bluuebunny/crossref_metadata_2025_split huggingface dataset:
Korean red ginseng to improve cancer-related fatigue in colorectal cancer patients with FOLFOX chemotherapy: A randomized, double-blind, placebo-controlled, parallel, multicenter trial, NCT02039635.
Authors: Kim Yeul Hong , Lim Yoojoo , Cho Jae Yong , Chung Ik-Joo , Kim Jong Gwang , Lee Kyung Hee , Park Keon Uk , Baek Sun Kyung , Oh Sang Cheul , Lee Myung Ah , Oh Doyeun , Shim Byoungyong , Kim Jin Won , Ahn Joong Bae , Shin Dongbok 
Published: September 2018

10008 Background: Cancer-related fatigue(CRF) is a common and severe symptom in patients with cancer. The purpose of this study is to evaluate the anti-fatigue effect of Korean Red Ginseng(Steamed Panax ginseng C.A. Meyer) on patients with colorectal cancer. Methods: 438 colorectal cancer patients in treatment with mFOLFOX-6 regimen were randomly assigned to either the Korean Red Ginseng[KRG](n = 219) or placebo(n = 219) group and received 2,000 mg/day test substances for 16 weeks. The primary endpoint was the Area Under Curve(AUC) of Brief Fatigue Inventory(BFI) over 16 weeks. The AUC and change from the baseline were calculated. The frequency and types of adverse events were determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0. Results: 438 colorectal cancer patients were enrolled from 15 institutions. Changes from the baseline in the global BFI were 78.54(Standard deviation [SD] = 16.91) in KRG group vs. 75.89(SD = 16.85) in placebo group at 16 weeks(P = 0.0363). Changes from the baseline in the Usual Fatigue were 76.15 (SD = 17.08) in KRG group vs. 73.08(SD = 17.03) in placebo group at 16 weeks(P = 0.0454). Changes from the baseline in the Mood were 80.46(SD = 17.16) in KRG group vs. 77.88(SD = 17.59) in placebo group at 16 weeks(P = 0.0086). Changes from the baseline in the Relations with Others were 82.09(SD = 17.49) in KRG group vs. 78.67(SD = 17.90) in placebo group at 16 weeks(P = 0.0080). Changes from the baseline in the Walking ability were 82.70(SD = 17.28) in KRG group vs. 80.77(SD = 16.47) in placebo group at 16 weeks(P = 0.0090). Changes from the baseline in the Enjoyment of life were 79.53(SD = 19.53) in KRG group vs. 77.51(SD = 18.02) in placebo group at 16 weeks(P = 0.0150). Toxicities per self-report and CTCAE grading did not differ statistically significantly between the groups. Conclusions: The data supports benefits of consuming 2,000 mg KRG water extract powder daily on CRF over 16-week period. There were no discernible toxicities associated with the treatment. More studies on mechanisms of KRG to guide its role in CRF improvement are needed. Clinical trial information: NCT02039635.
Anti-dementia and anti-hyperlipidemic medication use at end of life in elderly lung cancer patients: Analysis of SEER-Medicare data.
Authors: Kim Min Ji , Duan Zhigang , Zhao Hui , Holmes Holly Michelle , Manzano Joanna-Grace Mayo , Giordano Sharon Hermes , Suarez-Almazor Maria E. 
Published: September 2018

10027 Background: Despite risk for polypharmacy, elderly cancer patients may receive drugs whose time to benefit likely exceeds life expectancy. This study aims to describe use of drugs considered potentially unnecessary, namely anti-hyperlipidemics and anti-dementia drugs, and to identify factors associated with their use in Stage 3 or 4 non-small cell lung cancer (NSCLC) patients approaching end of life. Methods: We identified all patients older than 65 diagnosed with primary Stage 3 or 4 NSCLC between 2006 and 2011 in the Surveillance, Epidemiology and End Results (SEER)-Medicare database. Information on drug prescriptions was extracted from Medicare Part D files. First-time hospice enrollment or death date was used as the final endpoint in analysis. The primary outcome was use of drugs of interest at 4 months before NSCLC diagnosis, 6 months and 3 months before death or hospice. Associations with demographic or other factors were tested using the Pearson χ2 test. Results: Of all 7983 patients, 45.1% were taking statins before diagnosis, while 40.7% and 30.9% were still taking statins at 6 and 3 months before death or hospice. Use of bile acid sequestrants, fibric acid derivatives, and cholesterol absorption inhibitors were found to decrease toward death or hospice. In contrast, anti-dementia drug use did not decrease, with 3.4% before diagnosis and 4.2% and 3.5% at 6 and 3 months before death or hospice. Approximately 30% of anti-dementia medications were newly prescribed at 6 and 3 months before study endpoint. Having a higher number of prescriptions at 3 months before death or hospice was associated with higher rates of drug use both before and after cancer diagnosis. Having a higher Charlson comorbidity index correlated with greater anti-dementia drug use before diagnosis. Demographic, socioeconomic, and treatment factors were not found to be correlated with drug use. Conclusions: A high prevalence of statin use persists while a notable proportion of anti-dementia drugs are newly prescribed toward death or hospice. Our findings suggest an opportunity for clinicians to re-evaluate risks and benefits of potentially unnecessary medications in elderly patients nearing end of life.
Do elderly and young patients derive similar relative survival benefits from novel oncology drugs? A systematic review and meta-analysis.
Authors: Arciero Vanessa Sarah , Cheng Sierra , McDonald Erica , Qureshi Mahin Iqbal , Saluja Ronak , Chan Kelvin K. 
Published: September 2018

10029 Background: Elderly patients are commonly believed to derive less benefit from cancer drugs, even if they fulfil clinical trial eligibility. We aim to examine if novel oncology drugs provide differential treatment outcomes for elderly and young patients on clinical trials. Methods: A systematic review of randomized control trials (RCTs) cited for clinical efficacy evidence in novel oncology drug approvals by the Food and Drug Administration, European Medicines Agency, and Health Canada between 2006 and 2015 was conducted. Studies reporting age-based subgroup analyses for overall or progression free survival (OS/PFS), were considered. Independent reviewers extracted survival hazard ratios (HRs) and confidence intervals (CIs) for age-based subgroups. Meta-analyses based on an inverse variance random effects model were performed to examine patient subgroups < 65 and ≥ 65 years separately, and pooled HRs were compared to examine if differences in relative survival benefits existed between patient subgroups. Sensitivity analyses were conducted specific to cancer type, primary endpoint, and the type of systemic treatment. Results: Eighty-five RCTs, including 55,512 patients, reported age-based survival outcomes and were included. One study reported age-based toxicity and no studies age-based quality of life results. Pooled HRs [95% CIs] for patients < 65 and ≥ 65 years were 0.60 [0.56-0.65] and 0.66 [0.61-0.72], respectively with no difference between the two subgroups ( P= 0.08). All sensitivity analyses revealed similar results. Conclusions: Our results suggest that elderly and young patients derive similar relative survival benefits from novel oncology drugs. In settings where there is no other direct high-level evidence of elderly patients deriving less benefit than younger patients, it is reasonable to consider offering novel oncology drugs to elderly patients who fulfil trial eligibility. There is, however, a need to report age-based toxicity and quality of life results to support patient discussions regarding the balance of treatment benefit and harm, to encourage informed individualized decision-making.
Polypharmacy and potentially inappropriate medication use in older patients with aggressive non-Hodgkin lymphoma (NHL) leads to inferior survival and increased treatment-related toxicities.
Authors: Lin Richard Jirui , Ma Helen , Guo Robin , Grossbard Michael L. , Troxel Andrea B. , Magid Diefenbach Catherine S. 
Published: September 2018

10039 Background: Survival outcomes for older patients with aggressive NHL are disproportionally inferior to those of younger patients. While differences in tumor biology may play a role, older patients are often frail with comorbidities, polypharmacy, and use potentially inappropriate medications (PIM) such as anticholinergics and benzodiazepines. Methods: Using Cox proportional hazard and logistic regression models, we analyzed all aggressive NHL patients age ≥60 treated at our two affiliated hospitals from 2009-2014 to examine the association of polypharmacy and PIM use with progression-free survival (PFS), overall survival (OS), and treatment-related toxicities. Results: In this updated and final analysis, we included 171 patients with complete records from these two hospitals. They share similar demographic, clinical, and laboratory characteristics except for higher International Prognostic Index (IPI) in patients from one hospital. The median age was 70 years (range 65-77). At the time of diagnosis, 46% of patients used more than 4 medications (polypharmacy) and 47% used at least one PIM. Only 43% of patients received first-line chemotherapy of adequate relative dose intensity (>85% dosage), and 65% experienced ≥grade 3 toxicities. Polypharmacy and PIM use were associated with shortened PFS and OS by log-rank test. Most importantly, PIM use remained an independent predictor of PFS, OS, and ≥ grade 3 toxicities in multivariable analyses (Table). Conclusions: This is the first report of significantly adverse survival impacts of polypharmacy and PIM use in older patients with aggressive NHL, presumably from drug-drug interactions that increase toxicities and impair the delivery of adequate chemotherapy dosage. Our findings support the use of evidence-based geriatric principles to guide meticulous medication management to improve outcome disparity for these patients. [Table: see text]
Unmet supportive care needs of older adults with advanced cancer.
Authors: Temel Brandon , Ruddy Margaret , Olson Emily , Moran Samantha M.C. , Fuh Charn-Xin , Hashmi Ardeshir , Scott Erin , Jackson Vicki , El-Jawahri Areej , Temel Jennifer S. , Nipp Ryan David 
Published: September 2018

10040 Background: Cancer disproportionately affects older adults, yet research defining the supportive care needs of these patients is lacking. We sought to examine associations between geriatric impairments, quality of life (QOL), and physical and psychological symptom burden in older adults with newly diagnosed incurable gastrointestinal (GI) cancer. Methods: We prospectively enrolled patients age ≥70 within 8 weeks of diagnosis of incurable GI cancer at Massachusetts General Hospital from 10/2015-11/2016. We used surveys to assess geriatric impairments (Vulnerable Elders Survey-13 [range 0-10, scores ≥3 identify patients with impairments), QOL (EORTC QLQ-C30 [range 0-100, higher scores indicate better QOL]), physical symptoms (Edmonton Symptom Assessment System [range 0-10, higher scores indicate greater symptom burden]) and psychological symptoms (Geriatric Depression Scale, [range 0-15, higher scores indicate greater depression symptoms]). We used descriptive statistics to determine differences in patient characteristics by the presence or absence of geriatric impairments. We used linear regression adjusted for age, employment, cancer type, and comorbidity to examine associations between geriatric impairments, QOL, and physical and psychological symptom burden. Results: We enrolled 50 of 58 (86%) patients approached (mean age = 78.7; 52% with pancreatic cancer). Nearly half (46%) screened positive for geriatric impairments; these patients were older (81.7 vs 76.1, p < .01) and had more comorbid conditions (2.4 vs 1.2, p = .01). On linear regression, patients with geriatric impairments reported worse QOL across all domains (General QOL: B = -28.3, p < .01; Physical: B = -36.8, p < .01; Role: B = -36.8, p < .01; Emotional: B = -30.1, p < .01; Cognitive: B = -17.8, p = .03; Social: B = -39.7, p < .01), higher depression scores (B = 5.1, p < .01) and worse fatigue (B = 4.6, p < .01), drowsiness (B = 4.0, p < .01), appetite (B = 3.8, p < .01), and pain (B = 2.7, p = .02). Conclusions: Older adults with advanced cancer experience considerable unmet supportive care needs, particularly those with geriatric impairments. Future research is needed to assess older patients for geriatric impairments and address their unique palliative and supportive care needs.
Association between glycemic control, age, and outcomes among intensively treated patients with acute myeloid leukemia (AML).
Authors: Kuhlman Patrick , Isom Scott , Pardee Timothy S. , Burns Cynthia , Tawfik Bernard , Lamar Zanetta S. , Powell Bayard L. , Klepin Heidi D. 
Published: September 2018

10043 Background: Hyperglycemia and increased glycemic variability are associated with infection and increased mortality. We evaluated the relationship between glycemic control during AML induction and outcomes by age. Methods: We retrospectively evaluated outcomes in 262 consecutive patients (pts) with newly diagnosed AML hospitalized for intensive induction at Wake Forest Baptist Hospital (2002-2009). Data on mean blood glucose (BG) (mg/dL) during hospitalization and standard deviation (SD) of BG (measure of glycemic variability, GV), complete remission ± incomplete count recovery (CR+CRi), and overall survival (OS) were collected. Modified Charlson Comorbidity Index (CCI), diabetes, age, gender, race, cytogenetics, hemoglobin, WBC, LDH, body mass index, and insurance were used in uni- and multi-variate models. We used logistic regression to evaluate CR+CRi, and Cox proportional hazard models for OS, stratified by age ( < 60 vs ≥60 yrs). Results: 124 pts were < 60 (median age 47, median OS 23.1 months), 138 were ≥60 yrs (median age 70, median OS 7.9 months). Older pts had higher baseline comorbidity (CCI > 1 60.1% vs 25.8%) and a higher prevalence of diabetes (20.3% vs 7.3%). The mean ±SD number of BG values obtained per patient during hospitalization was 61±71. The mean ±SD of each individuals mean BG during hospitalization was 111.6±16.4 in younger versus 121.7±25.9 older pts. The mean SD of BG values [GV] was 26.8±18.6 in younger versus 33±22.8 in older pts. In multivariable analysis higher mean BG was associated with lower odds of CR+CRi in younger (odds ratio (OR) 0.67, 95% CI 0.48-0.93) and older pts (OR 0.78, 95% CI 0.65-0.93) per 10 mg/dL BG increase. Higher mean BG was associated with shorter OS in older adults (HR 1.12, 95% CI 1.04-1.21). Higher GV was associated with lower odds of CR+CRi in younger (OR 0.73, 95% CI 0.56-0.96) and older (OR 0.71, 95% CI 0.57-0.88), as well as shorter OS in older pts (HR 1.17, 95% CI 1.08-1.26) for each 10 mg/dL SD increase in GV. Conclusions: Hyperglycemia and GV during intensive induction are associated with lower CR+CRi rates (all ages) and shorter OS among older adults.Glycemic control during induction may be a modifiable factor to improve AML outcomes.
The importance of recognizing and addressing depression in patients with advanced cancer.
Authors: Wong Risa , El-Jawahri Areej , Irwin Kelly , D'Arpino Sara , Moran Samantha M.C. , Johnson Connor , Lage Daniel , Ruddy Margaret , Temel Brandon , Traeger Lara , Lennes Inga Tolin , Cashavelly Barbara J. , Martinson Holly S , Jackson Vicki , Greer Joseph A. , Ryan David P. , Hochberg Ephraim P. , Pirl William F. , Temel Jennifer S. , Nipp Ryan David 
Published: September 2018

10050 Background: Patients with cancer often experience depression, which is associated with worse outcomes, including longer hospital length of stay (LOS). Although antidepressant medication can improve depressive symptoms in patients with cancer, it is unclear whether their use translates into better outcomes. We sought to clarify the relationship between depressive symptoms, antidepressant medication, and hospital LOS in patients with advanced cancer. Methods: We enrolled hospitalized patients with advanced cancer from 9/2014 to 4/2016 as part of a longitudinal data repository. We examined patients’ medical records to obtain information about documented depressive symptoms in the 3 months prior to admission and use of antidepressant medication at the time of admission. Using descriptive statistics, we compared differences in patient characteristics and hospital LOS across these groups. We used linear regression to examine associations and moderation effects between depressive symptoms, use of antidepressant medication, and hospital LOS. Results: Of 1,036 enrolled patients (89.9% of approached), 126 (12.2%) had documented depressive symptoms in the 3 months prior to admission and 288 (27.8%) were taking an antidepressant medication at the time of admission. Patients with depressive symptoms were more likely to be on antidepressant medication at admission than those without depressive symptoms (48.4% vs 24.9%, p < .001). Patients taking antidepressant medication were younger (62.4 vs 64.4 years, p = .026) and more likely to be female (55.2% vs 47.2%, p = .021). Depressive symptoms were associated with longer hospital LOS (7.3 vs 6.1 days, p = .036), and antidepressant medication was a moderator of this relationship. Among patients not on antidepressant medication, depressive symptoms were associated with longer hospital LOS (7.9 vs 6.1 days, p = .025), but among those on antidepressant medication, depressive symptoms were not associated with hospital LOS (6.6 vs 6.2 days, p = .588). Conclusions: Antidepressant medication moderated the relationship between depressive symptoms and longer hospital LOS. Our results support the need to recognize and address depressive symptoms in patients with advanced cancer.
Treatment decisions and employment of breast cancer patients: Results of a population-based survey.
Authors: Jagsi Reshma , Abrahamse Paul , Lee Kamaria , Wallner Lauren P. , Janz Nancy K. , Hamilton Ann S. , Ward Kevin C. , Morrow Monica , Kurian Allison W. , Friese Christopher Ryan , Hawley Sarah T. , Katz Steven J. 
Published: September 2018

10052 Background: Many patients with breast cancer work for pay at time of diagnosis, and the treatment plan may threaten their livelihood. Given rapidly evolving policies, evidence, and treatment options, we evaluated work experiences in a contemporary population-based sample of breast cancer patients to inform initiatives to reduce the burden of cancer care. Methods: We surveyed women aged 20-79 years diagnosed with stages 0-II breast cancer as reported to the SEER registries of Georgia and Los Angeles in 2014-15. Of 3672 eligible women, 2502 responded (68%); we analyzed 1006 who reported working prior to diagnosis. Multivariable models evaluated correlates of missing > 1 month and stopping work altogether vs missing ≤1 month. Results: In this diverse sample (48% white, 19% black, 20% Latina, 11% Asian), most pts (62%) received lumpectomy; 16% had unilateral mastectomy (8% with reconstruction); 23% had bilateral mastectomy (19% with reconstruction). One third (33%) received chemotherapy. The vast majority (84%) worked full time at diagnosis, but only 50% had paid sick leave, 39% disability benefits, and 38% flexible work schedules. Surgical treatment was strongly associated with missing > 1 month of work (OR 7.8 for bilateral mastectomy with reconstruction vs lumpectomy) and with stopping altogether (OR 3.1 for bilateral mastectomy with reconstruction vs lumpectomy). Chemotherapy receipt (OR 1.3 for missing > 1 month; OR 3.9 for stopping altogether) and race (OR 2.0 for missing > 1 month and OR 1.7 for stopping altogether, blacks vs whites) also correlated. Those with paid sick leave were less likely to stop working (OR 0.5), as were those with flexible schedules (OR 0.3). Those with disability benefits were more likely to stop working (OR 1.6) or miss > 1 month of work (OR 2.7). Conclusions: Working patients who received more aggressive treatments, particularly surgery, were much more likely to experience substantial employment disruptions. Given the growing choice of bilateral mastectomy by patients seeking peace of mind, particularly among young women with years of potential employment ahead, these findings suggest the importance of discussing impact of treatment decisions on employment. Funded by NCI P01CA163233.
Patterns of osteoporosis (OP) in survivors of colorectal cancer (CRC) enrolled on SWOG trials.
Authors: Barzi Afsaneh , Hershman Dawn L. , Till Cathee , Lenz Heinz-Josef , Hochster Howard S. , Unger Joseph M. 
Published: September 2018

10056 Background: There are currently 1.5 million CRC survivors in US and this number will continue to rise with advancements in treatment. The risk of OP in CRC survivors has not been well described. Methods: We used data from 3 SWOG CRC treatment trials, all of which were phase III and had long term follow-up. Enrollees were linked to Medicare claim files for identification of OP and fractures using HCPCS and ICD9 codes. First, we compared patterns of osteoperosis and fracture risk by sex in colorectal cancer patients. To assess whether patterns of fracture risk by sex differed between patients with vs. without colorectal cancer, we compared the difference in fracture risk by sex in colorectal cancer patients to the difference in fracture risk by sex in the general U.S. population, using data from the National Health Interview Survey (NHIS) and the National Hospital Discharge Survey (NHDS). Finally, we assessed whether absolute estimates of osteoperosis and fracture risk differed between men with colorectal cancer and men without colorectal cancer. Comparison data for men without colorectal cancer were obtained from the placebo arm of the Prostate Cancer Prevention trial (PCPT). Results: We linked 1233 CRC cases with Medicare claims. The median age at CRC diagnosis was marginally higher for women (65 vs 64 ys, p = 0.03). 47% of females, 15% of men with CRC, and 19% of men without CRC had a OP diagnosis. The female to male ratio of osteoporotic fracture in general U.S. population was 1.67, while the same ratio in CRC survivors was 2.84, an increase of 70% (p-value < 0.001). Conclusions: Our study indicates that the risk disparity for OP fracture for females is much greater in CRC survivors than in the general U.S. population. This may be due to more OP diagnoses for female CRC survivors, but not for male CRC survivors.