bluuebunny/crossref_metadata_2025 huggingface dataset:
Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial.
Authors: Ligibel Jennifer A. , Ballman Karla V. , McCall Linda Mackie , Goodwin Pamela Jean , Weiss Anna , Delahanty Linda , Alfano Catherine M. , Crane Tracy E , Neuhouser Marian L. , Spears Patricia , Hershman Dawn L. , Paskett Electra D. , Hopkins Judith O. , Bernstein Vanessa , Stearns Vered , White Julia R. , Wadden Thomas , Winer Eric P. , Partridge Ann H. , Carey Lisa A.
Published: June 2023

12001

Background: Obesity is a poor prognostic factor in early breast cancer. The Breast Cancer Weight Loss (BWEL) trial (Alliance for Clinical Trials in Oncology A011401; NCT02750826) evaluates the impact of a WLI on invasive disease-free survival in breast cancer patients (pts) with a body mass index (BMI) ³27 kg/m2. Here we report the impact of the WLI on weight change. Methods: Eligible pts were within 14 months of diagnosis of stage 2-3 HER2-negative breast cancer, had completed chemotherapy and radiation (if administered), and were randomized 1:1 to a telephone-based WLI plus health education (HE) or an HE alone control group. The WLI was delivered by telephone-based health coaching and focused on caloric restriction and increased exercise. Height and weight were measured at baseline and 12 months. Changes in weight were compared between groups. Analysis was performed with univariable and multivariable (including arm, baseline weight, menopausal status, race/ethnicity, and hormone receptor [HR] status) regression models. A 0.05 level of significance was used. Results: 3181 women were randomized between 8/2016 and 2/2021. At baseline, mean BMI was 34.5 (±5.74) kg/m2, mean age was 53.4 (±10.58) years, and 57% of pts were postmenopausal at the time of diagnosis. 80.3% of participants were White, 12.8% were Black, and 7.3% were Hispanic. Follow-up weight was available from 2293 pts alive and disease-free at 12 months. The WLI led to a significant decrease in weight relative to controls; pts randomized to WLI lost an average of 4.8% (±7.9) of baseline body weight at 12 months vs. 0.8% (± 6.4) weight gain in controls (p<0.0001). Pts randomized to WLI experienced significant weight loss (vs controls) across demographic and tumor factors (Table). WLI effect differed significantly by menopausal status (interaction p value = 0.0057) and race/ethnicity (interaction p-value = 0.019), but not HR status (interaction p-value = 0.17). Conclusions: A telephone-based WLI induced significant, clinically meaningful weight loss in breast cancer pts with overweight and obesity across demographic and tumor factors. Additional tailoring of the WLI could be useful to enhance weight loss in Black and younger pts. Further follow-up of the BWEL trial will evaluate whether the WLI improves disease outcomes. Support: U10CA180821, U10CA180882, UG1CA189823; https://acknowledgments.alliancefound.org . Clinical trial information: NCT02750826 . [Table: see text]
Chemotherapy induced peripheral neuropathy (CIPN) due to paclitaxel versus docetaxel in patients with early-stage breast cancer receiving taxane therapy: SWOG S1714.
Authors: Trivedi Meghna S. , Unger Joseph M. , Hershman Dawn L. , Darke Amy , Hertz Daniel Louis , Brannagan Thomas , Smith Stephanie , Schneider Bryan P. , Irvin William Johnson , Hathaway Amanda Redden , Vander Woude Amy C. , Gudena Vinay K. , Henry Norah Lynn , Fisch Michael Jordan
Published: June 2023

12003

Background: Paclitaxel (Pac) and docetaxel (Doc) are used to treat early-stage breast cancer (BC). CIPN due to taxane therapy can cause sensory and motor deficits. CIPN symptoms caused by Pac versus Doc are not well described. Methods: SWOG S1714 enrolled patients ≥ 18 years with Stage I-III primary NSCLC, BC, or ovarian cancer starting treatment with a taxane-based regimen. CIPN was assessed by the patient-reported EORTC QLQ-CIPN20 (CIPN-20) and clinician-assessed NCI-CTCAE. Assessments occurred at baseline and 4, 8, 12, and 24 weeks after registration. Increase in CIPN-20 sensory subscale score ≥ 8 points was considered clinically meaningful. Chi-square and Fisher tests were used for baseline comparisons; logistic regression was used for multivariable analyses. Results: Among 1336 enrolled patients, 1106 of eligible patients had a diagnosis of BC, with median age 54.8 y (range 23.9-84.2 y), 99.3% female, and 72.3% White/11.3% Black/4.6% Asian/11.1% Hispanic/Latino. Pac was administered to 615 (55.6%) and Doc to 491(44.3%) patients. Between the Pac and Doc cohorts, there were significant baseline differences in median age, diabetes, and performance status. At 24 weeks, the proportion of patients with ≥8 point increase in CIPN-20 sensory score was lower for Doc (40.5%) vs Pac (50.2%) (odds ratio [OR] 0.64, 95% CI 0.50, 0.82; multivariable adjusted p<.001). At nearly every timepoint through 24 weeks, patients treated with Pac had more sensory and motor neuropathy as measured by both the CIPN-20 and NCI-CTCAE (Table). Conclusions: In this diverse cohort of patients with BC, the frequency of CIPN was higher than expected for both Pac and Doc and more severe in patients receiving Pac. These findings based on CIPN-20 can assist in treatment decision-making about taxane therapy. Long term follow up will better characterize the differences in the trajectory of CIPN between Pac and Doc. Funding: NIH/NCI/NCORP grant UG1CA189974. Clinical trial information: NCT03939481. [Table: see text]
Randomized double-blind, placebo-controlled study of topical diclofenac in prevention of hand-foot syndrome in patients receiving capecitabine.
Authors: Santhosh AKHIL , Batra Atul , kumar akash , Pramanik Raja , Gogia Ajay , Cheung Winson Y. , Sharma Atul , Prasad Chandra Prakash , Sehgal Tushar
Published: June 2023

12005

Background: Capecitabine induced HFS is associated with deterioration of quality of life of patients and dose of capecitabine is often reduced to manage this adverse event. Celecoxib is the only effective intervention in preventing HFS; however, its widespread use is limited due to its own safety concerns. We conducted this study to assess the efficacy of topical diclofenac in preventing capecitabine induced HFS. Methods: Patients with breast and gastrointestinal (GI) cancers, planned for capecitabine (monotherapy or combination) treatment were randomized in 1:1 to receive topical diclofenac or placebo gel for 4 cycles or until development of HFS, whichever was earlier. Stratified (male or female; capecitabine monotherapy or combination therapy) permuted variable size block randomization was done using a computer-generated random numbers sequence. Primary objective was to compare the incidence of grade 2 or higher HFS in diclofenac and placebo arms. Secondary objectives were incidence of any grade HFS, capecitabine dose changes due to HFS and self-reported adherence with application. Results: A total of 263 patients were randomized to apply topical diclofenac gel (n=130) or placebo (n=133). Baseline characteristics were similar in both the arms (Table). The incidence of grade 2 or higher HFS was 3.8% (95% CI, 1.6%-8.9%) in the diclofenac arm compared with 15.0% (95% CI, 9.9%-22.2%) in the placebo arm (P=0.003). Any grade HFS was significantly lower in the study arm compared with the placebo arm (6.1% vs 18.1%; P=0.003). A lower incidence of HFS was observed in the diclofenac arm across the subgroups (breast and GI cancers; males and females). Capecitabine dose reductions were less frequent in the diclofenac arm (3.8%) compared with the placebo arm (15%) (P=0.002). Adherence to topical treatment was similar in the diclofenac arm (96.7 +/- 19.1%) compared with the placebo arm (94.0 +/- 28.3%) (P=0.36). Other capecitabine associated adverse events, including diarrhea, mucositis, and myelosuppression were not significantly different in both the arms. Conclusions: Topical diclofenac is effective in preventing all grades of HFS in patients receiving capecitabine. Diclofenac application was also associated with lesser dose reductions of capecitabine. This trial establishes topical diclofenac as the new standard of care to prevent capecitabine associated HFS. Clinical trial information: CTRI/2021/01/030592 . [Table: see text]
Telehealth-based psychological intervention for caregivers of patients with primary malignant brain tumors: A randomized controlled trial.
Authors: Forst Deborah Anne , Podgurski Alyx F. , Strander Sumita Madhok , Datta Shibani , Pintro Kedie , Horick Nora K. , Sannes Timothy S. , Greer Joseph A. , El-Jawahri Areej , Jacobs Jamie M. , Temel Jennifer S.
Published: June 2023

12008

Background: Caregivers of patients with primary malignant brain tumors (PMBT) face unique challenges caring for someone with a progressive neurological illness. In preliminary studies, we found that 50% or more of caregivers had clinically significant anxiety symptoms in the months following the patient’s PMBT diagnosis. However, few interventions have been developed to specifically target anxiety symptoms in this population. Methods: We conducted a randomized controlled trial evaluating the efficacy of NeuroCARE, a population-specific intervention addressing anxiety in caregivers of patients receiving treatment at two academic centers. Eligible caregivers were within six months of the patient’s PMBT diagnosis and had clinically significant anxiety symptoms (score ≥ 5 on the Generalized Anxiety Disorder-7 tool). Participants were randomized 1:1 to NeuroCARE or usual care. NeuroCARE consisted of six one-on-one telehealth sessions with a mental health clinician or trainee and incorporated evidence-based skills for 1) coping with worry, 2) using assertive communication techniques, 3) optimizing social support, and 4) promoting relaxation and healthy sleep. Participants completed questionnaires at baseline, 11 weeks (immediately post-intervention) and 16 weeks (1 month post-intervention). Our primary endpoint was anxiety symptoms at 11 weeks (Hospital Anxiety and Depression Scale (HADS) – Anxiety Subscale score). We also assessed depression symptoms (HADS – Depression Subscale), quality of life (QOL; Caregiver QOL survey), caregiver burden (Caregiver Reaction Assessment), self-efficacy (Lewis Cancer Self-Efficacy scale), coping (Measure of Current Status) and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for DSM-5). We used analysis of covariance to evaluate the effect of NeuroCARE versus usual care on these outcomes. Results: We enrolled 120 caregivers (60 per arm, mean age = 53 years, 83% female), the majority of whom were caring for their spouse/long-term partner (70%), child (17%), or parent (7%). At 11 weeks, NeuroCARE participants reported significantly lower anxiety symptoms than those assigned to usual care (means: 8.87 vs 10.69, p = 0.008). NeuroCARE caregivers also reported significantly lower depression symptoms (6.08 vs 7.77, p = 0.004) and better self-efficacy (128.81 vs 111.17, p < 0.001) and coping (32.25 vs 25.65, p < 0.001) at 11 weeks. Study groups did not differ with respect to caregiver burden, PTSD symptoms, or QOL at 11 weeks. Conclusions: A population-specific telehealth-based psychological intervention (NeuroCARE) led to significantly lower anxiety and depression symptoms and better self-efficacy and coping among caregivers of patients with PMBT compared with usual supportive care. Clinical trial information: NCT04109209 .
Cost-utility of geriatric assessment in older adults with cancer: Results from the 5C trial.
Authors: Sahakyan Yeva , Li Qixuan , Abrahamyan Lusine , Puts Martine , Brennenstuhl Sarah , Anwar Mohammed Rashidul , Yeretzian Shant , Matosyan Emma , Mclean Bianca , Strohschein Fay , Wills Aria , Tomlinson George , Alibhai Shabbir M.H.
Published: June 2023

12012

Background: Geriatric assessment is a guideline-recommended approach to optimize cancer management in older adults. We conducted a cost-utility analysis alongside the recently published 5C randomized controlled trial to compare geriatric assessment and management (GAM) with usual care in older adults with cancer. Methods: The economic evaluation was conducted from a societal perspective, using a 12-month time horizon. The 5C study enrolled patients age 65+ from 8 Canadian hospitals and randomly assigned them to receive GAM or usual care. Patients were initiating systemic therapy with curative or palliative intent. Quality-adjusted life years (QALYs) were measured using the EQ-5D-5L questionnaire. Healthcare utilization was evaluated using cost diaries and chart reviews. The primary outcome, an incremental monetary benefit (INMB), was evaluated for the full sample and for preselected subgroups. Multiple imputation was used to account for missing data. The 95% confidence intervals (CI) were computed using bootstrapping. Results: The study included 350 patients, of which 173 received GAM and 177 received usual care. At 12 months, the average QALYs per patient were 0.747 and 0.753 for GAM and usual care respectively (ΔQALY = -0.006, 95%CI: -0.06 to 0.05). The total average costs per patient were $48,397 and $45,342 for GAM and usual care (ΔCost = $3,078 (95% CI: -$5,336 to $12,050). At a cost-effectiveness threshold of $50,000/QALY the INMB was negative (-$3,962; 95% CI: -$7,117 to -$794) meaning that GAM was not cost-effective compared to usual care. In a subgroup analysis the INMB was positive ($4,639, 95% CI: $61 to $8,607) for patients treated with curative intent, and the intervention was cost effective in 78% of simulations, but remained negative (i.e. not cost-effective) for patients treated with palliative intent (INMB -$13,307, 95% CI -$18,063 to -$8,264). Conclusions: This is the first cost-utility analysis of GAM in cancer. The findings showed that GAM was cost-effective for cancer patients treated with curative intent but not for patients with palliative intent. Although the primary results of the 5C trial were negative, extrapolating our costing data to positive GAM trials like GAIN, GAP70, and INTEGERATE will provide a more complete picture of the cost effectiveness of GAM in this setting. Clinical trial information: NCT03154671 .
Impact of immune checkpoint inhibition on ovarian reserve in patients with melanoma enrolled in the ECOG-ACRIN E1609 adjuvant trial.
Authors: Buchbinder Elizabeth Iannotti , Song Zihe , Lee Sandra J. , Keefe Kimberly W. , Manos Michael P. , Tarhini Ahmad A. , Dougan Michael L. , Cohen Justine Vanessa
Published: June 2023

12013

Background: Immunotherapy with immune checkpoint inhibition (ICI) is being widely adopted in the treatment of patients with a wide range of malignancies. However, we have no data on how these therapies influence fertility or ability to undergo fertility treatments after therapy. Within the melanoma community numerous women of childbearing age have been treated with ICI including ipilimumab, nivolumab and pembrolizumab. Anti-mullerian hormone (AMH) is a biomarker of ovarian reserve and a predictor of response to fertility treatments, including in vitro fertilization (IVF). In women under the age of 35 who have no reproductive pathology, AMH should be detectable and remain relatively stable over time. Above the age of 35 AMH decline accelerates as the number of eggs decreases more rapidly due to normal ovarian aging. Methods: Pre and post-treatment samples from women aged 20-35 whose melanoma was treated with 3 mg/kg ipilimumab (57%) or 10 mg/kg ipilimumab (43%) in the adjuvant setting on trial ECOG-ACRIN E1609 were analyzed in collaboration with the BWH Reproductive Endocrine Laboratory. Serum samples were tested for luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, AMH and prolactin. Results: Samples from E1609 were available from 28 female patients with a median age of 28 (min 20, max 35). The median time between samples was 8.0 months (min 0.7, max 16.4). 53% of patients had stage IIIB melanoma, 43% stage IIIC and one patient had M1a disease. AMH, estradiol and LH significantly decreased after treatment (p < 0.001, p = 0.016, p = 0.012, respectively) (Figure 1); there was no significant difference in the level of FSH and prolactin before and after the treatment (p = 0.68, p = 0.12, respectively). The median AMH was 4.24 ng/mL in the pre-treatment group and 3.51 in the post-treatment group. Conclusions: In this study of young women treated with ipilimumab there was a significant decrease in AMH before and after ICI therapy suggesting that ovarian reserve and possibly female fertility may be impacted by immune checkpoint inhibition. Further investigation is needed to look at PD-1 inhibition and combination immunotherapy effects on ovarian reserve and female fertility. In addition, there is a similar need to examine ICI effects on male fertility.
Long term efficacy of psilocybin in patients with cancer and major depressive disorder (MDD).
Authors: Agrawal Manish , Shnayder Sarah , Honstein Heather , Emanuel Ezekiel J. , Thambi Paul M.
Published: June 2023

12021

Background: Up to 25% of people living with cancer have depression. Existing psychological interventions have limited efficacy in treating depression. Psilocybin, a 5-hydroytrptamintergic psychedelic, coupled with group therapy is safe and effective in ameliorating symptoms of depression (Agrawal et al, ASCO 2022). Response to psilocybin treatment was observed in 83.3% of patients at 8 weeks, and 50% of patients showed full remission of depressive symptoms. This study evaluates the efficacy of psilocybin-assisted group therapy in relieving depression in cancer patients over 18 months. Methods: Adults with curable or metastatic cancer and MDD (according to DSM-5) underwent psychological assessments at baseline. They were treated with single-dose psilocybin 25 mg administered simultaneously in group cohorts of 3-4, supported with group and individual psychological therapy, and evaluated at 8 weeks and 18 months. Primary objectives were long-term effectiveness on depression and anxiety severity (as measured by change in Montgomery Asberg Depression Rating Scale [MADRS] and Hamilton Depression Rating Scale [HAM-A] scores by independent rater assessments) as well as clinical response (≥50% decrease in MADRS total score from baseline to 18 months) and remission (defined as patients with a MADRS total score ≤10 at 18 months). Results: Of 30 patients enrolled in the parent study, 2 died and 4 were lost to follow-up. Clinical response was demonstrated in 18/28 patients (64.2%) from baseline to 18 months follow-up (see table); 16/28 patients (57.1%) demonstrated remission of depression at 18 months. In 24 evaluable patients, continued reduction in mean depression severity scores was also demonstrated from baseline to week 8 (MADRS by 20.6 points [95% CI 23.2, 18.0, p < 0.001] and HAMA-A by 16.7 points [95% CI 19.7, 13.7, p < 0.001]) and from baseline to 18 months (MADRS by 16.7 points [95% CI 20.4, 12.9, p < 0.001] and HAMA-A by 14.4 points [95% CI 17.3, 11.4, p < 0.001]). Conclusions: Long-term follow-up suggests continued robust clinical response and remission from depression with a single dose of psilocybin and simultaneous psychological support in patients with cancer and MDD. These findings indicate psilocybin may play a role in treatment of depression in cancer patients, and further investigations are ongoing. [Table: see text]
Interventions to improve outcomes for caregivers of patients with advanced cancer: A systematic review and meta-analysis.
Authors: Chow Ronald , Mathews Jean J , Cheng Emily YiQin , Lo Samantha , Wong Joanne , Alam Sorayya , Hannon Breffni , Rodin Gary , Nissim Rinat , Hales Sarah , Kavalieratos Dio , Quinn Kieran , Tomlinson George , Zimmermann Camilla
Published: June 2023

12026

Background: More than one in ten adults in the US are family caregivers, with cancer among the most common diagnoses of care recipients. Family caregivers of patients with advanced cancer often have poor quality of life (QOL) and mental health. We examined the effectiveness of interventions offering support for caregivers of patients with advanced cancer on caregiver QOL and mental health outcomes. Methods: We searched Ovid MEDLINE, EMBASE, Cochrane CENTRAL, and CINAHL databases from inception through 6/2021. Eligible studies reported on randomized controlled trials for adult caregivers of adult patients with advanced cancer. Meta-analysis was conducted for primary outcomes of QOL, physical well-being, mental well-being, anxiety, and depression, from baseline to follow-up of 1-3 months; secondary endpoints were these outcomes at 4-6 months and additional caregiver burden, self-efficacy, family functioning and bereavement outcomes. Random effects models were used to generate summary standardized mean differences (SMD). Meta-regression was conducted for primary outcomes that were significant for the intervention, assessing for mediation effect modification by caregiver sex and age of patient and caregiver. Type I error was 0.05. PROSPERO Registration: CRD42019136321. Results: Of 12,193 references identified, 56 articles reporting on 49 trials involving 8,554 caregivers were eligible for analysis; 16 (33%) targeted caregivers (mostly psychoeducational or problem-solving interventions), 19 (39%) patient-caregiver dyads (mostly counseling/therapy), and 14 (29%) patients and their families (mostly palliative care teams). At 1-3 month follow-up, interventions had a significant effect on overall QOL (SMD 0.24 (0.10 to 0.39), I2 = 52.0%), mental well-being (SMD 0.14 (0.02 to 0.25), I2 = 0.0%), anxiety (SMD 0.27 (0.06 to 0.49), I2 = 74.0%), and depression (SMD 0.34 (0.16 to 0.52), I2 = 64.4%), compared to standard care. At 1-3-month follow-up, a larger age difference (older patient and younger caregiver) was associated with a greater positive effect on QOL (p = 0.04) and depression (p = 0.02). In narrative synthesis, interventions demonstrated improvements in caregiver self-efficacy and grief. Conclusions: Interventions targeting caregivers, dyads, or patients and families led to improvements in caregiver QOL and mental health outcomes. These data support the routine provision of available interventions to support caregivers of patients with advanced cancer.
Use of clinical pathways to identify patients with cancer who may benefit from serious illness conversations.
Authors: Cotner Cody E , Tramontano Angela , Jackman David Michael , Tulsky James A. , Jacobson Joseph , Rice Matthew , Post Alex , Finn Brian , Mwesigwa Sishemo , Lindvall Charlotta , Wright Alexi A. , Manz Christopher
Published: June 2023

12027

Background: Treatment pathways are widely used to provide decision support and encourage guideline adherence. Pathways data may be used to identify patients for targeted interventions to improve cancer care. For example, pathways data may enable the identification of patients with poor prognoses for whom serious illness conversations (SICs) should be prioritized to ensure goal-concordant care. Methods: For patients starting new therapies at Dana-Farber, oncologists select a node in clinical pathways to indicate the line of treatment. Subspecialty oncologists identified “poor prognosis” nodes in pathways, defined as therapies for patients with expected survivals of < 12 months and for whom an SIC would be appropriate (e.g., 3rd-line treatment for metastatic colon cancer). Pathway node navigations for patients with metastatic solid tumor malignancies with poor prognosis nodes (n = 21 disease pathways) were combined with electronic medical record data to identify SIC documentation in an advance care planning module within 6 months of pathway navigation and patients’ dates of death if present. For each node, we calculated the median overall survival (OS), the proportion of patients with an SIC, and the proportion of patients who died before reaching the next node. Results: There were 10,132 navigations for 7,031 patients (median age 67 years, 52% female, 86% White) between 8/16/2019 and 1/4/2023. With each treatment line, patients’ median OS decreased and SIC rates increased (examples for 3 diseases in Table). Among patients who reached poor prognosis nodes, the median OS was 4.9 months, mean SIC rate was 43.8%, and 60.2% of patients died without reaching a subsequent node. For nodes immediately prior to poor prognosis nodes, the median OS was 7.1 months, the mean SIC rate was 25.2%, and 31.3% of patients died without reaching the next node. 46.3% of patients died without reaching a poor prognosis node. The proportion of patients having an SIC at death was 40.9% among all decedents, 50.8% for decedents reaching a poor prognosis node, and 29.3% for decedents who do not reach a poor prognosis node. Conclusions: Clinical pathways can be used as a scalable method to identify patients with metastatic solid tumors and poor prognoses. In our study, only half of patients who reached a poor prognosis node had an SIC before death and nearly half of decedents never reached a poor prognosis node, underscoring the importance of identifying this population to improve end-of-life care. A clinical trial using pathways to identify and deliver interventions to increase SICs is ongoing. [Table: see text]
Quality for all: Clinical trial enrollment and end-of-life care in solid and hematologic malignancies.
Authors: Rosen Melissa R , Lambert Katherine A , Nakatani Morgan Megumi , Ibrahim Salam , Troung Tracy , Feng Kelvin , Fournier Chloe , Kamal Arif , LeBlanc Thomas William , Havrilesky Laura J , Davidson Brittany Anne
Published: June 2023

12028

Background: All patients with cancer deserve quality end-of-life (EOL) care.Despite established EOL quality metrics, many patients with cancer receive futile, aggressive EOL care with infrequent palliative care involvement and advanced care planning (ACP) documentation. Clinical trials are critical to advancing cancer care; at National Cancer Institute-designated cancer centers, ~20% of patients participate in clinical trials at some point. We aim to identify associations between trial enrollment in the last year of life (YOL) and EOL quality metrics for adults with solid or hematologic malignancies to identify opportunities to advance cancer care near death. Methods: This is a retrospective review of patients with solid or hematologic cancers treated at a single academic institution who died of disease between 2018 – 2022. Patients were identified using institutional registries. Inclusion criteria were ≥18 years of age with active disease at death. Outcomes include: initiation of new anti-cancer therapy, Intensive Care Unit (ICU) admission, hospitalization, or Emergency Department (ED) visit in the last 30 days of life (DOL), referral to hospice, palliative care involvement, and documentation of goals of care (GOC) and ACP paperwork. Results: Among 9,384 patients, 637 (6.8%) enrolled in clinical trials in the last YOL. Most common disease sites were gastrointestinal, thoracic, and genitourinary. Patients enrolled in clinical trials were more likely to initiate new anti-cancer treatments in the last 30 DOL (p=<0.001), less likely to be referred to palliative care (p=0.008) or have GOC documentation (p=<0.001), and less likely to visit the ED (p=0.016) or die in an inpatient setting (p=0.02). No differences were noted in referrals to hospice, ICU or hospital admissions in last 30 DOL, or ACP paperwork. Conclusions: Enrollment in a clinical trial in the last YOL was associated with several measures of aggressive EOL care. Low rates of palliative care and hospice engagement and infrequent documentation of ACP decisions across the study population suggest opportunities for improvement for all patients, regardless of trial enrollment. [Table: see text]
Trends in place of death in adolescents and young adults dying from cancer in the US, 2003-2019.
Authors: Hussaini S. M. Qasim , Blackford Amanda L. , Sedhom Ramy , Gupta Arjun
Published: June 2023

12029

Background: Adolescents and Young Adults (AYAs) face unique social challenges in navigating care at end-of-life (EOL). Place of Death (PoD) is an important determinant of patient and caregiver preference, access to home-based supportive care, and cost of caregiving at EOL. We sought to describe disparities in PoD in AYAs who died from cancer between 2003-2019. Methods: We used deidentified death certificate data via the CDC Wonder database. We included decedents aged 15-44 years with an underlying cause of death from cancer (through ICD codes) from 2003-2019. We stratified findings by age, race/ethnicity, sex, cancer site, and urban/rural metro status. We classified PoD as (1) medical facility (2) nursing home (3) home, or (4) hospice facility. Odds ratios (OR) for the association between PoD and geographic region were calculated using multinomial regression, adjusting for year of death. Results: We included 301,886 AYA deaths from cancer (53.9% female, 15.6% non-Hispanic Black, 18.4% Hispanic, 15.6% rural, 28.6% breast, 19.9% colorectal, 18.4% lung, 16.9% brain, 16.2% leukemia). From 2003-2019, deaths in a medical facility reduced from 11,579 (52.7%) to 7,952 (49.5%), home from 8,630 (39.3%) to 6032 (37.5%), and in a hospice facility increased from 152 (0.7%) to 2,245 (14.0%). Compared with older adults (>45), AYAs were 42% and 37% less likely to die at home or in a hospice facility than a medical facility. Within AYAs, similar trends were noted for Hispanic and non-Hispanic Blacks when compared to non-Hispanic Whites, and rural residents when compared to urban residents. AYAs with leukemia were most likely to die in a medical facility and least likely in hospice, brain cancer most likely to die at home or in a nursing facility, while colorectal and breast cancers had equal uptake of hospice. Conclusions: AYAs have lower hospice uptake at EOL with notable sociodemographic, geographic and disease-site specific variation. These data likely reflect complex treatment planning and care access/preference at EOL. Dying at home may be unattainable for AYAs, unless they are able to afford help or have family who are willing to be caregivers. Future work investigating whether the offerings of hospice meet the basic care needs of AYA with cancer at EOL is necessary. [Table: see text]
Patient characteristics associated with psychosocial distress about end-of-life.
Authors: Tergas Ana Isabel , Razavi Marianne , Loscalzo Matthew J. , Rocha-Cadman Xiomara , Maciejewski Paul K. , Prigerson Holly Gwen , Clark Karen L.
Published: June 2023

12031

Background: A cancer diagnosis and subsequent treatment can cause significant psychosocial distress, including fear about the end of life (EoL). Although distress is common, it often goes unrecognized due to the challenge of routine psychosocial distress screening. This study sought to determine patient characteristics associated with EoL-related distress. Methods: A validated psychosocial distress screening tool (SupportScreen) was administered to patients prior to treatment at an NCI-designated cancer center between 2009-2017. Fear about EoL was measured on a 5-point Likert scale with scores of ≥3 indicating “high” distress. Multivariable logistic regression was used to test the association between fear of Eol and patients’ characteristics (age, sex, education, household income, survey language, race/ethnicity, and cancer diagnoses). Pairwise comparisons were run for cancer types and p-values were adjusted. Results: A total of 4,198 patients with cancer were included. Of these, 21.5% reported high distress from fear about EoL. Most patients were women (61%) and non-Latino white (60%). The average age was 59.9 years (SD = 13.9). About 29% of the participants had household income < $40,000. The most common cancers in this sample were breast (22%), hematological (15%), gastrointestinal (14%) and gynecological (13%). Adjusted analyses showed that being a woman (OR = 1.30, p < 0.042), taking the survey in Spanish (OR = 1.71, p = 0.020) and having a household income < $40,000 (OR = 1.80, p < 0.001) were all associated with high distress for EoL. Among cancer types, lung cancer (versus breast, digestive, gynecological, hematological, and prostate cancers) was significantly linked to high distress (p-values < 0.05). Conversely, older age (OR = 0.99, p = 0.009) was associated with low distress. Conclusions: In this study, we identified patient clinical and demographic characteristics associated with high levels of distress due to fear of EoL. Patients who have lower household income, limited English proficiency, are younger, and female, as well as patients with lung cancer, may benefit from targeted screening for EoL distress, to facilitate early identification and tailored supportive care assistance.
Psychosocial health of patients engaging in medical aid in dying and their family members: A prospective descriptive analysis.
Authors: Turner Chloe , Singer Jonathan , Daum Courtney , Himes Katie P , Elliott Lauren , Caldwell Darcie , Lavell Laura , Armstrong Anne A , Hnida James , Cruz Jourdan , Loggers Elizabeth Trice
Published: June 2023

12032

Background: Medical Aid in Dying (MAID) allows patients (pts) with a terminal illness and less than 6 months prognosis to request a prescription that will end their life. MAID is controversial; opponents argue that negative psychological health underlies the choice, and that participation adversely effects pts and FMs. This is the first study to prospectively examine psychological health of pts and Family Members (FMs) who engaged in MAID and compare this to the psychological health of pts and FMs who did not utilize MAID. Methods: Pts and FMs were recruited prospectively from End-of-Life Washington (largest non-profit, public MAID advocacy/assistance organization in Washington State) from September 2022-January 2023 to a self-report, longitudinal study. Pts, FMs or the dyad were enrolled. Results of this study are compared to previously published results: *means (standard deviation, SD) taken from *Singer, et al. 2021; **Frikkel, et al. 2021; ^Robinson, et al. 2016 and ~Trevino, et al. 2013. + indicates no significant difference between MAID and non-MAID subjects at p > .05 level. Results: 16% (8/51) of eligible pts and 49% (20/41) of eligible FMs were recruited. 55% (n = 11) of FMs were spouses. There was no difference in sex and subjects were mostly white (pts 87.5%; FMs 95%) with college or higher degrees (pts 62.5%; FMs 85%). Most pts reported having cancer (n = 6 [75%]; neurologic condition, n = 1 [12.5%]; cirrhosis, n = 1 [12.5%]); most FMs also reported their pt had cancer (n = 17 [85%]; neurologic condition, n = 3 [15%]). There were no differences in psychological health between terminal cancer pts and FMs who engaged in MAID and advanced cancer pts & FMs who did not (see table). Conclusions: In this study, FMs and pts participating in MAID appear to have rates of negative psychological states that are in the low to moderate range. These rates appear similar to pts with advanced cancer and their FMs who are not engaging in MAID. Future research should study larger, heterogeneous populations earlier in the illness trajectory. [Table: see text]
Falls and hospitalization during chemotherapy in older women with early breast cancer.
Authors: Ji Jingran , Sun Can-Lan , Wildes Tanya Marya , Freedman Rachel A. , Magnuson Allison , O'Connor Tracy , Moy Beverly , Klepin Heidi D. , Chapman Andrew E. , Tew William P. , Dotan Efrat , Fenton Mary Anne , Kim Heeyoung , Bae Marie , Katheria Vani , Gross Cary Philip , Muss Hyman B. , Cohen Harvey Jay , Sedrak Mina S.
Published: June 2023

12035

Background: Hospitalizations are frequent, burdensome, and potentially avoidable complications of cancer treatment in older adults. While geriatric assessments can identify older patients at risk for hospitalization, the use of these assessments in clinic is limited by time and resources. Screening for falls in the past 6 months is a quick and simple question that clinicians can ask in clinic and fall history has been linked to chemo-related toxicity. Here, we hypothesized that in older adults with cancer fall history prior to chemo is associated with an increased risk of hospitalization during chemo. Methods: In a prospective multicenter study of 497 women age ≥65 with stage I-III breast cancer treated with neo/adjuvant chemo, we assessed baseline self-reported fall history in the past 6 months as a dichotomous (yes/no) and continuous variable (no. of falls). Our primary endpoint was hospitalization during chemo (yes/no, yes defined as incident hospitalization assessed from start to end of chemo and attributed to toxicity from chemo). We used multivariable logistic regression to examine the association between fall history and hospitalization during chemo, adjusting for sociodemographic and clinical covariates. Results: The median age was 70 (65-86), 65% had stage II/III disease, 37% had anthracycline, and 72% received primary prophylaxis with G-CSF. Of the 497 participants, 60 (12%) reported falls (median 1.0 [1-6]) at baseline, and 114 (23%) were hospitalized during chemo (median 1.0 [1-4]). The most common toxicities that resulted in hospitalization were febrile neutropenia (25%), anemia (13%), dehydration (13%), and fatigue (13%). Women who fell in the 6 months prior to chemo had greater odds (adjusted OR = 2.69, 95% CI 1.42-5.11, p= 0.003) of being hospitalized during chemo compared to women who did not fall. Conclusions: In this cohort of older women with early breast cancer, fall history prior to chemo was associated with an increased risk of hospitalization during chemo, independent of sociodemographic and clinical factors. Oncologists do not routinely assess fall history when considering chemo in older adults. Screening for falls is a quick, simple, and important indicator of vulnerability that oncologists may use to identify patients at risk for hospitalization during chemo and inform personalized, patient-partnered treatment decisions. Clinical trial information: NCT01472094 . [Table: see text]
Biologic profile to predict overall survival in non-metastatic breast cancer: A latent class analysis on aging biomarkers.
Authors: Falandry Claire , Brouwers Barbara Anna Henk , Kenis Cindy , Smeets Ann , Neven Patrick , Cuerq Charlotte , Chikh Karim , Hatse Sigrid , Wildiers Hans
Published: June 2023

12037

Background: The aging process is heterogeneous and the result of different biological mechanisms. Blood biomarkers involved in the aging process, aside from comprehensive geriatric assessment, may help clinicians when facing equivocal therapeutic decisions, for example adjuvant treatment at high risk of toxicities. Methods: This study was conducted on a previously published cohort (PMID 25989735) including 162 patients aged ≥70 years (“Old”) and 82 patients aged ≤60 years (“Young”) with newly diagnosed non-metastatic breast cancer. Serum samples collected from all patients at breast cancer diagnosis, before any treatment were available from the extensive Leuven blood biobank. Overall survival was evaluated with October 7, 2022 as data cutoff. A panel of blood aging biomarkers attributed to inflammation: IL6, MCP1, RANTES, telomere shortening: telomeric DNA ratio T/S, telomeric dysfunction: CRAMP, chitinase activity, and anabolism : IGF1. Considering a high risk of collinearity, we performed a latent class analysis (LCA) on the whole cohort, to delineate the respective roles of inflammaging, replicative senescence and sarcopenia on patient clusters. Results: In univariate analysis were significantly associated with a poorer survival: high MCP1, hazard ratio (HR) = 1.57 (95%CI 1.32-1.87), high chitinase activity, HR = 1.33 (95%CI 1.12-1.57), and low IGF1, HR = 1.76 (95%CI 1.47-2.11). The biomarkers correlation matrix identified a significant correlation of Chitinase activity with MCP1, IGF1, CRAMP; of CRAMP with IL6; and IGF1 with T/S ratio. LCA identified 2 biologic profiles within the population, representing 137 (56.1%, class 1) and 107 (43,9%, class 2) patients. Class 1 was associated with a significantly poorer overall survival: HR = 3.52 (95%CI 2.28-5.45), and age-adjusted HR = 1.77 (95%CI 1.12-2.80). The best predictors for class 1 membership were low IGF1 (89%), high MCP1 (82%), high chitinase activity (79%), high IL6 (69%). Class 1 represented 77% of the “Old” and 15% of the “Young” populations. Conclusions: Our results delineate an unfavorable biologic profile that transcends chronological age and significantly predicts a poorer overall survival, underpinned by markers of both inflammaging, telomeric dysfunction and sarcopenia. The strong correlation between markers argues for a unique underlying biological pathway. Noteworthy, high IGF1, usually considered as a risk factor for breast cancer progression, was associated with a better prognosis. Low IGF1, high chitinase activity and high MCP1 appear as promising predictive biomarkers.
Defining an abnormal geriatric assessment for older adults with cancer: Which deficits matter most?
Authors: Carrozzi Anthony , Alibhai Shabbir M.H.
Published: June 2023

12039

Background: At present, there is no universal, objective, and evidence-based definition of what constitutes an abnormal geriatric assessment (GA) in geriatric oncology (GO). In the literature, a threshold number of abnormal GA domains (ranging from 1-4) is often used to define an abnormal GA. However, it is not well-established whether having a specific number of abnormal domains more frequently leads to treatment plan modification (TPM), a key goal of GA, or if particular domains have a greater impact on TPM. The primary objectives of this study are: (1) to determine how well the current definitions of an abnormal GA predict TPM following GA, and (2) to identify particular GA domains associated with TPM. Methods: A retrospective review of the GO clinic database at Princess Margaret Cancer Centre was conducted. All new patients seen in clinic from May 22, 2015 to June 10, 2022 who met the following criteria were included: (1) referred for treatment decision making, (2) received a complete GA, and (3) had a proposed oncologic treatment plan. Demographic, oncologic, and GA-domain variables were extracted. Univariate and multivariate logistic regression modelling was conducted using SPSS to determine each variable’s association with TPM; age, sex, frailty (VES-13) score, and treatment intent were included in all multivariate models. Area under the curve (AUC) was calculated for each model. Results: The study cohort (n = 736) had a mean age of 80.7 years (61-100), 46.1% was female, and 78.3% had a VES-13 score indicating vulnerability. In univariate analysis, age, VES-13 score, disease stage, treatment intent, all GA domains (except Medication Optimization and Social Supports), and all threshold numbers of abnormal domains (except 1 and 7) were significantly associated (p-value < 0.050) with TPM. The best-performing threshold number of abnormal domains in univariate analysis was 4 (AUC 0.628). Overall, the best-performing multivariate model based on AUC was the model containing all 6 significant GA domains (AUC 0.710). In this model, age, treatment intent, Comorbidities, Falls Risk, and Cognition were independently associated with TPM (p-value < 0.05). The multivariate model with a threshold of 4 abnormal domains alone had an AUC of 0.689 and age, VES-13 score, treatment intent, and the threshold were independently associated with TPM. Of the models which included a single GA domain plus the threshold, the models with Comorbidities and Cognition performed best, having AUCs of 0.699 and 0.700, respectively. Conclusions: Overall, our results suggest that an abnormal GA (leading to TPM) may be best defined as one with abnormalities in the domains of Comorbidities, Falls Risk, and Cognition. In terms of a strictly numerical threshold, a GA may be best defined as abnormal if at least 4 GA domains are abnormal. When at least 4 GA domains are abnormal, abnormalities in Comorbidities and Cognition appear to best predict TPM.
Satisfaction in older patients by geriatric assessment using a novel tablet-based questionnaire system: A cluster-randomized, phase III trial of patients with non–small-cell lung cancer (ENSURE-GA study; NEJ041/CS-Lung001).
Authors: Soda Sayo , Mirokuji Kie , Saito Ryota , Takamura Kei , Morita Ryo , Furuya Naoki , Kuyama Shoichi , Shiono Ayako , Arai Daisuke , Hosokawa Shinobu , Masubuchi Ken , Matsumoto Naoko , Asahina Hajime , Kondo Haruka , Honda Ryoichi , Hattori Noboru , Yokoyama Akihito , Kobayashi Kunihiko , Isobe Takeshi , Tsubata Yukari
Published: June 2023

12041

Background: To provide optimal treatment for older cancer patients, it is necessary to carry out a geriatric assessment (GA) to evaluate geriatric syndrome. However, GA is not widely performed because it requires expertise. In this ENSURE-GA study, we evaluated if providing a GA summary and recommendations for GA-guided interventions using a novel tablet-based questionnaire system improved satisfaction about communication with physicians for older patients with non-small-cell lung cancer (NSCLC). Methods: Patients with NSCLC who were incapable of radical treatment aged 75 or older were enrolled. All patients underwent a standardized GA using a tablet before starting treatment. Participating institutions were cluster-randomized into the intervention group and the control group. In the intervention group, GA summary and recommendations for GA-guided interventions were immediately returned to guide physicians in selecting treatments and interventions. The control group did not provide a GA summary. The primary outcomes were difference in patient satisfaction pre-treatment and percent change pre- and post-treatment according to the HCCQ questionnaire. Results: A total of 1,021 patients from 78 institutions in Japan were enrolled between 2019–2022. There were no differences in patient backgrounds between the intervention group and the control group: mean age 80.1 yrs. vs. 80.0 yrs.; male 64.1% vs. 66.8%; adenocarcinoma 70.4% vs. 64.8%; and performance status 0-1, 82.4% vs. 79.0%, respectively. All GA domain evaluation results, such as ADL and cognitive function, also did not differ between the two groups. Pre-treatment satisfaction scores were significantly higher in the intervention group than in the control group (29.9 vs. 29.1, p = 0.003). There was no significant difference in the mean percent change between the two groups (-0.13 vs. 2.38, p = 0.165). Conclusions: Providing the oncologist with a GA summary and recommendations for GA-guided interventions improved patient satisfaction from the start of treatment. A novel system using a tablet may be effective at promoting GA more widely. Clinical trial information: UMIN0000037590 .