant treatment and antiplatelet aggregation treatment group (ATT). Baseline characteristics, efficacy endpoints (MACCEs/cerebrovascular ischemic events), and safety endpoints (bleeding events) were analyzed and compared between the different antithrombotic regiments. During 2016-2018, the use of oral anticoagulants (OAC) increased from 16.3% to 54.1% (P trend < 0.01). Since the introduction of non-vitamin K antagonist oral anticoagulants (NOACs), warfarin usage has decreased from 100% to 41.7%, and NOACs have rapidly replaced warfarin. The rate of persistent AF in the ATT group was significantly higher than the rate in the DAPT group (79.6% vs. 59.7%, P = 0.01), and the ATT group used more proton pump inhibitors (PPI) than the DAPT group (23.3% vs. 11.8%, P = 0.01). A significant decrease was observed in MACCEs (10.7% vs. 26.0%, P < 0.01) and cerebrovascular ischemic events (2.9% vs. 11.8%, P = 0.01) in the ATT group compared with the DAPT group. According to the ATT subgroup analysis, there was a significant difference in the incidence of overall bleeding between the triple anticoagulant therapy group (TT) and the dual anticoagulant therapy group (DT) (18.0% vs. 2.4%, P = 0.02). MACCEs were predicted independently by ATT and CHA2DS2-VASc scores, whereas bleeding was predicted independently by PPI use and HAS-BLED scores. As a result of NOAC introduction and use, the combination of antithrombotic regimens at discharge for elderly patients with AF after PCI has changed rapidly over the past few years toward a higher use of ATTs, while patients with AF undergoing PCI still rarely receive an appropriate antithrombotic regimen. It is essential to conduct ATT in elderly patients who are undergoing PCI, and further DT may be more appropriate.

Risk factor for progression to kidney failure with replacement therapy in elderly patients with chronic kidney disease: A retrospective single‐centre cohort study

Although the number of elderly patients with chronic kidney disease (CKD) has increased, few studies have examined their prognosis. The study design was a retrospective cohort study at a single centre. We evaluated 301 patients aged ≥75 years old with CKD stage G3a to G5. The primary endpoint was kidney failure with replacement therapy (KFRT) and secondary endpoints were all-cause mortality and annual decline rates of estimated glomerular filtration rate (eGFR). The incidence of KFRT was estimated using the cumulative incidence method considering the competing risk of death. To identify the independent risk factors related to KFRT, multivariate Fine-Gray regression model analysis were performed. The median age of the patients was 79 years and the median eGFR was 24.0 mL/min/1.73 m2 at baseline. Urinary protein was positive in 70% of patients. With a median follow-up of 24.5 months, 35% of the patients developed KFRT and 9% died. Kidney survival significantly decreased according to the CKD stage at baseline. In patients without proteinuria, the cumulative incidence of KFRT increased in CKD stage G5 patients, while in patients with proteinuria, the incidence of KFRT increased from patients with CKD stage G3b. Multivariate Fine-Gray regression model revealed that less aged, CKD stage G5, baseline data such as proteinuria, hypoalbuminemia, hyperphosphatemia, and hyperuricemia were independent risk factors for KFRT. Elderly CKD patients with proteinuria need to be carefully monitored even at an early CKD stage because of the risk of developing KFRT.

Dalbavancin as Consolidation Therapy in Elderly Patients

Dalbavancin as Consolidation Therapy in Elderly Patients

Antiplatelet therapy in elderly patients after acute coronary syndrome

Antiplatelet therapy in elderly patients after acute coronary syndrome

Impaired geriatric 8 score is associated with worse survival after radical intensity modulated radiation therapy in elderly patients with nasopharyngeal carcinoma

Background Geriatric 8 score (G8) was an independent prognostic factor for survival and toxicities in various malignancies, but it has never been tested in nasopharyngeal carcinoma (NPC). Objectives To evaluate the value of G8 in predicting survival in elderly patients with NPC. Material and Methods Patients with NPC aged ≥70 who received intensity-modulated radiation therapy were recruited into this study. The overall survival (OS), progression-free survival (PFS), locoregional recurrence rate (LRR), and distant metastasis rate (DMR) between the patients with G8 > 14 and G8 ≤ 14 were calculated using the Kaplan-Meier method and compared with the Log-rank test. Cox proportional hazards model was applied to perform univariate and multivariate analysis. Results G8 ≤ 14 had significantly reduced OS (p = .001) and PFS (p = .032) than those with G8 > 14 by log-rank test. G8 score remained an independent prognosticator for OS (HR = 0.490, 95% CI = 0.267–0.900, p = .021) and was a borderline significance towards PFS (HR = 0.639, 95% CI = 0.386–1.058, p = .082) in multivariate analysis. Grade 3–4 acute toxicities were significantly more common in patients with G8 ≤ 14 than in those with G8 > 14. Conclusions and significance G8 is useful in predicting the OS in elderly patients with NPC. Further prospective study stratified by G8 is needed to explore the value of CT in elderly patients with NPC.

Effect of rosuvastatin 20 mg versus rosuvastatin 5 mg plus ezetimibe on statin side-effects in elderly patients with atherosclerotic cardiovascular disease: Rationale and design of a randomized, controlled SaveSAMS trial

BackgroundCurrent guidelines recommend that patients with established atherosclerotic cardiovascular disease (ASCVD) use high-intensity statin therapy to lower low-density lipoprotein (LDL)-cholesterol levels by at least 50%, irrespective of age. However, in real-world practice, there is reluctance to maintain statin use in response to side-effects, particularly statin-associated muscle symptoms (SAMS). Moreover, no randomized trial has been conducted on the safety of statin therapy in elderly patients. Trial designThis investigator-initiated, multicenter, randomized clinical trial aimed to investigate the incidence of SAMS and its effect on LDL-cholesterol levels in elderly patients with established ASCVD. Eligible patients were aged 70 years or older with established ASCVD. Consecutive patients who met the inclusion criteria were randomized in a 1:1 fashion to receive either intensive statin monotherapy (rosuvastatin 20 mg) or combination therapy (rosuvastatin/ezetimibe, 5/10 mg). The primary endpoint of the study is SAMS at 6 months with regard to treatment strategy. Positive SAMS results are defined as patients with a proposed statin myalgia index score of 7 or higher. The key secondary end-points are target LDL-cholesterol achievement (LDL < 70 mg/dL), incidence of myopathy, rhabdomyolysis, frequency of drug discontinuation, and creatinine kinase, aspartate transaminase, alanine transaminase, total cholesterol, LDL-cholesterol, high-density lipoprotein-cholesterol, triglyceride, and highly sensitive C-reactive protein levels at 6 months. ConclusionsThe SaveSAMS study is a multicenter, randomized trial that will compare the incidence of SAMS in patients with established ASCVD who are 70 years or older on intensive statin monotherapy to that combination therapy.

Value of Safety of Anticoagulant Therapy in Elderly Patient with Atrial Fibrillation and High Risk of Bleeding

The review article discusses the safety issue of anticoagulant therapy in elderly patients with atrial fibrillation and high risk of bleeding. An evidence base is presented demonstrating the high safety of rivaroxaban in patients over 80 years of age, with a high risk of bleeding and cardiovascular complications, the presence of comorbid pathology, geriatric syndromes and chronic kidney disease (including in combination with anemia). The problem of low adherence to treatment in elderly patients and the possibility of solving it were separately considered.

The interaction between physical frailty and prognostic impact of heart failure medication in elderly patients.

Frailty is highly prevalent and associated with poor prognoses in elderly patients with heart failure (HF). However, the potential effects of physical frailty on the benefits of HF medications in elderly patients with HF are unclear. We aimed to determine the influence of physical frailty on the prognosis of HF medications in elderly patients with HF with reduced and mildly reduced ejection fraction (HFr/mrEF). From the combined HF database of the FRAGILE-HF and Kitasato cohorts, hospitalized HF patients with a left ventricular ejection fraction<50% and age≥65years were analysed. Patients treated with or without renin-angiotensin-aldosterone system inhibitors (RAASi) and beta-blockers at discharge were compared. Physical frailty was defined by the presence of ≥3 items on the Japanese version of the Cardiovascular Health Study criteria. The primary endpoint was all-cause mortality rate. Among the 1021 enrolled patients, 604 patients (59%) received both RAASi and beta-blockers, and 604 patients (59%) were diagnosed as physically frail. Patients receiving both RAASi and beta-blockers showed a significantly lower 1year mortality than those not receiving either, even after adjusting for covariates (hazard ratio: 0.50, 95% confidence interval: 0.34-0.75). This beneficial effect of both medications on 1year mortality was comparable between patients with and without physical frailty (hazard ratio: 0.53 and 0.51, respectively; P for interaction=0.77). The presence of physical frailty did not interact with the beneficial prognostic impact of RAASi and beta-blocker combination therapy in elderly patients with HFr/mrEF.

Efficacy and safety of high-flow nasal cannula therapy in elderly patients with acute respiratory failure

IntroductionTo assess the efficacy and safety of high-flow nasal cannula (HFNC) in elderly patients with acute respiratory failure (ARF) not due to COVID-19, refractory to treatment with conventional oxygen therapy and/or intolerant to noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP) and without criteria for admission to intensive care units (ICU). MethodsProspective observational study of patients with ARF treated with HFNC who presented clinical and arterial blood gas deterioration after 24 h of medical treatment and oxygenation by conventional systems. The degree of dyspnoea, gas exchange parameters (arterial O2 pressure/inspired O2 fraction ratio (PaO2/FiO2); oxygen saturation measured by oximetry/ inspired fraction of oxygen (Sp02/Fi02), ROX index), degree of patient tolerance and mortality were evaluated. These were measured at discharge from the emergency department (ED), 24 h after treatment with conventional oxygenation and 60, 120 min and 24 h after initiation of HFNC. The results were analyzed for all patients as a whole and for patients with hypercapnia (arterial carbon dioxide tension (PaCO2) < 45 mmHg) separately. Results200 patients were included in the study between November 2019 and November 2020, with a mean age of 83 years, predominantly women (61.9%), obese (Body Mass Index (BMI) 31.1), with high comorbidity (Charlson index 4) and mild-moderate degree of dependence (Barthel 60). A number of 128 patients (64%) were hypercapnic. None had respiratory acidosis (pH 7.39). Evaluation at 60 min, 120 min and 24 h showed significant improvement in all patients and in the subgroup of hypercapnic patients with respect to baseline parameters in respiratory rate (RR), dyspnoea, ROX index, PaO2/FiO2, SpO2/FiO2 and patient comfort. No changes in PaCO2 or level of consciousness were observed. HFNC was well tolerated. Ten patients (5%) died due to progression of the disease causing ARF. ConclusionsHFNC is an effective and safe alternative in elderly patients with ARF not due to COVID-19, refractory to treatment with conventional oxygen therapy and/or intolerant to NIV or CPAP and without criteria for admission to ICU.

The efficacy and safety of using pyrotinib combined with capecitabine as neoadjuvant therapy in elderly patients with HER2-positive breast cancer: a single-arm prospective clinical trial.

Pyrotinib combined with capecitabine has been approved for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer in China. To date, the management of early-stage or locally advanced HER2-positive breast cancer in the clinic remains challenging. We conducted this trial to investigate the efficacy and safety of pyrotinib combined with capecitabine as neoadjuvant therapy (NAT) in elderly patients with HER2-positive breast cancer. Due to the stimulation of blood vessels by chemotherapy drugs, the elasticity of blood vessels in the elderly decreases, and then chemotherapy infusion is more likely to lead to phlebitis. Both pyrotinib and capecitabine can be taken to facilitate home treatment for elderly patients with HER2-positive breast cancer (BC). From January 2020 to March 2021, patients aged between 70 and 81 years old with stage IIA-IIIB HER2-positive breast cancer were screened, enrolled, and assigned to receive six cycles of pyrotinib (320-400 mg, orally, once daily) plus capecitabine (1,250 mg/m2, orally, twice daily) on days 1-14 in every 21-day cycle. The primary endpoint was the objective response rate (ORR). Adverse events (AEs) were assessed in every neoadjuvant cycle. Surgery was performed after the last cycle, and the total pathological complete response (tpCR) was evaluated postoperatively. Of the 23 patients enrolled, the ORR was 100% (23/23; 95% confidence intervals: 85 to 100). All patients underwent surgery with a tpCR rate of 43.5% (10/23; 95% confidence intervals: 23 to 66). The most common AE was diarrhea, occurring in 19 of 23 patients (82.6%); most of these patients sustained mild diarrhea (Grade 1 or Grade 2) and only three had moderate diarrhea (Grade 3). The incidences of other AEs, including weakness, loss of appetite, leukopenia, nausea, vomiting, hand-foot syndrome, etc., were low and the symptoms were mild. No severe AEs (Grade 4 or 5) were observed throughout the treatment. In our study, pyrotinib combined with capecitabine as neoadjuvant therapy in elderly women with HER2-positive breast cancer is safe and showed efficacy in this population, which may be widely used as a protocol for clinical neoadjuvant therapy.

14-day pantoprazole- and amoxicillin-containing high-dose dual therapy for Helicobacter pylori eradication in elderly patients: A prospective, randomized controlled trial.

Background: Currently, the management of Helicobacter pylori (H. pylori) infection in elderly patients is controversial. We investigated whether high-dose dual therapy would serve as the first-line therapy in elderly patients. Methods: This was a single-center, randomized study of 150 elderly patients with H. pylori infection who were randomly assigned to 14-day therapy with pantoprazole 40mg 3 times daily and either amoxicillin 1,000mg 3 times daily or amoxicillin 1,000mg twice daily, clarithromycin 500mg twice daily and bismuth 220mg twice daily. H. pylori eradication was evaluated by a 13C-urea breath test 4 weeks after the completion of treatment. Results: Successful eradication was achieved in 89.3% of the high-dose dual therapy (HT) group in the intention-to-treat (ITT) analysis, 91.7% in the modified intention-to-treat (mITT) analysis, and 93.0% for per-protocol (PP) analysis which was similar to the bismuth-containing quadruple therapy (BQT) group (86.6%, 87.8%, and 90.3%, respectively). There were no significant difference between the HT group and the BQT group in the ITT analysis (p = 0.484), mITT analysis (p = 0.458), or PP analysis (p = 0.403). HT was associated with fewer side effects (10.6% of patients) than BQT (26.6%) (p = 0.026). Conclusion: In this trial, we found that 14-day HT had a similar eradication rate to BQT but fewer side effects, which may be better for elderly patients.

Biological therapy in elderly patients with acute myeloid leukemia

ABSTRACT Introduction The introduction of target molecules and immunological therapies is changing the treatment landscape of acute myeloid leukemia (AML). Areas covered We recapitulate the biological therapies that can be employed in the treatment of elderly patients with AML. Alongside small molecules inhibitors that target specific gene mutations, antibodies, tumor microenvironment modulators, and cellular therapies are being developed for the cure of the disease. Here, we report the biological activities, the efficacy and toxicities of humanized antibodies and antibody-drug conjugates that targets surface antigens as CD33 (gemtuzumab ozogamicine) or CD123 (pivekimab sunirine). We further explore mechanisms and effectiveness of medications that modify the microenvironment, such as glasdegib, or that harness the immune system against leukemia, such as CD47 antibody magrolimab, PD1/PDL1 inhibitors pembrolizumab and nivolumab, TIM3 inhibitor sabatolimab, T-cell and NK-cell engagers. Cellular therapies are considered, even if a large trial is still pending for the feasibility of the approach. In this scenario, a brief overview of the mechanism of action of target agents is provided, particularly with respect to their biological mechanisms. Expert opinion Overall, this therapeutic armamentarium will constitute the basis for multimodal and personalized combinations that, in the idea of precision medicine, will enormously benefit elderly AML patients.