Clinical trials for older cancer patients: A systematic review.

Improving Consistency and Quality of Care for Older Adults With Cancer: The Challenges of Developing Consensus Guidelines for Radiation Therapy

M. LYCKE, MSC, Cancer Centre, General Hospital Groeninge, Kortrijk, L. POTTEL, MSC, PHD, Cancer Centre, General Hospital Groeninge, Kortrijk, T. BOTERBERG, MD, PHD, Department of Radiation Oncology, Ghent University Hospital, Ghent, L. KETELAARS, MSC, Department of Psycho-oncology, General Hospital Groeninge, Kortrijk, H. WILDIERS, MD, PHD, Department of General Medical Oncology & Leuven Cancer Institute, Leuven University Hospital, Leuven, Belgium, P. SCHOFIELD, DIPN, PGDIPED, RGN, PHD, Centre for Positive Ageing, University of Greenwich, London, D. WELLER, MBBS(ADEL), MPH, PHD, FRACGP, FRCGP, FAFPHM, FRCP(EDIN), Centre for Population Health Sciences, University of Edinburgh, Edinburgh, & P.R. DEBRUYNE, MD, PHD, MSC, FRCP(GLASG), FCP, Cancer Centre, General Hospital Groeninge, Kortrijk Belgium, & Centre for Positive Ageing, University of Greenwich, London, UK

PC-FACS

G8 screening and health-care use in patients with cancer

The impact of comprehensive geriatric assessment on final treatment decisions

PC-FACS

Cognitive behavioral therapy (CBT) has been successfully utilized in improving mental health (MH) and quality of life (QoL) in the general population, regardless of age. Cancer, which is most frequently diagnosed in older adults, is a debilitating illness that has a detrimental and long-lasting effect on patients' MH and QoL. While numerous studies have demonstrated CBT's efficacy, little evidence exists for its role in older cancer patients. This study, using MH and QoL metrics, evaluates the effectiveness of CBT for older adult cancer patients. Focusing on MH and QoL and an average age of over 60 years old, a final analysis was performed on 17 clinical trials with a total of 124 effect sizes, including 3073 participants receiving CBT. "Metaphor" and "Robumeta" packages in R Statistical Software (version 4.2.2) were used for analysis, which included robust variance estimation (RVE) in intercept-only meta-regression, and univariate meta-regression for moderator analysis. With 17 clinical trials and 124 effect sizes, our results show that CBT moderately improves MH and QoL in cancer patients d = 0.19, 95% CI 0.0166-0.364, p < 0.0399. The delivery format was shown to be a strong moderator of CBT effectiveness with interpersonal technological interventions combined with pre-programmed segments having a very strong treatment effect size (d = 1.7307, 95% CI 1.5244-1.937, p < 0.001). The use of CBT in older adult cancer patients statistically improves MH and QoL, with delivery format and stages of treatment having important roles. Tech-only interpersonal interventions combined with pre-programmed CBT provide an avenue for targeting older adult cancer patients.

Since the initial scientific statement on Secondary Prevention of Coronary Heart Disease (CHD) in the Elderly was published in 2002,1 several trends have continued that make an update highly appropriate. First, the graying of the US population and those of other industrialized countries has progressed unabated because more adults are surviving into their senior years. The number of Americans aged ≥75 years was estimated at 18.6 million in 2010, representing ≈6% of the population,2 and it is expected to double by 2050. The population aged ≥85 years is growing the most rapidly, with numbers expected to reach 19.5 million by 2040. In 2008, 67% of the 811 940 cardiovascular deaths in the United States occurred in people aged ≥75 years.3 In parallel to this increase in the older adult demographic, the number of Americans with CHD has increased to an estimated 16.3 million, more than half of whom are >65 years of age.3 Similarly, 7 million have had a stroke, the incidence of which approximately doubles with successive age decades after 45 to 54 years.3 Peripheral artery disease (PAD) affects 8 to 10 million Americans, the majority of whom are >65 years of age. Between 2015 and 2030, annual US costs related to atherosclerotic cardiovascular disease (ASCVD) are projected to increase from $84.8 billion to $202 billion.3 Moreover, given that ASCVD often undermines functional capacity and independence and increases reliance on long-term care, indirect expenses related to ASCVD are also expected to increase. Thus, the need for effective secondary prevention measures in the older adult population with known ASCVD has never been greater. Notably, the 2011 American Heart Association (AHA)/American College of Cardiology Foundation (ACCF) updated guidelines for secondary prevention of CHD broadened …

1621 Background: While accounting for 40% of the cancer population, older adults are underrepresented in clinical trials. Older-age-selected studies are desirable, but their characteristics and overall performance are unknown. This systematic review assessed design and outcomes of trials focused on this patient population. Methods: We searched Embase and PubMed with the keywords “older adults”, “cancer” and “clinical trials”, from inception to March 1, 2023. We included phase (Ph) I, II and III trials testing systemic therapies in solid cancer patients (pts) aged ≥70 yrs. For each of the selected trials, we carried out an ad-hoc search for age-unselected trials testing the same interventions in the same setting. We followed the PRISMA guidelines for systematic reviews and registered the study on the PROSPERO database (CRD42023465089). Results: We screened 25,868 records and included 313 studies. 48 (15.4%) were Ph I-I/II, 232 (74.1%) Ph II, and 33 (10.5%) Ph III. The minimum-age threshold used to define ‘old’ was 70-74 yrs in 79.9%, 75-79 in 19.8%, and 80 in 0.3% of cases. Most trials (76.7%) were run in the palliative setting. Common tumors included lung (60.4%) and colorectal cancer (15%), while chemotherapy (88.5%) and targeted therapy (23.6%) were the most frequently tested treatments. Non-conventional primary endpoints (e.g., toxicity, feasibility, functional status, quality of life [QoL]) were used in 8.3% of Ph II-III trials. 24 studies were published in 1990-2000, 126 in 2001-2011, and 163 in 2012-2023. The median accrual time was 32 (IQR 21.5-44.5), 30 (IQR 20-43) and 43 months (IQR 36-65) for Ph I, I/II-II, and III, respectively. Of 234 trials reporting the pre-planned target accrual, 77.8% enrolled ≥90% of the required pts. Premature study discontinuation occurred in 50 studies (5.9% of Ph I, 14.2% of Ph II and 39.4% of Ph III), the major reason being slow accrual, while only 9 and 6 closed due to futility and overt efficacy, respectively. Among the 233 trials with a pre-defined statistical hypothesis, 60% met the primary endpoint, including 63.7% Ph I/II-II and 35.5% Ph III trials. Geriatric assessments (GA) and QoL analyses were carried out in 88 (28.1%) and 72 (23%) trials, respectively. Only 18 (5.8%) studies were dedicated to frail pts. Corresponding age-unselected trials were available for 154 older-patient studies. Compared with those, a higher proportion of age-unselected studies enrolled ≥90% of the required pts (95% vs 83.5%, p=0.03) and met the primary endpoint (80.3% vs 63.9%, p=0.03). Conclusions: The interest in clinical trials of solid tumors in older patients has increased over time. While Ph I and II trials are feasible, still a substantial proportion of Ph III trials suffer from slow accrual and premature discontinuation. Interventions to tackle barriers to recruitment should be implemented. Efforts should be made to systematically include GA and QoL analyses, which are key for this patient population.

In the management of elderly people with cancer under diagnosis, under treatment, or overtreatment, are often recurring problems that can be minimized through the application of Geriatric Assessment. Research studies show that older patients experience more incomplete investigations, toxicity complications, dose reductions and delays and decreased utilization of standard therapy compared to younger patients. The increased incidence of comorbidities in older adults can raise the risk of treatment related toxicities; however the assumption of sarcopenia and/or frailty based on a patient’s age alone may lead to inadequate and inappropriate treatment. The use of Geriatric Assessment, the best practices physicians currently have, can direct supportive care interventions. The Geriatric Assessment assists physicians in determining a patient’s medical decision making capacity, emphasizes the preservation of independent function and minimizes the risk of toxicity, regardless of treatment or treatment intent. The goal of this review is to explain the most relevant aspects of the comprehensive geriatric assessment in elderly cancer patients and provide the basis for supportive care therapies such as pain management, dyspnoea, cachexia and geriatric syndromes like sarcopenia.

Do Canadian Radiation Oncologists Consider Geriatric Assessment in the Decision-Making Process for Treatment of Patients 80 years and Older with Non-Metastatic Prostate Cancer? - National Survey.

Phase II Study of Longitudinal Geriatric Assessment with Risk-Adapted Interventions to Reduce Non-Relapse Mortality in Allogeneic Hematopoietic Cell Transplantation for Older Patients with Advanced Myeloid Malignancies

Comorbidities in the Aging Breast Cancer Population: Are Current Assessments Leading to Improved Outcomes?

12048 Background: Immunotherapy (Im) improved the survival of patients with lung cancer. It may be responsible for adverse events impacting these patients' quality of life. We have few data on the tolerance of older cancer patients (OP) to immunotherapy. The Toximmune study aims to describe the safety of older lung cancer patients to Im and identify clinical, biological and radiological markers that can help to predict immune-related adverse events for OP. Methods: All patients aged 60 years and older who had received at least one dose of ICI between June 2015 and December 2020 and diagnosed with lung cancer were included. We collected patients' baseline demographic characteristics, biological blood markers and imaging by PET-scanner. All adverse events (AEs) and immune-related AEs (irAEs) were recorded (CTCAE V.5.0). Results: 49 patients were included, median age was 71 (range 61-97). The incidence of grade 2 and grade 3-4 was 34% and 6% respectively. The main irAEs reported were: asthenia in 51% patients after 13.5 months median delay (grade ≥2 in 22%),musculoskeletal disorders in 45% after 21 months median delay (grade ≥2 in 10%), pneumonitis in 37% after 21 months median delay (grade ≥2 in 10%), and colitis in 35% after 21 months median delay (grade ≥2 in 6%). Female sex, primitive tumor SUV max &lt; 5, number of metastases ≥ 3, prior systemic therapy &gt; 1, PLR &lt; 250 were significantly associated with a risk of toxicity in univariate analysis (p &lt; 0.05) We developed the ToxImmune score (0, 1, or ≥2) to predict the risk of having a grade ≥2 adverse event by adding the following risk factors: Primitive Tumor SUV &lt; 5 = 1, Number of metastases ≥3 = 1, And L1 = 0 vs &gt; L1 = 1. The incidence of grade ≥2 adverse events was 31%, 35% and 86% with ToxImmune scores 0, 1 and 2 respectively (p = 0.032). Median overall survival times (OS) &amp; progression-free survival (PFS) were 21.8 &amp; 21 months, 15.1 &amp; 6.6 months, and 9.8 &amp; 2.1 months for ToxImmune scores 0, 1 and ≥ 2 respectively (p = 0.06 &amp; p = 0.001). There was significant association between the ToxImmune score and the risk of "progressive disease" at the first assessment of the disease: 16% for score = 0, 48% for score = 1, and 71% for score = 2, (p = 0.01). Conclusions: The quality of life is our goal for OP care. The ToxImmune score, which is based on objective clinical parameters, identifies OP with a significant higher risk of severe adverse events. Also, this score was significantly associated with patients’ PFS risk of developing rapid tumor progression. It could be used in clinical practice to personalize toxicity surveillance in OP treated for lung cancer with immunotherapy. This score will be validated in larger prospective cohorts.

BackgroundIn Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancer patients to determine whether GA with intervention improves patient satisfaction with their treatment.MethodsThe study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancer patients aged ≥ 75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician’s choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later.DiscussionThe purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancer patients and will provide a foundation for the development of a standardized geriatric oncology system.Trial registrationThe study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853.)