bluuebunny/crossref_metadata_2025 huggingface dataset:
Subjective cognitive complaints one year after ceasing adjuvant endocrine therapy for early-stage breast cancer: Findings from the Breast International Group (BIG) 1-98 trial.
Authors: Phillips Kelly-Anne , Ribi Karin , Aldridge Julie , Thompson Alastair Mark , Harvey Vernon J. , Thurlimann Beat J. K. , Cardoso Fatima , Pagani Olivia , Coates Alan Stuart , Goldhirsch Aron , Price Karen N. , Gelber Richard D. , Bernhard Juerg ,   BIG 1-98 Collaborative Group and International Breast Cancer Study Group
Published: March 2020

9022

Background: We have previously reported that, in the BIG 1-98 trial, objective cognitive function improved in postmenopausal women one year after cessation of adjuvant endocrine therapy for breast cancer. Here we evaluate changes in subjective cognitive function (SCF). Methods: One hundred postmenopausal women, randomized to receive five years of adjuvant tamoxifen, letrozole, or sequences of both, completed self-reported measures on SCF, psychological distress, fatigue and quality of life during the fifth year of trial treatment (year 5) and one year after treatment completion (year 6). Changes between years 5 and 6 were evaluated using the Wilcoxon signed-rank test. SCF and its correlates were explored. Results: Mean age of participants was 63.9 years [SD=7.1 years]. SCF and the other patient-reported outcomes did not change significantly after cessation of endocrine therapy with the exception of improvement in hot flushes (p=0.0005). No difference in changes was found between women who were taking tamoxifen or letrozole at year 5. SCF was the only psychosocial outcome with a substantial correlation between year 5 and 6 (Spearman’s R=0.80). Correlations between SCF and the other patient-reported outcomes were generally low. Conclusions: Although objective cognitive function improved after cessation of adjuvant endocrine therapy in the BIG 1-98 trial, improvement in SCF was not evident. The underlying reason for the clear disconnect between objective and subjective cognitive function seen in this and most other studies, is a crucial issue. It should be a research priority in order to effectively tackle the concerns of women about their cognition during and after breast cancer treatment.
YOCAS yoga for musculoskeletal symptoms in breast cancer patients receiving aromatase inhibitors: A URCC CCOP randomized, controlled clinical trial.
Authors: Peppone Luke Joseph , Mohile Supriya Gupta , Janelsins Michelle Christine , Sprod Lisa , Gewandter Jennifer S. , Heckler Charles E. , Chandwani Kavita Dayal , Morrow Gary R. , Ruzich Janet C. , Esparaz Benjamin , Mustian Karen Michelle
Published: March 2020

9028

Background: Up to 50% of breast cancer patients on aromatase inhibitor therapy report significant musculoskeletal symptoms such as joint and muscle pain, which decreases treatment adherence. We conducted a secondary data analysis of a multi-site, phase III randomized, controlled, clinical trial examining the efficacy of yoga for improving musculoskeletal symptoms among breast cancer patients currently receiving hormone therapy (aromatase inhibitors [AI] or tamoxifen [TAM]) through the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP). Methods: The original RCT randomized patients with any type of non-metastatic cancer without previous yoga participation into 2 arms: 1) standard care monitoring [controls] or 2) 4-week yoga intervention (2x/wk; 75 min/session) plus standard care. The yoga intervention utilized the UR Yoga for Cancer Survivors (YOCAS) program consisting of breathing exercises, 18 Hatha and Restorative yoga postures, and meditation. Only breast cancer patients currently receiving AI (N=95) or TAM (N=72) were included in this secondary analysis. Changes in musculoskeletal symptoms were assessed using ANCOVA with baseline values as covariates between the yoga and control groups. Results: Compared to TAM users at baseline, AI users reported higher levels of general pain (1-5 score: AI=2.65 vs. TAM=2.17; p=0.01), muscle aches (0-4 score: AI=2.14 vs. TAM=1.65; p=0.01), and total physical discomfort (0-24: AI=8.03 vs. TAM=5.92; p=0.01). Among AI users only, participants in the yoga group demonstrated greater reductions in general pain (CS=change score; Yoga CS= -0.37 vs. Control CS= +0.02; p=0.02), muscle aches (Yoga CS= -0.58 vs. Control CS= -0.15; p=0.03) and total physical discomfort (Yoga CS= -2.07 vs. Control CS= -0.58; p=0.04) from pre- to post-intervention than the control group. Conclusions: The severity of musculoskeletal symptoms was higher for AI users than for TAM users. Among breast cancer patients on AI therapy, the community-based YOCAS intervention significantly reduced general pain, muscle aches, and physical discomfort. Funding: NCI U10CA37420, KL2RR024136-05, K07CA120025.
The effect of pretreatment psychosocial factors on immune function and quality of life after brief presurgical stress management.
Authors: Gilts Chelsea D. , Parker Patricia A. , Pettaway Curtis A. , Cohen Lorenzo
Published: March 2020

9031

Background: It is important to identify factors that predict who will benefit the most from psychosocial interventions in cancer populations. Methods: We examined the association between pretreatment psychosocial factors and subjective and objective outcomes from a brief cognitive-behavioral stress management program. This three-arm randomized clinical trial investigated the effects of a presurgical stress management (SM; n=53) compared to supportive attention (SA; n=54) and standard care (SC; n=52) on quality of life (QOL) and immune outcomes in men with prostate cancer scheduled for radical prostatectomy. We previously reported improved QOL 1 year after surgery in the SM and SA groups compared to the SC group and higher pro-inflammatory cytokines 48h after surgery in the SM group. We investigated the moderating effects of baseline psychosocial factors (social support (SS), dyadic adjustment (DA), distress (BSIGSI), and impact of event (IES)), on QOL (SF-36 physical (PCS) and mental (MCS) component scores) 1 year after surgery and immune response 48h after surgery. Results: Baseline SS and BSIGSI interacted with group in predicting PCS 1 year after surgery (p’s <.05). Men who reported low baseline SS and were in SM had increased PCS 1 year after surgery compared to men with low SS in the SC group (b=.36, p<.01). Conversely, men who reported high BSIGSI at baseline and were in SA had increased PCS 1 year after surgery compared to those in SM (b=11.14, p=.03), with SC having an intermediate nonsignificant effect. All four psychosocial factors (SS, DA, BSIGSI, IES) interacted with group in predicting changes in pro-inflammatory cytokines (interleukin (IL)-1, IL-6, IL-8, IL-10, tumor necrosis factor, and interferon) 48h post-surgery (all p’s <.04). In all significant interactions, men who reported greater psychosocial vulnerability at baseline and were in SM had increased immune response 48h after surgery compared to psychosocially vulnerable men in either SC (all p’s <.02) or SA (all p’s <.02). Conclusions: These findings suggest that baseline psychosocial factors are important indicators of who may benefit most from a SM intervention on both subjective and objective outcomes.
Women know, and men wish they knew, prognostic information in advanced cancer.
Authors: Fletcher Kalen M , Prigerson Holly Gwen , Maciejewski Paul K
Published: March 2020

9037

Background: Little is known about gender differences in advanced cancer patient communication with oncologists. The few studies conducted have explored differences in preferences for prognostic disclosure. Our data allow us to test for gender differences in actual rates of audio-recorded, patient and oncologist reported, prognostic disclosures. We studied a group of advanced cancer patients to determine whether gender disparities exist in: a.) reported rates of prognostic disclosures from physicians and b.) willingness to estimate (versus not) one’s prognosis (i.e., amount of time left to live). Among patients who report never receiving a prognosis from their physician, we also tested for gender difference in wishing that this had been discussed. Methods: Coping with Cancer II is an NCI -funded multi-site, prospective longitudinal study of advanced cancer patients. Patients were interviewed after receiving scan results and asked if they have received a prognosis from their oncologist either at their most recent visit or at any time in the course of their disease. They are also asked if they would be willing to estimate their prognosis. Patients who state that they have not received a prognosis are asked if they wish that they had. Results: Among the advanced cancer patients studied (N=51; men=23, women=28), male cancer patients were significantly more likely to state never receiving a prognosis from their physician than female patients (OR=3.5; χ2=4.49, df=1, p=0.034). Male cancer patients were also significantly less willing to provide a life-expectancy estimate (OR=5.6; χ2=5.06, df=1, p=0.025). Among patients who stated never receiving a prognosis (N=27; men=16, women=11), male patients tended to be more likely than female patients to wish that their prognosis had been discussed (OR=7.8; χ2=3.11, df=1, p=0.078). Conclusions: Male advanced cancer patients are less likely than female cancer patients to state that they have received prognostic information and less willing to provide a life-expectancy estimate. Although male patients receive less open prognostic disclosure than female patients, male patients tend to be more likely than female patients to want prognostic information.
Psychosocial correlates of sleep architecture in women with advanced breast cancer.
Authors: Gerry Arianna Aldridge , Jo Booil , Palesh Oxana , Zeitzer Jamie , Neri Eric , Spiegel David
Published: March 2020

9051

Background: Sleep disturbance is prevalent among metastatic breast cancer (MBC) patients and few studies have objectively evaluated this problem using polysomnography (PSG). Disturbed sleep negatively affects quality of life. The current study examines the relationship of mood and family structure with sleep parameters assessed over three nights of PSG (2 at-home, 1 in-lab). Methods: MBC patients (n = 103) and healthy controls (n = 27) were recruited. Patients were 57.8 years (SD = 7.7), non-Hispanic white (86.3%), and had Karnofsky ratings of at least 70%. Multiple regression analyses assessed relationships among depression, cohabitation, and sleep parameters. Results: Among patients, sleep architecture was significantly related to depression and marital status/cohabitation. Women reporting more depressive symptoms had less deep sleep: lower percentage (B = -.26, p = .01) and fewer minutes of REM (B = -.23, p = .02), lower % (B = -.25, p = .02) and fewer minutes of stage 2 sleep (B = -.28, p = .01), and more % stage 1 sleep (B = .28, p = .01). Marriage/cohabitation was positively related to sleep quality indicators: less wake time after sleep onset (B = -.20, p = .05), better sleep efficiency (B = .28, p = .01), more total sleep time (B = .30, p < .01), more minutes of REM (B = .23, p = .02), more stage 2 sleep (B = .27, p < .01), and less % stage 1 sleep (B = -.27, p = .01). Relative to healthy women, patients had more sleep stage transitions/hour (B = .21, p = .03), more awakenings (B = .18, p = .04), and more time awake after sleep onset (B = .21, p = .02). Slow wave (deep, non-REM) sleep was shorter for patients as measured by both minutes (B = -.20, p = .04) and % of stage 4 sleep (B = -.23, p = .02). Conclusions: Depressed patients or those living alone have greater reductions in deep sleep. Relative to healthy women, patients’ sleep disturbance and quality was worse. These findings demonstrate that the architecture of deep sleep is linked to depression and family structure.
Randomized double-blind evaluation of dronabinol for the prevention of chemotherapy-induced nausea.
Authors: Grunberg Steven M. , Munsell Mark F. , Morrow Phuong Khanh H. , Giguere Jeffrey Kent , Ule Ulla Jo , Saccaro Steven J. , Onitilo Adedayo A. , Metzner-Sadurski Joanna K. , Fisch Michael ,   M. D. Anderson Community Clinical Oncology Program Research Base
Published: March 2020

9061

Background: Although great progress has been made in the control of chemotherapy-induced vomiting (CIV), prevention of chemotherapy-induced nausea (CIN) has been less successful. Preliminary data suggests that some families of lesser used antiemetic agents, such as the cannabinoids, may have greater efficacy against nausea than against vomiting. Methods: Adult solid tumor patients (pts) receiving cyclophosphamide ≤ 1500 mg/m2 (C) and/or doxorubicin ≥ 40 mg/m2 (A) were eligible. Pts could have received prior mildly emetogenic chemotherapy (EC). Pts were not eligible who were receiving other moderately or highly EC, were receiving cranial, abdominal or pelvic radiotherapy, had CIV/CIN with previous chemotherapy, had other causes for nausea/vomiting besides chemotherapy, or were scheduled to receive other antiemetics. Pts with habitual cannabinoid use were not eligible. All pts received palonosetron 0.25 mg (PALO) and dexamethasone 10 mg (DXM) IV before chemotherapy. Patients were randomized double-blind to receive dronabinol 5 mg (D) or matching placebo (P) 3 times a day for 5 days. Nausea, vomiting and toxicity data was collected daily for 5 days. Results: 62 pts were entered on study – female/male 61/1, White/Black/Hispanic/Other 45/14/2/1, median age (range) 58 (29-76). No significant difference was noted in CIV-dependent endpoints (including No Vomiting, Complete Response, or Complete Protection) or in rescue medication use. However pts receiving D had a shorter duration of nausea – Mean number of days of nausea (D vs P) 1.86 days vs 3.10 days (p=0.027) – and a trend toward greater frequency of No Nausea (D vs P) 37% vs 17% (p=0.143). Common toxicities included fatigue (D/P 17/11), headache (D/P 16/16), dizziness (D/P 14/7), constipation (D/P 14/11), and diarrhea (D/P 13/6) No pt discontinued therapy due to mood changes. Conclusions: Low-dose D decreased the duration of CIN and increased the frequency of No Nausea in pts receiving C and/or A. Agents to prevent CIV (such as PALO and DXM) and to prevent CIN (such as D) have complementary activity and result in improved overall control when used together.
Effect of complementary and alternative medicine on the survival and health-related quality of life among terminally ill cancer patients: A prospective cohort study.
Authors: Yun Young Ho , Lee Myung Kyung , Park Sang Min , Kim Young Ae
Published: March 2020

9066

Background: Few have examined the effect of complementary and alternative medicine (CAM) use on survival and health-related quality of life (HRQOL) in cancer patients. Methods: From July 2005 to October 2006, we conducted a prospective cohort study of 481 terminally ill cancer patients at 11 university hospitals and the National Cancer Center in Korea. We assessed how the use of CAM affected HRQOL and survival. Results: In a follow-up of 481 patients and 163.8 person-years, we identified 466 deceased cases. On multivariate analyses, CAM users did not have better survival than nonusers (adjusted hazard ratio (aHR), 0.91; 95% confidence interval (CI), 0.74-1.10). Among biologically based therapies, dietary supplements (aHR, 0.70; 95% CI, 0.48–1.01) and ginseng (aHR, 0.73; 95% CI, 0.52–1.04) did not show significantly better survival. Among mind-body interventions, prayer showed significantly worse survival (aHR,1.56; 95% CI, 1.00–2.43). Clinically, CAM users reported significantly worse cognitive functioning (-11.6 v -1.3; p < 0.05) and fatigue (9.9 v -1.0; p < 0.05) than non-users. Compared with non-users in subgroup analysis, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported clinically significant worse changes in some HRQOL subscales. Conclusions: While CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.
Attrition rates, reasons, and predictive factors in supportive/palliative oncology clinical trials at a comprehensive cancer center.
Authors: Glitza Isabella Claudia , Hui David , Chisholm Gary B. , Bruera Eduardo
Published: March 2020

9069

Background: Attrition is common among supportive/palliative oncology clinical trials. Few studies have documented the reasons and predictors for dropout. We aimed to determine the rate, reasons and factors associated with attrition both before reaching the primary endpoint (PE) and the end of study (EOS). Methods: We conducted a review of all prospective interventional supportive/palliative oncology trials by our department between 1999-2010. Patient and study characteristics and attrition data were extracted. We determined factors associated with attrition using multivariate logistic regression analysis. Results: 15 blinded randomized trials and 3 single arm trials were included. 16 of 18 studies did not reach accrual target. Baseline demographics for the 1214 patients were: median age 60 (range 23-93 years), female 56%, Caucasians 69%, ECOG performance status ≥3 41%, gastrointestinal malignancies (23%), median fatigue 7/10, appetite 5/10 and pain 4/10. Attrition rate was 26% (N=311) for PE and 44% (N=535) for EOS. Common reasons for EOS dropout were patient preference (N=93, 17%), symptom burden (N=87, 16%), death (N=45, 8%) and hospital admission (N=43, 8%), and were similar for PE dropouts. No predictors were identified for PE attrition. The Table shows poor performance status, anorexia and dyspnea are associated with EOS attrition in multivariate analysis. Conclusions: We found that attrition rate was high amongsupportive/palliative oncology clinical trials, and was associated with poor function and high baseline symptom burden. These findings have implications for future study designs including eligibility criteria and sample size calculation. [Table: see text]
A randomized, double blind, placebo-controlled crossover trial of a sustained release methylphenidate in cancer-related fatigue.
Authors: Escalante Carmelita P. , Meyers Christina A. , Reuben James M. , Wang Xuemei , Qiao Wei , Manzullo Ellen F. , Alvarez Ricardo H. , Morrow Phuong Khanh H. , Gonzalez-Angulo Ana M. , Mendoza Tito R. , Wang Xin Shelley , Liu Wenli , Holmes Holly Michelle , Hwang Jessica , Pisters Katherine , Overman Michael J. , Cleeland Charles S.
Published: March 2020

9072

Background: Cancer-related fatigue (CRF) is common and distressing. This study assessed the efficacy of OROS methylphenidate 18 mg daily (OM) vs. placebo (P) for CRF reduction. Other objectives were to compare the effects of OM vs. P on other symptoms, cognitive function, work yield, patient (pt) perceptions and preferences, and an exploratory analysis of cytokines. Methods: Initially, pts were randomly assigned (1:1) to receive OM-P or P-OM for 4 weeks (wks). Pts were crossed to the other treatment after 2 wks. Assessments were done at baseline, 2 and 4 wks. Continuous and categorical variables were assessed using Wilcoxon signed rank tests and McNemar tests, respectively. The primary efficacy end point was the change of “fatigue worst” on the Brief Fatigue Inventory (BFI) at the end of each 2 wk period. Results: 42 female breast cancer pts were enrolled (3 ineligible, 6 unevaluable); 33 pts were studied. The mean age was 58 (range, 32-79), 30% had metastasis, 82% were receiving chemotherapy (ctx), 9% hormonal therapy (ht), and 9% both ctx and ht. 94% were ECOG <1 and 52% were employed. 45% were on pain medicines and none on antidepressants. The mean baseline BFI was 5.7 (range 4.1-8.6). Fatigue worst did not differ between OM and P (p= 0.54) or in other symptoms. There was significance in WAIS-III Digit Symbol between OM and P (p=0.01), and Hopkins Verbal Learning Test with BFI interfere and BFI active (p=0.04, p=0.03, respectively). Hours (hrs) missed due to health (p=0.03) and hrs worked (p=0.04) differed in OM vs. P. At study end, pts were asked if OM improved CRF and if they wanted to stay on OM. 64% felt improved. Of these, 58% wanted to continue. There were no serious adverse events due to OM. There were differences in serum IL6 (p=0.03), IL10 (p=0.0004), and TNFα (p=0.02) among OM and P. Conclusions: Low dose OM did not show improvement in CRF on fatigue worst of BFI. Pts taking OM had better cognition and less work absences. Pts tolerated OM well and a majority felt better and wanted to continue OM. Future studies examining higher doses or longer treatment duration with OM, pt preferences and impact on productivity are necessary. Changes in serum cytokine levels should be further explored.
In-hospital and long-term outcomes in patients with malignancy undergoing percutaneous endoscopic gastrostomy (PEG).
Authors: Keung Emily Zhi-Yun , Liu Xiaoxia , Nuzhad Afrin , Rabinowits Guilherme , Patel Vihas
Published: March 2020

9086

Background: PEG is widely performed in cancer patients as a means of providing nutrition or palliation. Although considered safe, PEG-associated outcomes in these patients remain poorly described. We examined the safety and benefits of PEG placement in this patient population. Methods: A five year retrospective review of all patients with malignancy (excluding head/neck, thoracic) who underwent attempted PEG at our institution was performed. Results: PEG was placed in 187 of 189 patients; 64 with hematologic malignancy (H-M), 125 non-hematologic malignancy (NH-M). Median age at time of PEG was 60.8 years. Indication was nutritional support (100%) in H-M, enteral access (59.2%) and management of obstructive symptoms (38.4%) in NH-M. A minority were able to return home (27.5%), discontinue parenteral nutrition (22%), advance diet for nutrition (24.6%) or comfort (17.1%) with the rest remaining NPO. Overall rates of PEG-related major (aspiration, tube dislodgement/leakage, bleeding, visceral injury, respiratory failure after procedure, cardiac arrest) and minor (superficial infection, ileus) complications were 21.4% and 11.3%, respectively, with higher rates in H-M (34.4% and 20.3% vs 14.4% and 6.4%). All cause in-hospital mortality was high: 31.3% H-M, 13.6% NH-M. Median time from PEG placement to death was 54 days. Leading cause of death differed by malignancy: respiratory failure and sepsis in H-M (31% and 21%), primary malignancy in NH-M (75%). Overall one year mortality was 56%. Code status was changed in 21% of patients after PEG (“Full Code” to “Do Not Resuscitate/Do No Intubate” or “Comfort Measures Only”). Multivariate/subgroup analyses will be presented at time of meeting. Conclusions: PEG placement in this study population was associated with significant procedure-related complications and failed to achieve TPN independence or advancement of diet. Nearly 25% of patients declined aggressive resuscitation strategies after undergoing surgery for PEG. Thus, higher burden of counseling is needed to carefully weigh the risk and benefit of PEG placement in these patients. Further studies are needed to elucidate the factors affecting the decision process and patient selection.
Symptoms (Sx) in English (E) and Spanish (S) speaking children with cancer.
Authors: Zhukovsky Donna S. , Wells Robert J. , Robert Rhonda J. , Chisholm Gary B. , Palmer J. Lynn , Cohen Marlene Z. , Rozmus Cathy L. , Allo Julio , Bruera Eduardo
Published: March 2020

9096

Background: Sx in children receiving treatment for cancer are poorly described and often reported by proxies. Study aims were to 1. Characterize sx of pediatric oncology outpatients 2. Evaluate the agreement between patient (pt) and proxy reports 3. Report the association between pt assessed sx and treatments prescribed by physicians (MD). Methods: The pediatric Memorial Symptom Assessment Scale (pMSAS) is a validated tool that evaluates frequency, intensity and distress of 8 sx (version 7-12) or 30 sx (version 10-18) for pts of corresponding ages. Higher scores indicate greater sx burden. pMSAS was translated into S versions. Pt eligibility included ages 7-18, E or S speaking, advanced cancer, pediatric assent/parent consent and E or S speaking family caregiver (CG) with IRB approved consent for self participation. Pts and CG were administered age appropriate pMSAS in E or S independently just prior to MD visit and consenting MDs, the corresponding pMSAS after the visit. Subscale scores included total pMSAS score (TOTAL), psychological, physical and global distress index for older group (OG) and TOTAL for younger group (YG). Statistical analysis included Spearman correlation coefficients and weighted kappas. Results: E and S results were similar and combined. 60 children [age mean +SD 12 +.5, 62% male, 35 S] and their CG completed the pMSAS. 14 MD completed pMSAS for 20 pts. 9 pts (15%) had no sx and 38 (63%), ≥2. The most common sx for ages 7-10 were tired (N=12, 40%) and itch (N=9, 30%) and for ages 11-18, pain (15/30, 50%) and energy (13/29, 45%). Subscale score agreement varied by proxy type and subscale. For TOTAL, highest correlation was 0.6 (p<.001) for YG and 0.7 (p<.001) for OG. For individual sx, agreement between patient and proxy was highly variable (Table). Of symptomatic patients, 6% (3/51) received sx recommendations. Conclusions: Sx in children with cancer are common and undertreated. CG and MD ratings are often not congruent with pt reports which may explain the apparent under treatment of sx. [Table: see text]
Vitamin D3 supplementation to improve fatigue in patients with advanced cancer.
Authors: Trivanovic Dragan , Plestina Stjepko , Dobrilla-Dintinjana Renata , Honovic Lorena , Jerin Lems , Hrstic Irena
Published: March 2020

9097

Background: Fatigue is one of the most common symptoms of patients diagnosed with cancer. Vitamin D deficiency has been associated with an increased risk of mortality in oncology patients. We conducted a prospective vitamin D (cholecalciferol) supplementation study to analyse the response to oral D3 supplementation on fatigue in this population of chemo-naïve patients. Methods: Eligibility critera included life expectancy ≥ 6 months, ECOG PS 0-3, low serum 25-hydroxyvitamin D3 at the time of diagnosis (using cutoff value of 32 ng/mL), and normal serum calcium level. Cancer related fatigue was measured with the Functional Assessment of Cancer Therapy Fatigue module (FACT-F). Patients were randomized to receive oral supplementation with 2,000 IU of Vitamin D3 daily for 3 months with standard cancer treatment or to continue standard treatment without vit D3 supplementation. Primary endpoint was changes in the FACT-F scale. Secondary endpoints was improvement of vitamin D serum levels and safety. Results: 69 vit D deficient patients enrolled in the this study between November 2009 and November 2011 returned a baseline FACT-F. The mean serum 25(OH)D levels were 18.7 ng/ml (SD = 7.4) at baseline. Patients in experimental arm showed marked improvement from baseline in fatigue (p<0.05) and vitamin D serum levels after 3 months (p<0.001). There were significant difference in fatigue score in patients with experimental arm and control arm after 3 months of treatment (p< 0.001). Conclusions: Vitamin D supplementation resulted in a significant increase in Fatigue score and serum 25(OH)D levels in vitamin D deficient patients. Fatigue improve rapidly but remain worse in control arm. The safety profile of vitamin D in combination with chemotherapy or BSC was acceptable. [Table: see text]
Defining mild, moderate, and severe fatigue in cancer patients and survivors: E2Z02, a trial of the Eastern Cooperative Oncology Group.
Authors: Wang Xin Shelley , Zhao Fengmin , Fisch Michael , Mendoza Tito R. , O'Mara Ann M. , Cella David , Cleeland Charles S.
Published: March 2020

9099

Background: Although mild, moderate and severe categories have been used in clinical guidelines for fatigue management in cancer patients, the optimal cutpoints on a 0-10 scale for delineating these categories have not been replicated. Methods: A multicenter ECOG study (E2Z02) enrolled breast, lung, prostate, or colorectal cancer patients with any treatment status. Fatigue and symptom interference were measured on the 0-10 numerical rating scale of the M. D. Anderson Symptom Inventory (MDASI). The optimal boundaries for categorizing fatigue severity were determined by the largest F ratios from MANOVA (Serlin’s criteria, 1995). Logistic regression with robust standard errors was used to identify risk factors for moderate/severe fatigue for cancer survivors (defined as patients with no evidence of disease and receiving no cancer treatment). Results: The optimal cutpoints that identified 3 distinct levels of fatigue severity for the 2341 patients were: ratings of 1-3 as mild, 4-6 as moderate, and 7-10 as severe. Known-group validity for these cutpoints was established by significant differences of fatigue severity by ECOG performance status and patient-reported quality of life (all P<0.001). Using these cutpoints, 45% (983/2177) of patients undergoing active therapy had moderate/severe fatigue, with significant more mild fatigue in breast and colorectal cancer patients, while more severe fatigue in lung cancer patients (p<.001). Among cancer survivors, 29% (150/515) had moderate/severe fatigue (breast 31%, colorectal 27%, prostate 22%, lung 33%). Younger age (OR=0.97, 95% CI=0.95-0.99) and poor performance status (OR=4.21, 95% CI=2.36-7.51) were associated with more moderate/severe fatigue in cancer survivors. Survivor time was also associated with moderate/severe fatigue in breast and colorectal cancer survivors (>=5yrs vs. <5yrs: OR=0.23, P<0.01 for breast, OR=9.3, P=0.03 for colorectal). Conclusions: This multicenter study confirmed the standard cutpoints for fatigue severity used in NCCN fatigue management guidelines. It also provides a profile of moderate to severe fatigue prevalence for actively treated cancer patients and for cancer survivors.
Changes in patient-reported outcomes in women with breast cancer in a multicenter double-blind randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor-induced musculoskeletal symptoms (AIMSS).
Authors: Bao Ting , Betts Kelly , Tarpinian Karineh , Cai Ling , Gould Jeff , Jeter Stacie , Medeiros Michelle , Tait Nancy , Chumsri Saranya , Armstrong Deborah Kay , Bardia Aditya , Tan Ming Tony , Stebbing Justin , Kelleher William Peter , Folkerd Elizabeth , Dowsett Mitchell , Singh Harvinder , Snyder Claire Frances , Tkaczuk Katherine Hanna , Stearns Vered
Published: March 2020

9103

Background: Aromatase Inhibitors (AIs) have been associated with worsening of patient related outcomes (PROs) such as AIMSS, menopausal symptoms and depression. Acupuncture has been reported to alleviate such symptoms. We hypothesized that real acupuncture (RA) would improve PROs more than sham acupuncture (SA). Methods: We collected PROs at baseline, 4, 8, and 12 weeks (wks), from women enrolled in a multi-center double blind RCT designed to assess the effect of acupuncture in reducing PROs. Patients were randomized to 8 wkly RA or SA. PROs were measured by the revised National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression Scale (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQoL survey. We measured estrogen and cytokines concentrations at baseline and wk 8. We used Wilcoxon rank sum and signed-rank tests to make comparisons between and within group, respectively. Results: We included 23 patients from RA and 24 from SA arms in the intent-to-treat analysis. We have previously reported no significant difference in reduction of AIMSS between two arms. RA caused reduction of CESD scores compared to SA (median: -2 vs 0, p = 0.057). When compared to baseline, there were statistically significant improvements at wk 8 in hot flash severity score (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022) scores in RA arm; for EuroQoL (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005) scores in SA arm. The majority of patients’ estradiol concentrations were undetectable at baseline and wk 8. Changes in other time points, data and analysis of cytokines changes will be presented at the meeting. Conclusions: Real and sham acupuncture were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference in the change of PROs between real and sham acupuncture, except for CESD.
Spiritual care provided by oncology physicians and nurses to advanced cancer patients.
Authors: Epstein-Peterson Zachary , Sullivan Adam , Phelps Andrea C. , Balboni Michael J. , Vanderweele Tyler J. , Balboni Tracy A.
Published: March 2020

9116

Background: For many patients facing a diagnosis of advanced cancer, religion and/or spirituality (R/S) play an important role in coping with illness. Data suggest that cancer patients receiving spiritual care (SC) have better quality of life and receive less futile, aggressive interventions at the end of life. National palliative care guidelines include SC as a key component of end-of-life care. However, current SC practices and the role clinicians should play in SC provision remain unclear. Methods: The Religion and Spirituality in Cancer Care (RSCC) study is a survey-based, cross-sectional study of oncology physicians and nurses and advanced cancer patients from five Boston-area institutions. The survey elicited respondents’ R/S beliefs/practices, their views on the appropriateness of SC in the advanced cancer care setting, and their experiences in giving or receiving SC (e.g., spiritual history, referrals to chaplains). In total, 68 patients, 204 physicians, and 114 nurses responded (response rates: patients = 73%; clinicians = 63%). Multivariable analyses (MVAs) were performed to determine predictors (e.g., clinician demographics, R/S, spiritual care training) of SC provision by clinicians. Results: All respondents reported a low frequency of SC provision, with only 9% of patients receiving SC from physicians, 20% from nurses, and physicians reporting performing SC during only 8% of interactions, nurses during 12% of interactions. In MVAs, prior training in spiritual care was significantly associated with SC provision (OR physicians 5.89, CI 2.14-16.22; OR nurses 10.42, CI 1.30-89.19), as was the provider identifying as being spiritual (OR 3.85 physicians CI, 2.12-6.98; OR 2.92 nurses CI, 1.15-7.42). Conclusions: These data highlight the current inadequacies of SC provision by clinicians, despite national palliative care guidelines, and underscore the central role of SC training for doctors and nurses, as this was the strongest predictor of SC provision. Given the important role that SC has in end-of-life care and the paucity of data guiding its provision, we hope this research will advance the understanding of how to integrate SC into end-of-life care, and ultimately improve patient outcomes at the end-of-life.
Final results of a large collaborative, hospital-based quality improvement study aimed at the implementation of interventions for the psychosocial care of adult cancer patients (HUCARE project).
Authors: Passalacqua Rodolfo , Caminiti Caterina , Annunziata Mario , Borreani Claudia , Diodati Francesca , Fagnani Daniele , Isa Luciano , Filiberti Silvia , Ollari Maria Grazia , Saleri Jessica
Published: March 2020

9120

Background: Incorporating psychosocial research into practice is challenging. Aim of this study is to assess the feasibility and effectiveness in real life of interventions which have been tested in RCTs and have demonstrated to improve pts psychosocial conditions Methods: This is an implementation study of five EBM interventions conducted in 28 centers. We adopted the model of Pronovost (BMJ 2008), which includes context analysis to identify local barriers; introduction of the interventions, and evaluation of how many pts receive the recommended interventions. Primary EPs: degree of implementation detected in a blinded fashion by external personnel. Interventions included: 1) EBM communication courses for doctors and nurses; 2) use of a question prompt list (QPL) for all pts; 3) creation of the Point of Information and Support (PIS) in the ward (J Clin Oncol 27:1794-99,2009); 4) identification of a referring nurse (RN) for informing and educating pts; 5) screening of distress and social needs. Results: In December 2008, 28 eligible centers applied to participate. 27 are evaluable and 1 is too early. 156 oncologists and 401 nurses attended the 3 days training course. A QPL was subjected to cross-cultural adaptation, yielding the first validated Italian QPL (BMC Health Serv Res 2010). 24 centers (89%) have successfully implemented the intervention; 3 centers failed for various reasons: internal conflicts of the staff, poor motivation, etc. Main results for each intervention are shown in the table. Conclusions: A successful implementation of EBM measure was obtained in the vast majority of oncology centers and yields to significant changes in the delivery of psychosocial care. Project funded by the Italian Ministry of Health and Lombardia Region. [Table: see text]
Prospective cohort study of chemotherapy-induced alopecia with or without scalp cooling.
Authors: Lemieux Julie , Maunsell Elizabeth , Provencher Louise , Lauzier Sophie , Younan Rami , Abdous Belkacem
Published: March 2020

9138

Background: Scalp cooling can prevent chemotherapy-induced alopecia. Success varies according to the type of chemotherapy. A controversy exists regarding the use of scalp cooling because of the lack of efficacy data with modern chemotherapy regimen and safety data. We present a prospective cohort study design to measure alopecia. Methods: The prospective study was conducted at the Centre des Maladies du Sein Deschênes-Fabia (CMS) in Quebec City (where scalp cooling is offered routinely and 85% of women use it) and at the Centre Hospitalier Universitaire de Montreal (CHUM), in Montreal (where scalp cooling is not available). Women were eligible if they were going to receive neoadjuvant or adjuvant chemotherapy for breast cancer. The study involved completion of questionnaires (on degree of alopecia, hair type, hair care, use of head accessories, tolerance to scalp cooling and questions related to sick leave from work) and having pictures taken at baseline, cycle 3 and at the last cycle of chemotherapy. For the last 43 patients, the EORTC QLQ-C30/BR23 and an adaptation for Hairdex were added. Results: A total of 136 patients were recruited (110 at CMS over 2 years and 26 at the CHUM over a 9-month period). Preliminary efficacy results are shown in the Table (data on quality of life have not yet been analyzed). Hair preservation was defined as a SUCCESS for hair loss (since the beginning of chemotherapy) characterized as “not at all”, “a little” or “moderate” and “FAILURE” when characterized as “a lot” or “all” or “hair shaved”. Overall, in the scalp cooling group, 34% were considered a “success” using hairdresser evaluation and 49% using patient evaluation; for the non scalp-cooling group, these rates were 9% and 4% respectively. Conclusions: Scalp cooling appears to be efficacious for preventing chemotherapy-induced alopecia in this exploratory cohort study. [Table: see text]
Advance care planning (ACP) among hematopoietic cell transplant (HCT) patients and bereaved caregivers.
Authors: Loggers Elizabeth T , Lee Stephanie , Chilson Kate , Back Anthony , Block Susan , Loberiza Fausto R.
Published: March 2020

9139

Background: HCT remains a high risk, potentially curative treatment typically offered to young, otherwise healthy patients with hematologic malignancies. Given this, patients and caregivers may not have considered end-of-life ACP. This study investigated the effect of pre-transplant ACP in surviving patients or bereaved caregivers. Methods: A retrospective, mixed-methods, audio-taped telephone survey adapted from validated instruments was conducted by a trained interviewer with English-speaking HCT survivors (n=18) and bereaved caregivers (n=11), 6-12 months post-HCT. Subjects were identified via HCT databases at two high-volume, tertiary centers between 2001-2003. Analysis included percentages from quantitative sections and qualitative transcripts coding by 2 investigators, with differences resolved by consensus. Results: HCT survivors [median age 47 years (range 33-67); 50% college-educated; all white] were interviewed a median of 13 months after HCT for acute leukemia (7), lymphoma (5), or other (6). Twelve (67%) had discussed mortality risk pre-HCT with the medical team; of these, 83% felt hope was increased or unchanged (I/U) and 100% felt clinician commitment to transplant was I/U by the conversation. Regardless of whether mortality was discussed, 50% had living wills and >75% had a formal proxy, yet 67% didn’t discuss mortality with family members pre-HCT. “Ignorance is bliss” was expressed by 6 survivors while 2 survivors regretted not discussing mortality risk. Bereaved caregivers [73% spouses; all W] were interviewed a median of 10 months after their loved one’s death, which occurred a median of 31 days (range 13-152) post-HCT. 100% were the patient’s proxy. Nine (82%) had discussed mortality risk pre-HCT with the medical team; of these, 78% felt hope was I/U, 100% felt clinician commitment to transplant was I/U, and 78% discussed EOL preferences with the patient pre-HCT, with 67% feeling ACP reduced burden. Four expressed appreciation for “the straight story.” Conclusions: Discussions of potential mortality with patients and caregivers before HCT did not affect hope, and supported confidence in medical teams.
Physical and functional well-being in women with breast cancer taking gabapentin for hot flashes.
Authors: Chandwani Kavita Dayal , Roscoe Joseph , Heckler Charles E , Mohile Supriya Gupta , Mustian Karen Michelle , Sprod Lisa , Janelsins Michelle Christine , Peppone Luke Joseph , Kirshner Jeffrey J. , Lord Raymond S. , Pandya Kishan J. , Guttuso Thomas , Morrow Gary R.
Published: March 2020

9141

Background: Hot flashes reduce quality of life (QOL) in women with breast cancer. In a randomized, double-blind, placebo-controlled trial of gabapentin for hot flashes, 900 mg of the drug was found to reduce hot flashes in women with breast cancer; however, their QOL of has not been studied. We conducted secondary analyses to study two domains of QOL: physical (PWB) and functional well-being (FWB) in women in this trial. Methods: A nationwide sample of women with breast cancer and hot flashes ≥ 2/day was studied at baseline (T1), 4 weeks (T2), and 8 weeks (T3) of treatment with gabapentin 300mg/day (G300) and 900mg/day (G900) in divided doses, and a matching placebo (PL). PWB and FWB were assessed via subscales of the Functional Assessment of Cancer Therapy-Breast. Linear mixed model analyses of PWB and FWB were conducted, adjusted for demographic and treatment variables. Results: The mean age of women (N=384) was 54.9 years ± 8.07 (range: 31-81, 72% >50 years); 76% were married; 71% had more than high school education; 95% were Caucasian and 3% African-American; 10% were undergoing chemotherapy, and 9% radiotherapy (RT). PWB showed significant time effect (p<.0001) and interaction of time and treatment (p<.0001). There was an improvement in PWB in the G300 by T2 with no change at T3, while the improvement in PL and G900 was more modest at T2 and continued at T3 (PL - T1 20.7, T2 21.2, T3 21.6; G300 - T1 20.9, T2 22.2, T3 22.2; and G900 - T1 21.2, T2 21.5, T3 21.7). FWB also showed a significant time effect (p=.001) and interaction of time and treatment (p<.002). FWB in G300 improved by T2, with no additional improvement at T3; it was unchanged in G900 at T2 with a slight reduction at T3; PL showed a modest improvement at T2 followed by a modest worsening at T3 (PL - T1 17.8, T2 18.1, T3 17.9; G300 - T1 17.9, T2 18.6, T3 18.6; G900 - T1 18.6, T2 18.6, T3 18.5). Conclusions: As reported previously, G900 is effective in reducing hot flashes. In this analysis, however, PWB and FWB showed different patterns of change over time between the two gabapentin and placebo groups with G900 showing minimal effects on PWB and FWB. Future trials to further study the changes in physical and functional well-being of women with breast cancer taking gabapentin for hot flashes are needed.
A phase I/II study of LDE225, a smoothened (Smo) antagonist, in pediatric patients with recurrent medulloblastoma (MB) or other solid tumors.
Authors: Geoerger Birgit , Aerts Isabelle , Casanova Michela , Chisholm Julia C. , Hargrave Darren R , Leary Sarah , Ashley David M , Bouffet Eric , MacDonald Tobey , Hurh Eunju , Dey Jyotirmoy , Kalambakas Stacey , Amakye Dereck Dokyi , Kieran Mark W.
Published: March 2020

9519

Background: Hedgehog (Hh) signaling is crucial in the development and homeostasis of many human organs and tissues. Aberrant Hh signaling is involved in tumorigenesis through promotion of cell proliferation, survival, and differentiation in wide range of human cancers, including approximately 30% of MBs. LDE225 is a potent and selective inhibitor of Smo, a key positive regulator of Hh signaling. The phase I is exploring the safety and pharmacokinetics of LDE225 in pediatric patients with advanced solid tumors that are potentially dependent on Hh signaling. Preliminary data from the ongoing phase I are presented. Methods: Dose-escalation was performed according to a Bayesian design starting at 372 mg/m2 of continuous once daily oral LDE225. Safety and preliminary efficacy of LDE225 at the maximum tolerated dose will be assessed in pediatric and adult patients with recurrent MB in a phase II expansion part. Pharmacokinetic profiles were performed at Day 1 and 21. Tumor samples were analyzed for Hh pathway activation status using a 5-gene Hh signature assay. Results: Thirty-three patients (24 MB, 3 rhabdomyoscarcoma [RMS], 3 osteosarcoma, and 1 each of neuroblastoma, gliomatosis and oligoastrocytoma) with a median age of 13 years (range, 4–17 y) have enrolled. Dose-limiting toxicity of Grade 4 creatine phosphokinase elevation occurred in 1 RMS patient out of 7 patients treated at 372 mg/m2. No dose-limiting toxicity was observed at 233 and 425 mg /m2. LDE225 at 233 and 372 mg/m2 was absorbed with a median Tmax of 2 h (range, 1–24 h). Systemic exposures were comparable with adults. Two MB patients achieved a confirmed complete response (CR) at doses of 372 and 425 mg/m2. Analysis of 14 available MB tumor samples using the 5-gene Hh signature assay showed that the 2 CR patients have Hh‑activated tumor. The remaining 12 tumor samples were from patients who did not achieve response and were determined to be Hh pathway non-activated. Conclusions: LDE225 is well tolerated in pediatric patients with advanced malignancies. Preliminary data show promising efficacy in medulloblastoma patients and support the use of the 5-gene Hh signature assay as a pre-selection tool in future trials.