Age Differences in Clinical Trial Understanding in Non-Hodgkin Lymphoma Patients

BackgroundClinical trials are often an important component of cancer care but are misunderstood by many patients. Few studies have examined age differences in clinical trial understanding in older versus younger adults, especially among patients with indolent non-Hodgkin lymphoma (NHL), a slowly progressive and not typically curable cancer diagnosed primarily in older adults.Patients and MethodsParticipants aged ≥21 years with a diagnosis of NHL were recruited from a single academic medical center in an urban setting. Age was dichotomized as <65 and ≥65 years. Clinical trial understanding was assessed using a four-item survey of potential goals of a clinical trial, with responses including “yes,” “no,” and “I don't know.” Survey responses were examined by age using Chi-square tests.ResultsThe sample was comprised of 74 patients who were predominantly non-Latino White, with a mean age of 60.4 years (SD = 12.27). Compared to younger patients, older patients were more likely to respond “I don't know” to the clinical trial goals of reducing the lymphoma (41.4% vs. 13.3%; P = .023) and keeping the lymphoma from worsening (41.4% vs. 13.3%; P = .017). Age differences for the remaining goals were not statistically significant. Similar findings emerged when the sample was restricted to patients under active surveillance.ConclusionRelative to younger adults, older adults may have a less nuanced understanding of clinical trial goals. Therefore, older adults may benefit from developmentally-tailored interventions to improve clinical trial understanding. Future research should examine the relationship between clinical trial understanding and enrollment by age using validated measures in diverse samples.     

Accrual of older adults to cancer clinical trials led by the Canadian cancer trials group – Is trial design a barrier?

BackgroundOlder adults (OA), aged 65 years and over, are under-represented in studies. Strict exclusion criteria have been identified as a potential barrier to accrual of OA. This study aims to determine: 1) whether accrual of OA to trials led by the Canadian Cancer Trials Group (CCTG) has increased since 2003; 2) whether exclusion criteria have broadened over time; 3) whether exclusion criteria are associated with lower accrual of OA.Materials and MethodsPhase III and randomized phase II CCTG-led trials initiated from 1990 onwards were included. Trial protocols were reviewed for exclusion criteria. Associations between trial characteristics and percentage of OA accrued were compared using multivariate linear regression modelling. The frequency of exclusion criteria in trials initiated pre- and post-2003 was compared using the Chi-Square test or Fisher exact test.ResultsSixty-nine trials involving 34,957 patients were included. Accrual of OA to trials remained low compared to OA diagnosed with cancer in Canada (40.8% vs. 56.1%, p < .001). There was a small increase in the accrual of OA since 2003 (42.8% vs. 39.3%, p = .04). There was no relaxation of exclusion criteria over time. Studies initiated prior to 2003, breast cancer studies and studies with exclusion criteria based on renal dysfunction were associated with lower accrual of OA (p < .05). Central nervous system studies were associated with higher accrual of OA (p = .03).ConclusionOA remain under-represented in trials. While there has been minimal change in exclusion criteria over time, renal dysfunction was the only exclusion criteria associated with lower accrual of OA.     

The association of age with acute toxicities in NRG oncology combined modality lower GI cancer trials

PurposeExpected toxicity from chemoradiation (CRT) is an important factor in treatment decisions but is poorly understood in older adults with lower gastrointestinal (GI) malignancies. Our objective was to compare acute adverse events (AAEs) of older and younger adults with lower GI malignancies treated on NRG studies.MethodsData from 6 NRG trials, testing combined modality therapy in patients with anal or rectal cancer, were used to test the hypothesis that older age was associated with increased AAEs. AAEs and compliance with protocol-directed therapy were compared between patients aged ≥70 and < 70. Categorical variables were compared across age groups using the chi-square test. The association of age on AAEs was evaluated using a covariate-adjusted logistic regression model, with odds ratio (OR) reported. To adjust for multiple comparisons, a p-value <0.01 was considered statistically significant.ResultsThere were 2525 patients, including 380 patients ≥70 years old (15%) evaluable. Older patients were more likely to have worse baseline performance status (PS 1 or 2) (23% vs. 16%, p = 0.001), but otherwise baseline characteristics were similar. Older patients were less likely to complete their chemotherapy (78% vs. 87%, p < 0.001), but had similar RT duration. On univariate analysis, older patients were more likely to experience grade ≥ 3 GI AAEs (36% vs. 23%, p < 0.001), and less likely to experience grade ≥ 3 skin AAEs (8% vs. 14%, p = 0.002). On multivariable analysis, older age was associated with grade ≥ 3 GI AAE (OR 1.93, 95% CI: 1.52, 2.47, p < 0.001) after adjusting for sex, race, PS, and disease site.ConclusionsOlder patients with lower GI cancers who underwent CRT were less likely to complete chemotherapy and had higher rates of grade 3+ GI AAEs. These results can be used to counsel older adults prior to treatment and manage expected toxicities throughout pelvic CRT.     

Treatment Patterns and Outcomes of Patients With Advanced Pleural Mesothelioma at an Academic Referral Centre

BackgroundOverall survival (OS) for malignant pleural mesothelioma (MPM) in vulnerable subgroups remains poorly understood with scarce data available to guide treatment decisions. The study describes real-world detailed treatment patterns and outcomes of patients with advanced MPM overall and specifically in elderly and poor performance status (PS) patients.MethodsRetrospective chart review was performed for all patients with histologically confirmed MPM seen at University Health Network/Princess Margaret Cancer Centre (UHN-PM).ResultsA total of 667 patients with MPM were identified and 304 advanced-disease MPM (aMPM) patients had continuing care at UHN-PM (UP-cohort). In the UP-cohort, 77% of patients received ≥ one line of systemic treatment. Systemic therapy trial participation was 39%. Patients not treated with systemic therapy (29%) were more likely to be ≥ 75 years and PS ≥ 2. Median OS was 15.3 months (95%CI 13.6-18.3), with longer survival in treated vs. untreated patients (17.4 vs. 10.6 months; P = .01). Longer survival with systemic treatment was seen in patients ≥75 years (12.7 vs. 6.6 months) and patients with poor PS (9.1 vs. 5.9 months). Median progression-free-survival (PFS) and OS for patients treated with second-line therapy was poor (3.0 and 8.9 months, respectively).DiscussionIn our real-world analysis of patients with aMPM treated at an academic referral centre, systemic treatment was given to the majority of patients and benefit was seen even in the elderly and poor PS patients frequently underrepresented in clinical trials. Trial participation was potentially facilitated by the formation of a dedicated multidisciplinary MPM clinic.     

Barriers to clinical trial participation by older women with breast cancer.

PURPOSE: Although 48% of breast cancer patients are 65 years old or older, these older patients are severely underrepresented in breast cancer clinical trials. This study tested whether older patients were offered trials significantly less often than younger patients and whether older patients who were offered trials were more likely to refuse participation than younger patients. PATIENTS AND METHODS: In 10 Cancer and Leukemia Group B institutions, using a retrospective case-control design, breast cancer patients eligible for an open treatment trial were paired: less than 65 years old and > or = 65 years old. Each of the 77 pairs were matched by disease stage and treating physician. Patients were interviewed as to their reasons for participating or refusing to participate in a trial. The treating physicians were also given questionnaires about their reasons for offering or not offering a trial. RESULTS: Sixty-eight percent of younger stage II patients were offered a trial compared with 34% of the older patients (P =.0004). In multivariate analyses, disease stage and age remained highly significant in predicting trial offering (P =.0008), when controlling for physical functioning and comorbidity. Of those offered a trial, there was no significant difference in participation between younger (56%) and older (50%) patients (P =.67). CONCLUSION: In a multivariate analysis including comorbid conditions, age and stage were the only predictors of whether a patient was offered a trial. The greatest impediment to enrolling older women onto trials in the setting of this study was the physicians' perceptions about age and tolerance of toxicity.     

Enrolment of older adults with advanced or metastatic non-small cell lung cancer in first-line clinical trials in the multicentre ESME cohort

IntroductionThere is a great need for data based on clinical trials for the older population in order to improve treatment. Historically, the inclusion rate of older adults in clinical trials has been low, but the rate specific to lung cancer is unknown, as are the factors associated with enrolment.Materials and MethodsWe used the national Epidemio-Strategy and Medical Economics Advanced or Metastatic Lung Cancer (AMLC) Data Platform, a multicentre real-life database. Inclusion criteria were patients with advanced or metastatic non-small cell lung cancer (AMNSCLC) aged 70 years or older, with at least one line of systemic treatment from 01 January 2015 to 31 December 2018. The primary objective was to evaluate the proportion of older adults enrolled in clinical trials. Secondary objectives were to identify factors associated with enrolment in clinical trials for older patients and to compare the overall survival of older adults included in trials versus those not included.ResultsThere were 3488 patients aged ≥70 years (median age at AMNSCLC 75 years). Among older patients, 234 (6.7%) were enrolled in a clinical trial in the first-line setting. Significant factors associated with enrolment in the multivariable analysis in older patients were: good Eastern Cooperative Oncology Group (ECOG) Performance Status (PS 0) (p < 0.001), de novo versus recurrent presentation at diagnosis (p < 0.001), and non-central nervous system (CNS) metastases versus advanced setting or CNS metastases (p < 0.001). Medical history was associated with fewer inclusions (odds ratio [OR] = 0.74, 95% confidence interval [CI] [0.56; 0.99]). Among older patients, being enrolled in a trial in the first-line setting was not associated with better overall survival (OS) (hazard ratio [HR] = 1.03; 95%CI 0.86–1.22) in the multivariable analysis.DiscussionIn this large database, few older AMNSCLC patients were enrolled in a trial. Factors associated with enrolment were: good ECOG PS, absence of medical history, de novo AMNSCLC, and presentation with non-CNS metastases.     

Are clinical trial eligibility criteria representative of older patients with lung cancer? A population-based data linkage study

ObjectivesOlder adults constitute the majority of patients with lung cancer. However, they are under-represented in clinical trials as eligibility criteria often restrict enrolment based on comorbidities that are common with aging. We aimed to describe comorbidities relating to trial exclusion criteria in older adults with lung cancer, determine the proportion that would typically be excluded from trials, and examine the impact on treatment uptake.Materials and MethodsWe conducted a population-based study of people aged ≥65 years diagnosed with metastatic lung cancer using linked data for clients of the Australian Government Department of Veterans' Affairs (2005–2015). We defined trial-typical patients based on the absence of comorbidities related to the following: inadequate organ (cardiac, renal, hepatic, marrow) function; cognitive dysfunction; poor performance status (PS); prior malignancy within 5 years. We report systemic therapy uptake within 3 months of diagnosis.ResultsOur study included 677 patients (median age 84). Over half (53.4%) were not trial-typical, with the most common reasons being poor PS (37.5%), cardiac disease (19.2%), and prior cancer (12.9%). Eighty-two (12.1%) received systemic therapy. Patients with poor PS, cardiac disease, and dementia had lower treatment uptake rates. However, there was no significant difference in treatment uptake between trial-typical and non-trial-typical patients (13.4 vs 11.0%).ConclusionMore than half of older adults with advanced lung cancer would be typically excluded from trial participation. Future clinical trials of older adults need to consider broader eligibility criteria to better reflect this population to gain the best evidence for their care.     

Outcomes of trimodality CROSS regimen in older adults with locally advanced esophageal cancer

BackgroundChemoradiotherapy for Esophageal cancer followed by Surgery (CROSS regimen) is standard of care for locally-advanced esophageal cancer. We evaluated CROSS completion rates, toxicity, and postoperative outcomes between older and younger adults receiving trimodality therapy.MethodsRetrospective analysis of patients with locally-advanced esophageal cancer who underwent CROSS regimen from May 2016 to January 2020 at a single academic center. Outcomes of those aged ≥70-years-old and <70 years-old were analyzed.ResultsOf 201 patients, 136 were <70 and 65 were ≥70 years. Older adults were more likely to be male (91% vs. 79%; p = 0.045), have higher ECOG scores (median 1 vs. 0; p = 0.003), Charlson-comorbidity index (median 6 vs. 4; p < 0.001), and undergo open procedures (20% vs. 8% p = 0.008). Most completed CROSS regimen (78% vs. 84% respectively) with similar rates of treatment discontinuation and dose reduction (all p > 0.05). Time to surgery following neoadjuvant therapy was similar between age groups, except in those ≥80-years-old as compared to <70-years-old (p < 0.05). Overall toxicity rates were similar (68% vs. 71% respectively; p = 0.676). Only rates of delirium (19% vs. 5%) and urinary retention (9% vs. 0%) were higher in older adults (both p < 0.05). Length of stay, discharge disposition, mortality, and overall survival were similar. Age was not an independent risk factor for complication, neoadjuvant toxicity or completion, surgery timing, nor worse overall or recurrence-free survival (p > 0.05).ConclusionTrimodality CROSS regimen for esophageal cancer in older adults is feasible, with similar completion rates and postoperative outcomes as compared to their younger counterparts.     

eHealth literacy in older adults with cancer

ObjectiveRecent advances in health monitoring technology have coincided with increases in the number of older adults with cancer, many of whom report difficulty using health information technology (HIT). Previous studies have identified lower electronic health (eHealth) literacy among older adults (≥65 years) compared to younger adults (<65), but studies in older adults with cancer are limited. The goal of this study was to examine age differences in eHealth literacy and use of technology devices/HIT in patients with cancer, and characterize receptivity towards using home-based HIT to communicate with the oncology care team.Materials and MethodsPatients (n = 198) in a Radiation Oncology clinic were offered an anonymous written questionnaire assessing demographics, eHealth literacy (eHealth Literacy Scale), current use of HIT, and interest in using home-based HIT.Results and ConclusionCompared to younger patients, older patients had significantly lower eHealth literacy (p < .01), and were less likely to feel confident evaluating health resources on the Internet (p < .01) or knowing how to use the health information found on the Internet to help them (p < .01) or answer health questions (p = .01). Older patients were also less likely than younger patients to have an email address (p = .04), own a smartphone (p < .01), or use the online patient portal (p = .03). Regardless of age, most patients were not opposed to using home-based HIT to communicate with their oncology care team. Future studies on HIT use in older adults with cancer should further evaluate barriers to using HIT and ways to maximize implementation and accessibility.     

Clinical Outcomes of Patients With Breast Cancer in a Phase I Clinic: The M. D. Anderson Cancer Center Experience

PurposePatients with metastatic breast cancer (MBC) refractory to standard therapy have a poor prognosis. We assessed prognostic factors and clinical outcomes for patients with MBC referred to a phase I clinic focused primarily on targeted agents.Patients and MethodsWe reviewed the medical records of sequential patients with MBC who presented to our phase I clinic between September 2004 and May 2008 to assess baseline patient characteristics, overall survival (OS), and clinical benefit.ResultsA total of 92 patients were identified, with a median age of 53 years (range, 28–83 years). The median number of previous therapies was 5 (range, 1–16 therapies). Of 92 patients, 78 were eligible for and offered ≥ 1 phase I clinical trial. With a median follow-up of 7.4 months, the median OS was 6.7 months (95% CI, 5.2–9.7). In multivariate analysis, independent factors predicting shorter survival were ≥ 10 previous treatments (vs. < 10 previous treatments; hazard ratio [HR], 3.27; 95% CI, 1.37–7.81; P = .008), Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2/3 (vs. 0/1; HR, 2.92; 95% CI, 1.28–6.66; P = .01), and albumin level < 3.5 g/dL (vs. > 3.5 g/dL; HR, 2.88; 95% CI, 1.41–5.89; P = .004).ConclusionPatients with locally advanced or metastatic breast cancer referred for our phase I studies had a median survival of 6.7 months. Heavily pretreated disease, poor ECOG PS, and/or low albumin levels were associated with significantly shorter survival in a multivariate analysis.     

Comparing attitudes of younger and older patients towards cancer clinical trials

ObjectivesTo determine the attitudes of patients towards cancer clinical trials (CCTs) and assess the differences between older and younger patients.Materials and MethodsPatients with cancer, receiving treatment or in follow-up in University Hospital Waterford, Ireland were eligible. Patients completed a self-administered questionnaire. To determine attitudes towards CCTs, patients indicated their preference if offered participation in three hypothetical studies (cancer prevention/screening trial; CCT comparing standard to new treatment; a trial of new drug where no standard exists). Patients' reasons to or not to participate in CCTs were explored.ResultsFrom May 2014 to March 2015, 219 patients were accrued, 119 < 65 years and 100 ≥ 65 years. Twenty-two (18%) younger and 4 (4%) older patients had been/were actively enrolled on a CCT (p = 0.0012). No older patient and 5 (4%) of younger patients had enquired about CCT availability. For the CCT questions, 85 (71%) younger vs 57 (57%) older patients would participate in a prevention/screening CCT (p = 0.033); 60 (50%) vs 44 (44%) for standard vs new drug (p = 0.415), and 83 (69%) vs 78 (78%) for a CCT where no standard exists (p = 0.218). The most common reason to participate in a CCT was a recommendation from the oncologist − 98% < 65 years vs 87% ≥ 65 years (p = 0.001), with health problems being the leading reason not to participate, 86% vs 72% (p = 0.01), respectively.ConclusionsOlder and younger patients in this study gave similar importance to reasons for and against participation in CCTs. Most patients did not actively seek out a CCT, which may reflect a lack of awareness and a need for better education.     

Accrual to breast cancer clinical trials at a university-affiliated hospital in metropolitan Detroit

Despite the large number of available studies, most women with breast cancer do not participate in clinical trials, and this is especially true among lower income and minority women. In this study the authors surveyed the practice patterns of four medical oncologists who comprised the clinical breast service at a large urban university hospital to develop a better understanding of the clinical trials enrollment process for women with breast cancer. Of 136 new female breast cancer patients seen by the four physicians over a 7-month period, there were 47 women (34%) offered participation in a clinical trial, and 16 women (12%) were eventually enrolled. Women who were offered participation were more likely to be younger (p = 0.068) and to have earlier stage disease then were women not offered participation (p = 0.008). Women enrolled into a trial were also more likely to be younger, although this difference was not statistically significant (p = 0.114). Patient race was not associated with the accrual or enrollment process. Over half of the women were not offered participation in clinical trials because of the lack of available studies. Further work evaluating the process of patient enrollment and physician and patient barriers is necessary to develop effective strategies for recruitment into breast cancer clinical trials.     

Real-world adverse events associated with CAR T-cell therapy among adults age ≥ 65 years

IntroductionChimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment for relapsed or refractory large B-cell lymphoma (LBCL) with the Food and Drug Administration (FDA) approvals of axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel). Although the incidence of LBCL is highest among patients age ≥ 65, clinical trials supporting approval of these 2 products primarily enrolled younger patients. Safety data for axi-cel and tis-cel in older patients is limited.MethodsIn this analysis, we queried the FDA Adverse Events Reporting System (FAERS) database for cases associated with axi-cel or tis-cel from the FDA approval dates for the LBCL indication for each product through December 31, 2019, and compared adverse events (AEs) reported for cases involving patients aged <65 and ≥ 65.ResultsA total of 804 cases were retrieved, with 333 (41%) involving patients age ≥ 65. Cytokine release syndrome (CRS) was the most common AE reported in both age groups. Cases involving older patients had a significantly higher proportion of neurological AEs, including CAR T-cell-related encephalopathy syndrome (8% vs. 4%, p = 0.03). Some individual clinical features of CRS were significantly more common among younger age group cases, including pyrexia (33% vs. 23%, p < 0.01), tachycardia (10% vs. 5%, p < 0.01), and thrombocytopenia (4% vs. 2%, p = 0.03).DiscussionIn this age-based analysis of FAERS reports for patients treated with axi-cel or tis-cel, we identified differences in patterns of AEs experienced. This large-scale post-marketing study complements clinical trial safety data and may help inform clinicians' decision making when treating adult patients with CAR-T cell therapy.     

Radiotherapy for Stage III Non–Small-Cell Lung Carcinoma in the Elderly (Age ≥ 70 years)

BackgroundElderly patients are underrepresented in trials that establish definitive chemoradiotherapy as the standard of care for inoperable stage III non–small-cell lung carcinoma (NSCLC). This study analyzed radiotherapy treatment delivery and outcomes at our institution according to elderly (≥ 70 years old) or younger (< 70 years) age.MethodsRecords of patients who received radiotherapy for stage III NSCLC between January 1998 and February 2010 were reviewed. Factors analyzed included Eastern Cooperative Oncology Group Performance Status (ECOG PS), weight loss, radiation therapy intent, and chemotherapy administered.ResultsA total of 189 patients with stage III NSCLC were analyzed (age range, 28-92 years). Elderly patients (n = 86) were more likely to have ECOG PS ≥ 2 (P < .05) and receive palliative treatment (P < .05). Elderly patients less often received concurrent chemoradiotherapy (P < .05) as well as cisplatin (P < .05). Median survival was 10.3 months for elderly patients compared with 17.2 months for younger patients (P < .05 ). In addition, elderly patients with ECOG PS (P < .05) as well as those who received definitive concurrent chemoradiotherapy (P < .05) had inferior outcomes compared with otherwise similar younger patients. However, on multivariate analysis, elderly age was not associated (P = .428) with increased risk of death, whereas poor ECOG PS (≥ 2) was significant (P < .05). In elderly patients, definitive treatment (P < .05), chemotherapy administration (P < .05), and ECOG PS of 0-1 (P < .05) were associated with improved outcome.ConclusionsAlthough elderly patients with stage III NSCLC experience inferior outcomes than younger patients with comparable disease, they are also more likely to receive suboptimal therapy. On multivariate analysis, advanced age was not associated with worse survival, which indicates that appropriately selected elderly patients should receive definitive chemoradiotherapy.     

Oncologic Outcomes in Young Adults With Kidney Cancer Treated During the Targeted Therapy Era

BackgroundThe objective of this study was to determine the outcomes of young adults with kidney cancer treated during the targeted therapy era and evaluate the impact of young age on survival.Materials and MethodsWe reviewed the records from 445 patients younger than 55 years with kidney cancer at a single institution from 2006 to 2017. Overall survival (OS) and recurrence-free survival were estimated with the Kaplan-Meier method and log-rank test. Cox proportional hazards regression was used to determine the impact of clinical and pathologic variables on all-cause mortality.ResultsOverall, 104 (23%) patients 40 years or younger were compared with 341 (77%) patients who were 41 to 55 years old. Younger patients presented with more advanced stages of the disease, including metastasis at diagnosis, positive lymph nodes, venous tumor thrombus and had more non-clear cell tumors (54% vs. 30%; P < .001). Young adults had significantly worse OS at 2 and 5 years (67% vs. 82% and 53% vs. 69%, respectively). Younger patients with metastatic disease received targeted agents less often compared with the older group (64% vs. 75%). There was no difference in recurrence-free survival across patients with localized disease. Independent prognostic factors associated with increased mortality were metastasis at diagnosis, pT2 or greater, and age younger than 40 years (hazard ratio, 1.65; 95% confidence interval, 1.0-2.6; P = .03).ConclusionPatients younger than 40 years with kidney tumors treated during the targeted therapy era have worse OS compared with older adults. Young age is an independent predictor of mortality.     

Treatment and Outcomes of Oligometastatic Colorectal Cancer Limited to Lymph Node Metastases

IntroductionThe optimal management of isolated distant lymph node metastases (IDLNM) from a colorectal primary, is not clearly established. We aimed to analyze the outcomes of patients with IDLNM treated with systemic therapies plus locoregional therapy with curative intent versus systemic therapies with palliative intent.Materials & MethodsClinical data were collected and reviewed from the Treatment of Recurrent and Advanced Colorectal Cancer registry, a prospective, comprehensive registry for metastatic colorectal cancer (mCRC) treated at multiple tertiary hospitals across Australia. Clinicopathological characteristics, treatment modalities and survival outcomes were analyzed in patients with IDLNM and compared to patients with disease at other sites.ResultsOf 3408 mCRC patients diagnosed 2009 to 2020, with median follow-up of 38.0 months, 93 (2.7%) were found to have IDLNM. Compared to mCRC at other sites, patients with IDLNM were younger (mean age: 62.1 vs. 65.6 years, P = .02), more likely to have metachronous disease (57.0% vs. 38.9%, P < .01), be KRAS wild-type (74.6% vs. 53.9%, P< .01) and BRAF mutant (12.9% vs. 6.2%, P = .01). Amongst mCRC patients with IDLNM, 24 (25.8%) received treatment with curative intent and had a significantly better overall median survival than those treated with palliative intent (73.5 months vs. 23.2 months, P = .01). These 24 patients had an overall median survival similar (62.7 months, P = .82) to patients with isolated liver or lung metastases also treated with curative intent.ConclusionCurative treatment strategies (radiotherapy or surgery), with or without systemic therapy, should be considered for mCRC patients with IDLNM where appropriate as assessed by the multidisciplinary team.     

Lymphadenectomy in elderly patients with high-intermediate-risk,high-risk or advanced endometrial cancer: Time to move from personalized cancer medicine to personalized patient medicine!

BackgroundPelvic and paraaortic lymphadenectomy are recommended for women with high-intermediate, high-risk and advanced endometrial cancer (EC). Lymphadenectomy is less frequently performed in elderly patients than in younger patients. We examined the survival of elderly women diagnosed with high-risk EC according to whether lymphadenectomy was performed or not.MethodsWe selected women over 70 years with high-intermediate risk, high-risk or advanced EC from a multicenter retrospective cohort of women diagnosed between 2001 and 2013. Multivariate logistic regression models and Cox proportional hazards survival methods for overall survival (OS), disease-free survival (DFS) and cancer-specific survival (CSS) were used for analyses.Results71 women had lymphadenectomy and were compared with the 213 who did not. Recurrence was similar in both groups (42% vs 33%, respectively, p = 0.17) but more deaths were reported in the group without lymphadenectomy (38% vs 23%, respectively, p < 0.001). There was no difference in adjuvant treatment in the two groups (17% vs 27%, respectively, p = 0.27). Elderly patients without lymphadenectomy had lower 3-year DFS (56% vs 71%, p = 0.076), CSS (67% vs 85%, p < 0.001) and OS (50% vs 71% p < 0.001). The Cox proportional hazard models showed independently poorer prognosis in women without lymphadenectomy (3.027, 95% CI 1.58–5.81, p < 0.001), histology type 2 (3.46, 95% CI 1.51–7.97, p = 0.003) and lymphovascular space involvement (3.47, 95% CI 1.35–8.98, p = 0.01) on 3-year CSS.ConclusionNo lymphadenectomy in elderly patients with high-risk or advanced EC is independently associated with poorer prognosis. Elderly patients with EC should benefit from lymphadenectomy when indicated.     

Predictors and effects of toxicity experienced by older adults with cancer receiving systemic therapy in a randomized clinical trial of geriatric assessment

IntroductionOlder adults represent a large segment of the oncology population, however, they remain underrepresented in clinical research. Treatment of older adults is often extrapolated using data from younger and fitter patients, which may not be appropriate. Furthermore the implications of toxicity from treatment can be greater for this population. Predicting toxicity from treatment and its effect on quality of life and functional status for older adults therefore is important.Materials and MethodsWe analyzed data from a clinical trial of geriatric assessment and management for Canadian elders with cancer (5C study). We assessed whether the baseline Cancer and Aging Research Group (CARG) toxicity score, G8 score, and Eastern Cooperative Oncology Group (ECOG) performance predicted grade 3–5 toxicity using logistic regression and pattern mixture models. We also assessed the impact of toxicity on quality of life and functional decline. Patients were followed for six months.ResultsThree hundred sixteen patients were included. Mean age was 76 years old and 40% of patients were female. One hundred nineteen patients (38%) experienced at least one grade 3–5 toxicity. Neither the CARG toxicity score, G8, or ECOG were predictive of grade 3–5 toxicity. Patients who experienced grade 3–5 toxicity were more likely to have functional impairments over time (odds ratio 3.71, p = 0.03). However, they maintained their quality of life.DiscussionIn this secondary analysis of a randomized controlled trial of geriatric assessment and management we did not find any predictors of grade 3–5 toxicity. Patients who did experience toxicity were more likely to report functional decline over time. Older adults who do experience treatment related toxicity may benefit from increased supports.Clinical trial information: NCT0315467.     

Patterns of care and survival of older patients with malignant pleural mesothelioma

ObjectiveMalignant pleural mesothelioma (MPM) is a cancer that primarily affects older adults. However this patient population is frequently under-represented in clinical studies. Therefore, we studied the impact of advancing age on treatment utilisation and clinical outcomes in an extensive series of minimally selected MPM patients.Materials and MethodsPatients with MPM receiving compensation from the New South Wales (NSW) Dust Diseases Authority (2002–2009) were assessed. They were categorised by age (<70 years, 70–80 years or > 80 years) and chi-square testing was used to assess the relationship between clinical and demographic variables, age, treatment and overall survival (OS).ResultsWe identified 910 patients; 41% were aged <70 years, 40% were aged 70–80 years, and 19% were aged >80 years old. Median OS decreased with increasing age: 13.5 months in <70 years, 9.5 months in 70–80 years and 7.1 months in >80 years as did chemotherapy use (66%, 35% and 8% respectively). Radical surgical intervention, adjuvant, and palliative radiotherapy were less frequently used with advanced age. A Kaplan Meier analysis revealed that there was a significant survival advantage (p < .001) for patients <70 and 70–80 years receiving chemotherapy (16.8 vs 7.0 months; 13.9 vs 5.8 months respectively), but not for patients >80 years.ConclusionAdvancing age group of NSW patients with MPM was associated with reduced treatment utilisation and a decline in OS. Prospective studies are warranted to verify if current treatment guidelines are relevant for the older adults with MPM.