bluuebunny/crossref_metadata_2025_split huggingface dataset:
Does gabapentin prevent delayed chemotherapy-induced nausea and vomiting (N/V)? Results of a randomized placebo controlled trial, NCCTG N08C3 (Alliance).
Authors: Barton Debra L. , Sloan Jeff A. , Novotny Paul J , Fuloria Jyotsna , Kottschade Lisa A. , Lyss Alan P. , Jaslowski Anthony John , Mazurczak Miroslaw , Blair Scott Cameron , Terstriep Shelby A. , Loprinzi Charles L. 
Published: March 2020

9513 Background: The need for more research in N/V control is exemplified by agents that are costly, interfere with cytochrome P450 metabolism, and inadequately address delayed N/V. Based on pilot data, there was justification for evaluating whether gabapentin could improve the prevention of delayed N/V from highly emetogenic chemotherapy (HEC). Methods: Patients (pts) about to receive HEC were randomized to prophylactic treatment with 20 mg of dexamethasone (dex) and a 5HT3 receptor antagonist (RA) on the day of chemotherapy, followed by either gabapentin (gaba) 300 mg BID and dex or placebo (plac) and dex. Gaba/plac was started the evening of the day of chemotherapy and continued through day 5 of the first chemotherapy cycle. Dex was given at 8 mg BID days 2-3, then 4 mg BID for day 4, in both arms. The primary endpoint was complete response (CR), defined as no emesis and no rescue medications day 2-6, using a nausea and vomiting diary. The percent of CR were compared in each group by Fisher’s exact test. Secondary outcomes included the Functional Living Index-Emesis (FLIE), satisfaction, and a side effect questionnaire. Results: 430 pts were enrolled in this study between 5/2009 and 2/2011. 47% of pts in the gaba arm and 41% in the plac arm had a CR (p=.23). At some time during days 2-6, 30% in the gaba and plac arms experienced emesis, and 45% and 53% in the gaba and plac arms, respectively, took rescue medication. Mean diary nausea scores over days 2-6 ranged from 0.9 – 1.2 (gaba arm) and 1.0-1.3 (plac arm)(7 = the worst); mean number of diary emetic episodes ranged from 0.1 -0.3 (gaba arm) and 0.1-0.2 (plac arm). The FLIE was not significantly different between arms. Mean vomiting satisfaction was 9.1 in both arms and for nausea was 8.3 for gaba, 8.1 for plac (10= totally satisfied). There were no significant differences in toxicities by CTCAE provider grading or by self-report. Conclusions: In this study, gaba did not improve delayed N/V. Overall, there was little emesis and nausea severity was low. Patients were satisfied with the control of their N/V, irrespective of arm. The use of standard prophylactic guidelines that include a 5HT3RA and dex provided good control of N/V for most patients. Clinical trial information: NCT00880191.
Screening for depression in community-based radiation oncology settings: Results from RTOG 0841.
Authors: Wagner Lynne I. , Pugh Stephanie L. , Small William , Kirshner Jeffrey J. , Sidhu Kulbir , Bury Martin Joseph , DeNittis Albert S. , Alpert Tracy E. , Tran Binh N. , Bloom Beatrice , Mai Julie , Bruner Deborah 
Published: March 2020

9527 Background: Depression screening is recommended in routine cancer care. Brief tools are needed to identify depressed patients in radiation oncology treatment settings. Methods: Patients starting radiotherapy for first diagnosis of any tumor were eligible. Screening measures administered prior to or within the first 2 weeks of radiation therapy included: Hopkins Symptom Checklist (HSCL-25), Patient Health Questionnaire (PHQ-9; PHQ-2), and the National Comprehensive Cancer Network-Distress Thermometer (NCCN-DT). Patients exceeding validated cutoff scores on the HSCL-25, PHQ-9 or PHQ-2, and a systematic sample of patients who screened negative, completed telephone-based administration of the Structured Clinical Interview for DSM-IV (SCID) Mood Disorder modules. Results: 463 patients from 35 community-based and 2 academic radiation oncology sites were accrued. The majority were women (n=298, 66%). Participants had breast (45%), GI (11%), lung (10%), gynecologic (6%), or other (27%) cancers. All 454 eligible patients completed the screening questionnaires and 100% of questionnaire items were completed. 75 (16%) screened positive for depressive symptoms. A total of 70 SCID interviews were administered to 37 patients who screened positive and 33 who screened negative. Among those who screened positive, 14 (20%) met SCID criteria for major depression. One participant who screened negative met depression criteria (1.4%). Results indicate the prevalence of depression is 3%. The PHQ-2 demonstrated good psychometric properties for identifying current major depressive episode, using a cut-off score > 3 (ROC area under the curve=0.839). The PHQ-9 > 9 was comparable (AUC=0.837). The NCCN-DT > 4 did not adequately detect depression (AUC=0.64). Conclusions: The prevalence of depression was low (3%) among this community-based sample of adults receiving radiotherapy. The PHQ-2 demonstrated excellent psychometric properties to detect depression, which were equivalent to the PHQ-9 and superior to the NCCN-DT. Our findings support using the PHQ-2 to identify patients in need of further assessment and treatment for depression, a low prevalence but clinically significant comorbidity.
The impact of positive spousal support on trauma symptoms and sleep disturbance among prostate cancer survivors.
Authors: Kamen Charles Stewart , Peoples Anita Roselyn , Tejani Mohamedtaki Abdulaziz , Palesh Oxana , Mustian Karen Michelle , Peppone Luke Joseph , Janelsins Michelle Christine , Kamen Francis , Lord Raymond S. , Flynn Patrick J. , Weiss Matthias , Spiegel David , Morrow Gary R. 
Published: March 2020

9533 Background: Receiving a diagnosis of cancer can lead to psychological effects including symptoms of traumatic stress. Trauma symptoms can dysregulate sleep and sleep disturbance has been linked with negative health outcomes. Cancer-related trauma symptoms and sleep disturbance can affect the spouse of the cancer patient and the couple’s relationship; conversely, a supportive relationship can improve cancer survivors’ mental health. The impact of spousal support on trauma and sleep disturbance among prostate cancer survivors has not yet been examined. Methods: 315 prostate cancer survivors (mean age 66, 89% Caucasian), of whom 265 were married and 50 were unmarried (single, widowed, separated or divorced) completed the Impact of Events Scale (IES), Stanford Sleep Questionnaire, and a measure of positive spousal support. Data are self-report. Rates of trauma symptoms and sleep disturbance by marital status were compared using t-tests, and the contribution of marital status and spousal support to variance in these outcomes was evaluated using linear regression. Results: 13.4% of survivors reported significant (i.e., >27 point IES cutoff) symptoms of traumatic stress and 23.2% reported moderate or higher rates of sleep disturbance. Trauma symptoms (t= -2.16, p<.01) and sleep disturbance (t= -3.14, p<.01) were significantly lower in married than unmarried survivors. Spousal support was negatively associated with trauma symptoms (r= -.18, p<.01) and sleep disturbance (r= -.20, p<.05), and inclusion of spousal support as a covariate rendered the linear relationship between marital status and both trauma symptoms and sleep disturbance non-significant (p>.05). Conclusions: Spousal support is associated with reductions in trauma and sleep disturbance, over and above dichotomous marital status. This area needs further study, given high rates of trauma symptoms and difficulty disclosing health-related concerns among men with prostate cancer. Future research needs to explore mechanisms by which spousal support leads to improvement in trauma symptoms and sleep outcomes. Interventions bolstering spousal support could improve mental health in prostate cancer survivors.
Palliative sedation (PS) given to patients treated at the Fundación Santa Fe de Bogotá.
Authors: Lombana Quinonez Milton Alberto , Santacruz Juan G. , Pino Luis , Camacho Maria I. , Acevedo Andres , Buendia Maria J. , Zamora Ivonne , Torres Ana , Mendez Catalina , Cardona Zorrilla Andres Felipe 
Published: March 2020

9541 Background: Around 50% of advanced-stage cancer patients have inadequate control of symptoms during the final period of life; palliative sedation (PS) would seem to be appropriate in such scenario. Methods: A retrospective cohort analytical study was carried out for determining the effectiveness of PS, evaluating the non-reduction of the number of final days of life in patients suffering advanced-stage cancer. PS therapy consisted of using a continuous infusion of benzodiazepines, opioids, antipsychotics and/or anaesthetics. Results: The study included 145 patients recorded between July 2008 and October 2012. Median age was 68 years (24% of the patients being aged over 80). The main motives for considering PS were dyspnoea (30%), uncontrolled pain (25%), delirium (26%) and presenting more than one of these symptoms (19%). The drugs used were opioids (in 87% of the patients), benzodiazepines (54%) and anaesthetics (2%). Using PS led to symptoms becoming controlled in 79% of the cases compared to 53% without it; symptoms became controlled in 85% of the cases in less than 24 hours when PS was used compared to 15% when it was not used (p<0.001). Mean overall survival (OS) was 6.8 days for those who received PS and 7.2 for those who did not (RR 0.94, 0.97-1.33 95%CI; p=0.72) and final days of life after starting PS was 2.2 days (<1-16 days). Multivariate analysis showed that using PS (HR 1.49, 1.08-2.07 95%CI; p=2.04) and the presence of oedema (RR 0.79, 0.61-1.0 95%CI; p=0.01) modified the course of controlling symptoms. Conclusions: PS improved the time to controlled cancer symptoms in patients suffering terminal illness, and their presentation profile without modifying the OS.
Differences in patterns of care and outcomes of elderly versus younger metastatic pancreatic cancer (mPC) patients.
Authors: Vijayvergia Namrata , Dotan Efrat , Devarajan Karthik , Hatahet Kamel , Rahman Farah , Cohen Steven J. 
Published: March 2020

9546 Background: Despite a median age at diagnosis of 72, elderly pancreatic cancer patients (pts) are poorly represented in clinical trials. We thus compared patterns of care and outcomes of mPC pts ≤ and > 65 yrs of age. Methods: We retrospectively analyzed medical charts of 277 mPC pts treated at an academic center between 2000 and 2009. Age groups ≤ 65 yrs and >65 yrs were compared with respect to gender, comorbidities, performance status (PS), tobacco/alcohol use, primary site, stage, histological grade, metastatic sites, treatment modalities, type and number of chemotherapeutic agents received, and survival after diagnosis of mPC (OS). Log-rank tests and Cox proportional hazards models were used to analyze survival endpoints and Fisher’s exact test to compare categorical variables. Results: 155 pts ≤65 yrs with median age of 58 and 122 pts >65 yrs with median age of 73.5 were evaluated. The groups were well balanced with respect to sex (majority male), PS (majority ≤1), stage (majority 3, 4), and primary site (majority head). Cardiovascular (CV) disease was more prevalent among older pts (OR 1.7, p=0.04). Older pts were less likely to receive any chemotherapy for mPC (79% vs 92%; OR 0.33, p< 0.001) and if treated were less likely to receive more than one agent (34% vs 52%; OR 0.48, p=0.003). Median OS was shorter in older pts (5m vs 6m, p=0.01). OS was longer with higher number of agents received (RR: 0.57 for young, 0.51 for old; p< 0.001). CV and renal disease negatively impacted OS only in younger pts. The presence of lung metastases was associated with longer survival (10m vs 6m (p=0.01)) and liver metastases with decreased survival (5m vs 8m (p<0.01)) only among younger pts. Conclusions: Elderly mPC pts have shorter OS, are less likely to receive chemotherapy, and if treated receive fewer agents compared to younger pts. These differences cannot be explained solely by PS or disease characteristics and warrant further study.
Comparing elderly and non-elderly adult cancer survivors: Differences in modifiable behaviours of smoking and alcohol cessation and physical activity.
Authors: Niu Chongya , Eng Lawson , Qiu Xin , Shen Xiaowei , Espin-Garcia Osvaldo , Pringle Dan , Mahler Mary , Halytskyy Oleksandr , Charow Rebecca , Lam Christine , Shani Ravi M. , Villeneuve Jodie , Tiessen Kyoko , Brown M Catherine , Selby Peter , Howell Doris , Jones Jennifer M. , Xu Wei , Alibhai Shabbir M.H. , Liu Geoffrey 
Published: March 2020

9551 Background: In developing a cancer survivorship program at Princess Margaret Cancer Centre (Canada), cancer survivors were surveyed on modifiable behaviours: smoking/alcohol intake and physical activity. We evaluated whether special considerations should be given to elderly cancer survivors (age 65 years or higher), where few data currently exists. Methods: 616 adult cancer survivors of all disease sites were asked about their smoking, alcohol, and physical activity habits, and their attitudes and knowledge about effects of these habits on cancer outcomes. Univariate and multivariate logistic regression models evaluated the effect of age on these factors. Results: 23% were elderly; 53% female; 15% breast, 20% gastrointestinal/gynecologic, 24% hematologic, 19% thoracic/head and neck, and 13% genitourinary cancers. Median follow up was 24 months. Elderly survivors were more likely to be ever smokers (OR=1.69, 95% CI [1.12-2.53]) and ex-smokers than current (OR=4.11 [2.02-8.33]), but less likely to know how smoking could affect cancer treatment (OR=1.72 [1.09-2.69]) or outcome (OR=1.66 [1.07-2.60]). Elderly patients were less likely to binge drink (OR=2.07 [1.34-3.19]), but more likely to perceive alcohol as improving quality of life (OR=1.98 [1.11-3.56]) and overall survival (OR=2.32 [1.22-4.41]) in their own situation. Elderly survivors were less likely to receive information about alcohol use (OR=2.89 [1.29-6.49]). Meeting exercise guidelines at diagnosis (OR=1.76 [1.16-2.67]) and improving/maintaining them after treatment (OR=2.02 [1.12-2.93]) was substantially lower in elderly survivors, but perceived benefits/harms of exercise did not differ with age. Conclusions: Elderly patients know less about the impact of smoking on their overall health, despite having higher rates of cumulative exposure. A lower proportion received information on alcohol use. Elderly patients are less able to achieve the same exercise goals as younger patients. Survivorship programs may need to tailor counselling on modifiable behaviours by age group. CN, LE, SMHA, and GL contributed equally.
The influence of autologous stem cell transplant (ASCT) on survival in older adults with multiple myeloma (MM).
Authors: Wildes Tanya Marya , Finney Joseph D , Fiala Mark , Gao Feng , Vij Ravi , Stockerl-Goldstein Keith , Carson Kenneth Robert , Colditz Graham A. 
Published: March 2020

9559 Background: In randomized trials, ASCT improves survival in MM patients (pts) < age 65. The impact of ASCT on survival in older adults with MM is unknown. Methods: In a retrospective cohort study, all pts ≥ age 65 with MM diagnosed between 2000 and 2010 were identified from the Barnes-Jewish Hospital Oncology Data Services Registry (N=199), including demographic, comorbidity (ACE-27 index) and survival data. Medical records were reviewed for stage, ECOG Performance Status (PS) and treatment. Pts > age 77 or who received only steroids/supportive care were excluded (N=53). The primary endpoint was overall survival (OS), defined as time from diagnosis to death, censored at last follow-up. Univariate analyses for factors associated with undergoing ASCT were performed using Fisher’s exact test or nonparametric rank-sum test; multivariate logistic regression was used to create propensity scores for ASCT. The association between ASCT and OS was assessed using a multivariate Cox proportional hazard model with propensity scores adjustment; missing values in predictors were imputed using multiple imputations. Results: Of 146 pts included, the median age was 68 (range 65-77); 53% were male, 81% Caucasian; 43% underwent ASCT. Comorbidities were common (43.9% mild, 21.6% moderate and 9.3% severe). Durie-Salmon Stages were I – 9.5%, II-18.1%, III-72.4%. PS at diagnosis was 0 - 18.3%, 1 - 51.0%, 2 - 21.2% and 3 - 9.6%. Most received novel agents (thalidomide, lenalidomide or bortezomib) in their initial treatment (25.2% alkylators only, 58.6% novel single agents ± steroids, 16.2% novel combination regimens). Age (p<0.0001) and insurance/payer (p=0.02) were associated with ASCT. On univariate analysis, ASCT [Hazard Ratio (HR) 0.54 (95% confidence intervals (CI) 0.35-0.82)] and PS [PS 1: HR 2.3 (CI 1.0-4.9), PS2: HR 3.3 (1.4-7.9); PS 3: HR 3.5 (CI 1.3-9.3)] were associated with mortality. On multivariate analysis controlling for PS, comorbidity, stage and propensity to undergo ASCT, ASCT was associated with reduced mortality [HR 0.52 (CI 0.30-0.92), p=0.02]. Conclusions: In pts over age 65 with MM, ASCT is associated with better OS after adjusting for propensity to undergo ASCT.
Patient-reported outcomes for determining prognostic groups in veterans with stage IV solid tumors starting systemic therapy.
Authors: Chang Victor T , Scott Charles B. , Einhorn Jan , Yan Houling , Gonzalez Melanie L. , Sullivan Maryann , Srinivas Shanthi , Zhong Fengming , Paz-Querubin Emma R , McPherson Monica , Crump Barbara , Duque Lourdes , Kasimis Basil 
Published: March 2020

9567 Background: A Recursive Partitioning Analysis (RPA) algorithm predicted four groups with distinct median survivals in patients with advanced cancer entering palliative care (ASCO 2010, Abst 9040). We investigated whether this algorithm could apply to cancer patients starting systemic therapy. Methods: The RPA algorithm is based upon Karnofsky performance status (KPS), Functional Assessment of Cancer Therapy (FACT) physical well-being (PWB) subscale, and Memorial Symptom Assessment Scale Short Form (MSAS-SF) physical symptom distress (PHYS) subscale. Starting in 2007, a convenience sample of Veterans who were prescribed systemic treatment for their cancer was enrolled in an IRB approved protocol, and completed quality of life (FACT- G) and symptom (MSAS SF) questionnaires prior to starting the first cycle of treatment. We analyzed records of patients with stage IV metastatic solid tumors enrolled through August 2011, and determined survival as of December 1, 2012. Analyses were performed with STATA 11.0. Results: There were 72 patients (pts). The median age was 63 yrs, (range 46-86). Men comprised 71 (98%) pts. First line systemic therapy was given to 59 (82%) pts. The most common primary sites were lung cancer (25 pts, 35%), prostate 9 pts(12%) and colon 7 pts (10%). Median KPS was 90% (range 40-100%), PWB median 23 (range 6-28), and MSAS SF median PHYS 0.73 (range 0-2.93). Overall median survival was 269 days (range 6-1762) and 57 pts (79%) had died. There was 1 pt in group 1, 45 pts in group 2, 8 pts in group 3, and 18 pts in group 4. Median survival (days) by RPA group was 155 for group 1, 177 for group 2, 292 for group 3, and 610 for group 4 (p=.011). Conclusions: These preliminary findings suggest that this algorithm is capable of dividing patients with metastatic solid tumor who are starting chemotherapy into prognostic groups. It may have applications in clinical trials. Further development is indicated. [Table: see text]
Breaking bad news: Comparison of perspectives of Middle Eastern cancer patients and their relatives.
Authors: Zekri Jamal M , Karim Syed Mustafa , Bassi Sawsan , Bin Sadiq Bakr M , Fawzy Ehab Esmat , Nauf Yousseff Ibrahim 
Published: March 2020

9568 Background: It is believed in some Middle Eastern (ME) cultures that disclosure of bad news to cancer patients may cause loss of hope. On many occasions the relatives’ and patients’ wishes are opposed regarding this matter. This study investigates cancer patients’ and their relatives’ perspectives regarding communication of cancer-related bad news in a ME population. Methods: Nine close-ended questions were designed in a questionnaire format to obtain cancer patients’ (cohort I) and their relatives’ (cohort II) perspectives regarding communication of cancer related bad news from diagnosis to end-of-life. The questionnaire was answered by patients and relatives during out-patient visits. Chi-square test was used to test differences in responses between the two cohorts. Results: 203 participants (100 patients and 103 relatives) completed the questionnaire. In cohorts I and II, 28% and 58% of participants were males respectively (p<0.001). In contrast to relatives’ views, majority of patients preferred to be informed of diagnosis and possible adverse outcome of their illness, as detailed in the Table. Conclusions: Our study indicates that there is significant discordance between the preferences of ME cancer patients and their relatives regarding disclosure of cancer related bad news to the patient. As opposed to relatives’ beliefs, most patients would prefer to know bad news throughout the course of their illness. Unless a patient indicates otherwise, physicians should strive to keep cancer patients informed of their health related events. [Table: see text]
Use of modafinil to moderate the relationship between cancer-related fatigue and depression in 541 patients receiving chemotherapy: A URCC CCOP study.
Authors: Conley Claire , Heckler Charles E , Morrow Gary R. , Mustian Karen Michelle , Kamen Charles Stewart , Janelsins Michelle Christine , Peppone Luke Joseph , Scalzo Anthony Joseph , Gross Howard M. , Dakhil Shaker R. , Palesh Oxana 
Published: March 2020

9572 Background: Over 50% patients with cancer report symptoms of depression; 15% meet diagnostic criteria for Major Depressive Disorder. Depression is associated with increased insomnia, fatigue and reduced quality of life. We previously found that modafinil is effective for reducing high levels of fatigue among patients undergoing chemotherapy. This study aims to test whether modafinil can alleviate symptoms of depression by reducing fatigue. Methods: This study is a secondary analysis of 541 cancer patients receiving chemotherapy and experiencing fatigue (Brief Fatigue Inventory (BFI) >=3) that were randomized to receive either 200 mg of modafinil (N=260) or placebo (N=281) daily from baseline (Cycle 2) until post-test (Cycle 4). Depression was measured by the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and post-test. The CES-D total score and its subscales (Positive Affect, Negative Affect, Somatic Symptoms, and Interpersonal Symptoms) were analyzed. A linear model with CES-D post (outcome) and BFI baseline, Arm, and BFI*Arm interaction term (independent variables) was used to address the hypothesis; p<0.05 indicates significance. Results: We found no overall effect of modafinil on depression; however, the model demonstrated a significant moderating effect of modafinil on the relationship between baseline fatigue and CES-D total scores (p = 0.04). For subjects with severe fatigue (BFI ≥ 7), the drug reduced CES-D scores by 3-4. Modafinil also significantly moderated the relationship between baseline fatigue and Positive Affect subscale scores (p = 0.003), but not the relationship between baseline fatigue and Somatic, Negative Affect, or Interpersonal subscales. Conclusions: Modafinil differentially impacts depression based on a patient’s level of fatigue; reduced depressive symptoms occurred in those with extreme fatigue. This effect is driven by increases in positive affective symptoms. These results have significant implications for intervention; in patients with high levels of fatigue, modafinil might also reduce depression. Future RCTs are needed to confirm these results. Funding: U10CA37420, K07CA120025, K07CA132916.