bluuebunny/crossref_metadata_2025 huggingface dataset:
Effects of electroacupuncture and auricular acupuncture for chronic pain in cancer survivors: The PEACE randomized controlled trial.
Authors: Mao Jun J. , Liou Kevin , Panageas Katherine , Baser Raymond E , Romero Sally A. D. , Li Qing Susan , Xiao Han , Bao Ting , Kantoff Philip W.
Published: May 2020

12004

Background: The national opioid crisis has created new challenges in oncology pain management and highlighted an urgent need for non-pharmacological treatments. We evaluated the comparative effectiveness of electro-acupuncture (EA) and auricular acupuncture (AA) versus usual care (UC) for chronic musculoskeletal pain in cancer survivors. Methods: We conducted a randomized controlled trial of cancer survivors experiencing moderate-severe musculoskeletal pain for at least 3 months. EA used a semi-individualized protocol involving electrical stimulation of needles placed in the body. AA used the standardized Battlefield Acupuncture protocol involving up to 10 needles placed in the ears. EA and AA groups received 10 weekly treatments, whereas participants in the UC group received standard care prescribed by their providers. The primary endpoint was average pain severity change measured by the Brief Pain Inventory at week 12 compared to baseline. Functional interference and quality of life were secondary outcomes. We analyzed longitudinal mixed-effects models based on intent-to-treat principles. Results: Among 360 participants, mean age (SD) was 62.1 (12.7) years, 251 (69.7%) were women, and 88 (24.4%) were non-white. Compared from baseline to week 12, EA significantly reduced pain severity by 1.9 points (95% Confidence Interval 1.5-2.3, p < 0.001), and AA significantly reduced pain severity by 1.6 points (1.1-2.0, p < 0.001). AA was non-inferior to EA at reducing pain severity (p = 0.04). Both EA and AA also significantly improved functional interference (both p < 0.001), physical health (both p < 0.001), and mental health (p = 0.003, p < 0.001) compared to UC. Adverse events (AEs) were mild in both groups; however, 16 (11.2%) in AA stopped treatment due to AEs (mostly ear discomfort) as compared to 1 in EA (0.7%), p = 0.001. Conclusions: Among cancer survivors with chronic musculoskeletal pain, both EA and AA effectively reduced pain and improved quality of life. AA was non-inferior to EA at reducing pain but associated with higher discontinuation rates. These results will guide implementation of acupuncture in oncology care to address the unmet pain management needs of cancer survivors in the era of the opioid epidemic. Clinical trial information: NCT02979574 .
Neuroleptic rotation for refractory agitation in cancer patients with delirium in the acute palliative care unit: A double-blind randomized clinical trial.
Authors: Hui David , De La Rosa Allison , Wilson Annie , Nguyen Thuc , Wu Jimin , Delgado Guay Marvin , Azhar Ahsan , Arthur Joseph Anthony , Epner Daniel E. , Haider Ali , De La Cruz Maxine Grace Jaucian , Heung Yvonne , Tanco Kimberson Cochien , Dalal Shalini , Armstrong Terri , Breitbart William , Bruera Eduardo
Published: May 2020

12006

Background: Terminal agitation commonly occurs in the last days of life and is highly distressing. The role of neuroleptics is controversial and few studies have examined agitation as a primary outcome. We assessed the effect of 3 neuroleptic strategies on refractory agitation in cancer patients with terminal delirium. Methods: In this single-center, double-blind, double-dummy parallel group randomized trial, patients admitted to a palliative and supportive care unit with refractory agitation despite low dose haloperidol were randomized in a 1:1:1 ratio to (1) haloperidol dose escalation, (2) neuroleptic rotation to chlorpromazine, or (3) combined haloperidol and chlorpromazine. Intravenous medications at equivalent doses were scheduled every 4 h and every 1 h as needed until discharge. The primary outcome was change in Richmond Agitation Sedation Scale (RASS) from time 0 to 24 hours. With 15 patients per group and 13 measurements over time, we had 90% power to detect an effect size of 0.2 with alpha=2.5%. One way ANOVA was used to examine within group differences. We also compared among groups with the Wilcoxon rank sum test. Results: 68 patients were enrolled and 45 received the blinded study interventions. The median survival was 73 h (95% CI 49, 106 h). RASS decreased significantly within 30 minutes and remained low at 24 hours in the dose escalation group (mean RASS change between 0 and 24 h [95% CI]: -3.6 [-5, -2.2]) v. rotation group (-3.3 [-4.4, -2.2]) v. combination group (-3 [-4.6, -1.4]), with no difference among groups (P=0.71). A majority of patients were perceived to be more comfortable after treatment by blinded caregivers (escalation v. rotation v. combination: 62% v. 71% v. 60%; P=0.83) and bedside nurses (64% v. 75% v. 64%; P=0.82); however, the rotation group had significantly fewer breakthrough restlessness (escalation v. rotation v. combination: 73% v. 19% v. 50%; P=0.009), required fewer upward dose titration (escalation v. rotation v. combination: 27% v. 6% v. 50%; P=0.03) and required less rescue neuroleptics in the first 24 hours (haloperidol equivalent: 4 mg vs. 2 mg vs. 6 mg, P=0.09, trend only). Hypotension was more frequently observed with chlorpromazine. Overall survival did not differ (>0.99). Conclusions: Preliminary data from this study supported that all 3 strategies of neuroleptics reduced agitation and improved comfort in patients with terminal delirium; however, neuroleptic rotation provided better agitation control and confirmatory studies are needed. Clinical trial information: NCT03021486 .
A phase III randomized, double-blind placebo controlled study of armodafinil (Nuvigil) to reduce cancer-related fatigue in patients with high-grade glioma (Alliance A221101).
Authors: Porter Alyx B. , Liu Heshan , Kohli Sadhna , Cerhan Jane H. , Sloan Jeff A. , McMurray Ryan , Le-Rademacher Jennifer , Loprinzi Charles L. , Villano John L. , Kizilbash Sani Haider , Mehta Minesh P. , Jaeckle Kurt A. , Brown Paul D.
Published: May 2020

12007

Background: Up to 96% of patients with high grade glioma (HGG) report moderate to severe fatigue. Armodafinil, the R-enantiomer of modafinil, is a psychostimulant with low potential for abuse that has shown potential for improving severe fatigue in HGG patients. Methods: In this phase III double blinded placebo-controlled study, adults with HGG and moderate to severe fatigue, > 4 weeks after completing radiotherapy, were randomized to receive armodafinil daily (150 mg or 250 mg) or placebo for a total of 8 weeks. The primary outcome was efficacy in treating severe fatigue. Secondary outcomes included evaluation of tolerability, neurocognitive function, and quality of life. Patients were evaluated at baseline, 4 and 8 weeks. Results: A total of 328 patients were enrolled between 6/3/13-3/1/19. There were 103 (150 mg arm), 97 (250 mg arm) and 97 (placebo arm) evaluable patients with primary endpoint data available. The median age was 60 years (20-85) with a median Brief Fatigue Inventory (BFI) worst fatigue score of 8 (6-10). 60.3% were male, 80.5% received concomitant chemotherapy, and 39.7% were on corticosteroids. The global fatigue score at end of weeks 4 and 8 were lower than at baseline (p<0.0001) and in the 250 mg arm than placebo (p=0.0356) and was higher for corticosteroid users than non-users (p=0.0002). There was no statistically significant difference for clinically meaningful improvement in BFI usual fatigue score from baseline to end of week 8 between the three arms (p=0.9601). Patients reported an improvement in concentration at week 4 from baseline on the 150 mg arm(P=0.0311). There was no statistically significant difference on neurocognitive tests from baseline to end of week 4 (p>0.05) or week 8 (p>0.05) between arms. More patients reported insomnia on the 250 mg arm (p=0.0083). Conclusions: There is no meaningful benefit of the use of armodafinil to reduce moderate to severe fatigue in patients with HGG. In certain cases there may be benefit of armodafinil 150 mg to aid concentration without the risk of insomnia.Support: UG1CA189823;U10CA180868 (NRG). Clinical trial information: NCT01781468 .
Geriatric assessment-driven intervention (GAIN) on chemotherapy toxicity in older adults with cancer: A randomized controlled trial.
Authors: Li Daneng , Sun Can-Lan , Kim Heeyoung , Chung Vincent , Koczywas Marianna , Fakih Marwan , Chao Joseph , Chien Leana , Charles Kemeberly , Fernandes Dos Santos Hughes Simone , Trent Monica , Roberts Elsa , Soto Perez De Celis Enrique , Jayani Reena , Katheria Vani , Moreno Jeanine , Kelly Cynthia , Sedrak Mina S. , Hurria Arti , Dale William
Published: May 2020

12010

Background: Geriatric assessment (GA) can predict chemotherapy (chemo) toxicity in older adults (age ≥65) with cancer. However, evidence regarding the effect of GA-driven intervention (GAIN) on the incidence of chemo toxicity has been limited. Therefore, we conducted a randomized controlled trial evaluating the impact of GAIN vs. standard of care (SOC) on chemo toxicity in older adults with cancer. Methods: Patients (pts) age ≥65, diagnosed with a solid malignancy, and starting a new chemo regimen at City of Hope were eligible (NCT02517034). In a 2:1 ratio, 600 pts were randomly assigned to either GAIN (n = 398) or SOC (n = 202) arms. All pts completed a baseline GA prior to chemo. In the GAIN arm, a multidisciplinary team led by a geriatric oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist, reviewed GA results and implemented interventions based on predefined triggers built into the GA’s various domains. In the SOC arm, GA results were sent to treating oncologists to use at their discretion. Pts were followed until either end of chemo or 6 months after start of chemo, whichever occurred first. The primary endpoint was incidence of grade 3-5 chemo-related toxicity (NCI CTCAE v.4.0). Secondary endpoints included advance directive (AD) completion, emergency room (ER) visits, hospitalizations, and average length of stay (ALOS). Chi-square and Fisher’s exact tests were used to compare the categorical outcomes, and Kruskal-Wallis test was used to compare the ALOS between arms. Results: Pt characteristics were balanced between arms. Median age was 71 (range 65-91). Cancer types included: 33% gastrointestinal, 23% breast, 16% lung, 15% genitourinary, and 13% other. Most (71%) had stage IV disease. The incidence of grade 3-5 chemo-related toxicity was 50.5% (95% CI: 45.6-55.4%) in the GAIN arm and 60.4% (95% CI: 53.7-67.1%) in the SOC arm (p = 0.02). Compared to SOC, the GAIN arm had a reduction of 9.9% (95% CI: 1.6-18.2%) in chemo-related toxicity. At the end of study, AD completion increased 24.1% in the GAIN arm vs. 10.4% in the SOC arm (p < 0.001). No significant differences in ER visits (27.4% vs. 30.7%), hospitalizations (22.1% vs. 19.3%), or ALOS (median 4.8 vs. 5.0 days) were observed between the GAIN and SOC arms, respectively. Conclusions: Integration of multidisciplinary GA-driven interventions reduced grade 3-5 chemo-related toxicity and improved AD completion in older adults with cancer. GA-driven interventions should be included as a part of cancer care for all older adults. Clinical trial information: NCT02517034 .
Randomized trial of a symptom monitoring intervention for hospitalized patients with advanced cancer (NCT03396510).
Authors: Nipp Ryan David , Horick Nora K. , Qian Carolyn L. , Kaslow-Zieve Emilia R. , Azoba Chinenye C. , Elyze Madeleine , Knight Helen Perry , Jackson Vicki A. , Ryan David P. , Greer Joseph A. , El-Jawahri Areej , Temel Jennifer S.
Published: May 2020

12014

Background: Hospitalized patients with advanced cancer experience a high symptom burden, which is associated with poor clinical outcomes and increased health care use. Symptom monitoring interventions are increasingly becoming standard of care in oncology, but studies of these interventions in the hospital setting are lacking. We evaluated the impact of a symptom monitoring intervention in hospitalized patients with advanced cancer. Methods: We randomly assigned hospitalized patients with advanced cancer who were admitted to the oncology service to a symptom monitoring intervention or usual care. Patients in both arms reported their symptoms (Edmonton Symptom Assessment System [ESAS] and Patient Health Questionnaire 4 [PHQ4], higher scores on both indicate greater symptom severity) daily via tablet computers. Patients assigned to the intervention had their symptom reports presented graphically with alerts for moderate/severe symptoms during daily oncology rounds. The primary endpoint was the proportion of days with improved symptoms for those who completed two or more days of symptoms. Secondary endpoints included hospital length of stay (LOS) and readmission rates. Results: From 2/2018-10/2019, we randomized 390 patients (76.2% enrollment rate); 320 completed two or more days of symptoms (median age=65.6 [range 18.8-93.2]; 43.8% female). The most common cancers were gastrointestinal (36.9%), lung (18.8%), and genitourinary (12.2%). Nearly half of patients (48.5%) had one or more comorbid conditions in addition to cancer. We found no significant differences between intervention and usual care regarding the proportion of days with improved ESAS total (B=-0.05, P=.17), ESAS physical (B=-0.02, P=.52), PHQ4 anxiety (B=-0.03, P=.33), and PHQ4 depression (B=-0.02, P=.44) symptoms. Intervention patients also did not differ from usual care with respect to secondary endpoints of hospital LOS (7.50 v 7.59 days, P=.88) and readmission rates within 30 days of discharge (32.5% v 25.6%, P=.18). Conclusions: For hospitalized patients with advanced cancer, this symptom monitoring intervention did not have a significant impact on their symptom burden and health care use. These findings do not support the routine integration of this type of symptom monitoring intervention for hospitalized patients with advanced cancer. The positive outcomes seen in previous studies of symptom monitoring interventions may not be reproduced in other patient populations and care settings. Support: UG1CA189823; Clinical trial information: NCT03396510 .
Onset of cardiovascular disease risk factors in women with and without a history of breast cancer: The Pathways Heart Study.
Authors: Kwan Marilyn L. , Iribarren Carlos , Neugebauer Romain , Rana Jamal S , Nguyen-Huynh Mai , Cheng Richard , Shi Zaixing , Izano Monika , Laurent Cecile , Lee Valerie S. , Roh Janise M. , Santiago-Torres Margarita , Shen Hanjie , Hershman Dawn L. , Kushi Lawrence H. , Greenlee Heather
Published: May 2020

12017

Background: Women with a history of breast cancer (BC) are at increased long-term risk of dying from cardiovascular disease (CVD). However, the onset of CVD risk factors in women with BC has not been well-described. We compared risk of incident CVD risk factors in women with and without BC enrolled in the Kaiser Permanente Northern California (KPNC) integrated health system. Methods: Data were extracted from KPNC electronic health records. All invasive BC cases diagnosed between 2005-2013 were identified and matched 1:5 with controls on birth year, race/ethnicity and KPNC membership at the date of BC diagnosis. Cox regression models assessed the hazard of incident hypertension (based on diagnosis codes and filled prescriptions), dyslipidemia (based on diagnosis codes, filled prescriptions, and lab values), and diabetes (KPNC Diabetes Registry). Models were adjusted for baseline BMI, menopausal status, smoking status, neighborhood median household income, education, prevalent CVD conditions, and other baseline CVD risk factors. Subgroups of women who received chemotherapy, radiation therapy, and endocrine therapy were compared with controls. Results: A total of 14,942 women with a new diagnosis of invasive BC were identified and matched to 74,702 controls. On average, women were 62.0 years, 28.3 kg/m2BMI, 64.9% non-Hispanic white. Overall, cases were more likely to develop hypertension (HR: 1.18, 95% CI: 1.13, 1.24) and diabetes (HR: 1.23, 95% CI: 1.16, 1.31). Across the board, receipt of any of the three therapies (chemotherapy, radiation therapy and endocrine therapy) was associated with increased risk of hypertension and diabetes, compared to controls. Risk-factor specific hazard ratios for receipt of chemotherapy were (HR 1.18, 95% CI: 1.10, 1.27) and (HR 1.38, 95% CI: 1.26, 1.51), for hypertension and diabetes, respectively. For receipt of radiation therapy, risk-factor specific hazard ratios were (HR: 1.17, 95% CI: 1.09, 1.26) and (HR: 1.15, 95% CI: 1.04, 1.27), for hypertension and diabetes, respectively. Risk-factor specific hazard ratios for receipt of endocrine therapy were (HR: 1.22, 95% CI: 1.14, 1.30) and (HR: 1.16, 95% CI: 1.06, 1.27), for hypertension and diabetes, respectively. Conclusions: The risk of developing hypertension and diabetes is increased in women with BC who received chemotherapy, radiation therapy, and/or endocrine therapy. Future studies should examine the roles of CVD risk factor diagnosis and management on cardiometabolic risk in women with a BC history.
Effect of a tailored exercise intervention during or after chemotherapy on cardiovascular morbidity in cancer patients.
Authors: van der Schoot Gabriela G.F. Giovanna Femma , Ormel Harm Laurens , Westerink Nico-Derk L. , Velden Annette Van Der , Poppema Boelo Jan , Fehrmann Rudolf Stephan Nicolaas , Lefrandt Joop D. , van Roon Arie M. , van Melle Joost , Van der Meer Peter , Wempe Johan B. , ten Wolde Marcel , Stel Joyce , Vrieling Aline H. , de Boer Niek , May Anne Maria , Elias Sjoerd G. , Gietema Jourik A. , Walenkamp Anna Maria Elisabeth
Published: May 2020

12018

Background: Cancer treatment outcome may be impaired due to treatment-related adverse effects like decreased cardiorespiratory fitness. Evidence on exercise during or after chemotherapy shows positive effects on cardiorespiratory fitness, fatigue and quality of life (QoL) in cancer patients. However, optimal timing of starting exercise is unknown. This study aimed to investigate if an exercise intervention that starts during chemotherapy (early group) is superior to a program starting after completion of chemotherapy (late group) to reduce cardiovascular morbidity. Methods: In this multicenter randomized controlled trial, 266 patients (testicular-, (n = 95), breast-, (n = 139), and colon cancer (n = 30) or non-Hodgkin lymphoma (NHL) (n = 2)), treated with curative chemotherapy were randomized to a 24 week aerobic and resistance exercise intervention starting either early, i.e. during chemotherapy (n = 131) or late, i.e. at completion of chemotherapy (n = 135) (NCT01642680). Effect on VO2 peak was evaluated with intention-to-treat linear mixed-effect models, adjusted for baseline values (T0) and diagnosis at post-chemotherapy (T1), post-exercise intervention (T2) and 1-year post-exercise intervention (T3, i.e., primary endpoint). Here we report T0, T1 and T2 data. Secondary endpoints were QoL (EORTC-QLQ-C30) and fatigue (MFI-20), with higher scores indicating more fatigue. Results: Median age was 33 yrs for testicular-, 52 yrs for breast- and 64 yrs for colon cancer and NHL patients. Patients in the early group declined significantly less in VO2 peak and QoL at T1 compared to the late group (adjusted between-group differences were 3.2 ml/min/kg (95% confidence interval CI 2.3 to 4.1, P < 0.0001) and 5.8 (95% CI 0.6 to 10.9, P = 0.028). Patients in the early group experienced reduced general and physical fatigue at T1 (adjusted between-group differences were -2.0 (95% CI -3.3 to -0.8, P = 0.002) and -2.9 (95% CI -4.3 to -1.5, P < 0.0001). At T2, VO2 peak, QoL, general and physical fatigue were comparable and regained baseline levels (adjusted between-group differences - 0.08 ml/min/kg (P = 0.9), -1.4 (P = 0.7), 0.7 (P = 0.3) and 0.2 (P = 0.7), respectively. Conclusions: A supervised exercise program for patients with testicular-, breast- and colon cancer that is initiated at start of curative chemotherapy effectively reduces a decline in VO2 peak and QoL and reduces fatigue. After completion of the exercise intervention, initiated both during and after chemotherapy, patients regained their baseline VO2 peak, levels of fatigue and QoL. Clinical trial information: NCT01642680 .
Integrating PROs with prognostic value into oncologic care: High ESAS global distress score associated with lower overall survival in advanced cancer patients.
Authors: Subbiah Ishwaria Mohan , Charone Maira , Roszik Jason , Azhar Ahsan , De la Cruz Maxine Grace , Haider Ali , Epner Daniel E. , Delgado Guay Marvin , Reddy Akhila Sunkepally , Vidal Marieberta , Wong Angelique , Dalal Shalini , Dev Rony , Arthur Joseph Anthony , Reddy Suresh , Bruera Eduardo
Published: May 2020

12021

Background: Despite compelling data supporting their use, patient reported outcomes (PROs) are not widely integrated into routine cancer care. In our Palliative Care (PC) practice, all patients complete the Edmonton Symptom Assessment Scale (ESAS), a simple, validated 10-item PRO tool which uses a 0 to 10 rating of 10 common symptoms (pain, fatigue, nausea, drowsiness, appetite, sleep, dyspnea, well-being, anxiety & depression). Our team has previously validated the Global Distress Score (GDS), a sum of 9 physical + psychosocial ESAS items. Here, we studied the implementation of the GDS as a streamlined way to capture the overall symptom burden while providing prognostic value. Methods: We queried a PC database for patients w metastatic cancer at time of 1st PC visit. GDS was calculated & grouped into 3 cohorts based on previous work & clinical experience: high (GDS of 35+), Moderate (16-34) or Low (0-15). Overall Survival was defined as time from 1st PC visit date to death. Regression analysis, ANOVA and t-tests were conducted. Results: 333 patients met the inclusion criteria: median age 62.4y (range 20.5-88.4y), 25 AYA (15-39y), 169 mid age (35-64y), 140 seniors (65y+); 190 female 143 male; median prior therapies 2 (range 0-11), 227 patients were in 2nd line + above therapy. Median ECOG PS 2; 124 patients w ECOG PS 3 & 33 w ECOG PS 4. 262 patients had died at time of analysis. Lower OS was associated w higher GDS (r 0.21, P < 0.001). OS in Low, Mod, High GDS cohorts was 13.1m, 7.9m, & 3.7m, respectively (p < 0.001). There were no sig OS difference between 3 age cohorts (AYA 5.2m, mid age 6m, seniors 5.4m, p0.56). Conclusions: Higher GDS score was associated with a clinically significant decrease in overall survival highlighting the potential of the ESAS as a PRO tool in prognostication and clinical decision making for patients with advanced cancers with a high symptom burden. In the realm of increasingly complex PRO instruments, the ESAS represents a simple, well-validated tool which, in our studies and 25 years of clinical experience, takes the patient less than a minute to complete, with subscores such as the GDS which carry a highly prognostic utility for patients with advanced cancers.
Aggressive care at end-of-life in the Veteran’s Health Administration versus fee-for-service Medicare among patients with advanced lung cancer.
Authors: Presley Carolyn J , Kaur Kiranveer , Han Ling , Soulos Pamela R. , Zhu Weiwei , Corneau Emily , O'Leary John R. , Chao Herta H. , Shamas Tracy , Rose Michal G. , Lorenz Karl , Levy Cari , Mor Vincent , Gross Cary Philip
Published: May 2020

12025

Background: The Veteran’s Health Administration (VHA) allows simultaneous receipt of cancer treatment and hospice care, termed concurrent care, while fee-for-service Medicare does not. Although many physicians who care for patients in the VHA also care for private sector patients, it is unclear whether there is a “spillover” relation between end of life (EOL) care in the VHA and Medicare systems at the regional level. We examined temporal trends, as well as regional-level associations between Medicare and VHA EOL practice for patients with advanced lung cancer. Methods: We conducted a retrospective study on VHA and SEER-Medicare (SM) decedents from 2006-2012 with stage IV non-small cell lung cancer (NSCLC) who received any lung cancer care. Aggressive care (AC) at EOL was defined as any of the following within 30 days of death– intensive care unit (ICU) admission, no-hospice care, cardiopulmonary resuscitation(CPR), mechanical ventilation (MV), > 1 inpatient admission and receipt of chemotherapy. Descriptive statistics were used to compare outcomes. We also analyzed the association between Medicare hospital referral region (HRR) hospice admissions, Medicare HRR EOL spending, and VHA AC use adjusted for patient’s characteristics using a random intercept mixed effect logistic regression model after matching VHA facilities with Medicare facilities in a particular HRR. Results: AC use significantly decreased during the study period, from 46% to 31% among 18,371 Veterans and from 42% to 38% among 25,283 in the SM cohort, (t-test P < .05). Hospice use significantly increased within both cohorts (p < .001). The receipt of chemotherapy at EOL was similar for both cohorts throughout the study period. Veterans who received care in regions with higher hospice admissions among Medicare beneficiaries were significantly less likely to receive AC at EOL (adjusted Odds Ratio (aOR): 0.13 95%CI: 0.08-0.23, P < .001) than veterans in regions with lower Medicare hospice use. Medicare HRR spending at the EOL was not associated with receipt of AC among Medicare beneficiaries (aOR): 1.004 95%CI: 1.00-1.009, P = 0.07). Conclusions: Perhaps due to availability of concurrent care, VHA patients received less aggressive care at EOL as compared to SM patients. At the regional level, greater hospice use among Medicare beneficiaries was significantly associated with reduced AC within the VHA.
Development and validation of an early death risk score for older patients treated with chemotherapy for cancer.
Authors: Feliu Batlle Jaime , Pinto Alvaro , Basterretxea Laura , Paredero Pérez Irene , Llabres Elisenda , Jimenez-Munarriz Beatriz , Rebollo Maite Antonio , Losada Vila Beatriz , Espinosa Enrique , Girones Regina , Custodio Ana B. , Muñoz María del Mar , Díaz-Almirón Mariana , Gómez-Mediavilla Jeniffer , Torregrosa Maria Dolores , Soler Gemma , Cruz Patricia , Higuera Oliver , Molina-Garrido MJ
Published: May 2020

12030

Background: Determining life expectancy in older patients is needed to select the best treatment strategy. We aimed to develop and validate a score to predict early death risk ( < 6 months) in elderly patients with cancer that are planned to initiate chemotherapy treatment. Methods: Patients over 70 years starting new chemotherapy regimens were prospectively included in a multicenter study. A pre-chemotherapy assessment that included sociodemographics, tumor/treatment variables, and geriatric assessment variables, was performed. Association between these factors and early death was examined by using multivariate logistic regression. Score points were assigned to each risk factor based on their b coefficient. We validated the risk score with an external validation cohort of 206 patients. Results: Three hundred forty two patients were included in the training cohort. The independent predictors for early death were metastasic cancers (odds ratio [OR] 4.8, 95% confidence interval [CI], [2.4-9.6]), ECOG performance status (OR 2.3, 95% CI:1.084-5.232), ADL (OR 1.7, 95% CI:1.08-3.5), serum albumin levels (3.3, 95% CI: 1.6-6.6), BMI (OR 2.4, 95% CI:1,2-4.8), serum GGT levels (OR 1.5, 95% CI:1.05-1.8) and hemoglobin levels (OR 2.3, 95% CI:1.2-4.6). With these results, a score was to stratify patients regarding their risk of early death: low (0 to 2 points; 5%), intermediate (3 to 5 points; 19%) or high (6 to 14 points; 50%) (p < 0.001). The area under the curve of the receiver-operating characteristic (ROC) curve was 0.79 for the training cohort (95% CI, 0.74 to 0.85), and 0.70 (95% CI: 0.60-0.80) for the validation cohort (difference between cohorts not statistically different). Conclusions: We developed a highly accurate tool that uses basic clinical and analytical information to predict the probability of early death in elderly patients with cancer that are planned to initiate chemotherapy treatment. This tool can help physicians in decision making for this population of patients.
Is there a benefit of immune checkpoint inhibitors for patients over 75 years of age with advanced cancer in first and second line setting: A meta-analysis.
Authors: Landre Thierry , Des Guetz Gaetan , Chouaid Christos , Morere Jean F. , Chouahnia Kader , Fossey-Diaz Virginie , Culine Stephane
Published: May 2020

12031

Background: The impact of aging on Immune Checkpoint Inhibitors (ICIs) effectiveness is controversial. Currently, data from clinical studies do not show any difference between patients over 65 years and those under 65 years. We propose to compare the clinical benefit of ICIs in those over 75 and in those under 75. Methods: We performed a meta-analysis of published randomized control trials (RCTs) concerning ICIs versus standard therapy in patients with advanced solid tumours. Overall Survival (OS) among the older (≥75 years) was compared with that of younger patients ( < 75 years) in first and second line setting. Hazard ratios (HRs) with their 95% confidence interval (CI) were collected from the studies and pooled. Results: Fifteen phase III studies evaluating anti-PD-1 (nivolumab or pembrolizumab), anti-PD-L1 (atezolizumab or avelumab) or anti-CTLA-4 (ipilimumab) were included. Patients were enrolled for Non-Small-Cell-Lung-Cancer, Renal-Cell-Carcinoma, Melanoma, Head-and-Neck-Squamous-Cell-Carcinoma or Gastric-Cancer. Eight studies assessed treatment in first line setting and seven in second line. The median age was 64 years, with 906 patients over 75 years of age and 5233 younger. In first line setting, HRs for death were 0.78 (95% CI: 0.61-0.99) in patients ≥75 years versus 0.84 (95% CI: 0.71-1.00) in younger. In second line setting, HRs for death were 1.02 (95% CI: 0.77-1.36) in patients ≥75 years versus 0.68 (95% CI: 0.61-0.75) in younger with a statistically significant difference observed between subgroups (p interaction = 0.009). Conclusions: ICIs appears to be effective in patients over 75 years of age. However, the survival benefit comes mainly from the first line of treatment. This result encourages the use of ICIs early in the therapeutic management of patients over 75 years of age.
Association of geriatric comanagement with reduction in adverse surgical outcomes among patients 75 or older with cancer with prolonged hospital stay.
Authors: Shahrokni Armin , Kim Soo Jung , Alexander Koshy , Sun Sung W. , McMillan Sincere , Downey Robert J. , Korc-Grodzicki Beatriz
Published: May 2020

12036

Background: Patients with prolonged hospital stay following surgery are at higher risk of readmission, emergency room visits, and mortality. In our study, we assessed the relationship between Geriatric Comanagement (GERI-CO) and adverse outcomes among these patients. Methods: In a retrospective study, patients aged 75+ with cancer who had hospital length of stay longer than 75% of cohort (8 days or longer) postoperatively at Memorial Sloan Kettering Cancer Center from 2011-18 were studied. GERI-CO status was obtained from medical records. Differences in sociodemographic, frailty, surgery, and comorbid conditions between GERI-CO and non-GERI-CO patients were assessed. Frailty was assessed by Memorial Sloan Kettering Frailty Index, score 0 to 11, higher score reflective of more frailty. Composite adverse outcome is a composite score of 30-day readmission, or emergency room visit, or 90 day mortality. Multivariable regression analysis was used to assess the relationship between GERI-CO and postoperative adverse outcome. Results: In total 1118 patients (634, 56.7% in the GERI-CO) were included. Patients in GERI-CO were older (80.8 vs. 79.9), more likely to undergo 3+ hours of surgery (66% vs. 43%), have 100+ cc intraoperative blood loss (78% vs. 72%), and have liver disease (16% vs. 10%), but were less likely to have kidney disease (19% vs. 25%), cardiac disease (28% vs. 35%), myocardial infarction (8% vs. 12%), pulmonary disease (15% vs. 20%), ASA-PS 4+ (11% vs. 21%) compared to non-GERI-CO patients. Gender, Frailty and the rest of comorbid conditions, and average length of stay (15 days) did not differ between groups. GERI-CO patients were less likely to have 30-day hospital admission (11% vs. 18%), emergency room visit (14% vs. 22%), or 90 day mortality (6% vs. 15%), and composite adverse outcome (20% vs. 37%) compared to non-GERI-CO patients. In the multivariable analysis, after adjustment for age, frailty, ASA-PS, operation time, intraoperative blood loss, kidney, cardiac and pulmonary disease, patients in GERI-CO were less likely to have composite adverse outcome (OR = 0.57, p = 0.002). Conclusions: GERI-CO program for patients with prolonged length of stay following surgery is associated with reduced 30-day hospital readmission, emergency room use, and 90-day mortality.
Treatment patterns and outcomes by age in metastatic melanoma: A study of the National Cancer Database.
Authors: Moyers Justin , Chong Esther G , Nagaraj Gayathri
Published: May 2020

12037

Background: Metastatic melanoma carries poor prognosis and traditional chemotherapy has limited efficacy. Immune checkpoint inhibitors (ICI) have drastically improved disease outcomes since first approved in 2011. Elderly patients were underrepresented in landmark early trials of ICI leading to limited clinical trial data on efficacy and treatment patterns in this population. We aimed to examine the real-world IO outcomes and demographics of elderly patients in the National Cancer Database. Methods: We queried the database for patients with stage IV melanoma diagnosed between 2011-2015 with survival data available. Patients were divided into receipt of immunotherapy (IO) or no receipt of IO; those without documentation were excluded. Cases were separated into 3 cohorts of age at diagnosis (60 years-old or younger, 61-74 years-old, and 75 years-old and greater). Descriptive variables were compared by Chi-squared analysis and survival analyses were performed by Kaplan-Meier method and log-rank test. Results: 11,265 cases met inclusion criteria: 4,117 aged 60 or less, 3,940 aged 61-74, and 3,208 aged 75 or older. Those receiving immuno-oncologic agents (IO) in all age groups showed a longer median OS (mOS) than those who did not receive IO (mOS overall 17.28 v 7.49; p <0.01). Survival was longer in all age cohorts when IO was received compared to not received; ages less than 60 (mOS 20.3 v 9.2m; p<0.01), ages 61-74 (mOS 15.5 v 7.8m; p<0.01), and ages 75 or greater (mOS 14.4 v 5.8m; p<0.01). A greater percentage of patients received IO in younger than older cohorts, 20.1% in ≥ 75, 37.6% in 61-74, and 42.3% in ≤ 60; p <0.01. Additional descriptive variables shown in the table were compared between the cohorts include care at academic or integrated cancer network, uninsured, Charlson-Deyo Comorbidity Index (CDCI) of 2 or greater, and documented inclusion of palliative care treatment. Conclusions: Substantial survival benefit is realized with IO in all age cohorts although elderly cohorts did not receive IO as often as younger cohort. Elderly patients experienced lower rates of care at academic/network cancer programs, lower uninsured rate, and higher CDCI. [Table: see text]
Metastasis free survival in older men with nonmetastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: An FDA-pooled analysis.
Authors: Singh Harpreet , Zhang Lijun , Amatya Anup , Gong Yutao , Suzman Daniel L. , Weinstock Chana , Chang Elaine , Anscher Mitchell Steven , Chi Dow-Chung , Xu James , Brewer Jamie Renee , Agrawal Sundeep , Brave Michael Holman , Hadadi Mehrnoosh , Theoret Marc Robert , Kluetz Paul Gustav , Ibrahim Amna , Pazdur Richard , Beaver Julia A.
Published: May 2020

12038

Background: The FDA has approved three androgen receptor (AR) inhibitors for nonmetastatic castration-resistant prostate cancer (nmCRPC) based on improvements in metastasis-free survival (MFS). MFS is an earlier endpoint, defined as the time from randomization to either imaging-detectable distant disease or death. This pooled analysis examines MFS, time to initiation of cytotoxic chemotherapy (TTCyto), and safety outcomes in men over 80 treated with AR inhibitors. Methods: Data was pooled from three randomized controlled studies (n=4117) of AR inhibitors for nmCRPC. The treatment effect of AR inhibitors on MFS and TTCyto across age groups was evaluated using Kaplan-Meier estimates and a Cox proportional hazards regression model. Hazard Ratios for MFS and TTCyto were adjusted for baseline ECOG, total Gleason score, PSA doubling time, and prior bone-targeting therapy. Results: For patients age 80 years or older (n=675) who were treated with AR inhibitors, the hazard ratio was 0.38 (95% CI 0.29, 0.49) with an estimated median MFS of 40 months (95% CI 36, 41) versus 22 months (95% CI 18, 29) for those treated with placebo (n=348). For patients <80 (n=2019) treated with AR inhibitors, the HR was 0.31 (95% CI 0.27, 0.36) with an estimated median MFS of 41 months (95% CI 36, NR) versus 16 months (95% CI 15, 18) for those treated with placebo (n=1075). Patients over 80 also derived similar improvements in time to initiation of cytotoxic chemotherapy (HR 0.43 95% CI 0.23, 0.82), compared to their younger counterparts (HR 0.41 95% CI 0.33, 0.50). See Table for selected safety outcomes. Conclusions: In an exploratory subgroup analysis, older men (≥80) with nmCRPC derived similar benefit in MFS and time to initiation of cytotoxic chemotherapy with AR inhibitors compared with younger patients. Men age 80 and above experienced higher rates of Grade 3-4 adverse events, serious adverse events, falls, and fractures. This trend towards increased toxicity was observed regardless of treatment arm. Analysis of patient reported outcomes is ongoing. [Table: see text]
Hospitalizations following cancer diagnosis: National values for frequency, duration, and charges.
Authors: Halpern Michael T. , Zhang Fanni , Enewold Lindsey
Published: May 2020

12039

Background: US medical care costs for cancer are projected to be $158 billion in 2020. Hospitalization is a substantial component of these costs; however, little is known about national patterns of hospitalization among individuals with cancer. This study used Medicare data to determine national rates and charges for hospitalizations among older cancer patients. Methods: We used data from 100% of individuals diagnosed with cancer in SEER-Medicare in the most recent 5 years available, 2011-2015. Analyses determined proportion of patients hospitalized, number/duration of hospitalizations, and charges by patient clinical and sociodemographic characteristics within 12 months of diagnosis. Results: Among 307,944 unique patients, 65% were hospitalized in the first year following diagnosis. Rates ranged from 34% for patients with in situ disease to 82%-84% for patients with advanced disease; 31% had 2 or more hospitalizations. Hospitalization rates were lowest among skin melanoma (25%) and breast (42%) cancer patients, highest for brain/nervous system (97%) and ovarian (96%) cancer patients. Hospitalized patients had a mean of 2.1 hospitalizations; mean days per hospitalization within 12 months was 8.8 (median 4). Duration of hospitalization varied little by stage at diagnosis. Mean days per hospitalization was shortest for thyroid and prostate cancer patients (5.7 & 6.0 days), longest for colorectal cancer and leukemia patients (10.6 & 11.3 days). DRGs varied substantially by cancer type; DRG for chemotherapy administration was more frequent among hospitalizations for patients with hematologic malignancies or distant stage disease. Mean Medicare charge (2016 $) per hospitalization was $67,368 (median $41,973), and was lowest for breast cancer patients ($48,021), highest for leukemia patients ($91,799). Patient charges per hospitalization averaged $1107 (median $1317) and showed little variation by cancer type or stage. Conclusions: Most older individuals experience at least one hospitalization within 12 months of cancer diagnosis. Frequency, duration, and charges of hospitalizations vary by cancer type and stage. This nationally representative information will aid in projecting cancer care costs and potential economic impacts of new therapies and treatment program.
Investigating the disparate enrollment of older adults on phase I clinical trials: Evolving participation patterns of patients 65 years and older w advanced cancer on phase I trials.
Authors: Subbiah Ishwaria Mohan , Buzdar Aman , Ileana Dumbrava Ecaterina Elena , Fu Siqing , Janku Filip , Karp Daniel D. , Naing Aung , Pant Shubham , Rodon Jordi , Tsimberidou Apostolia Maria , Yap Timothy A , Subbiah Vivek , Meric-Bernstam Funda , Hong David S.
Published: May 2020

12044

Background: While safety and dose-finding remain the primary objective of Phase 1 trials, the potential for clinical benefit has taken a greater meaning in the last decade with the novel therapies. With data from phase I trials being submitted for regulatory approval, the finer details of these studies are under even more scrutiny: in particular, do the trial participants reflect the general patient population for whom the drug may be indicated? To that end, we investigated age-based enrollment on phase I clinical trials over time. Methods: We queried a prospectively maintained database at a major phase I trials center to identify eligible patients and demographic + clinical variables including phase I trial characteristics, age at date of enrollment into 3 age-based cohorts: AYA ages 15-39y, mid-age 40-64y, older adults aged 65y+. We calculated descriptive statistics, and explored correlations (Pearson/Spearman) and associations (linear regression) between age and independent variables. Results: Over a 3-year period (1/1/17 to 12/31/19), we identified 6267 pts enrolled on 338 phase I trials. Median overall age 58.4y (range 15.5-95.1y). 729 (12%, median age 34.8y) were AYA, 3652 (58%, median age 55.4y) mid-age and 1886 (30%, median 70y) older adults, of whom 870 pts were aged 70-79y and 76 pts aged 80y+ (18 being >85y). There was no association b/w senior participation and year of enrollment (2017 31%, 2018 29%, 2019 30%, b/w age and type of therapy (i.e. targeted vs immunotherapy, etc.) or b/w age and # of drugs given on trial (single agent vs combo) (all p > 0.05). Conclusions: Older adults remain underrepresented on phase I trials esp. when compared to incidence of cancer in that age group (30% enrollment vs 60% incidence), a discordance more staggering in the oldest old pts (85y+; only 18 pts enrolled over 3 yrs when compared to 140,690 pts 85y+ w a new cancer dx in just 2019). Once enrolled, older adults received similar types of phase I therapies with comparable number of drugs as compared to middle age patients, i.e. older adults were just as likely to get immunotherapy or targeted therapy as well mono- vs combo therapy as mid-age pts. [Table: see text]
Association of geriatric conditions with survival and health care use in older adults with colon cancer living in long-term care facilities.
Authors: Lage Daniel E , Nipp Ryan David , El-Jawahri Areej , Temel Jennifer S. , Williams Grant Richard , Kenzik Kelly
Published: May 2020

12045

Background: Older adults with colon cancer residing in nursing homes are at risk for experiencing geriatric conditions such as cognitive decline, limitations in activities of daily living (ADLs), needing pain medications, and incontinence, due to cancer and its treatment. We sought to investigate these factors pre- and post-diagnosis and explored their relationship with health care use and survival. Methods: We identified 483 patients age 65+ with colon cancer from 2011-2015 in SEER-Medicare with linked quarterly nursing home assessments from the Minimum Data Set both pre- and post-cancer diagnosis. We determined the number of geriatric conditions (cognitive functioning, limitation in any ADL, pain medication use, bowel/urinary incontinence) at the pre- and post-cancer diagnosis assessment. We created four groups based on changes in these factors from pre- to post- assessment: improved (n = 105), worsened (n = 25), remained limited (n = 240), never limited (n = 113). Regression models estimated how changes from pre- to post-cancer diagnosis were associated with number of emergency department (ED) visits, hospitalizations, and survival, adjusted for age, sex, race/ethnicity, insurance status, cancer stage, number of pre-cancer comorbidities, urban/rural status, and time from diagnosis. Results: Overall, 55.3% of patients were age > 80 at diagnosis, with 64.8% female; 73.3% non-Hispanic white; and 9.9% Stage IV. Pre- versus post-diagnosis, 20.7% vs. 34.8% of patients were limited in cognitive functioning, and 75.4% vs. 77.8% were limited in ADLs. About a third of patients required pain medication, and about half of patients had urinary incontinence, which did not change pre- and post-diagnosis. Patients who remained limited had higher rates of ED visits (Risk ratio [RR] 1.05, p < .01) compared to those never limited. Those who worsened had higher rate of hospitalization (RR 1.44, p < .01) and ED visits (RR 1.63, p < .01). 12-month and 5-year survival was 46.7% and 6.1%, respectively. Factors associated with worse survival in a multivariable model included: remaining limited at both assessments (OR 1.52, p < .01), worsening from prior (OR 2.00, p = .01), as well as older age and higher cancer stage. Conclusions: Older adults with colon cancer residing in nursing homes have high prevalence of geriatric conditions and differential health care use and survival based on the presence of geriatric conditions, highlighting the need to consider geriatric conditions when providing cancer care to this population.