Adverse events need for hospitalization and systemic immunosuppression in very elderly patients (over 80 years) treated with ipilimumab for metastatic melanoma

2019 ◽  
Vol 68 (4) ◽  
pp. 545-551 ◽  
Author(s):  
Vaianu Leroy ◽  
Emilie Gerard ◽  
Caroline Dutriaux ◽  
Sorilla Prey ◽  
Aurelia Gey ◽  
...  
2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9565-9565
Author(s):  
Shivanshan Pathmanathan ◽  
Hari S Babu ◽  
Robert Mason ◽  
Saw Htut ◽  
Zulfiquer Ali Otty ◽  
...  

9565 Background: The incidence of melanoma increases with age, however, elderly patients remain under-represented in landmark immunotherapy trials for metastatic melanoma. This study aims to investigate the impact of age on efficacy and toxicity of immunotherapy, and complications of immunosuppression to treat toxicity. Methods: A multicentre retrospective study involving centres in Australia [Gold Coast University Hospital, Cairns Base Hospital, Townsville University Hospital] was performed to compare the efficacy and toxicity of immunotherapy in metastatic melanoma in patients ≥70 years versus patients < 70 years treated between 2015 and 2019. Data collected included: baseline demographics, PFS, OS, Grade 3 or higher (Gr3+) adverse events as per CTCAEv5, adverse events leading to discontinuation, duration of steroids used to treat toxicity and complications secondary to steroids. Comparison of survival outcomes between the groups was calculated using Kaplan Meier, Log rank test and multivariate Cox regression analysis. Fisher exact test was used to determine differences in toxicity between the two groups. Results: A total of 229 patients were included with 106 patients ≥70years and 123 patients < 70 years. Baseline demographics were similar. Dual immunotherapy (ipilimumab + nivolumab) was less commonly used in patients ≥70years [13 v 38% p < 0.001]. Although the median PFS was numerically higher amongst ≥70years [10.8 v 6.9months p = 0.99], the landmark PFS was not [3yr PFS: 31 v 39%; 4yr PFS: 22 v 39%]. The median OS was similar in patients ≥70 years v < 70years [27.5 v 28.7 months p = 0.91], with similar landmark survival [3yr OS: 46 v 49%; 4yr OS: 42 v 49%]. Age was not associated with a difference in overall survival on multivariate analysis. There was no increase in Gr3+ adverse events in patients ≥70 years [22 v 21% p = 1.00] or discontinuation rates [26 v 20% p = 0.35]. There was one death in a patient < 70years secondary to colitis. There was a significantly higher rate Gr3+ adverse events in ≥70years patients receiving dual immunotherapy [71 v 35% p = 0.029] and a similar rate of Gr3+ adverse events with PDL1 inhibitors [13 v 11% p = 0.7]. Median duration of steroids was similar in both group [15 v 17wks], as was the median duration of high dose steroids defined as greater than 10mg of prednisone [5 v 6wks]. Complications of steroids was numerically higher in the elderly population [42 v 25% p = 0.15]. The most common adverse event to immunosuppression was infection. Conclusions: Patients ≥70years received similar benefit from immunotherapy in comparison to their younger counterparts. Toxicity related to PDL1 inhibitors was similar in both groups and was higher in patients ≥70years receiving dual immunotherapy. Patients ≥70 years had a clinically significant higher rate of complications secondary to steroids.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 606-606
Author(s):  
Alessandro Sanna ◽  
Laura Cannella ◽  
Antonella Gozzini ◽  
Massimo Breccia ◽  
Francesca Sassolini ◽  
...  

Abstract Abstract 606 Myelodysplastic syndromes (MDS) are affecting mainly elderly patients, and age is considered per se a negative prognostic factor. Most of the elderly patients have comorbidity that presumably negatively impact the overall survival and quality of life and may influence response to therapy. A subanalysis of a recently concluded international trial demonstrated that MDS patients aged > 75 yrs treated with azacitidine have a significantly longer overall survival respect to best supportive care treated patients (Seymour, 2010). We analyzed whether presence and number of comorbidities could have an impact on response and management of azacitidine treatment in elderly and very elderly patients treated in our Center, outside clinical trials. We evaluated outcome, survival and type of response, as well as adverse events in all patients. We analyzed 59 elderly MDS patients (IPSS INT-1 15/59, INT-2 32/59 and High 12/59) treated with Azacitidine 75 mg/kg/day sc for 5 days every 28. Mean number of cycles was 9 (range:2-42). Mean age was 69 yrs (50-82); 30% of patients (18/59) were >= 75 yrs and 39% of the latter (7/18) >= 80 yrs. We also evaluated Charlson comorbidity index (CCI) (10 patients scored =<1, 44 patients 2 or 3, and 5 patients >= 4), the Cumulative Illness Rating Scale (CIRS) (25 patients scored =<1, 25 patients 2 or 3 and 9 patients >= 4) and the Adult Comorbidity Evaluation-27 (ACE-27) (13 patients scored =<1, 43 patients 2,3 or 4 and 3 patients >=5). Overall response rate (HI, CR and PR) according IWG criteria 2006 was 49.1%, stable disease was obtained in 37.1 % of MDS patients. We demonstrated by Fisher test that these IWG responses did not correlate with age. We also evaluated CCI, CIRS, and the ACE-27 in relation to age and to hematological response and no correlation was showed. Hematological or non hematological adverse events were presented by 34% and 36% of patients, respectively. Adverse events were uniformly distributed independently from age. Median overall survival (OS) of our patient cohort was 21 months. Median OS in patients < 75yrs (20 monthts) and >= 75 yrs (16 months) was not significantly different (p value > 0.65). OS in patients with higher CCI, CIRS, and the ACE-27 was respectly 10 months, 6,5 months and 6 months. 5 patients presented renal failure, but treatment with standard dose aza did not worsen creatinine clearance. Very elderly patients with comorbidities may be treated with success with azacitidine, without any substantial increase in AE. Nevertheless comorbidities negatively influence overall survival. Evaluation of comorbidities with validated indexes is an useful and easily applicable tool to refine prognostic evaluation. ACE-27, although more complex, seems to give best prognostic evaluation. Disclosures: No relevant conflicts of interest to declare.


2020 ◽  
Vol 11 (8) ◽  
pp. 1340-1343 ◽  
Author(s):  
Héloïse Barailler ◽  
Guillemette Salomon ◽  
Caroline Dutriaux ◽  
Sorilla Prey ◽  
Emilie Gérard ◽  
...  

2019 ◽  
Vol 1 (9) ◽  
pp. 13-19
Author(s):  
S. V. Topolyanskaya ◽  
T. M. Kolontai ◽  
O. N. Vaculenko ◽  
L. I. Dvoretski

Modern concepts about features of diabetes mellitus in very elderly patients are described in the article. Special attention to the therapeutic methods of management of very elderly patients with diabetes mellitus has been devoted. The results of diabetes mellitus study in patients with coronary artery disease older than 75 years in comparison with younger patients are presented.


2018 ◽  
Vol 36 (Supplement 1) ◽  
pp. e249
Author(s):  
M. Mellado-Ferreiro ◽  
V. Jarne-Betrán ◽  
M. Arteaga-Mazuelas ◽  
A. Redondo-Arriazu ◽  
L. Urbina-Soto

2021 ◽  
Vol 10 (7) ◽  
pp. 1468
Author(s):  
Yusuke Watanabe ◽  
Kazuko Tajiri ◽  
Hiroyuki Nagata ◽  
Masayuki Kojima

Heart failure is one of the leading causes of mortality worldwide. Several predictive risk scores and factors associated with in-hospital mortality have been reported for acute heart failure. However, only a few studies have examined the predictors in elderly patients. This study investigated determinants of in-hospital mortality in elderly patients with acute heart failure, aged 80 years or above, by evaluating the serum sodium, blood urea nitrogen, age and serum albumin, systolic blood pressure and natriuretic peptide levels (SOB-ASAP) score. We reviewed the medical records of 106 consecutive patients retrospectively and classified them into the survivor group (n = 83) and the non-survivor group (n = 23) based on the in-hospital mortality. Patient characteristics at admission and during hospitalization were compared between the two groups. Multivariate stepwise regression analysis was used to evaluate the in-hospital mortality. The SOB-ASAP score was significantly better in the survivor group than in the non-survivor group. Multivariate stepwise regression analysis revealed that a poor SOB-ASAP score, oral phosphodiesterase 3 inhibitor use, and requirement of early intravenous antibiotic administration were associated with in-hospital mortality in very elderly patients with acute heart failure. Severe clinical status might predict outcomes in very elderly patients.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Xi-Lei Zhou ◽  
Chang-Hua Yu ◽  
Wan-Wei Wang ◽  
Fu-Zhi Ji ◽  
Yao-Zu Xiong ◽  
...  

Abstract Background This retrospective study was to assess and compare the toxicity and efficacy of concurrent chemoradiotherapy (CCRT) with S-1 or docetaxel and cisplatin in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Methods Patients with locally advanced ESCC who received CCRT with S-1 (70 mg/m2 twice daily on days 1–14, every 3 weeks for 2 cycles, S-1 group) or docetaxel (25 mg/m2) and cisplatin (25 mg/m2) on day 1 weekly (DP group) between 2014 and 2016 were retrospectively analyzed. Radiotherapy was delivered in 1.8–2.0 Gy per fraction to a total dose of 50–60 Gy. Treatment-related toxicities (Common Terminology Criteria for Adverse Events version 4.0), response rate, and survival outcomes were compared between groups. Results A total of 175 patients were included in this study (72 in the S-1 group and 103 in the DP group). Baseline characteristics were well balanced between the two groups. The incidence of grade 3–4 adverse events were significantly lower in the S-1 group than that of the DP group (22.2% vs. 45.6%, p = 0.002). In the DP group, elderly patients (> 60 years) had a significantly higher rate of grade 3–4 adverse events than younger patients (58.1% vs. 31.3%, p = 0.01). The objective overall response rate (complete response + partial response) was 68.1% in the S-1 group, and 73.8% the DP group (p = 0.497). The 3-year overall survival was 34.7% in the S-1 group, and 38.8% in the DP group (p = 0.422). The 3-year progression free survival in the DP group was higher than that in the S-1 group but without significant difference (33.0% vs. 25.0%, p = 0.275). Conclusion CCRT with S-1 is not inferior to CCRT with docetaxel and cisplatin and is better tolerated in in elderly patients with locally advanced ESCC.


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