Effectiveness and safety in very elderly patients treated by bevacizumab (BV) plus chemotherapy in first-line therapy of metastatic colorectal cancer: Results of ETNA, a French cohort study.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 555-555 ◽  
Author(s):  
D. Smith ◽  
M. Rouyer ◽  
P. Noize ◽  
R. Lassalle ◽  
O. Bernard ◽  
...  
Keyword(s):  
Cohort Study ◽  
Elderly Patients ◽  
Median Duration ◽  
Real Life ◽  
Survival Outcomes ◽  
Ageing Population ◽  
Curative Surgery ◽  
First Line Therapy ◽  
Grade 3

555 Background: In view of the ageing population, oncogeriatrics has become a priority for public health. Elderly cancer patients are often excluded from clinical trials and there is no therapeutic standard for their care management. Cohort studies have been conducted in US and Europe but not in France. The ETNA study aimed to describe BV use and survival outcomes in real-life practice. Here, the population aged >75 years was compared to that aged >75. Methods: ETNA is a cohort study conducted in 28 French centers that included 411 patients initiating BV between Jan 2006 and Dec 2007, with 24 month follow-up. Results: Fifty-one patients (12.4%) of the cohort were over 75 years old: mean age 78.3 years (vs 61.9 years for the rest of the cohort), male 66.7% (vs 56.1%), ECOG≥2 17.6% (vs 10.8%). BV was combined with FOLFIRI/XELIRI in 88.2% of patients aged >75 years (vs 87.5%) and FOLFOX/XELOX in 11.8% (vs 12.2%). Median duration of BV treatment was 5.6 months (m) (vs 5.5 m), and median duration of the 1st-line was 10.3 m (vs 9.8 m). More patients >75 years had treatment-free intervals (39.2% vs 28.6%), and 13.7% had a maintenance therapy (vs 12.8%). Curative surgery performed in 15.7% of patients (vs. 20.6%). Among the 43 patients who discontinued the 1st-line, only 9.3% discontinued BV prematurely (vs 18.2%). The incidence of any grade-3/4 adverse event was 43.1% (vs 41.7%). In-line with the known safety profile of BV (any grade), hypertension was observed in 21.6% (vs 18.9%), proteinuria 23.5% (vs 27.2%), there were no GI perforations (vs 0.3%), thrombotic events 5.9% (vs 7.8%), and grade 3/4 arterial thrombotic events 2.0% (vs 0.6%). The 1-year OS rate was 78.0%, 95%CI [63.9-87.2] (vs 80.5%, 95%CI [76.0-84.2]) and the median OS was not reached for both groups. The median PFS was 10.6 m, 95%CI [9.0-12.8] (vs 9.9 m, 95%CI [9.3-11.1]). Conclusions: Effectiveness and safety of BV plus chemotherapy in elderly patients were similar to those of the rest of the ETNA cohort. Estimations of survival outcomes (1-year OS rate, median OS and PFS) were also comparable to those found in elderly patients (75-80 years) from the BRITE cohort (72.0%, 20.3 m and 10.0 m, respectively). No significant financial relationships to disclose.

scholarly journals Old Does Not Necessarily Mean Worse: Standard Stupp Regimen for Elderly Patients (≥ 70 years) with Newly Diagnosed Glioblastoma

2021 ◽  
Author(s):  
Loig Vaugier ◽  
Loïc Ah-Thiane ◽  
Maud Aumont ◽  
Emmanuel Jouglar ◽  
Mario Campone ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Real Life ◽  
Treatment Decision ◽  
Hematologic Toxicity ◽  
Newly Diagnosed ◽  
Class Iii ◽  
Newly Diagnosed Glioblastoma ◽  
Grade 3 ◽  
Neurological Disabilities

Abstract Introduction Glioblastoma (GBM) is frequent in elderly patients, but their frailty provokes debate regarding optimal treatment in general, and the standard Stupp regimen in particular, although this is the mainstay for younger (<65 years) patients. Methods All patients with newly diagnosed GBM and age ≥ 70 who were referred to our institution for Stupp treatment were reviewed from 2004 to 2018. MGMT status was not available for treatment decision. The primary endpoint was overall survival (OS). Secondary outcomes were relapse-free survival (RFS), early (≤ 1 month after RCT) adverse neurological events (symptoms of intracranial hypertension and/or use of corticosteroids and/or hospitalization) and temozolomide hematologic toxicity assessed by CTCAE v5. Results 128 patients were included. The median age was 74.1 (IQR: 72-77). 15% of patients were ≥80 years. 62.5% and 37.5% of patients fulfilled the criteria for RPA class I-II and III-IV, respectively. 81% of patients received the entire RCT and 28% completed the maintenance temozolomide. With median follow-up of 11.7 months (IQR: 6.5-17.5), median OS was 11.7 months (CI95%: 10-13 months). Median RFS was 9.5 months (CI95%: 9-10.5 months). 60% of patients had early adverse neurological events, of whom 44% had progression and 8% experienced grade ≥3 hematologic adverse events. RPA class III-IV and occurrence of neurological events were associated with lower OS rates, whereas post-operative neurological disabilities were not. Age ≥80 was not associated with worsened outcomes. Conclusions Stupp radiochemotherapy was feasible and effective for “real-life” elderly patients diagnosed with glioblastoma, even in the case of post-operative neurological disabilities.

scholarly journals Real Life Use of Bendamustine in Elderly Patients with Lymphoid Neoplasia

2021 ◽  
Vol 11 (4) ◽  
pp. 249
Author(s):  
Irene Dogliotti ◽  
Simone Ragaini ◽  
Francesco Vassallo ◽  
Elia Boccellato ◽  
Gabriele De Luca ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Rating Scale ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Real Life ◽  
Lymphocytic Leukemia ◽  
Factors Affecting ◽  
Lymphoid Neoplasia ◽  
Baseline Factors ◽  
Grade 3

Background. Bendamustine is a cytotoxic alkylating drug with a broad range of indications as a single agent or in combination therapy in lymphoid neoplasia patients. However, its tolerability in elderly patients is still debated. Methods: An observational, retrospective study was carried out; patients with chronic lymphocytic leukemia (CLL) or lymphoma, aged ≥ 65 years old, treated with bendamustine-based regimens in first or subsequent lines between 2010 and 2020 were considered eligible. Results: Overall, 179 patients aged ≥ 65 years were enrolled, 53% between 71 and 79 years old. Cumulative Illness Rating Scale (CIRS) comorbidity score was ≥6 in 54% patients. Overall survival (OS) at 12 months was 95% (95% confidence interval [CI]: 90–97%); after a median follow up of 50 months, median OS was 84 months. The overall response rate was 87%, with 56% complete responses; the median time to progression (TTP) was 61 months. The baseline factors affecting OS by multivariable analysis were sex, histological diagnosis, renal function, and planned bendamustine dose, while only type of lymphoma and bendamustine dose impacted on TTP. Main adverse events were neutropenia (grade ≥ 3: 43%) and infections (any grade: 36%), with 17% of patients requiring hospital admission. Conclusions: The responses to bendamustine, as well as survival, are relevant even in advanced age patients, with a manageable incidence of acute toxicity.

Prospective cohort study of Kaposi sarcoma treated under real-world conditions in Malawi.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11569-11569
Author(s):  
Edwards Kasonkanji ◽  
Yolanda Gondwe ◽  
Morgan Dewey ◽  
Joe Gumulira ◽  
Matthew Painschab ◽  
...  
Keyword(s):  
Cohort Study ◽  
Kaposi Sarcoma ◽  
Median Number ◽  
Sub Saharan Africa ◽  
Worst Case ◽  
Loss To Follow Up ◽  
Presenting Symptoms ◽  
Grade 3 ◽  
Lost To Follow Up

11569 Background: Kaposi sarcoma (KS) is the leading cancer in Malawi (34% of cancers). Outside of clinical trials, prospective KS studies from sub-Saharan Africa (SSA) are few and limited by loss to follow up. We conducted a prospective KS cohort study of standard of care bleomycin/vincristine (BV) at Lighthouse HIV clinic, in Lilongwe, Malawi. Methods: We enrolled pathologically confirmed, newly diagnosed, HIV+ KS patients from Feb 2017 to Jun 2019. We collected clinical and treatment characteristics, toxicity, and outcomes of KS with follow-up censored Jun 2020. Patients were treated with bleomycin (25 mg/m2) and vincristine (0.4 mg/m2) every 14 days for a planned maximum of 16 cycles. STATA v13.0 was used to calculate descriptive statistics and Kaplan Meier survival analysis. Toxicity was graded using NCI CTCAE v5.0. Results: We enrolled 138 participants, median age 36 (IQR 32-44) and 110 (80%) male. By ACTG staging, 107 (78%) were T1 (tumour severity), 46 (33%) were S1 (illness severity) and 46 (33%) had Karnofsky performance status ≤70. Presenting symptoms included edema in 69 (53%), visceral disease in 9 (7%), and oral involvement in 43 (33%). Prior to KS diagnosis, 70 (51%) participants were aware of being HIV+ for median 17 months (IQR 6-60) and had been on ART for median 16 months (IQR 6-60). Median CD4 count was 197 (IQR 99-339), median HIV-viral load was 2.6 log copies/mL (IQR 1.6 – 4.8) and 57% were HIV-suppressed ( < 1000 HIV copies/ml). The median number of cycles was 16 (IQR 7-16). 62 (45%) participants missed at least one dose due to stock out. Amongst patients with missed doses, the median number was 3 (IQR 2-4) for bleomycin and 2 (IQR 1-3) for vincristine. 14 (10%) participants experienced at least one reduced dose due to toxicity. 5 (4%) participants suffered grade ≥3 anaemia, 13 (9%) grade ≥3 neutropenia, and one participant had grade 4 bleomycin-induced dermatitis. There was no reported grade ≥3 bleomycin lung toxicity or vincristine-induced neuropathy. Of 115 evaluable participants, responses at the end of therapy were: complete response in 52 (45%), partial response in 27 (23%) stable disease in 5 (4%), and progressive disease in 31 (28%). Median duration of follow-up was 20 months. At censoring, 69 (50%) were alive, 36 (26%) dead, and 33 (24%) lost to follow-up. Overall survival is shown Table as crude and worst-case scenario; worst-case assumes all participants lost to follow up died. Conclusions: Here, we present one of the most complete characterizations of KS presentation and treatment from SSA. As in other studies from the region, the majority of patients presented with advanced disease, chemotherapy stock-outs and loss to follow up were common, and mortality was high. Studies are planned to understand the virologic characteristics, improve therapies, and better implement existing therapies.[Table: see text]

Efficacy of Melphalan and Prednisone Plus Thalidomide in Patients Older Than 75 Years With Newly Diagnosed Multiple Myeloma: IFM 01/01 Trial

2009 ◽  
Vol 27 (22) ◽  
pp. 3664-3670 ◽  
Author(s):  
Cyrille Hulin ◽  
Thierry Facon ◽  
Philippe Rodon ◽  
Brigitte Pegourie ◽  
Lotfi Benboubker ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Elderly Patients ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Standards Of Care ◽  
Newly Diagnosed ◽  
Grade 3 ◽  
To Receive

Purpose Until recently, melphalan and prednisone were the standards of care in elderly patients with multiple myeloma. The addition of thalidomide to this combination demonstrated a survival benefit for patients age 65 to 75 years. This randomized, placebo-controlled, phase III trial investigated the efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed myeloma. Patients and Methods Between April 2002 and December 2006, 232 previously untreated patients with myeloma, age 75 years or older, were enrolled and 229 were randomly assigned to treatment. All patients received melphalan (0.2 mg/kg/d) plus prednisone (2 mg/kg/d) for 12 courses (day 1 to 4) every 6 weeks. Patients were randomly assigned to receive 100 mg/d of oral thalidomide (n = 113) or placebo (n = 116), continuously for 72 weeks. The primary end point was overall survival. Results After a median follow-up of 47.5 months, overall survival was significantly longer in patients who received melphalan and prednisone plus thalidomide compared with those who received melphalan and prednisone plus placebo (median, 44.0 v 29.1 months; P = .028). Progression-free survival was significantly prolonged in the melphalan and prednisone plus thalidomide group (median, 24.1 v 18.5 months; P = .001). Two adverse events were significantly increased in the melphalan and prednisone plus thalidomide group: grade 2 to 4 peripheral neuropathy (20% v 5% in the melphalan and prednisone plus placebo group; P < .001) and grade 3 to 4 neutropenia (23% v 9%; P = .003). Conclusion This trial confirms the superiority of the combination melphalan and prednisone plus thalidomide over melphalan and prednisone alone for prolonging survival in very elderly patients with newly diagnosed myeloma. Toxicity was acceptable.

scholarly journals Baseline Functional Status and One-year Mortality After Hospital Admission in Elderly Patients: a prospective cohort study

2020 ◽  
Vol 77 (3) ◽  
pp. 143-148
Author(s):  
Victoria Sáenz ◽  
Nicolas Zuljevic ◽  
Cristina Elizondo ◽  
Iñaki Martin Lesende ◽  
Diego Caruso
Keyword(s):  
Cohort Study ◽  
Elderly Patients ◽  
Hospital Admission ◽  
Functional Status ◽  
Prospective Cohort ◽  
Functional Decline ◽  
Long Term Outcomes ◽  
One Year

Introduction: Hospitalization represents a major factor that may precipitate the loss of functional status and the cascade into dependence. The main objective of our study was to determine the effect of functional status measured before hospital admission on survival at one year after hospitalization in elderly patients. Methods: Prospective cohort study of adult patients (over 65 years of age) admitted to either the general ward or intensive Care units (ICU) of a tertiary teaching hospital in Buenos Aires, Argentina. Main exposure was the pre-admission functional status determined by means of the modified “VIDA” questionnaire, which evaluates the instrumental activities of daily living. We used a multivariate Cox proportional hazards model to estimate the effect of prior functional status on time to all-cause death while controlling for measured confounding. Secondarily, we analyzed the effect of post-discharge functional decline on long-term outcomes. Results: 297 patients were included in the present study. 12.8% died during hospitalization and 86 patients (33.2%) died within one year after hospital discharge. Functional status prior to hospital admission, measured by the VIDA questionnaire (e.g., one point increase), was associated with a lower hazard of all-cause mortality during follow-up (Hazard Ratio [HR]: 0.96; 95% Confidence Interval [CI]: 0.94–0.98). Finally, functional decline measured at 15 days after hospital discharge, was associated with higher risk of all-cause death during follow-up (HR: 2.19, 95% CI: 1.09–4.37) Conclusion: Pre-morbid functional status impacts long term outcomes after unplanned hospitalizations in elderly adults. Future studies should confirm these findings and evaluate the potential impact on clinical decision-making.

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.

scholarly journals Association of postoperative covert stroke and cognitive dysfunction among elderly patients undergoing non-cardiac surgery: protocol for a prospective cohort study (PRECISION study)

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034657 ◽  
Author(s):  
Qianyu Cui ◽  
Dexiang Wang ◽  
Min Zeng ◽  
Jia Dong ◽  
Hailong Jin ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cohort Study ◽  
Elderly Patients ◽  
Cognitive Dysfunction ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Brain Mri ◽  
Postoperative Cognitive Dysfunction ◽  
Ageing Population ◽  
Increased Risk

IntroductionThe incidence of covert stroke and cognitive dysfunction has gradually increased due to an ageing population. Recently, a prospective cohort study reported perioperative covert stroke was associated with an increased risk of postoperative cognitive dysfunction (POCD) 1 year after non-cardiac surgery. However, the mechanism remains unclear.Methods and analysisThis is a prospective observational trial aiming to investigate the cumulative incidence of perioperative covert stroke and test the hypothesis that perioperative covert stroke associates with POCD in elderly patients undergoing non-cardiac and non-neurological surgery. Data on risk factors, brain MRI, cognitive function evaluation and serum immune-inflammatory cytokines will be collected and analysed.Ethics and disseminationEthical approval has been granted by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (reference number: KY2017-027-02). The results of this study will be disseminated through presentations at scientific conferences and publication in scientific journals.Trial registration numberNCT03081429.

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