bluuebunny/crossref_metadata_2025 huggingface dataset:
Does the addition of chemotherapy to neoadjuvant radiotherapy impact survival in high-risk extremity and trunk soft tissue sarcoma?
Authors: Chowdhary Mudit , Chowdhary Akansha , Sen Neilayan , Zaorsky Nicholas George , Patel Kirtesh R. , Wang Dian
Published: March 2020

11054

Background: Large, high-grade extremity/trunk (ET) non-rhabdomyosarcoma soft-tissue sarcoma (STS) is at high risk for distant recurrence and death. The integration of chemotherapy (C) to standard of care neoadjuvant radiotherapy (RT) remains controversial, even for these patients. This study examines the impact of adding C to neoadjuvant RT on overall survival (OS) in high risk ET-STS. Methods: The National Cancer Data Base (NCDB) was queried for patients ≥18 years with high risk (≥5 cm + high grade) non-rhabdomyosarcoma ET-STS (WHO histology) who received neoadjuvant RT and limb sparing surgery from 2006-2014. Patients were next stratified based upon receipt of C (RT and CRT cohorts). Overall survival (OS) for RT vs CRT cohorts was analyzed using the Kaplan-Meier (KM) method, log-rank test, and Cox proportional hazards models. Propensity score-matched analysis (PSM) was employed to account for potential treatment selection bias between cohorts. Results: A total of 848 (71.1%) and 344 (28.9%) patients received RT and CRT, respectively. Patient cohorts were well-balanced except for the CRT cohort having higher rates of treatment in the West (22.1% vs 10.6%) & Midwest (28.3% vs 22.7%), Charlson-Deyo [CD] score 0 vs ≥1 (85.5% vs 79.4%), younger age (≤50) (45.9% vs 21.7%), synovial sarcoma histology (18.9% vs 3.2%), earlier year of diagnosis (2006-2010) (39.5% vs 32.3%), and positive lymphovascular invasion (2.0 vs 1.51%), (p < 0.05 each). The KM 5-year OS was significantly higher in the CRT vs RT cohort: 69.2% vs 58.1% on univariate (p < 0.0001) and multivariate analysis (Hazard Ratio [HR]: 0.66; 95% Confidence Interval [CI]: 0.52-0.85; p = 0.001) even after adjusting for age, race, income, CD score, histology, tumor size, tumor grade, and primary site (lower extremity; upper extremity; trunk). PSM identified evenly matched cohorts of 300 patients each with respect to age, income, CD score, histology, grade, tumor size, and primary site. The addition of neoadjuvant C remained prognostic for OS on PSM (HR: 0.74 [0.56-0.99], p = 0.042). Conclusions: The addition of C to neoadjuvant RT was associated with improved OS in patients with high risk non-rhabdomyosarcoma ET-STS in the NCDB. These hypothesis generating results support prospective evaluation.
Effects of exercise on cancer-related fatigue and muscular strength in patients with breast cancer.
Authors: Lin Po-Ju , Loh Kah Poh , Inglis Julia Ellen , Dunne Richard Francis , Kleckner Ian , Fung Chunkit , Gilmore Nikesha , Lopez Gilberto , Heckler Charles E. , Culakova Eva , Peppone Luke Joseph , Janelsins Michelle Christine , Kamen Charles Stewart , Mustian Karen Michelle
Published: March 2020

11507

Background: Cancer-related fatigue (CRF) is a persistent daily lack of energy commonly experienced by breast cancer (BC) patients. Due to CRF, BC patients have difficulties carrying out daily activities, become less active and consequently reduce muscular strength. Exercise can improve muscular strength and increase energy level; therefore it may alleviate CRF. This phase II RCT assessed the effects of exercise on CRF and muscular strength in BC patients. Methods: Ninety BC patients (55.5±9.6 years, 79% white, 48% and 46% under radiation or hormone therapy) were randomized into two arms: a 6-week Exercise for Cancer Patients (EXCAP) program or standard care (Control). EXCAP is a home-based, personalized, progressive exercise program combining aerobic walking and resistance band training. The Brief Fatigue Inventory was used to assess CRF and CRF interference with daily activities and a 7-10 repetition maximum chest press and leg extension strength test was used to assess upper- and lower-body strength at pre- and post-intervention. T-tests and ANCOVA with pre-intervention as the covariate were used to analyze within- and between-group changes, respectively. Results: Participants in the EXCAP group decreased CRF (-0.9±0.3, p = 0.01) and CRF interference with daily activities (-1.1±0.3, p < 0.01) from pre- to post-intervention while participants in the Control group did not. The mean improvement (from pre- to post-intervention) in CRF and CRF interference of daily activities for the EXCAP group were significantly higher than the change in the Control group (both p < 0.01). Participants in the EXCAP group increased upper- (3.9±1.4, p < 0.01) and lower-body strength (6.4±1.3, p < 0.01) from pre- to post-intervention, while participants in the Control group did not. The mean increase (from pre- to post-intervention) in lower-body strength for the EXCAP group was significantly higher than the change in the Control group (p = 0.01). Conclusions: Exercise combining aerobic walking and resistance band training reduces CRF and CRF interference with daily activities and improves muscular strength in BC patients. Results from this study provide further evidence of the benefits of exercise for supportive cancer care. Clinical trial information: NCT00851812.
Validating the Cancer and Aging Research Group (CARG) toxicity prediction tool in older men receiving chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) and extending it to androgen receptor targeted agents.
Authors: Alibhai Shabbir M.H. , Breunis Henriette , Gregg Richard William , Hansen Aaron Richard , Warde Padraig Richard , Timilshina Narhari , Tomlinson George , Joshua Anthony M. , Fleshner Neil Eric , Emmenegger Urban
Published: March 2020

11510

Background: Multiple treatment options are available for mCRPC. Being able to predict toxicity risk for different treatments in older adults can aid treatment decision-making and supportive care. The CARG tool is a promising toxicity risk prediction tool for chemotherapy, but has not been specifically validated in the mCRPC setting for either chemotherapy or androgen receptor targeted agents. We prospectively evaluated the ability of the CARG tool to predict risk of clinically relevant grade 2 and grade 3+ toxicity of treatment with chemotherapy (CHEMO) and abiraterone or enzalutamide (A/E) in older adults with mCRPC. Methods: Men age 65+ were enrolled in this prospective observational study at 3 academic centres, Princess Margaret Cancer Centre, Sunnybrook Health Sciences Centre, and Kingston Health Sciences Centre in Ontario, Canada. All grade 2 and grade 3+ toxicities were documented during cycle 1 of CHEMO or in the first 3 months of A/E via structured interviews and chart review. Lab abnormalities were documented only if resulting in emergency room visits, requiring treatment, or affecting subsequent oncologic treatment. Toxicity was rated using the Common Terminology Criteria for Adverse Events version 4. Logistic regression was performed to identify predictors of toxicity. Results: 64 men starting CHEMO (primarily docetaxel 60-75 mg/m^2, mean age 73y) and 59 men starting A/E (mean age 76y) were included. Clinically important grade 2 toxicities occurred in 86% and 70% of CHEMO and A/E patients, respectively. Grade 3+ toxicities occurred in 48% and 25% of CHEMO and A/E patients, respectively. The CARG tool was predictive of grade 3+ toxicities with CHEMO, which occurred in 22%, 53%, and 71% of low, moderate, and high risk groups (p = 0.017). However, the CARG tool was not predictive of grade 2 toxicities with CHEMO, or grade 2 or 3+ toxicities with A/E (Table). Conclusions: We provide external validation of the CARG tool in predicting grade 3+ toxicity in older men with mCRPC undergoing CHEMO. Grade 2 toxicities are very common with both CHEMO and A/E, and grade 3+ toxicity occurs in 1 in 4 older men on A/E. Additional efforts to identify men at higher risk of toxicity from various mCRPC treatments are warranted. [Table: see text]
Predictors of suicide risk in adolescent and young adults (AYA) with cancer.
Authors: Lewin Jeremy Howard , Thompson Kate , Moncur Donovan , Mancuso Sam
Published: March 2020

11519

Background: Whilst AYA accounts for a small proportion of annual cancer cases, the complexity of this subgroup places them at a disproportionately high risk of psychological distress and poor mental health. This study aimed to identify patient and disease characteristics associated with suicide in AYA patients. Methods: A retrospective analysis of AYA (aged 15-39) between the years 1973 to 2015 from the Surveillance, Epidemiology, and End Result Research database were included. A training and test set were used to develop a model predicting suicide. The SMOTE sampling algorithm was used for the training set due to severe class imbalances. A random forest model was trained with 10 clinical features (cancer subtype, age, sex, race, marital status, diagnostic year, number of in situ/malignant tumours, chemotherapy, surgery, and radiation therapy) with recursive feature elimination (RFE) via 10-fold cross validation. Results: There were 139,394 AYA included with 974 (0.7%) having a documented suicide or self/inflicted injury yielding an incidence of 1499 suicides / 100,000 person years. The standardized mortality ratio (SMR) for AYA was 34.4 (95% CI: 32-37)(Aged 15-24: 47.4 (39-57); Aged 25-39: 32.3 (29-35)). Suicide rates increased over time (1973-1980: SMR = 18.0 (15-22); 2001-2015: SMR = 127.0 (102-155)). Univariate analyses observed high rates of suicide in: females (43.8 (38-51)); single/unknown relationship status (47.1 (42-52)); “other” race (85.2 (52-132)) and by cancer type: leukaemia (77.1 (42-129)), soft tissue sarcoma (73.7 (57-94)), unspecified malignancy (71.0 (9-256)) and brain (63.6 (43-91)). We randomly assigned AYAs to a training set (n = 97,576) and test set (n = 41,818), stratified by cause of death. All 10 clinical features were retained with RFE. The prediction model achieved an AUC of 0.59, accuracy of 0.78, sensitivity of 0.40 and specificity of 0.78. Conclusions: Risk of suicide in AYA is high compared to normative data, further heightened in females, single/unknown relationship and certain tumour subtypes. The prediction model performed poorly, potentially related to the exclusion of mental health variables, which are not collected by the SEER dataset. Our findings suggest that dedicated psychosocial supports and targeted mental health assessments are critical components of care for AYA.
Is there a shift in use of subacute rehabilitation (SAR) instead of hospice referral since immunotherapy became available?
Authors: Yeh Jonathan , Knight Louise , Kane Joyce M. , Doberman Danielle , Gupta Arjun , Smith Thomas J.
Published: March 2020

11530

Background: Immunotherapy has rapidly become mainstream treatment. Since the first drug approval in 2011, we have noted a decline in referrals from inpatient oncology to hospice, and an increase in referrals to sub-acute rehabilitation (SAR) facilities, possibly with the aim of “getting strong enough” for immunotherapy and other promising drugs. This study explores outcomes after discharge to SAR, including rates of cancer-directed therapy after SAR, overall survival, and hospice utilization. Methods: Electronic chart review of patients discharged from oncology units to SAR facilities from 2009-2017. Demographics, admission statistics, and post-discharge outcomes were gathered from discharge summaries and targeted chart searches. Results: SAR referrals increased from 28 in 2012 to 82 in 2016. Age 66, males 52%, solid tumors 58%. 358 patients were referred to SAR 413 times. 174 patients (49%) returned to the oncology clinic prior to re-admission or death, and only 117 (33%) ever received further cancer-directed treatment (chemotherapy, radiation, or immunotherapy). 219 of 358 (61%) died within 6 months. Only 3 individuals who were not on immunotherapy at time of admission went on to receive immunotherapy after discharge to SAR. Among all discharges, 28% led to readmissions within 30 days. 74 patients (21%) were deceased within 30 days, of whom only 31% were referred to hospice. Palliative care involvement resulted in more frequent do not resuscitate (DNR) code status (33 v 22%), documented goals of care (GOC) discussions (81 v 23%), and electronic advance directives (42 v 28%).(All p<0.05). Conclusions: A growing number of oncology inpatients are being discharged to SAR, but two-thirds do not receive further cancer therapy at any point, including a substantial fraction that are re-admitted or deceased within 1 month. Many patients lose the opportunity to use hospice for optimal end of life care, as few SAR facilities offer this. These data can help guide decision-making and discharge planning that aligns with patients’ goals of care. More clinical data are needed to predict who is most likely to benefit from SAR and proceed to further cancer therapy.
Prognostic factors among older adults with advanced non-small cell lung cancer (NSCLC): A multisite cohort study.
Authors: Wong Melisa L. , Miaskowski Christine , Smith Alexander K. , Boscardin W. John , Cohen Harvey Jay , Hurria Arti , Lam Vivian , Ursem Carling Jade , Blakely Collin Michael , Gubens Matthew A. , Jahan Thierry Marie , McCoach Caroline Elizabeth , Allen Gregory Maners , Rotow Julia , Dixit Niharika , Musinipally Vivek , Webber Katey R. , Walter Louise Christie
Published: March 2020

11540

Background: Prognosis in NSCLC is vital for clinical decision making. With the aging US population and rapidly changing treatment landscape, we aimed to identify prognostic factors among older adults with advanced NSCLC receiving chemo-, immuno-, and/or targeted therapy. Methods: We conducted a prospective cohort study of adults age ≥65 with advanced NSCLC starting a new non-curative systemic treatment (chemo-, immuno-, and/or targeted therapy) at a Comprehensive Cancer Center, Veterans Affairs Medical Center, and safety-net hospital. Prior to treatment initiation, patients completed a geriatric assessment including cognition, function, comorbidities, mood, social support, and quality of life. Cox proportional hazards models were performed to identify prognostic factors for overall survival (OS). Results: In a sample of 51 patients, median age was 73 (range 65-94). The majority of patients had stage IVB (59%) or IVA (39%) NSCLC. Current treatment included immunotherapy (37%), targeted therapy (29%), chemoimmunotherapy (18%), and chemo (16%). Most patients had received prior NSCLC treatment (80%): chemo (51%), targeted therapy (35%), immunotherapy (22%), radiation (RT; 47%), and/or surgery (19%). At enrollment, 73% had an abnormal Montreal Cognitive Assessment score < 26 (MoCA; median score 23) and 35% had an abnormal Timed Up and Go time ≥13.5 secs (TUG; median time 12.7 secs). Median OS was 12.5 months. In univariable analyses, stage IVB disease (HR 6.99, 95% CI 1.55-31.5), prior RT (HR 2.98, 95% CI 1.08-8.21), worse MoCA score (HR 1.15 per 1 point change, 95% CI 1.03-1.28), and longer TUG time (HR 1.13 per 1 sec change, 95% CI 1.05-1.23) were associated with worse OS. Of note, age, current NSCLC treatment, line of therapy, and Karnofsky Performance Status were not associated with OS. In multivariable analysis, MoCA score was the only statistically significant prognostic factor (HR 1.15, 95% CI 1.01-1.30). Conclusions: We found that abnormal pretreatment cognition is very common and an important prognostic factor among older adults with advanced NSCLC. Pretreatment screening for cognitive impairment should be considered to inform prognostication, decision making, and treatment planning.
Older adults’ preferred and perceived roles in decision making about palliative chemotherapy: Their decision priorities, and information preferences.
Authors: Moth Erin , Kiely Belinda Emma , Martin Andrew James , Naganathan Vasi , Della-Fiorentina Stephen A. , Honeyball Florian , Zielinski Rob , Steer Christopher B. , Mandaliya Hiren A. , Ragunathan Abi , Blinman Prunella
Published: March 2020

11546

Background: We sought older adults’ preferred and perceived roles in decision-making about palliative chemotherapy; their decision-making priorities; and information received and desired. Methods: Patients aged ≥65 years with incurable cancer who had discussed palliative chemotherapy with an oncologist and made a decision about whether or not to receive palliative chemotherapy were invited to complete a written questionnaire. Preferred and perceived decision-making roles were assessed by the Control Preferences Scale (CPS). Associations with preferred decision-making role were examined using Wilcoxon rank sum tests. Factors important in making a decision about chemotherapy, and receipt of and desire for information were described. Results: The 179 respondents had a median age of 74 years (range 65 to 92 years). Most were male (114, 64%) and had chosen to receive chemotherapy (148, 83%). Half (92, 52%) were vulnerable by the Vulnerable Elders Survey-13 (score ≥3). Preferred decision-making roles (n = 173) were active in 39%, collaborative in 27%, and passive in 35%. Perceived decision-making roles (n = 172) were active in 42%, collaborative in 22%, and passive in 36%, and matched the preferred role for 63% of patients. Preference for an active role was associated with being single/widowed (p = 0.004, OR 1.49) and declining chemotherapy (p = 0.02, OR 2). Factors ranked most important when making a decision about chemotherapy (n = 159) were “doing everything possible” (30%), “my doctor’s recommendation” (26%), “my quality of life” (20%), and “living longer” (15%). A minority expected chemotherapy to cure their cancer (14%). Most had discussed expectations of cure (70%), side effects (88%) and benefits (82%) of chemotherapy, though fewer had received quantitative prognostic information (49%) than desired this (67%). Conclusions: Older adults showed varied preferences for involvement in decision-making about palliative chemotherapy, and most played the role that they preferred. To facilitate shared decision-making, oncologists should seek patients’ decision-making preferences, priorities and information needs when discussing palliative chemotherapy.
Impact of health behavior change on health utility (HU) and financial toxicity in head and neck cancer (HNC) survivors.
Authors: Eng Lawson , Hueniken Katrina , Brown M. Catherine , Hope Andrew , Giuliani Meredith Elana , Selby Peter , Chan Kelvin K. , Mittmann Nicole , Xu Wei , Goldstein David Paul , Liu Geoffrey , de Almeida John R.
Published: March 2020

11561

Background: Health behavior changes including tobacco cessation and increasing physical activity (PA) are important aspects of cancer survivorship. Understanding how these behaviours impact on HU and financial toxicity will help when evaluating survivorship programs. We evaluated the impact of tobacco cessation and PA on HU, function and financial toxicity among HNC patients (pts). Methods: HNC pts from Princess Margaret Cancer Centre completed questionnaires at baseline (diagnosis) and 12 months between 2014-2018 evaluating tobacco use, PA with the Godin questionnaire, cancer related monthly out of pocket costs (OOPC), HU using HU Index Mark 3, function using Lawton Brody Scale (LBS) and lost annual income. Multivariable linear regression analyses evaluated the impact of health behaviour change on OOPC, HU, LBS and lost income. Results: Among 296 pts, mean age 61, 76% male; 29% smoked at diagnosis, 60% quit 1 year after; 26% met PA guidelines at diagnosis, 52% continued to meet guidelines at 1 year. 19% of those not meeting PA guidelines at diagnosis, met them at 1 year. Among all, mean HU [SEM] was 0.84 [0.01] (baseline), 0.80 [0.01] (12 months); mean monthly OOPC [SEM] were $171 [27] (12 months); mean annual lost individual income was $25897 [2945]. Among smokers at diagnosis, those continuing to smoke at 1 year lost a mean of $21272 (95% CI [$2783-39761] P= 0.03) more in individual annual income compared to pts who quit, adjusted for baseline income and education. Current smokers who quit smoking at 1 year had an adjusted mean increase in HU of 0.15 ([0.00-0.30] P= 0.05) greater than pts continuing to smoke. Pts who continued meeting PA guidelines at 1 year had an adjusted mean increase in HU scores of 0.11 ([0.02-0.20], P= 0.02) compared to those reducing PA levels after diagnosis. Changes in PA and tobacco were not associated with change in function or OOPC; improving to meet PA guidelines after diagnosis was not associated with HU or lost income ( P> 0.05). Conclusions: Quitting smoking and maintaining PA levels after diagnosis were associated with improvements in HU scores; quitting smoking reduced lost income. Cancer survivors should be made aware of the potential economic impact of behaviour change.
Cardiovascular disease risk in survivors of 20 adult cancers.
Authors: Strongman Helen , Gadd Sarah , Matthews Anthony , Mansfield Kathryn , Stanway Susannah Jane , Lyon Alexander R. , dos-Santos-Silva Isabel , Smeeth Liam , Bhaskaran Krishnan
Published: March 2020

11571

Background: There are concerns about long-term cardiovascular disease (CVD) risk in cancer survivors, but few studies have quantified the risks for a wide range of cancers and specific CVD outcomes. Methods: Using UK electronic health records, we identified cohorts of adults alive one year after a cancer diagnosis at 20 different sites. Risks of a range of CVD outcomes were compared to age, sex and general practice matched cancer free controls using Cox regression; crude and adjusted models were compared to investigate the role of shared cancer/CVD risk factors (e.g. smoking and diabetes). Results: 126 120 cancer survivors and 603 144 controls were followed over a median (IQR) 4.6 (2.5-8.1) and 5.6 (3.2-9.2) years. Crude and adjusted hazard ratios (HRs) were similar. In adjusted models, there was strong evidence (p<0.01) of increased risk of CVDs among cancer survivors compared with controls: venous thromboembolism (VTE, 18 cancers), heart failure/cardiomyopathy (7 cancers), arrhythmia (4 cancers), and stroke (3 cancers). In stratified analyses HRs were higher in younger people and continued beyond 5 years post diagnosis. Conclusions: We found increased long term CVD risk among survivors of several cancers compared to the general population, which varied by cancer site and specific CVD outcome.[Table: see text]
Body weight changes in young breast cancer survivors and associated predictors.
Authors: Sella Tal , Tan-Wasielewski Zhenying , Rosenberg Shoshana M. , Poorvu Philip Daniel , Ruddy Kathryn Jean , Gelber Shari I. , Tamimi Rulla M. , Schapira Lidia , Come Steven E. , Peppercorn Jeffrey M. , Borges Virginia F. , Partridge Ann H. , Ligibel Jennifer A.
Published: March 2020

11574

Background: Weight gain after cancer diagnosis is common in cancer survivors and has been linked to increased treatment toxicity, poor quality of life, and increased risk of second cancers and overall mortality. Young breast cancer (BC) survivors may be especially susceptible to weight changes given the impact of treatments such as chemotherapy and hormonal therapy on menopausal status. Methods: We identified women with Stage 0-III breast cancer diagnosed at ≤40 years (y) between 2006-2016 from a multi-center prospective cohort study. Clinical data including self-reported pre-diagnosis and follow-up weights were obtained using baseline and follow-up patient surveys. Participants missing baseline weight, pregnant at diagnosis/within 1y of diagnosis or with BC recurrence within 1y were excluded; those pregnant or with BC recurrence between 1-3y from diagnosis were excluded from the 3y analysis. Menopausal status at baseline and treatment-related amenorrhea (TRA) in follow-up were defined by self-reported last menstrual period. Factors associated with weight gain (>5%) were evaluated using univariate two-sided Fisher's exact test. Results: At baseline, 1y and 3y post diagnosis, 956, 899 and 687 women were eligible for analysis respectively. Median age at diagnosis was 37y (17 - 40), 65% received endocrine therapy and 74% chemotherapy. Premenopausal status was verified in 94% at baseline. Mean BMI at baseline was 24.4 (SD 5.3) kg/m2; 20% (187/956) were overweight and 12% (116/956) obese. At 1y and 3y, mean BMI increased modestly to 24.7 (SD 5.6) and 24.9 (SD 5.2), respectively with weight gain (>5%) observed in 18% (164/899) and 13% (87/687) respectively. 37% (300/804) and 32% (196/615) of eligible premenopausal subjects experienced TRA at 1y and 3y, respectively. Receipt of chemotherapy, receipt of endocrine therapy and TRA were not associated with weight gain at any timepoint. Conclusions: In this large prospective cohort of young BC survivors, mean BMI increased only modestly over time. Self-reported weight gain was not associated with treatment and not exacerbated by TRA. Further analysis to understand the effects of physical activity and other predictors of weight gain in this population are ongoing.
Combination of olanzapine and aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients.
Authors: Shanthilal Mukesh , M Sathya , Jk Akshay
Published: March 2020

11577

Background: Olanzapine and Aprepitant have been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare Olanzapine, Aprepitant and their combination in the prevention of CINV. Methods: Prospective randomized controlled study in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; were included. Patients with seizure disorder, brain metastasis were excluded. Olanzapine group received Tablet Olanzapine 10 mg on day 1 to 3. Aprepitant group received Tablet. Aprepitant 125mg on day 1, 80mg on days 2-3. The combination group received Aprepitant 125mg on day 1, 80mg on days 2-3 and Olanzapine 10mg on day 1. All groups received Palnosteron 0.25mg and Dexamethasone 8mg on day 1. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute, delayed and overall periods. Secondary endpoint was CR for vomiting and no use of rescue drugs in all periods. Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. They were asked to record daily episodes of vomiting (number and time) and the utilization of rescue therapy. Results: A total of 141 patients were evaluated and consented for the study. The median age was 47 years; range 29-80; CR for nausea in the acute period (within 24 hours) was 83%, 63.8% and 78.7% (p=0.078); for the delayed period (days 2-5) 59.6%, 55.3% and 63.8% (p=0.702); for the overall period (0-120 hours) 57.4%, 53.2% and 59.6% (p=0.817) for the Olanzapine, Aprepitant and combination arm respectively. CR for vomiting in the acute period was 91.5%, 91.5% and 97.9.7% (p=0.344); for the delayed period 74.5%, 85.1% and 97.9% (p=0.005); for the overall period 70.2%, 85.1% and 97.9% (p=0.001) for the Olanzapine, Aprepitant and combination arm respectively. There were no Grade 3/4 toxicities. Conclusions: The combination strategy shows trend towards better prevention of CINV. Clinical trial information: CTRI/2017/12/010864.
Patient level factors associated with chronic opioid use in cancer patients.
Authors: Cuthbert Colleen Ann , Xu Yuan , Boyne Devon J. , Kong Shiying , Hemmelgarn Brenda R. , Cheung Winson Y.
Published: March 2020

11580

Background: Opioid prescribing in oncology is increasingly scrutinized given public health concerns about chronic opioid use, misuse, and harms. We aimed to evaluate patient reported pain scores, mental health indicators, prior opioid use, and number of opioid prescribers as potential risk factors for chronic opioid use in a large Canadian province. Methods: This was a population-based cohort study using administrative health data of patients in Alberta, Canada, diagnosed between Jan 2016 and Jan 2017, and completed a prospective comprehensive symptom survey within +/- 60 days of diagnosis. Patients were divided into two groups: chronic opioid use (COU) (defined as continuous prescriptions for opioids for at least 90 days post diagnosis) and non-chronic opioid use (NCOU). Logistic regression models were used to evaluate factors associated with COU. Results: We included 694 patients. Most had breast (20%), colorectal (13%), and lung (33%) cancers. There were no differences in mean age (65 years) or gender (50% female) between the groups. In total, 32% had moderate to high pain scores at diagnosis. Of the 14% with COU, 79% were opioid naïve at diagnosis. Those in the COU group were more often diagnosed with advanced stage of disease (66% vs 40%), had lung cancer (47%), and were opioid tolerant at diagnosis (defined as > 90 days of continuous opioids within 1 year prior to their diagnosis) (21% vs 3%). In comparison, 64% of COU versus 27% of NCOU had moderate to severe pain scores at diagnosis (p < 0.001). COU had significantly higher anxiety and depression scores at diagnosis versus NCOU (p = 0.004). Among patients with COU, morphine equivalent daily doses increased from 27.3 (pre-diagnosis) to 65.1 (post-diagnosis). Irrespective of treatment type or stage, those who had moderate to high pain scores, were opioid tolerant at diagnosis, or had multiple prescribers were at greater risk for COU (see Table). Conclusions: Specific patient groups were at increased risk of COU and should be the focus of adaptive prescribing approaches to ensure that opioid use is appropriate. [Table: see text]
Naldemedine for opioid-induced constipation in patients receiving palliative care: A real-world registry study (Phase-R OIC Study).
Authors: Shimizu Masaki , Kessoku Takaomi , Ishiki Hiroto , Matsuura Tetsuya , Hiratsuka Yusuke , Matsuda Yoshinobu , Hasegawa Takaaki , Imai Kengo , Maeda Isseki , Oyamada Shunsuke , Satomi Eriko
Published: March 2020

11582

Background: Although naldemedine, a new peripherally-acting mu-opioid receptor antagonist, was approved for the management of opioid-induced constipation (OIC), its safety and effectiveness in real world clinical practice is unknown. Methods: We conducted a real world registry study in 14 hospital palliative care teams and inpatient palliative care units in Japan between April and December 2018. Consecutive cancer patients who received naldemedine for OIC were enrolled in a 7-day observational study. All treatment and assessment procedures were performed according to the accepted clinical practice. The primary outcome of the study was the proportion of patients who experienced spontaneous bowel movement within 24 hours after the initial administration of naldemedine. Adverse events, which indicated a possible or stronger causal relationship with naldemedine treatment, were reported according to the Common Terminology Criteria for Adverse Events (CTCAE) ver 4.0. Results: Overall, 204 patients were enrolled in the study. The mean age of the patients was 63±14 years, and 103 (50.5%) were male. The most common primary cancer site was lung (23.5%), followed by gastrointestinal (13.7%), and urological organs (9.3%). The proportion of patients undergoing active cancer treatment was 59.9%. Oxycodone was the most frequently used regular opioid (n = 115, 56.4%), and the median oral morphine-equivalent daily dose of opioids was 30 mg (interquartile range: 20-60 mg). Magnesium oxide (64.2%) and Senna (17.2%) were used as concomitant laxatives. All patients received 0.2 mg of naldemedine orally once daily. Most patients (90.2%) completed the 7-day observation. In 146 patients, spontaneous bowel movement was observed within 24 hour after the first administration of naldemedine (71.6%, 95% confidence interval 65.4-77.8%). Nearly two-thirds of the patients experienced increased frequency of spontaneous bowel movement in the week after naldemedine administration. The most prevalent adverse events were diarrhea (CTCAE grade 1-2, 35 cases; grade 3, 1 case) and abdominal pain (CTCAE grade 1-2, 10 cases; grade 3, 1 case). No serious adverse events including gastrointestinal perforation were reported. Conclusions: Naldemedine for opioid-induced constipation is safe and effective in the real world oncology and palliative care settings. Clinical trial information: UMIN000031381.
A community oncology palliative program: Early results for cost and quality measures within OCM program claims data.
Authors: Akhtar Adil Jamal , Margolis Jeffrey , Maxwell Karma , Muskovitz Andrew A. , Zekman Richard Philip , Sheth Karna , Ballouz Samer , Qamruzzaman Yusuf , Ibrahim Mohammed , Scott-Barney Tammy , Stortz Lexi , Fabbiano Maria
Published: March 2020

11585

Background: Oncology Care Model (OCM) is an initiative of the Centers for Medicare and Medicaid Innovation which aims to provide higher quality and more coordinated oncology care while lowering the cost. Oncology Division of Michigan Health Professionals (MHP) participates in OCM. Palliative and End of Life care was identified as one of the quality improvement areas. A community oncology Palliative care (PC) program was launched in October 2017. Methods: The multidisciplinary PC team was led by Board certified palliative care and hospice physicians. Patients appropriate for PC referral were identified by participating medical oncologists. Patients were contacted by the PC team. If the patients agreed a Nurse Practitioner (NP) would assess and follow the patients at home. Care was coordinated by the NP’s in communication with the palliative care team and the primary medical oncologists. Last 30-day (limited by the OCM episode or patient death) OCM program claims data was analyzed by IntegraConnect. Results: From October 2017 to October 2018 a total of 273 patients were referred to the PC program. Fifty-eight patients were identified as having OCM episodes, of these 36 patients had claims data through June 30, 2018. Twenty patients accepted and were engaged with PC,16 patients declined or were unable to reach for PC and formed the comparison group. Even when drug and office costs were excluded, PC engaged patients spent 17% less versus the comparison group (93k vs 112k) in last 30-day claims data. PC engaged patients had a lower acute care facility costs which accounted for 50% (46k) of reimbursement, compared with 95% (105k) for the comparison group. Fourteen OCM patients referred to Palliative program died within episode. 80% (8/10) of engaged patients met quality measure for OCM-3, at least 3 days in hospice vs. 0% (0/4) of patients who declined palliative care, before episode-death. Conclusions: Palliative engaged OCM patients experienced more care at their homes at a lower cost. Palliative program improved practice performance in OCM-3 quality measure. MHP Palliative program is reaching patients in OCM episodes but the numbers are still small.
Risk factors for opioid abuse/dependence in hospitalized cancer patients in the United States.
Authors: Bakalov Veli , Tang Amy , Yellala Amulya , Babar Laila , Shah Rupin , Sadashiv Santhosh K. , Kaplan Robert B. , Lister John , Cuevas Elizabeth , Monga Dulabh K.
Published: March 2020

11589

Background: Opioid medications are the mainstay for treating cancer pain. Goal of this study was to identify risk factors for opioid abuse/dependence in patients hospitalized with cancer, explore whether risk of opioid abuse/dependence varies by cancer type and to assess whether opioid abuse/dependence in cancer patients effects the outcomes of hospitalization. Methods: The Nationwide Inpatient Sample for the years of 2011-2015 was queried for the analysis. We used ICD-9-CM codes of solid tumors as a primary diagnosis for hospitalization, and opioid abuse/dependence as a secondary diagnosis of the hospitalization. We performed univariate and multivariate logistic regression analyses to examine the association between risk factors and opioid abuse/dependence. Data were analyzed using SAS v9.4 (SAS Institute, Cary, NC). Results: Total of 524,624 patients were included in our cohort. Rate of opioid abuse/dependence was highest in patients with liver cancer (1.77%). Opioid abuse/dependence was less associated with age (>65 years old: OR 0.29, 95% CI 0.21-0.39). Patients with Medicaid insurance associated with increased risk of opioid abuse/dependence comparing to other insurances (OR 5.29, 95% CI 4.78-5.86). Strongest association with opioid abuse/dependence were in patients with liver cancer (OR 6.07, 95% CI 5.11-7.20) followed by head and neck cancer (OR 3.20, 95% CI 2.67-3.84). Substance abuse (OR 9.9, 95% CI 9.04-10.84), mental disease (OR-2.87, 95% CI 2.64-3.13) and nutrition deficiency (OR-2.09, 95% CI 1.90-2.31) were highly associated with opioid abuse dependence. Inhospital mortality rate, total cost of hospitalization, and length of stay were significantly higher in patients with opioid abuse/dependence (Table). Conclusions: We identified risk factors for opioid abuse/dependence in hospitalized patients with cancer and demonstrated that risk of opioid abuse varies by cancer type, and opioid abuse/dependence affects the outcomes of hospitalization. Findings of our study can be used for development of the screening tools with higher sensitivity and specificity for predicting the risk of opioid abuse/dependence in cancer patients.[Table: see text]
Safety of intravenous (IV) NEPA and oral NEPA for prevention of CINV in patients (pts) with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy (CT).
Authors: Schwartzberg Lee S. , Voisin Daniel , Rizzi Giada , Patel Kamal , Aapro Matti S.
Published: March 2020

11594

Background: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with IV aprepitant, fosaprepitant and rolapitant, with the highest rate (35%) for fosaprepitant in the AC setting. This study (NCT03403712) evaluates the safety of IV NEPA in BC pts receiving repeat cycles of AC CT. Methods: This was a Phase 3b, double-blind study in females with BC naïve to highly/moderately emetogenic CT. Pts were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1, prior to AC. Oral dexamethasone was also given to all patients before CT. The primary objective was a safety evaluation of IV NEPA based primarily on treatment-emergent adverse events (TEAEs). No formal between groups statistical comparison was planned. Results: 402 pts were treated with IV NEPA or oral NEPA and included in the safety population. The AE profiles were similar for the two groups; cycle 1 results are reported (Table). Comparable complete response (no emesis, no rescue) rates were seen during the cycle 1 overall phase (0-120h) (73.0% IV NEPA, 77.2% oral NEPA). Conclusions: There were no infusion-site AEs related to IV NEPA and no anaphylaxis reported for either formulation. Consistent with the pivotal study, IV NEPA is safe and effective in pts receiving AC. As a simplified single-dose formulation, IV NEPA may be better tolerated than other NK1 RAs. Clinical trial information: NCT03403712. [Table: see text]
Validation of a new prognostic body composition parameter in cancer patients.
Authors: Pedrazzoli Paolo , Caccialanza Riccardo , Stobäus Nicole , Turri Annalisa , Klersy Catherine , Caraccia Marilisa , Brugnatelli Silvia , Secondino Simona , Cicognini Daniela , Imarisio Ilaria , Filippi Andrea Riccardo , Monaco Teresa , Giannoni Atonello , Norman Kristina , Cereda Emanuele
Published: March 2020

11597

Background: In cancer patients protein-calorie imbalances are responsible for decreased lean body mass and, in turn, for worse clinical outcome. We evaluated the prognostic value of a new body composition parameter (creatinine height index [CHI]) obtained from bioimpedance vectorial analysis-derived body cell mass and its association with nutritional and functional status. Methods: Data from Italian and German cancer patients based on information from previous prospective cohort studies were used. Multivariable models (adjusted for age, gender, hydration status, performance status, and disease stage) were built in both cohorts to assess the association between body composition outcome parameters (low fat-free mass [FFM], <15 [females] and <17 [males] kg/m2; low standardized phase angle [SPA], <-1.65; low CHI, <510 [females] and <660 [males] mg/24h/m) and 1-year all-cause mortality, low body mass index (BMI; <20 [<70 years] and <22 [>/=70 years] kg/m2), clinically significant weight loss (WL; >/=10% in 6 months) and low handgrip strength (HG; <20 [females] and <30 [males] kg). Results: Overall, 1084 cancer patients were included (Italians, N=454; Germans, N=630). Low CHI was independently associated with mortality in both Italian and German cohorts (Table). Low FFMI and low SPA did not predict survival in the German cohort. In patients with low CHI, worse nutritional and functional status were observed in both study populations. Performance of models addressing the study endpoints showed substantial consistency with both cohorts, particularly of those including low CHI. Conclusions: We validated a new prognostic body composition parameter, which is easier to interpret than standard nutritional parameters and may be useful for identifying cancer patients at nutritional risk, requiring early nutritional support. [Table: see text]
Effect of high flow oxygen on exertional dyspnea in cancer patients: A double-blind randomized clinical trial.
Authors: Hui David , Larsson Liliana , Thomas Sajan , Harrison Carol , Wu Jimin , Mahler Donald , Hess Kenneth R. , Lopez-Mattei Juan , Thompson Kara , Gomez Daniel Richard , Jeter Melenda , Lin Steven H. , Tsao Anne S. , Eapen George , Basen-Engquist Karen , Bruera Eduardo
Published: March 2020

11600

Background: High flow oxygen therapy is effective for hypoxemic respiratory failure. However, its effect on dyspnea in non-hypoxemic patients is unknown. In this 2x2 factorial, double-blind randomized clinical trial, we assessed the effect of flow rate (high vs. low) and gas (oxygen vs. air) on exertional dyspnea in cancer patients. Methods: Non-hypoxemic patients with cancer completed two structured cycle ergometer exercise tests with Low Flow Air [LFAir] at 2 L/min. They were then randomized to receive High Flow Oxygen [HFOx] with up to 60 L/min, High Flow Air [HFAir], Low Flow Oxygen [LFOx] or LFAir during a constant work rate exercise test at 80% maximum. Dyspnea intensity was assessed with the modified 0-10 Borg scale. The primary outcome was difference in the slope of dyspnea intensity vs. time during the third test. Secondary outcomes included difference in exercise time, vital signs, and adverse events. We estimated that 10 patients per arm will provide 86% power to detect a 1-standard deviation main effect and 86% power to detect a 2-SD interaction effect with an alpha of 5%. A linear mixed effects model was used to assess the impact of flow rate and gas on study outcomes. Results: 45 patients were randomized and 44 completed the study (10, 11, 12, 11 patients on HFOx, HFAir, LFOx, LFAir, respectively). The mean age was 63 (range 47-77); 18 (41%) were female; 34 (44%) had lung cancer; and 20 (46%) had metastatic disease. In mixed effects model, the association between the change in dyspnea intensity over time with flow rate differed significantly between oxygen and air (P = 0.04). Specifically, HFOx (slope difference -0.20, P < 0.001) and LFOx (-0.14, P = 0.01) were significantly better than LFAir, but not HFAir (+0.09, P = 0.09). Exercise time also significantly increased with HFOx (difference +2.5 min, P = 0.009) compared to LFAir, but not HFAir (+0.63 min, P = 0.48) or LFOx (+0.39 min, P = 0.65). HFOx was well tolerated without significant adverse effects. Conclusions: The combination of high flow rate and oxygen improved dyspnea and exercise duration during constant work exercise test in non-hypoxemic cancer patients. Larger trials are needed to confirm the benefits of HFOx during exercises. Clinical trial information: NCT02357134.
Learning from best scalp cooling practices in a registry: Differences in results from n>7000 patients with solid tumors.
Authors: van den Hurk Corina , Dercksen Martin W , Nortier J. W. R. , Breed Wim
Published: March 2020

11610

Background: Hair loss is a frequently occurring and stigmatizing side effect of chemotherapy. Worldwide scalp cooling is being introduced to prevent chemotherapy-induced alopecia (CIA). In the Netherlands scalp cooling is implemented in many hospitals since 2005. FDA clearance has been approved for scalp cooling among breast cancer patients in the USA in 2016. Recently approval has been expended for solid tumors. Methods: In a prospective, longitudinal registry data have been collected between 2006 and 2017. Patients could be included if they received chemotherapy that induced severe alopecia, regardless type of solid tumor, stage of disease, age, gender or receiving adjuvant or palliative treatment. Patients were eligible for evaluation of hair loss after they received at least 2 cycles of chemotherapy or if they ceased scalp cooling because of severe hair loss after the first cycle. Failure was defined as feeling the need to use a wig or head cover. Data will be presented using descriptive statistics and multivariate regression analysis to explore determinants of scalp cooling efficacy per largest groups of chemotherapy regimen, and evaluate variety between hospitals. Results: Preliminary results show data of 7378 patients from 68 hospital locations of whom 75% had breast cancer and 8% prostate cancer. Overall 57% of patients did not feel the need to wear a wig or head cover. Variation was observed between hospitals in scalp cooling procedures: e.g. wetting the hair (0-100% of patient) and cooling- and infusion times that varied per type of chemotherapy. Also results varied between hospitals per type and dose of chemotherapy (n > 10 patients), e.g. minimal 37% and maximal 86% success rates between hospitals for paclitaxel-carboplatin (n = 498), 17-54% success for irinotecan monotherapy (n = 275), 25-79% success for 5FU/epirubicin/cyclophosphamide-docetaxel (n = 843) and 79-94% for docetaxel monotherapy (n = 824). Also variation in satisfaction with information about scalp cooling and nursing expertise was observed. Results from the regression analyses will be presented at the conference. Conclusions: Scalp cooling efficacy varied enormously between hospitals. A registry is a useful tool to identify best practices and to provide guidance to further improve results. An international registry has been set up to also collect data on CIA among scalp cooled and non-scalp cooled patients in the USA, Australia and the UK.