Although frailty can arise in middle age, very few studies have investigated frailty before 65 years. Our objectives were to assess the prevalence of frailty parameters in middle-aged individuals and ...probe the association with future adverse events. We performed cross-sectional and longitudinal analyses of community-dwelling individuals aged 50 to 65 (n = 411, median age: 59.0) having undergone a multidomain geriatric assessment (2010-2015) in an outpatient clinic in the greater Paris area of France (SUCCEED cohort). The primary outcome was a composite measure of adverse events (non-accidental falls, fractures, unplanned hospitalizations, death), recorded in 2016/2017. Multivariable logistic regression models were built to identify independent predictors. Six frailty parameters were highly prevalent (> 20%): low activity (40.1%), exhaustion (31.3%), living alone (28.5%), balance impairment (26.8%), weakness (26.7%), and executive dysfunction (23.2%). Female sex (odds ratio: 2.67 95% confidence interval: 1.17-6.11), living alone (2.39 1.32-4.33), balance impairment (2.09 1.16-3.78), executive dysfunction (2.61, 1.18-5.77), and exhaustion (2.98 1.65-5.39) were independent predictors of adverse events. Many frailty parameters are already altered in middle-aged individuals and are predictive of adverse health events. Our findings highlight a possible need for frailty screening and preventive programs targeting middle-aged individuals.
Background.
A multidimensional geriatric assessment (GA) is recommended in older cancer patients to inventory health problems and tailor treatment decisions accordingly but requires considerable time ...and human resources. The G8 is among the most sensitive screening tools for selecting patients warranting a full GA but has limited specificity. We sought to develop and validate an optimized version of the G8.
Patients and Methods.
We used a prospective cohort of cancer patients aged ≥70 years referred to geriatricians for GA (2007–2012: n = 729 training set; 2012–2014: n = 414 validation set). Abnormal GA was defined as at least one impaired domain across seven validated tests. Multiple correspondence analysis, multivariate logistic regression, and bootstrapped internal validation were performed sequentially.
Results.
The final model included six independent predictors for abnormal GA: weight loss, cognition/mood, performance status, self‐rated health status, polypharmacy (≥6 medications per day), and history of heart failure/coronary heart disease. For the original G8, sensitivity was 87.2% (95% confidence interval, 84.3–89.7), specificity 57.7% (47.3–67.7), and area under the receiver‐operating characteristic curve (AUROC) 86.5% (83.5–89.6). The modified G8 had corresponding values of 89.2% (86.5–91.5), 79.0% (69.4–86.6), and 91.6% (89.3; 93.9), with higher AUROC values for all tumor sites and stable properties on the validation set.
Conclusion.
A modified G8 screening tool exhibited better diagnostic performance with greater uniformity across cancer sites and required only six items. If these features are confirmed in other settings, the modified tool may facilitate selection for a full GA in older patients with cancer.
Implications for Practice:
Several screening tools have been developed to identify older patients with cancer likely to benefit from a complete geriatric assessment, but none combines appropriate sensitivity and specificity. Based on a large prospective cohort study, an optimized G8 tool was developed, combining a systematic statistical approach with expert judgment to ensure optimal discriminative power and clinical relevance. The improved screening tool achieves high sensitivity, high specificity, better homogeneity across cancer types, and greater parsimony with only six items needed, facilitating selection for a full geriatric assessment.
In an effort to develop an optimized G8 tool combining a systematic statistical approach with expert judgment to ensure optimal discriminative power and clinical relevance, a large prospective cohort study was conducted. The improved screening tool achieves high sensitivity, high specificity, better homogeneity across cancer types, and greater parsimony with only six items needed, facilitating selection for a full geriatric assessment.
Background
The primary objective was to evaluate the rates of older patients with colorectal cancer (CRC) who were eligible for a clinical trial, invited to participate, and, ultimately, included. ...The secondary objective was to assess the reasons for ineligibility, noninvitation, and noninclusion and factors associated.
Materials and Methods
The Sujets AGés dans les Essais Cliniques (SAGE; Older Subjects in Clinical Trials) multicenter prospective cohort was established in seven centers (10 departments of medical oncology, digestive oncology, and digestive surgery) between 2012 and 2016. All patients with CRC aged 65 or older were studied. The endpoints were clinical trial availability, patient's eligibility, invitation, and enrollment in a trial.
Results
We included 577 older patients (mean age ± SD: 75.6 ± 7 years; males: 56%; metastasis: 41%). Thirty‐seven trials were ongoing (one trial for older patients). Of the 474 patients with at least one available trial for their cancer stage and site, 127 (27%) were eligible; 84 of these 127 (66%) were invited to participate, and 70 of these 84 (83%) were included. In a multivariate analysis, noninvitation was found to be associated with older age (p = .016): adjusted relative risk (95% confidence interval), 0.14 (0.02–0.60) for ≥80 vs. 65–69; 0.54 (0.18‐1.04) for 75–79 vs. 65–69; 0.47 (0.17‐0.93) for 70–74 vs. 65–69.
Conclusion
Three‐quarters of older patients with CRC were ineligible for a clinical trial. One‐third of the eligible patients were not invited to participate in a trial, and 17% of invited patients were not included. Few trials are reserved for older patients. Patients aged 80 or older were significantly less likely to be eligible for a trial and invited to participate. Clinical trial identification number: NCT01754636.
Implications for Practice
The results of this study suggest that barriers to participation of older patients in clinical trials are particularly marked at age 80 years or older. Secondly, the results emphasize the need for trials for older patients. Thirdly, there is also a need for more pragmatic “real‐world” trials, rather than solely randomized trials performed in idealized settings with strictly selected patients. Large prospective observational cohorts with a precise follow‐up of toxicity, functional decline, and quality of life may constitute one way of generating more data on the risk‐benefit ratio for cancer treatments in older patients.
Underrepresentation of older patients in cancer clinical trials reduces knowledge of the benefit/risk balance of cancer treatments and restricts access to innovative therapies in this patient population. Considering the frequency of colorectal cancer in older patients, this study evaluated trial participation of older patients with colorectal cancer and assessed reasons for trial ineligibility, noninvitation, and noninclusion.
To identify Comprehensive Geriatric Assessment (CGA) components independently associated with changes in planned cancer treatment.
We prospectively included 375 consecutive elderly patients with ...cancer (ELCAPA01 study) assessed by geriatricians using the CGA. Multivariate analysis was used to identify factors associated with changes in the cancer treatment (intensification, decrease, or delayed > 2 weeks). Change was defined as a difference between the initial treatment proposal and the final treatment selected in a multidisciplinary meeting.
Mean age was 79.6 years (standard deviation SD, 5.6 years), and 197 (52.5%) were women. The most common tumor location was the digestive system (58.7%). The mean number of comorbidities was 4.2 (SD, 2.7) per patient, and the mean Cumulative Illness Rating Scale for Geriatrics score was 11.8 (SD, 5.3). After the CGA, the initial cancer treatment plan was modified for 78 (20.8%) of 375 patients (95% CI, 16.8 to 25.3), usually to decrease treatment intensity (63 80.8% of 78 patients). By univariate analysis, cancer treatment changes were associated with Eastern Cooperative Oncology Group performance status ≥ 2 (73.3% in the group with changes v 41.1% in the in the group without changes; P < .001), dependency for one or more activities of daily living (ADL; 59.0% v 24.2%; P < .001), malnutrition (81.8% v 51.2%; P < .001), cognitive impairment (38.5% v 24.9%; P = .023), depression (52.6% v 21.7%; P < .001), and greater number of comorbidities (mean, 4.8 SD, 2.9 v 4.0 SD, 2.6; P = .02). By multivariate analysis, factors independently associated with cancer treatment changes were a lower ADL score (odds ratio OR, 1.25 per 0.5-point decrease; CI, 1.04 to 1.49; P = .016) and malnutrition (OR, 2.99; CI, 1.36 to 6.58; P = .007).
Functional status assessed by the ADL score and malnutrition were independently associated with changes in cancer treatment.
Background
The systematic use of susceptibility testing and tailored first‐line treatment for Helicobacter pylori eradication has yet to be established.
Aim
To compare 14‐day tailored PCR‐guided ...triple therapy to 14‐day non‐Bismuth concomitant quadruple therapy for first‐line Helicobacter pylori eradication.
Patients and Methods
We performed a multicenter, parallel‐group, randomized noninferiority controlled trial. Naive adult patients with Helicobacter pylori infection were treated with 14‐day tailored PCR‐guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14‐day non‐Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was H. pylori eradication.
Results
We screened 991 patients for eligibility and randomized 241 patients. The first‐line eradication rate was 99.2% in the tailored PCR‐guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at −0.68%). Both first‐line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR‐guided group (61.4% vs. 41.2%, p = 0.003). Economic analyses revealed a lower cost of the tailored PCR‐guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population.
Conclusion
In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14‐day tailored PCR‐guided triple therapy as a first‐line H. pylori eradication therapy compared to 14‐day non‐Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).
Background Conflicting opinions have been reported regarding the epidemiology of hidradenitis suppurativa. Objective We sought to evaluate the prevalence of hidradenitis suppurativa and to identify ...associated factors. Methodology Prevalence was evaluated using a representative sample of the French population (n = 10,000). Associated risk factors were assessed using two case-control studies, one population-based with 67 self-reported patients and 200 control subjects, and the other clinic-based with 302 medically assessed patients and 906 control subjects. Results The prevalence was 1% of the French population. Multivariate analyses showed a strong association with current smoking in self-reported (odds ratio = 4.16, 95% confidence interval 2.99-8.69) and in medically assessed (odds ratio = 12.55 8.58-18.38) populations. Association with body mass index was significant in medically assessed patients (odds ratio = 1.12 1.08-1.15) for each increase of 1 U of BMI. Limitations A causal relationship could not be established with such a cross-sectional study. Conclusion Hidradenitis suppurativa is a common disease, frequently associated with smoking and being overweight.
To identify the underlying subtypes of hidradenitis suppurativa (HS), we performed latent class analysis on prospective clinical data of 618 consecutive patients seen between 2002 and 2010. The ...median patient age was 31 years (Q1=26; Q3=38), median age at HS onset was 20 years (16–25), and median Sartorius score was 18 (11–19); 34.4% of patients were of Hurley stage II or III. A three-class model showed the best fit. Latent class 1 (LC1) patients (48%) had a high probability of breast and armpit lesions (0.74) and hypertrophic scars (0.41). LC2 patients (26%) had a high probability not only of breast and armpit lesions (0.96) but also of lesions in the ears, chest, back, or legs (0.55); follicular lesions (pilonidal sinus: 0.48; comedones: 0.74); severe acne (0.47); and a family history of HS (0.44). Compared with LC1 patients, LC2 patients were more often male (odds ratio, 4.6; 95% confidence interval, 3–7; P<0.001) and current smokers (2.2; 1.3–3.9; P=0.005), and had greater disease severity (odds ratio, 1.6; 1.3–1.9; P<0.001). LC3 was characterized by gluteal involvement (0.54), papules, and folliculitis (0.71). LC3 patients were less often obese (0.6; 0.3–0.95; P=0.03) and had less severe disease (0.9; 0.7–1.1; P<0.001). These three phenotypes (“axillary–mammary”, “follicular”, and “gluteal”) may help stratify patients for clinical trials.
Cancer is common in older patients, who raise specific treatment challenges due to aging-related, organ-specific physiologic changes and the presence in most cases of comorbidities capable of ...affecting treatment tolerance and outcomes. Identifying comorbid conditions and physiologic changes due to aging allows oncologists to better assess the risk/benefit ratio and to adjust the treatment accordingly. Conducting a Comprehensive Geriatric Assessment (CGA) is one approach developed for this purpose. We reviewed the evidence on the usefulness of CGA for assessing health problems and predicting cancer treatment outcomes, functional decline, morbidity, and mortality in older patients with solid malignancies.
We searched Medline for articles published in English between January 1, 2000 and April 14, 2014, and reporting prospective observational or interventional studies of CGA feasibility or effectiveness in patients aged ≥65 years with solid malignancies. We identified studies with at least 100 patients, a multivariate analysis, and assessments of at least five of the following CGA domains: nutrition, cognition, mood, functional status, mobility and falls, polypharmacy, comorbidities, and social environment.
All types of CGA identified a large number of unrecognized health problems capable of interfering with cancer treatment. CGA results influenced 21%-49% of treatment decisions. All CGA domains were associated with chemotoxicity or survival in at least one study. The abnormalities that most often predicted mortality and chemotoxicity were functional impairment, malnutrition, and comorbidities.
The CGA uncovers numerous health problems in elderly patients with cancer and can affect treatment decisions. Functional impairment, malnutrition, and comorbidities are independently associated with chemotoxicity and/or survival. Only three randomized published studies evaluated the effectiveness of CGA-linked interventions. Further research into the effectiveness of the CGA in improving patient outcomes is needed.
Background
In older patients with cancer, comorbidities compete with cancer for cause of death. The objectives were to evaluate cancer mortality and factors associated, according to metastatic ...status.
Methods
Between 2007 and 2014, patients with cancer aged ≥70 referred for pre‐therapeutic geriatric assessment (GA) were included through the ELCAPA prospective cohort study. The underlying cause of death was defined according to the International Classification of Diseases, 10th Revision. The World Health Organisation definition was used to categorise the cause of death as cancer versus another disease (e.g. cardiovascular disease, infectious disease, etc.) Competing risk models were used.
Results
Mean (SD) age of the 1445 included patients was 80.2 (5.8) and 48% were women. Most common tumour sites were colorectal (19%), breast (17%) and urinary (15%); 773 patients (49%) had metastases. After a 34‐month median follow‐up, 706 cancer deaths were observed among 843 deaths. The 6‐month and 3‐year cancer mortality rates (95% CI) were 12% (9–15) and 34% (29–38) for non‐metastatic patients and 43% (39–47) and 79% (75–82) for metastatic patients, respectively. Dependency in activities of daily living and comorbidities were associated with 6‐month and 3‐year cancer mortality in non‐metastatic (adjusted subhazard ratio aSHR = 1.68 0.99–2.85 and 1.69 1.16–2.45; and 1.98 1.08–3.63 and 3.38 1.47–7.76, respectively) and metastatic patients (aSHR = 2.81 2.01–3.93 and 2.95 2.14–4.07; and 1.63 1.18–2.25 and 2.06 1.39–3.05, respectively). Impaired Timed‐Get‐Up‐and‐Go test was associated with 6‐month and 3‐year cancer mortality in metastatic patients (aSHR = 1.5 1.06–2.12 and 1.38 1.06–1.81, respectively). Obesity was negatively associated with 3‐year cancer death in non‐metastatic (aSHR = 0.53 0.29–0.97) and metastatic patients (aSHR = 0.71 0.51–1.00).
Conclusions
The majority of older adults with cancer referred for pre‐therapeutic GA die from cancer. Geriatric parameters are independently associated with cancer mortality and should be considered for prognosis assessment, decision‐making and care.
The majority of older adults with cancer referred for pre‐therapeutic GA died from cancer and not from other causes. An altered general status, loss of independency and co‐morbidities were independently associated with cancer death at 6 months and at 3 years, regardless of metastatic status; mobility impairment was independently associated with cancer death at 6 months and at 3 years in metastatic patients.
Background Factors associated with the severity of hidradenitis suppurativa (HS) are not known. Objective We sought to identify factors associated with the severity of HS. Methodology The severity of ...disease in a series of 302 consecutive patients with HS was assessed using the Sartorius score. Results Atypical locations were more common in men than in women (47.1% vs 14.8%; P < .001). Men also had more severe disease (median Sartorius score: 20.5 vs 16.5; P = .02). Increased body mass index ( P < .001), atypical locations ( P = .002), a personal history of severe acne ( P = .04), and absence of a family history of HS ( P = .06) were associated with an increased Sartorius score. The Sartorius score was highly correlated with the intensity and duration of pain and suppuration (all P values < .001). Limitations The referral center base of the study may have biased recruitment. Conclusion Our data showed a significant association between the severity of HS and several clinical and behavioral factors. Prospective studies are needed to confirm the prognostic role of these factors.
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