Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide.

BACKGROUND: The phase III SPARTAN study demonstrated that apalutamide significantly improves metastasis-free survival and overall survival vs. placebo in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). However, patients receiving apalutamide experienced falls more frequently vs. those receiving placebo (15.6% vs. 9.0%). METHODS: 806 patients with nmCRPC randomized to apalutamide in SPARTAN and treated with apalutamide in addition to ongoing androgen deprivation therapy (ADT) were included in this post-hoc analysis investigating clinical variables associated with a subsequent fall. Time to a fall was assessed with Cox proportional-hazards models adjusted for baseline characteristics and time-varying factors. Statistical inference was based on final multivariable models. RESULTS: Falls were reported for 125/803 (15.6%) patients treated with apalutamide and ADT. Most falls were grade 1 or 2 and did not require hospitalization. Median time from randomization to first fall was 9.2 months (range 0.1-25.3 months). In the final multivariable model of both baseline and after-baseline covariates, baseline patient characteristics (older age, poor Eastern Cooperative Oncology Group performance status, history of neuropathy, and α-blocker use before study treatment) remained significantly associated with fall; after-baseline clinical characteristics significantly associated with time to fall were development of neuropathy, arthralgia, and weight loss before fall. CONCLUSIONS: This analysis identified risk factors for fall among nmCRPC patients treated with apalutamide. Clinical management can minimize these identified risks while enhancing patient outcomes. Preventive interventions should be considered when the identified baseline conditions and post-treatment neuropathy, arthralgia, or weight decrease are present, to reduce risk of fall. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01946204.

A multidisciplinary team-based approach with lifestyle modification and symptom management to address the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study.

BACKGROUND: Androgen deprivation therapy (ADT) is associated with numerous toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic, STAND (Supportive Therapy in Androgen Deprivation) Clinic, designed to provide individualized lifestyle modification and management of ADT-related side effects. METHODS: This phase II study recruited men with prostate cancer who had started ADT <6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the STAND Clinic or usual care. Patients randomized to the STAND Clinic were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Primary outcome was change from baseline to 12 months in percent body fat. Feasibility outcomes were also assessed by measuring percentage of completed visits. Secondary outcomes included change from baseline to 12 months in 3 domains: (1) metabolic impact and bone health, (2) quality of life (QOL), and (3) physical activity. RESULTS: A total of 25 men were randomized to STAND clinic, and 23 were randomized to usual care. The study did not meet its accrual target of 32 men in each arm and was closed early due to lack of financial support. Overall, 91% (295 of 325) of STAND clinic visits were completed. Eighteen out of the 25 patients in STAND clinic arm (72%) completed all 12 months of STAND clinic visits, and 80% (20 of 25) completed the first 6 months. For all primary and secondary outcomes, there were no statistically significant differences between treatment arms. CONCLUSION: Individualized and comprehensive management of ADT toxicities in a multidisciplinary clinic was well attended by patients. However, we did not find any differences in the outcomes assessed between the intervention arm and control.

Embracing the complexity: Older adults with cancer-related cognitive decline-A Young International Society of Geriatric Oncology position paper.

Cancer-related cognitive decline (CRCD) may have particularly significant consequences for older adults, impacting their functional and physical abilities, level of independence, ability to make decisions, treatment adherence, overall quality of life, and ultimately survival. In honor of Dr. Hurria's work we explore and examine multiple types of screening, assessment and non-pharmacologic treatments for CRCD. We then suggest future research and clinical practice questions to holistically appreciate the complexity of older adults with cancer's experiences and fully integrate the team-based approach to best serve this population.

A novel geriatric assessment tool that predicts postoperative complications in older adults with cancer.

INTRODUCTION: Comprehensive geriatric assessment prior to oncologic surgery can help predict surgical outcomes. We tested whether an abbreviated geriatric assessment tool, the Vulnerable Elderly Surgical Pathways and outcomes Assessment (VESPA), would predict post-operative complications among older adults undergoing oncologic surgery. METHOD: From 2008 to 2011, geriatric assessments were completed using the VESPA tool for patients age ≥ 70 seen in a pre-operative clinic. The VESPA assessed functional status, mood, cognition, and mobility, and can be completed in <10 min. We selected the subset of patients who underwent oncologic surgery and evaluated the VESPA's ability to predict post-operative surgical complications, geriatric complications (e.g., delirium), length of stay, and geriatric post-discharge needs (e.g., new functional dependence). RESULTS: A total of 476 patients who underwent oncologic surgery received the assessment using VESPA. Compared to patients with low VESPA scores (<9), patients with high VESPA scores (≥9) had longer length of stay (mean 6.6 vs. 2.0 days; p < .001), more geriatric complications (39.5% vs. 5.7%; p < .001), more surgical complications (29.5% vs. 11.8%; p < .001), and more likely to have post discharge needs (76.0% vs. 31.7%; p < .001). Using logistic regression, each additional point on the VESPA scale was also associated with increased probability of geriatric complications (OR = 1.3; 95% CI = 1.2-1.4), surgical complications (OR = 1.2; 95% CI = 1.1-1.2), and geriatric post-discharge needs (OR = 1.3; 95% CI = 1.2-1.3). CONCLUSION: The VESPA identifies older patients with cancer who are at risk for postoperative surgical and geriatric complications as well as functional needs at hospital discharge.

Unrealistic Postsurgical Expectation of Independence Predicts Complex Hospital Discharge.

BACKGROUND: Careful discharge planning for older surgical patients can reduce length of stay, readmission, and cost. We hypothesized that patients who overestimate their self-care ability before surgery are more likely to have complex postoperative discharge planning. MATERIALS AND METHODS: The Vulnerable Elders Surgical Pathways and Outcomes Assessment is a brief preoperative assessment that can identify older (age ≥70) patients with multidimensional geriatric risk, defined by all three of the following: (1) physical or cognitive impairment, (2) living alone, and (3) lack of handicap-accessible home. The Vulnerable Elders Surgical Pathways and Outcomes Assessment also asks a novel postoperative self-care ability question, whether patient can independently provide self-care for several hours after discharge. Classifying patients into four groups based on multidimensional geriatric risk (full versus none or partial) and the self-care ability question (yes or no), we hypothesized those with unrealistic postsurgical expectation of independence (UPSI) (both fully at risk and "yes" to self-care ability question) would be at the increased risk for complex discharge planning. Complex discharge planning was defined as prolonged stay because of nonmedical reasons or multiple changes in discharge plans. RESULTS: In 382 hospitalizations of ≥2 d, 366 had a nonmissing answer to the self-care question; of those 5% had UPSI and 6.3% needed complex discharge planning. The UPSI group was independently associated with greater risk of complex discharge planning compared with the normal group (odds ratio = 4.3 [95% confidence interval, 1.1-16.1]). CONCLUSIONS: Complex discharges were rare, but predictable by preoperative geriatric screening. Patients with UPSI should be targeted for postoperative care planning in advance of surgery.

Age-related Disparity: Breast Cancer in the Elderly.

Aging poses an unique opportunity to study cancer biology and treatment in older adults. Breast cancer is often studied in young women; however, much investigation remains to be done on breast cancer in our expanding elderly population. Diagnostic and management strategies applicable to younger patients cannot be empirically used to manage older breast cancer patients. Lack of evidence-based data continues to be the major impediment toward delivery of personalized cancer care to elderly breast cancer patients. This article reviews the relevant literature on management of curable breast cancer in the elderly, the role of geriatric assessment, complex treatment decision making within the context of patient's expected life expectancy, comorbidities, physical function, socioeconomic status, barriers to health care delivery, goals of treatment, and therapy-related side effects. Continuing efforts for enrolling elderly breast cancer patients in contemporary clinical trials, and thus improving age-appropriate care, are emphasized.

Adjuvant radiation use in older women with early-stage breast cancer at Johns Hopkins.

PURPOSE: In 2004, The National Comprehensive Cancer Network (NCCN) Guidelines incorporated omission of radiation therapy after breast-conservation surgery in women ≥70 years old with stage I, estrogen receptor-positive breast cancer who plan to receive endocrine therapy. One study demonstrated wide variation in implementing this change across 13 NCCN institutions. We evaluated the practice pattern at our institution. METHODS: We identified women ≥70 years old treated at our institution from 2009 to 2014. We calculated radiation therapy omission rate in those meeting the guidelines. We explored associations between radiation therapy omission, year of diagnosis, and patient characteristics with Wilcoxon rank sum tests and Fisher's exact tests. RESULTS: A total of 667 women met the inclusion criteria, and 117 (18 %) were candidates for radiation therapy omission. Mean age among the 117 was 76.3 years (Range: 70-95). Overall radiation therapy omission rate was 36.8 %, but varied greatly by year of diagnosis (Range: 7.7-54.5 %). This variation persisted after excluding women who did not receive endocrine therapy (Mean: 39.0 %, Range: 0.0-75.0 %). Factors associated with higher radiation therapy omission rates included older age and not having pathological nodal evaluation. The radiation therapy omission rate did not vary by race, tumor type, grade, or size. CONCLUSIONS: The implementation of the NCCN guideline has not been consistent at our institution. Our data suggest that other tools should be considered to apply the guidelines more consistently. We have implemented a quality improvement protocol that incorporates life expectancy estimate and geriatric assessment in women meeting the NCCN guideline at our institution.