bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events
Authors: Basch E. M. , McDonough T. , Iasonos A. , Siegel E. , Culkin A. , Kris M. , Scher H. I. , Schrag D. 
Published: April 2020

8515 Background: During NCI-sponsored clinical trials, clinicians elicit and report patient toxicity symptoms using the Common Terminology Criteria for Adverse Events (CTCAE). Alternatively, patients may be able to report this information directly, but it remains unclear how these patient reported outcomes (PROs) compare to clinician reports. Methods: Language from the CTCAE version 3 was adapted for patient self-reporting and pilot tested to assure comprehension. Then, a paper questionnaire containing 12 common CTCAE symptoms was administered to consecutive outpatients and their clinicians (physicians and nurses) in clinics specializing in lung or genitourinary malignancies at a specialty cancer center. Results: Between March and May 2005, 435 patients and their clinicians were approached in order to obtain 400 completed paired surveys. For most symptoms agreement was high and this was especially true for more observable symptoms (vomiting, diarrhea) compared to more subjective areas (fatigue, dyspnea) (Table). Most discrepancies were within one point. Only rarely would differences have altered treatment decisions (grade <2 vs. ≥3). Patients more commonly assigned greater severity than clinicians. There was no significant difference when patients reported before versus after caregivers. Kappa values did not accurately measure agreement due to asymmetry in the marginal distribution of scores. Conclusion: Patients and clinicians generally agree on CTCAE symptom severity. Future research should examine the impact of symptom PROs on clinical outcomes and the use of real-time reporting for early detection of SAEs. [Table: see text] No significant financial relationships to disclose.
Improving palliative care: A 2x2x2 factorial cluster randomized controlled trial of case conferencing and educational outreach visiting
Authors: Abernethy A. P. , Currow D. C. , Shelby-James T. , Williams H. , Roder-Allen G. , Hunt R. , Rowett D. , Esterman A. , May F. , Phillips P. A. 
Published: April 2020

8517 Background: Evidence-based palliative care service delivery models are needed. General practitioner (GP) and patient-centered case conferences may increase multidisciplinary interaction and enhance patient care. Educational outreach visiting in pain management may empower learners and improve care. Methods: Three interventions were tested against a routine care control in a 2×2×2 cluster factorial randomized controlled trial. Interventions were case conferencing, educational visiting for GPs, and educational visiting for patients. Subjects were adult patients referred to palliative care services in southern Adelaide, Australia, with any pain in the preceding 3 months. Participants were followed longitudinally until death. Main outcomes included performance status (Australian-modified Karnofsky Performance Status (AKPS)) and hospitalization rates. Longitudinal intention-to-treat analyses using cluster-specific methods were conducted. The sample goal was 460. Results: 461 participants were enrolled from 4/02–6/04. Mean age was 71 yrs, 50% were male, 91% had cancer. Mean and median survival was 146 and 87 days; median baseline AKPS was 60%. When participants had AKPS <70 (i.e. required a caregiver) at referral, those randomized to case conferencing or patient education had higher mean performance status than routine care (case conferencing: average daily AKPS, 54.9% vs 46.3%, p=0.0106; patient education: 54.7% vs 46.4%, p=0.0120). GP education did not improve performance status. Both case conferencing and patient education significantly decreased hospitalization rates compared to routine care (case conferencing: least-squares mean number of hospitalizations, 1.4 (standard error (SE) 0.1) vs 1.9 (SE 0.1), p=0.0002; patient education: 1.4 (SE 0.1) vs 1.8 (SE 0.1), p=0.0078). The addition of both interventions decreased hospitalizations to 1.2 (SE 0.1). Conclusion: At a time when declining function and higher healthcare utilization is the norm, palliative care that includes a case conference or patient educational visiting for pain leads to improved performance status and decreased hospitalizations. Patients with deteriorating performance status derive the greatest benefit. No significant financial relationships to disclose.
Treatment decision-making preferences in older patients with metastatic colorectal cancer
Authors: Elkin E. B. , Lee S. , Casper E. S. , Kissane D. , Kemeny N. E. , Schrag D. 
Published: April 2020

8519 Background: Shared decision-making is a tenet of contemporary oncology practice. However, it is uncertain how involved elderly patients want to be in making treatment decisions and how physicians perceive patient preferences for involvement in decision-making. Methods: In structured interviews about multiple facets of chemotherapy treatment decision-making, we asked patients age 70 and older seen at our specialty cancer center with a recent diagnosis of metastatic colorectal cancer (CRC) about their preferences for making treatment decisions. We used Degner’s control preference scale to measure patient preference for decision control. Treating oncologists described their perception of each patient’s preference for decision control using the same scale. Control preference was assessed in relation to socio-demographic characteristics and functional status. Results: Of 52 patients interviewed, the mean age was 76 years (range 70–89), 52% were male, 60% were educated beyond high school and 25% required some help with activities of daily living (ADL). Preferences for involvement in treatment decision-making demonstrated marked variation (Table). Compared with female patients, males expressed a stronger preference for decision control (p<0.05). Preference for decision control was somewhat greater in patients under age 80, those with more education, and those with no ADL impairment, but these associations were not statistically significant. In 26% of cases, the treating physician’s perception and the patient’s expressed preference for decision control were concordant. Conclusions: In older patients with advanced CRC, preference for control in treatment decision-making shows marked heterogeneity and some correlation with socio-demographic characteristics and functional status. Physicians’ perceptions of patient preference for decision control are often inconsistent with patients’ actual preferences. [Table: see text] No significant financial relationships to disclose.
Do pain, depression and fatigue cluster in advanced cancer?
Authors: Hauser K. , Rybicki L. , Walsh D. 
Published: April 2020

8522 Background: A cancer symptom cluster of pain, depression and fatigue has been proposed. We evaluated the frequency and strength of association between these symptoms in advanced cancer, and the risk factors for experiencing all three. Methods: Symptoms from 1,000 patients presenting to a palliative medicine program were recorded prospectively. Possible clustering of pain, depression and fatigue was tested (Spearman correlations). Univariate and multivariate logistic regression analyses were performed of demographics, disease site, laboratory and clinical risk factors for the presence all three symptoms. Results: No association was found between pain and depression (r=0.051, p=0.13), or pain and fatigue (r=0.001, p=0.97) and little between depression and fatigue (r=0.173, p<0.001). 27% (n=261) had all three symptoms and in 9% (n=71) all were moderate or severe. Univariate predictors for the presence of all three were: anorexia-cachexia, anxiety, dyspnea, nausea, sleep problems (all p<0.001), vomiting (p=0.007), and younger age (p=0.007). Univariate predictors of moderate-severe pain, depression and fatigue were: anorexia and early satiety (p<0.001), anxiety (p<0.001), dyspnea (p=0.004), low creatinine (p=0.07), poor performance status (p=0.002), sleep problems (p=0.002), >10% weight loss (p=0.046) and vomiting (p=0.047). Those with pain, depression and fatigue had a median 12 (range 2–24) other symptoms vs. 5 (range 1–14) if none were present (p<0.001). Multivariate predictors of pain, depression and fatigue were: anxiety OR 3.81 (95% CI 2.74–5.30, p<0.001); early satiety OR 1.86 (1.35–2.56, p<0.001); nausea OR 1.44 (1.05–1.97, p=0.023); sleep problems OR 1.52 (1.11–2.08, p=0.009); weight loss OR 1.47 (1.08–2.01, p=0.016). Multivariate predictors of moderate-severe pain, depression and fatigue were anorexia OR 3.11 (1.74–5.55, p<0.001); anxiety OR 6.53 (3.64–11.73, p<0.001); poor performance status OR 1.49 (1.09–2.04, p=0.012). Conclusions: The 3 symptoms co-occur in 1 in 4 advanced cancer patients. Risk factors include younger age, symptom burden and the anorexia-cachexia syndrome. Pain, depression and fatigue do not cluster in advanced cancer. No significant financial relationships to disclose.
Nutritional status in elderly cancer patients: Why is it so important?
Authors: Terret C. , Pérol D. , Albrand G. , Fingal C. , Roux P. , Courpron P. , Droz J. 
Published: April 2020

8532 Background: To assess the prevalence of malnutrition in elderly patients (pts) with cancer and to determine the effect of malnutrition on Overall Survival (OS). Methods: Cancer pts aged 65 and older underwent a multidimensional geriatric assessment at our institution. Data were collected for calorie and protein intakes, Mini Nutritional assessment (MNA Nestlé), functional status (ADL score), and comorbidity (CIRS-G). Survival time was defined as the time from geriatric assessment to date of death or last follow-up. A Cox regression model was used to estimate the hazards ratio (HR) and 95 percent confidence intervals (95%CI) of risk factors for death. Results: 133 consecutive pts (68% male, 50% hospitalized) were evaluated from 05/1999 to 08/2002. Median age was 78 years (range: 66–92). Main tumour sites were prostate (36%), breast (15%), bladder (12%) and Head and Neck (10%). Forty eight pts (36%) had metastatic disease. Only 55 pts (43%) were fully independent in ADLs (score = 6), and 15 pts were completely independent in IADLs (score = 14). Fifty one pts (43%) had mild to severe disability/morbidity status (CIRS-G severity index ≥2). Regarding nutritional status, only 34% were estimated well nourished with MNA >23.5, 54% had calorie intake ≤1500 kcal/day and 38% had body weight loss > 5% in the last 3 months. Survival analysis was performed with a 16-month median follow up. Median survival time was 7 months (95%CI 6–9 months). In the univariate analysis, male gender, metastatic stage, MNA, ADL score and CIRS-G severity index were significantly correlated with OS. In the multivariate analysis, male gender (HR=2.3, 95% CI: 1.3–4.1), metastasis (HR=1.6, 95% CI: 1.0–2.6), MNA<23.5 (HR=3.3, 95% CI: 1.8–6.0), CIRS-G severity index ≥2 (HR=2.8, 95%CI: 1.7–4.7) and ADL score <6 (HR=1.9, 95%CI: 1.1–3.3), were found to be independent prognostic factors for shorter OS. Conclusions: These data show that malnutrition has a major impact on survival independently of cancer severity. Thus, nutritional status must be systematically assessed before treatment decision-making. Benefits of nutritional interventions need to be studied in future trials. No significant financial relationships to disclose.
Gene expression patterns identify patients with non-small cell lung cancer (NSCLC) who are at increased risk for venous thromboembolism (VTE)
Authors: Ramiah V. S. , Potti A. , Dressman H. , Bild A. , Peterson R. , Moore M. , Conlon D. , Harpole D. , Nevins J. R. , Ortel T. L. 
Published: April 2020

8535 Background: VTE is the leading cause of death in patients with cancer. The 1 year survival rate in patients diagnosed with cancer at time of VTE is 12% compared to 36% in cancer patients who are free of VTE .Also, a thrombotic event in a hospitalized cancer patient leads to higher in-hospital mortality.Thus,VTE in cancer patients may indicate a more aggressive phenotype. Methods: With the overarching goal of testing the ability of genomic profiling to detect biologically and clinically significant differences in patients with cancer and VTE, using NSCLC as a proof of principle, we expanded on previous work wherein we have shown the ability of multiple gene expression patterns (‘metagenes’) to predict a thrombotic event .96 patients with NSCLC were enrolled in this study. RNA was extracted and gene array data obtained using an Affymetrix U133 2.0 plus GeneChip. The clinical history of all 96 patients was reviewed to identify patients with a definitive VTE episode after the initial diagnosis of cancer and not within six weeks of surgery.14/96 (14.5%) patients met these criteria. We then identified 14 additional patients with NSCLC matched by age, gender and clinical stage patients who did not have VTE for at least 2 years following the diagnosis of cancer. Gene expression data was analyzed using a binary regression analysis. Results: Using the metagene approach, a discriminator gene set (n = 45) that differentiated patients with NSCLC and VTE from patients with NSCLC without VTE was identified. A leave-one-out cross validation performed to further assess the reliability of the discriminator metagene set was more than 85% accurate in identifying patients with NSCLC and VTE. Also, significant biologically relevant differences were seen between the comparison groups, to include genes such as P53, VEGFC, E2F4, TFPI and EPHB2 Conclusions: Our data suggests that a genomic approach can be used to identify with NSCLC that develop VTE, while also providing information important to an understanding of the underlying biology of the association between cancer and thrombosis. We are in the process of validating these results in a prospective trial. No significant financial relationships to disclose.
Communicating adjuvant treatment goals and side effects to older breast cancer patients
Authors: Naeim A. , Pezeshki B. , Levin J. , Bartfeld N. , Coscarelli A. 
Published: April 2020

8541 Background: The use of adjuvant therapy, particularly adjuvant chemotherapy, in older breast cancer patients is controversial. For patients to participate and provide their treatment preferences, information regarding adjuvant treatment and its side effects need to be communicated in lay language. This study explored what older breast cancer women understand about adjuvant therapy, and to elicit feedback on a pre-developed informational handout. Methods: This qualitative study of 35 women with breast cancer over the age of 65 with recent experience with adjuvant therapy participated in six focus groups in Los Angeles County. Focus groups were audio taped and transcribed. In addition, patients filled 2 questionnaires: (a) a demographic questionnaire regarding age, income, education, insurance, and beliefs about cancer and treatment benefits and (b) another to define adjuvant therapy and document patient specific experiences with side effects and physician-patient discussion related to adjuvant therapy. Transcript based analysis was used to identify themes and patterns that arise during the groups. Results: One (3%) of the 35 participants was able to define the term correctly and 63% of participants were unable to answer or provided an incorrect guess to the definition of adjuvant therapy. In addition, patients perceptions were spit between: (a) curing current disease versus (b) preventing future re-occurence. In terms of symptoms, many participants were shocked at their underestimation of fatigue and reoccurring discussions occurred within and throughout each group as to whether side effects were related to treatment or advanced age. Participants unanimously agreed that a handout describing adjuvant therapy would be beneficial. Conclusion: Discussions regarding adjuvant therapy are conceptually challenging, thus providing information regarding the goals and side effects of treatment using lay language is the 1st step in helping older breast cancer patients participate in the decision making process. [Table: see text] [Table: see text]
Short-term acenocumarine (A) or dalteparine (D) for the prevention of central venous catheter-related thrombosis (CVCrT) in cancer patients. A randomized controlled study based on serial venographies
Authors: De Cicco M. , Matovic M. , Pacenzia R. , Fantin D. , Caserta M. , Bortolussi R. , Fabiani F. , Santantonio C. , Nigri P. , Veronesi A. 
Published: April 2020

8549 Background: Timing and frequency of non occlusive (nO) or occlusive (O) CVCrT in cancer patients (pts) remain unclear. In this randomized controlled trial we studied these points and evaluated the efficacy and safety of short-term prophylaxis with A or D in the prevention of CVCrT. Methods: Consecutive cancer pts without contraindications to short-term anticoagulation, scheduled for chemotherapy via CVC, were randomly assigned to receive: A 1 mg/day for 3 days before and 8 days after CVC insertion; D 5,000 IU 2 hours before and daily for 8 days after CVC insertion; no anticoagulant treatment (NT). All pts underwent venography (V) at day 8 and 30 after CVC insertion and then every two months until CVC removal . The primary endpoint was V detected CVCrT, evaluated as nO or O when it was partially or completely occlusive of the vein lumen, respectively. Bleeding episodes were recorded. Proportions were compared using chi-square test together with odds ratio (OR). Results: 450 pts were randomized, 348 of whom (120/150 A, 114/150 D, and 114/150 NT) underwent V (median number of procedures 4, range 2–8). Both A and D reduced the frequency of V detected CVCrT (21.9% A vs 55.3% NT, OR= 4.35 (95% CI 2.43–7.69), p<0.001; 40% D vs 55.3% NT, OR= 1.85 (95% CI 1.10–3.13), p=0.02). A was more effective than D (OR= 2.37 (CI 1.34–4.22), p= 0.003). The frequency of O CVCrT was not different in the 3 groups (0.9% A, 5.0% D, 4.4% NT; p= 0.18). Overall, 5.1% of pts with CVCrT were symptomatic, all presenting O CVCrT (42% of pts with O CVCrT were not symptomatic). Most CVCrTs (95.6%) were observed at day 8 after CVC insertion. No major bleeding or pulmonary embolism occurred. Conclusions: In this study, acenocumarine was more effective than dalteparine in reducing V detected CVCrT. The doses of prophylactic agents used in this study proved to be safe. Symptomatic CVCrT evaluation alone underestimates the actual CVCrT frequency. The first days following CVC insertion are at highest risk for CVCrT. Short term thrombosis prophylaxis appears to be superior to no treatment without the expenses and inconveniences inherent in long-term prophylaxis. No significant financial relationships to disclose.
Characterization of cancer pain syndromes (PS) seen at a Comprehensive Cancer Center (CCC) and pain response (PR) to palliative care consultation (PCC)
Authors: Zhukovsky D. S. , Palmer J. , Bruera E. , Pei B. , Zhang T. , Nekolaichuk C. , Fainsinger R. 
Published: April 2020

8551 Background: Comparison of cancer PS across settings is challenging due to differences in prognostic features. Data from 1 CCC participating in a multi-site international study of a pain classification system is presented to characterize cancer PS & response to PCC. Methods: The Edmonton Classification System for Cancer Pain was completed by prospective chart review to characterize PS of 100 consecutive hospitalized patients (pts) seen in PCC. Pts were followed until major PR, hospital discharge or death. Major PR was defined as <2 p.r.n. opioid doses/d & pain intensity (PI) <3/10 for 3 consecutive days (d). Results: 85% of pts had pain (n=85), with age 62.9+13.3, 47.1% male & KPS 44.5+23.1. The most common tumor diagnoses were lung (24.7%) & GU (21.2%). Pts were followed for a median of 4 d (0–27). 39% achieved a major PR. Except for steroids (49.4%) & anticonvulsants (29.4%), other adjuvant analgesic use was all <10%. Pain-associated features: *Numeric Rating Scale 0–10, 10=worst suggestivie of alcoholism + Mean morphine equivalent dailydose On univariate analysis, older age (p=.006), lower initial PI (p=.003), lower final PI (p=.001) & lower final MEDD (p=.002) were significantly associated with achieving major PR. On multivariate analysis, lower initial PI (p=.03) & lower final MEDD (p=.02) retained significance for achieving major PR. Conclusions: Only 39%of pts with cancer pain seen in PCC achieve a major PR by discharge or death. Despite aggressive opioid titration, 61% do not achieve a major PR & require better pain management. Potential strategies for achieving improved PR include earlier PCC, identification of more sensitive prognostic variables &critical evaluation of targeted therapies. [Table: see text] No significant financial relationships to disclose.
International multi-centre study of incidence and risk factors of symptomatic deep venous thrombosis (DVT) and or pulmonary embolism (PE) in prostate cancer patients undergoing laparoscopic radical prostatectomy (LRP)
Authors: Secin F. P. , Fournier G. , Gill I. S. , Abbou C. C. , Schulmann C. , Tuerk I. , Piéchaud T. , Janetschek G. , Vickers A. , Guillonneau B. 
Published: April 2020

8555 Background: There is no data regarding the incidence and variables associated with symptomatic DVT and or PE in patients undergoing LRP. Our aim was to evaluate the multi-centric incidence and risk factors for perioperative symptomatic DVT and PE after LRP. Methods: Patients with symptomatic DVT and or PE occurring within 2 months of surgery since start of the respective institutional LRP experience were included. Eight academic centers from both the United States and Europe participated. Diagnoses were made by Doppler ultrasound for DVT; and lung ventilation/perfusion scan and or chest computed tomography for PE. Associations between variables and DVT and/or PE were evaluated using Fisher’s exact test for categorical predictors and logistic regression for continuous predictors. Results: Patient reoperation (p value) (<0.001), tobacco exposure (0.02), prior DVT (0.007), larger prostate size (0.02) and length of hospital stay (0.009) were significantly associated with higher risk of symptomatic DVT/PE. The nonuse of perioperative heparin was not a risk factor (1), as well as neoadjuvant therapy (1), perioperative transfusion (0.1), body mass index (0.9), surgical technique (0.3), operating time (0.2) and pathologic stage (0.5). There were no related deaths. Patients receiving preoperative heparin had significantly higher mean operative blood loss, 480cc vs 332cc (<0.001) However, this did not translate into longer hospital stay (0.07); higher transfusion rates (0.09) or reoperation rates (0.3). The estimated cost of heparin prophylaxis in these patients exceeded $2.5 million. Conclusion: The incidence of symptomatic DVT or PE was similar despite different prophylactic regimens. Our data does not support the administration of prophylactic heparin in LRP to low risk patients (no prior DVT, no tobacco exposure, no prostate enlargement and or no anticipation of prolonged hospital stay). [Table: see text] No significant financial relationships to disclose.