bluuebunny/crossref_metadata_2025_split huggingface dataset:
NK1 receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting: An updated meta-analysis.
Authors: dos Santos Lucas Vieira , Brunetto Andre Tesainer , Sasse Andre Deeke , Souza Fabiano Hahn , Lima Joao Paulo 
Published: March 2020

e20506 Background: We have previously shown (dos Santos JNCI 2012) that NK1 receptor antagonists (NK1RA), such as aprepitant and casopitant, improve chemotherapy-induced nausea and vomiting (CINV) at the cost of increasing severe infection risk. Herein, we update our results. Methods: We searched MEDLINE, EMBASE, CENTRAL and meeting proceedings to identify randomized controlled trials (RCTs) comparing standard antiemetic therapy (dexamethasone + 5-HT3R inhibitors) versus NK1RA plus standard therapy for CINV prevention. Complete response (CR) was defined as absence of emesis and rescue therapy. The endpoints were CR post-chemotherapy in the overall phase (first 120 hours), CR in the acute phase (first 24 hours), and the delayed phase (24–120 hours), nausea, and toxicity. Subgroup analyses evaluated the type of NK1RA, the emetogenic potential of the chemotherapy, and prolonged use of 5-HT3R inhibitor. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using a random-effects model. Results: A total of 20 trials (9,935 patients) were included. NK1RA increased CR rate and nausea in all phases and subgroups. The CR in overall phase improved from 56% to 72% (OR = 0.52, 95% CI = 0.46 to 0.59, P < .00001, NNT=6). The side effects of NK1RA followed our previous report: the severe infection rate increased from 2.4% to 5.6% in the NK1RA group (four trials, 1656 patients; OR = 2.87; 95% CI = 1.58 to 5.19, P = .0005, NNH=31). Conclusions: NK1RA consistently improve CINV control in the acute, delayed, and overall phases, either for moderately or highly emetogenic chemotherapy regimens. Their use might be associated with increased infection rate, and a patient-level meta-analysis is warranted to clarify this safety issue.
Quality of life and psychosocial distress in young women with advanced breast cancer.
Authors: Seah Davinia Shien , Gelber Shari , Ruddy Kathryn Jean , Tamimi Rulla M. , Schapira Lidia , Come Steven E. , Meyer Meghan E , Larsen Bryce G. , Winer Eric P. , Partridge Ann 
Published: March 2020

e20508 Background: Little is known about the quality of life (QOL), prevalence and predictors of psychosocial distress in young women with advanced breast cancer (ABC). Methods: As part of an ongoing longitudinal multi-center study of women aged < 40 with newly diagnosed breast cancer, we identified women with ABC. Using baseline survey and medical chart data, we assessed QOL (measured by the Medical Outcomes Study Short Form-36 [SF-36], with norm based means [NBM] <47 indicating a clinically meaningful worsening QOL compared to the general population), and evaluated relationships between demographic and clinical variables and psychosocial distress (measured by the Hospital Anxiety and Depression Scale [HADS], with higher scores indicating more distress). Demographic and clinical factors were tested in univariate models. Factors with a p < 0.2 were evaluated in multivariate models to determine factors associated with anxiety or depression (HADS subscale scores >11). Results: Of the 725 women who completed a baseline survey, 40 had ABC. Median age of ABC diagnosis was 37 (range 23-40). Median time between diagnosis and survey completion was 143 days. Other than general health (NBM 56.8) and role limitations due to emotional problems (NBM 53.8), SF-36 subscale scores of young women with ABC were lower compared to the general population, especially, bodily pain (NBM 27.4), social functioning (NBM 33.5) and mental health (NBM 44.3) scores. Physical and mental component summary NBM scores were 44.3 and 45.8 respectively. 30% (12/40) were anxious and 10% (4/40) were depressed according to HADS. The 4 depressed women also met criteria for anxiety. Women who were more financially comfortable were less anxious (OR 0.07, p=0.04). Logistic regression identified no other factors associated with anxiety, and no factors were associated with depression. Conclusion: QOL is impaired in young women with recently diagnosed ABC, particularly from bodily pain and disruption to social functioning. Many young ABC patients are anxious, while few are depressed. This study will be expanded to include young women who progressed to ABC. Further research is warranted to evaluate interventions to improve QOL and psychosocial distress in this population.
Lack of patient-clinician concordance (LOC) across disease and treatment status in cancer.
Authors: Chandwani Kavita Dayal , Zhao Fengmin , Morrow Gary R. , De Shields Teresa , Minasian Lori M. , Manola Judith , Fisch Michael 
Published: March 2020

e20520 Background: The number and severity of cancer patients’ concerns is associated with their distress. Discrepancies between patient (pt) and clinician reporting of cancer pts’ symptoms and concerns have been reported during treatment. However, information on LOC across the disease and treatment status is lacking. This study explored LOC between pts and clinicians about pts’ bother related to disease and treatment status in those who needed assistance with questionnaires (NA) or self-administered (SA). Methods: Cancer pts and their clinicians in the Symptom Outcomes and Practice Patterns study rated pts’ bother (scale:0=Not at all, 4=Extremely) due to difficulties related to cancer, its treatment, side effects (SE), and comorbidity (COMORB), recoded to LOC ( 0=no difference between pts and clinicians, 1=any difference). Comparison of LOC proportions was conducted based on the disease status (4 groups: no evidence of disease [NED], local/regional [LR], metastases [mets], and mets+ LR) and current treatment (yes/no) using Chi square test. Results: The majority of pts (N=3013) were Caucasian (86%) females (70%) and had ECOG PS= 0 (87%). Mean age was 61.2 years (SD=12.4). 86.7% did not need help with the questionnaires/SA. Eight subgroups defined by disease status and current treatment showed statistically significant differences in LOC proportions re: bother due to treatment, SE, and COMORB in both the SA (range: 52.8%-86.7%, 41.6%-80.0%, 52.3%-81.3%, respectively, p<.001) and NA groups (range: 40.7%-82.4%, 29.6%-70.6%, 48.1%-72.8%, respectively, p<.05). Differences in the proportions of pts with LOC re: bother due to cancer were statistically significant for SA group only (range: 55.6%-81.3%, p=.01). In both SA and NA groups, pts with mets or mets+ LR had higher proportion of LOC re: bother due to treatment, SE, and COMORB than pts with NED or LR (p<.05). Conclusions: This study provides evidence of LOC in patient-clinician reporting of cancer pts’ bother re: disease and treatment status. Greater proportion of pts with advanced disease showed LOC. Further study of LOC in reporting bother related to various aspects of cancer experience is needed to confirm these results and to understand how they relate to outcomes of care. Clinical trial information: NCT00303914.
Association between cancer-related fatigue and other symptoms in breast cancer patients.
Authors: Peoples Anita Roselyn , Heckler Charles E. , Roscoe Joseph A. , Kamen Charles Stewart , Peppone Luke Joseph , Mustian Karen Michelle , Janelsins Michelle Christine , Moore Dennis Frederic , Coles Charlotte , Hoelzer Karen L. , Williams Jacqueline P , Morrow Gary R. 
Published: March 2020

e20526 Background: Cancer-related fatigue (CRF) is one of the most prevalent side effects of cancer treatment and has a detrimental effect on a patient’s normal functioning and quality of life. At present, the underlying pathophysiology of CRF is poorly understood, as it is complex phenomenon involving the interaction of many factors. The relative contributions of the disease itself, different cancer therapies, and comorbid conditions (e.g., sleep disorders, nausea) remain unclear. Therefore, it is important to understand the association between them in order to develop better strategies for the prevention and treatment of CRF. Methods: The purpose of these secondary analyses was to examine the association between post-treatment fatigue with disturbed sleep (on a 0–10 scale), delayed nausea (on a 1–7 scale), age, and baseline fatigue. Analyses were performed on 541 breast cancer patients (mean age 54, 100% female) who completed a four-day diary assessing nausea and sleep following initial chemotherapy. Fatigue as its worst during the prior week (0 = no fatigue to 10 = fatigue as bad as you can imagine) was assessed both prior to chemotherapy and on Day 4. To determine associations between variables, Pearson’s correlation analysis and linear regression were performed. Results: Post-treatment CRF was significantly associated with baseline fatigue (r = 0.40, p < 0.0001), disturbed sleep (r = 0.45, p < 0.0001), delayed nausea (r = 0.37, p < 0.0001), and age (r = -0.22, p < 0.0001). Linear regression showed that a one unit increase in baseline fatigue, disturbed sleep, and delayed nausea was associated with increase in post-treatment CRF by 0.29, 0.37, and 0.42, respectively, all p’s < 0.0001. In addition, every ten years of increased age was associated with a decrease in post-treatment CRF by 0.33 (p < 0.0013). Conclusions: Post-treatment fatigue was found to be significantly correlated with baseline fatigue, disturbed sleep, and delayed nausea while negatively correlated with age in patients with breast cancer. These results demonstrate the importance of further research to better understand the underlying psychological and biological mechanisms for CRF in order to develop effective treatments. Supported by NCI grant CA37420.
Development and validation of the functional assessment of cancer therapy: Antiangiogenesis (FACT-AntiA).
Authors: Yount Susan , Kaiser Karen , Beaumont Jennifer L , Webster Kimberly , Wagner Lynne I. , Schenk Tom L. , Kuzel Timothy , Cella David 
Published: March 2020

e20527 Background: Anti-angiogenesis therapies represent a significant and promising advancement in cancer treatment. Side effects from angiogenesis inhibitors, although generally milder than chemotherapy side effects, have the potential to impact Health-related Quality of Life (HRQOL) and may lead to dose reduction or discontinuation. Currently, there are no patient-reported outcomes (PRO) measures that specifically assess HRQOL related to anti-angiogenesis therapy. This study describes the development and validation of a PRO questionnaire for anti-angiogenesis therapy, the FACT-AntiA. Methods: Scale development included identification of 59 anti-angiogenesis side effects from the literature and clinician and patient input. Patient and clinician ratings of the importance of these side effects led to the development of a 24-item scale. Cognitive interviews with 10 patients confirmed item wording and meaning. To assess psychometric properties of the scale, 132 kidney cancer patients completed the FACT-AntiA and other PRO measures including the Functional Assessment of Cancer Therapy-General (FACT-G), the FACT-Kidney Cancer Symptom Index-19 (FKSI-19), and PROMIS Global Health at 3 time points. Patient responses to the FACT-AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. Results: FACT-AntiA side-effect subscales scores and total score were found to have good internal consistency reliability (most Cronbach’s alpha > 0.70). Test-retest reliability was greater than 0.70 for most subscales and individual items. All single items (except nosebleeds), subscales, and the total score significantly differentiated between groups defined by level of side effect bother. Conclusions: The number of patients who reported a change in their side effect bother was small so evaluation of FACT-AntiA responsiveness to change requires further study. The FACT-AntiA was developed and validated as a tool to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies and is a reliable and valid index for evaluation of therapy side effects.
Prediction of major surgical complications by comprehensive geriatric assessment in elderly patients with gynecologic cancers: A prospective cohort study.
Authors: Kim Jae Weon , Suh Dong-Hoon , Kim Mi-Kyung , Kim Hee-Seung , Chung Hyun Hoon , Park Noh Hyun , Song Yong Sang 
Published: March 2020

e20530 Background: To evaluate the ability of a preoperative comprehensive geriatric assessment (CGA) to predict the risk of postoperative complications in elderly patients who underwent primary surgery for gynecologic cancers. Methods: Sixty consecutive patients (26 ovarian, 16 cervical, 7 endometrial, 5 uterine sarcoma, 4 vulvar, and 2 metastatic cancers) older than 70 years scheduled to take surgery electively for gynecologic cancer were preoperatively assessed by CGA. Every category of CGA was evaluated for in-hospital postoperative complications and mortality within 30 days of surgery. Major complication included any complication of 2 or higher grade according to Memorial Sloan-Kettering Surgical Complication Criteria 12/99. Results: Mean age was 73.6±3.5 years (range 70-85). Overall postoperative complication rate was 30.0% (18/60) including 9 (15.0%) major and 8 (13.3%) multiple complications. Mean hospital stay was 18.4±13.3 days (range 3-81), during which in-hospital mortality was 2 (3.3%). Univariate analysis revealed that dependent instrumental activity of daily living (IADL) was associated with any postoperative complication (p=0.023), especially for multiple complications (p=0.019). However, poor performance status (PS) was associated only with major and multiple complications (p=0.021 and p=0.014, respectively). Multiple regression analysis revealed that dependent IADL was the independent risk factor for any postoperative complication (relative risk [RR] 8.0, 95% confidence interval [CI] 1.1-59.8, p = 0.042). Notably, poor PS was significantly associated with postoperative mortality (p = 0.006), however, dependent IADL with a marginal significance (p = 0.059). Conclusions: IADL and PS were useful to predict postoperative complications and related mortality in elderly patients with gynecologic cancers. Postoperative complications and related mortality can be prevented by identifying the elderly patients with gynecologic cancers who showed dependent IADL and poor PS in CGA.
Body composition in head and neck cancer patients undergoing concurrent chemoradiation.
Authors: Zatarain Lauren Azure , Murphy Barbara A. , Dietrich Mary S. , Silver Heidi J. , Gilbert Jill , Ridner Sheila H , Cmelak Anthony 
Published: March 2020

e20531 Background: We report results of a randomized pilot study assessing the impact of amifostine and a low weight tailored resistance exercise (LWTRE) on body composition in head and neck cancer (HNC) patients undergoing concurrent chemoradiation (CCR). Methods: Forty patients with stage III-IVB HNC scheduled for primary or adjuvant CCR were enrolled. Patients underwent primary randomization to CCR +/- amifostine and secondary randomization to nutrition counseling +/- LWTRE. IV amifostine was administered prior to radiation. Nutritional counseling and LWTRE began day 1 of CCR and continued through month 6 post-CCR. Weight was obtained at baseline, 1, 3 and 6-months post-CCR. Patients underwent lean mass measures by dual-energy X-ray absorptiometry (DEXA) at baseline, 1 and 3 months post-CCR. Results: Mean weight loss (WL) was 11.6 ± 6.3 kg (p < 0.001) from baseline to 6 months post-CCR. Mean lean mass loss (LML) was 3.5 ± 3.0 kg (p< 0.001) from baseline to 3 months post-CCR. The greatest change occurred from baseline to 1-month post-CCR: 10% and 7% decrease in weight and lean mass respectively. The LWTRE was feasible and safe (no adverse events). Neither amifostine nor LWTRE impacted weight or lean mass loss. Conclusions: Results failed to demonstrate decline in WL/LML with either intervention. Data confirmed WL/LML as profound acute treatment toxicity. It underscored the protracted course of WL/LML. LML has been shown to predict clinical outcomes such as reduced functionality leading to decreased quality of life. Long term follow-up of patients is needed to clearly understand the trajectory and sequellae of body composition changes in HNC patients post-CCR. Novel interventions must be designed and tested to prevent LML. Clinical trial information: NCT00503776. [Table: see text]
The ability of physical performance test and Karnofsky performance status to identify elderly cancer patients requiring a comprehensive geriatric assessment: A comparative study.
Authors: Nassani Najib Antoine , Ghanem Sassine , Kassouf Elie , El Osta Lana , El Karak Fadi , Ghosn Marwan 
Published: March 2020

e20534 Background: The role of Physical Performance Test (PPT) as a screening tool for patients in geriatric oncology requiring a Comprehensive Geriatric Assessment (CGA) has not been studied so far. We undergo this study to assess PPT as a screening tool in comparison with Karnofsky Performance Status (KPS) and CGA. Methods: One hundred patients, aged ≥ 70 and diagnosed with cancer participated in our study. Inclusion criteria were knowledge of Arabic, French or English and absence of significant cognitive impairment. Exclusion criteria were: KPS<60% or severe medical condition. ROC curves were used to compare PPT and KPS in identifying ≥ 2 impairments on CGA. Results: Median age was 76 years (70 – 89). Most frequent malignancies were: Lung (19%), colo-rectum (16%), and breast (15%). Stage IV was present in half of patients. Patients were at increased risk of malnutrition (46%) and malnourished (15%), had moderate to severe pain uncontrolled by medication (41%), were at risk of falls (42%), were suffering from frequent sleeping problems (43%), had vision (56%) and hearing (36%) impairment, have had urinary incontinence within one year (21%). All had social support in case of emergency. Cardiovascular (67%), diabetes mellitus (30%) and pulmonary (26%) were the most frequent comorbidities. A remarkable prevalence of geriatric problems was noted with 69% having ≥ 2 impairments on CGA. A good correlation existed between KPS and PPT r = 0.68 (p<.0001). PPT (Se=65%, Sp=84%, PPV=90%, NPV=52%, cut-off ≤24) was equivalent to KPS (Se=65%, Sp=81%, PPV=88%, NPV=51%, cut-off ≤80%) in identifying ≥ 2 impairments on CGA. Conclusions: Patients aged ≥ 70, diagnosed with cancer and having a KPS ≤ 80% or a PPT ≤ 24 must be referred to specialists in geriatric oncology or to geriatricians for a thorough assessment.
Development and validation of the hand-foot reaction and quality of life (HF-QoL) questionnaire for oncology.
Authors: Anderson Roger T. , Keating Karen N. , Doll Helen A 
Published: March 2020

e20537 Background: Skin toxicity (hand-foot syndrome and hand-foot skin reaction, HFS/R) related to antineoplastic therapy is a significant issue in oncology practice with potentially large impacts on health-related quality of life (HRQL). Methods: A brief, patient self-reported questionnaire, The Hand-Foot Quality of Life (HF-QoL), was developed to measure HFS/R symptoms associated with cancer therapeutic agents and their effect on daily activities. The validity and reliability of the HF-QoL was tested in a phase 2b trial of sorafenib in 223 patients with locally advanced or metastatic breast cancer. Other measures completed included a patient rating of condition severity, the FACT-B, and the clinician-rated NCI-CTCAE [version 3.0] grading for rash. Psychometric properties tested included factor loadings, internal consistency, construct and discriminant validity, and responsiveness. The minimal clinically important difference (MCID) was estimated. Results: The final HF-QoL instrument comprises a 20-item Symptom rating scale and an 18-item Daily Activities scale. Each scale demonstrated excellent measurement properties and strongly discriminated between NCI-CTCAE grade and patient-rated condition severity with moderate to large effect sizes (>0·50 standard deviation). The Daily Activities domain had excellent internal consistency (Cronbach’s alpha 0·96) and was correlated with FACT-B, FACT-G (both r=-0·53) and Symptom scores (r=0·82). Both HF-QoL scores increased notably and linearly with increasing patient-rated condition severity (p<0·001). The MCIDs were estimated as 4 units for Daily Activities and 6 units for Symptoms means. Conclusions: The HF-QoL is a valid and reliable measure of symptoms associated with HFS/R and its effects on daily activities in this population of patients with advanced breast cancer. The HF-QoL is thus suitable for assessing HRQL impairment associated with HFS/R with cancer chemotherapeutic agents.
CYP2D6 pharmacogenetic testing: Beliefs and psychological effects in breast cancer patients treated with adjuvant tamoxifen (T).
Authors: Magnani Katia , Pezzolo Elisa , Gusella Milena , Bononi Antonio , Falci Cristina , Da Corte Donatella , Cretella Elisabetta , Nicolardi Linda , Menon Daniela , Brunello Antonella , Rosti Giovanni , Raiti Concetta , Montin Lisa , Soraru' Mariella , Vastola Francesca , Koussis Haralabos , Bozzi Paola , Parolin Veronica , Greco Filippo , Pasini Felice ,   Italian TAM Group
Published: March 2020

e20541 Background: Pharmacogenetic tests (PGT) are intended to predict the efficacy and toxicity of a specific treatment. There is a common concern that they may be misunderstood by patients (pts), confused with predictive tests for hereditary disorders and induce psychological distress. Methods: As part of a study aimed at correlating individual T activation capability with disease recurrence, CYP2D6 genotyping was offered to 203 early breast cancer pts. On enrolment, they received complete verbal and written information by their oncologist about the test and its purpose. Six months later they were asked to answer 4 questions concerning the nature and the possible psychogenic stress aroused by PGT. Their level of anxiety was assessed by the Zung-Self-Rating anxiety scale. Results: Anxiety was absent in 39%, within the normal limits in 50% or mild in 9% of pts. Only two pts had a moderate score. Anxiety was not associate with age or time from cancer diagnosis. Although not significantly, its score was higher in pts with larger tumors and positive lymph nodes. All pts agreed on the usefulness of PGT to enable the prediction of differences in drug response and toxicity. Some of them believed that they could predict some disease risks: the misperception was higher among elderly pts (> 70y, 50%) while was infrequent in younger pts (<39y, 12%). There was no association with the anxiety score. PTG related worries, although not generating a clinically detectable anxiety, were reported by 0%, 10% and 16% of all pts <39, 40-69 and >70 years old, respectively. Conclusions: CYP2D6 genotyping to predict tamoxifen activation was welcomed, well understood and was not associated with anxiety in the majority of breast cancer pts on adjuvant treatment. It seems that, when properly informed by their physician, patients show a positive attitude towards PG testing and no psychological distress. Funded by Regione Veneto. Clinical trial information: 532.