bluuebunny/crossref_metadata_2025_split huggingface dataset:
The better bisphosphonate in patients with bone metastasis: Zoledronic acid or ibandronic acid? A study from Eastern India
Authors: Pandey R. , Dey S. , Mukhopadhyay A. 
Published: August 2020

e20524 Background: Ibandronic acid is a third generation bisphosphonate which acts by inhibition of osteoclasts. Zoledronic acid also has a similar mechanism of action. This study was designed to study superiority or inferiority of either agent over other in terms of efficacy in reducing bone pain and complications in patients with bone metastases. Methods: From Jan 2005 to Dec 2008, 240 patients of various malignancies with bone metatstasis were enrolled and were randomized on a 1:1 basis to receive monthly IV infusions of ibandronate or zoledronate and were analysed for pain relief, skeletal related events and adverse events. Results: Patients in both the arms were well matched for their diagnosis, stage of disease, burden of skeletal disease and performance status. Different diagnoses were, carcinoma breast (n=99), carcinoma prostate (n=54), myeloma (n=48), carcinoma lung (n=23), others (n=20). Median follow up was 18 months. At 18 months, mean increases in British Pain Inventory pain scores were lower with zoledronate compared to ibandronate (0.43 vs 0.88 [p=0.02]). Analgesic use as defined by 4 point analgesic scale was less with zoledronate as compared to ibandronate. Incidence of skeletal related events was not significantly different between two arms (33% for zoledronate vs 39% for ibandronate [p=0.2]). Median time to first skeletal related event was not reached in either arm. At 18 months of median follow up, percentage of patients with skeletal related events were 39% in zoledronate arm vs 43% in ibandronate arm (p=0.06). Zoledronate caused fever in 30 (12.5%) patients and hypocalcemia in 10 patients. Ibandronte caused hypocalcemia in 3 patients. No cases of osteonecrosis of jaw were observed. Conclusions: Zoledronate is the preferred bisphosphonate in developing countries for its shorter infusion time and availability of cheaper generic brands. This study also indicates that it may be slightly better than ibandronate in reducing bone pain and preventing skeletal related events. No significant financial relationships to disclose.
The effect and safety of Clino-san on vaginal symptoms in breast cancer survivors: A randomized, controlled study
Authors: Kim J. , Lee Y. , Park N. , Song Y. , Kang S. 
Published: August 2020

e20525 Background: The purpose of this study was to determine the effect of Clino-san on vaginal symptoms and atrophy in breast cancer survivors treated with chemotherapy or endocrine therapy. Methods: A randomized, double-blind, placebo-controlled study. Breast cancer survivors who experienced menopause after chemotherapy or endocrine therapy were enrolled voluntarily and randomly applied vaginal topical lactic acid, Clino-san or placebo three times per week for 12 weeks. Vaginal dryness and dyspareunia measured by visual analogue scale, vaginal health index, vaginal pH, and the effect on endometrium or ovary were evaluated. Results: Among 89 enrolled women, 81 were evaluated. Forty-two received Clino-san treatment, and the remaining 39 received placebo. Vaginal dryness and dyspareunia in Clino-san treatment group improved compared with placebo group (p=0.012). Clino-san increased vaginal health index, however it is not statistically significant (p=0.058). Vaginal pH decreased more in Clino-san treatment group (p=0.025). There was no significant difference of adverse effects between two groups other than mild irritation at the early time of Clino-san use. Conclusions: Vaginal topical Clino-san could relieve the vaginal symptoms and improve the vaginal health in breast cancer survivors who experienced menopause after cancer treatment. No significant financial relationships to disclose.
The predictors of information needs and different views of patients and relatives on disclosure and treatment participation: A multicentric survey study
Authors: Ozdogan M. , Bozcuk H. , Er O. , Abali H. , Coskun H. S. , Zengin N. , Artac M. , Savas B. 
Published: August 2020

e20526 Background: We wanted to explain if the views of patients and their relatives differed on disclosure and treatment participation or not, and if so, to evaluate the predictors of this difference. Methods: The survey aimed to unveil the attitude of patients and their relatives in 3 domains; disclosure of diagnosis, prognosis and participation to treatment. Multinomial logistic regression models with forward selection procedure were constructed for the multivariate analysis to explain the origins of discordance in these domains. Results: A total of 1,052 consecutive cases (526 patients and their 526 relatives) were interviewed. The relatives, when they were asked to imagine themselves with a new diagnosis of cancer, opted for disclosure of diagnosis, prognosis, and participation to treatment in 92.4%, 84.6%, and 86.3% of cases. When patients were asked for their information needs in disclosure of diagnosis, prognosis, and participation to treatment, 83.8%, 70.2%, and 70% wanted disclosure, whereas, their relatives wanted disclosure for their patients in these 3 domains in 32.9%, 40.5%, and 60.3% of cases, respectively. The multivariate predictors of discordance for disclosure of diagnosis between patients and relatives were patient age, social insurance, and oncology centers (P=0.003, 0.007, and <0.001, respectively). The associates of discordance for disclosure of prognosis were again oncology centers and relatives’ relationship with the patients (P<0.001 and 0.012). Likewise, the correlates of discordance for treatment participation were again oncology centers and patient age (P<0.001 and 0.016). Conclusions: Information needs of patients and their relatives, when they imagine themselves as cancer patients, are quite similar. However, relatives are not in favor of disclosure to their patients of diagnosis and prognosis, moreover, in spite of this, they want their patients to actively participate in treatment decisions. We believe this paradox represents a desire of the relatives to escape from responsibility and emotional burden of the care of the cancer patients. This paradox, in addition, is a threat to a healthy patient and physician communication. No significant financial relationships to disclose.
Single- versus multiple-item assessment of quality of life in patients with advanced cancer
Authors: Bush S. H. , Parsons H. A. , Palmer J. L. , Chacko R. , Li Z. , Scott C. , Bruera E. 
Published: August 2020

e20528 Background: The main objective of palliative cancer care is to improve quality of life (QOL). As multiple dimensions impact on the construct of QOL, multi-dimensional instruments are usually used in its measurement. These are time consuming and burdensome for repeated use. Recent authors have suggested that brief single-item global assessments can provide a reliable measure of QOL. We assessed the performance of the Edmonton Symptom Assessment System ‘feeling of well-being’ item (ESAS WB) using the Functional Assessment of Cancer Therapy - General (FACT-G) instrument as a gold standard. Methods: After obtaining IRB approval, we reviewed the data from 213 advanced cancer patients who had participated in six studies from March 2006 to June 2008 and determined the level of association between baseline ESAS WB and FACT-G total score and subscale domains (Physical (Pwb), Social/Family (Swb), Emotional (Ewb), and Functional (Fwb) Well-Being) and also the 9 ESAS symptom intensity scores using Spearman correlation coefficients. We also calculated the change between the baseline (T1) and second (T2) observations of ESAS WB and of FACT-G total score and determined their level of association using a Pearson correlation coefficient. In addition, we predicted the change in FACT-G as predicted by the change in ESAS WB score using regression analysis. Results: Mean age was 60 (SD 12) years and 48% were female. At T1, the Spearman correlation coefficient of ESAS WB and FACT-G was -0.48 (p<0.0001). Spearman correlation coefficients for ESAS WB and FACT-G subscale domains and ESAS symptom intensity scores were also highly significant (p<0.0001) for all physical and emotional symptoms (other than p=0.003 for nausea) except for FACT Swb (p=0.08). The Pearson correlation coefficient for difference between T1 and T2 in ESAS WB and FACT-G for 146 patients was -0.36 (p<0.0001). The regression analysis was highly significant (p<0.0001). The change in ESAS WB corresponding to FACT-G published minimally important difference (MID) was -0.24 for 3, -1.55 for 5, and -2.87 for 7, respectively. Conclusions: ESAS WB is a practical instrument for clinical use and best reflects the Pwb, Ewb and Fwb domains of FACT-G as compared to Swb. No significant financial relationships to disclose.
Management of cancer-related vertebral compression fracture: Comparison of treatment options: A literature meta-analysis
Authors: Bhargava A. , Trivedi D. , Kalva L. , Tumas M. , Hooks M. , Speth J. 
Published: August 2020

e20529 Objective: The objective of this review was to compare the efficacy and safety of treatment options for management of vertebral compression fractures (VCF) secondary to multiple myeloma and/or metastatic tumors based on a meta-analysis of the literature. Methods: A search was performed of published literature through November 2008. All articles reporting at least one clinical outcome were included. VAS pain scores and cement extravasation were the most common efficacy and safety outcomes reported in the included studies and were considered for analysis. The mean weighted difference in VAS scores or the effect size was calculated using the number of patients in each study as the weights. The paired t-test was used to assess significance of these differences. A 95% confidence interval (CI) was computed around these differences. The significance of difference (VAS and % cement extravasations) between different modes of treatment was assessed using a two sample t-test. Results: A total of 59 studies met the inclusion criteria and were included in the meta-analysis. The majority of the included studies (56 studies) were case series. No randomized controlled study was identified. The total sample size from the included study was 4,460 patients - 73% of patients had a diagnosis of tumor metastasis to the vertebral column; 18% had a diagnosis of multiple myeloma. Percutaneous vertebroplasty (VP) was described in 57.6% studies; balloon kyphoplasty (BKP) in 20.3%; conservative/combined (CC) therapy in 22%. Results are shown in the Table . Conclusions: This meta-analysis indicates that BKP is more effective than either VP or conservative therapy in relieving pain secondary to cancer-related VCF and that BKP is a safer intervention than VP based on the analysis of the rates of cement extravasation. [Table: see text] No significant financial relationships to disclose.
The association between autonomic dysfunction and survival in advanced cancer: A preliminary report
Authors: Fadul N. A. , Strasser F. , Palmer J. L. , Dalal S. , Allo J. , Bruera E. 
Published: August 2020

e20534 Background: Autonomic nervous system dysfunction (AD) is a common syndrome in patients with advanced cancer. It is associated with decreased survival in several patient populations including diabetes mellitus, heart failure and neurological diseases. Based on this available evidence, we hypothesized that autonomic dysfunction is associated with reduced survival in patients with advanced cancer. The objective of this preliminary study was to test the association between AD as measured by the standardized Ewing test and Heart Variability (HRV) measures and survival in patients with advanced cancer. Methods: We examined the relationship between survival and parameters of AD in male patients with advanced cancer who participated in a prospective study of autonomic dysfunction and hypogonadism. Eligibility criteria were defined based on the prospective study protocol. We collected demographic information, date of study entry and Ewing and HRV scores. Date of death was obtained from the online Social Security Death Index database. We defined survival as the interval between study entry and date of death. A survival analysis was used to test the association between survival (days) and Ewing test (0–5) and measures of heart rate variability (HRV), including time domain (SDNN) and frequency domain (Ultra low, Very low, Low, and High frequency) parameters.A spearman correlation test was also performed. Results: 47 male patients were included in this study. Median age was 59 (20–79) and 63% were caucasians. Autonomic dysfunction (AD), defined as Ewing score >2, was present in 80% (38/47) of the patients. Median Ewing score was 3 (1–5), indicating moderate to severe AD. Spearman correlation for Ewing and SDNN HRV was 0.44 (p=0.002). There was a significant association between abnormal Ewing score and survival (p<0.0001), and abnormal SDNN HRV and survival (p=0.056). Spearman correlation for Ewing score and survival and SDNN HRV and survival were r = -0.27620 (p=0.0602) and r =0.24198 (p= 0.1013) respectively. Conclusions: Autonomic dysfunction is associated with shorter survival in male patients with advanced cancer. Further longitudinal research in a larger cohort is justified based on these findings. No significant financial relationships to disclose.
Functional recovery after surgery in patients with breast cancer
Authors: Springer B. , Danoff J. , Levy E. , Stout N. , Pfalzer L. , McGarvey C. , Gerber L. , Soballe P. 
Published: August 2020

e20539 Background: Upper extremity dysfunction and decreased quality of life are frequently reported sequelae of the treatment for early stage breast cancer (BC). Surgical trauma and/or radiation therapy may lead to upper extremity (UE) impairments, functional limitations and disabilities including pain, stiffness, lymphedema, decreased strength and range of motion (ROM) and decreased activity tolerance. In this study we examined specific functional characteristics of shoulder impairments and associated limitations. Methods: Women (n=88, mean age = 53y [SD=11.81]) newly diagnosed with unilateral, Stage I to III BC were screened pre-operatively for this prospective trial. Patient data and physical therapy based assessments were recorded at the pre-operative visit (baseline) and at 1, 3, and 12+ months (BA, M1, M3, M12) after surgical treatment including pain (VAS on 10 point scale), bilateral shoulder ROM and strength (MMT). Volumes for upper extremities were taken using an optoelectric device (Perometer®). During post BC treatment visits, appropriate physical therapy was provided, and if there was a diagnosis of lymphedema, a light-grade compression garment was fitted. ROMs (shoulder Abd, ER, Flex, IR), a composite MMT value, and volume were analyzed with one-way repeated ANOVA including Greenhouse-Geisser correction for non-normal data where necessary. Post hoc testing was done using Within-Subjects Contrasts. Limited range of values for pain resulted in a highly skewed distribution, inappropriate for statistical testing. Results: For the variables Abd, ER, Flex, and sumMMT there was a decrease in function from BA to M1, improvement from M1 to M3, and further improvement from M3 to M12 (all p < 0.0001). For IR there was a decrease from BA to M1, no difference between M1 and M3, and an improvement from M1 and M3 to M12 (p < 0.3). Pain remained relatively low with 60–80% of the women reporting ≤2/10. Conclusions: After surgery for breast cancer, a decrement in shoulder function may be expected around 1 month after the procedure. Most subjects demonstrated significant improvement in function by 3 months after the procedure, and by 12 months, subjects achieved near complete recovery of shoulder impairment. No significant financial relationships to disclose.
Impact of an outpatient interdisciplinary team (IDT) consultation on symptom clusters in advanced cancer patients seen at a supportive care outpatient clinic (OSC) in a tertiary cancer center
Authors: Yennurajalingam S. , Urbauer D. L. , Chacko R. , Hui D. , Amin Y. A. , Evans A. C. , Orihuela C. , Casper K. L. , Poulter V. , Coldman B. , Bruera E. 
Published: August 2020

e20542 Background: Advanced cancer patients develop severe physical and psychosocial symptom clusters. There is limited data on the impact of an outpatient interdisciplinary team (IDT) consultation lead by palliative care specialists on symptom clusters. Cluster composition and consistence, response rate and predictors of response are unknown. Methods: 914 consecutive patients with advanced cancer presenting in the OSC from Jan 2003 to Oct 2008 with a complete Edmonton symptom assessment scale at the initial and follow-up visit (median 14 days, range 1–4 wks), and CAGE status (alcohol screening) were reviewed. Wilcoxon ranked sign test was used to determine whether symptoms changed over time. Principal components factor analysis with varimax rotation was used to determine clusters of symptoms at baseline and at follow-up. The number of factors calculated was determined based upon the number of eigen values that were greater than one. Results: Median age was 59 yrs, female were 46%. The most common primary cancer was Lung (19%). Baseline and follow-up visit scores (mean, SD) were: fatigue 5.7 (2.1) and 5.2 (2.2, p<0.0001), pain 4.9 (2.6) and 4.1 (2.6 p<0.0001), nausea 1.8 (2.4) and 1.7 (2.3, p=0.1), depression 2.6 (2.5) and 2.2(2.4,p<0.0001), anxiety 2.9 (2.7) and 2.4 (2.4, p<0.0001), drowsiness 3.2 (2.8) and 3.2 (2.6, p=0.7), dyspnea 2.6 (2.7) and 2.4 (2.6), p=0.0027), appetite 4.2(2.7) and 3.9 (2.7, p<0.0001), sleep 4.2 (2.6) and 3.8 (2.6, p<0.0001) and well being 4.3 (2.5) and 3.9 (2.3, p<0.0001). During the follow- up the symptom clusters varied from a 3 factor to a 2 factor model, reflecting the impact of the IDT on symptom burden. CAGE positive and CAGE negative patients had a significantly different symptom cluster model. Conclusions: Cluster composition differs when patients are assessed and managed by an IDT and among patients who screen positive for alcoholism. [Table: see text] No significant financial relationships to disclose.
Effect of oral aprepitant in management of delayed chemotherapy-induced nausea and vomiting (DCINV) after high-dose chemotherapy (HDC) and hematopoietic stem cell transplant (HCT)
Authors: Isola L. M. , Goldberg G. , Chandra G. 
Published: August 2020

e20548 Background: This study assessed the safety and efficacy of Aprepitant, a neurokinin 1 receptor antagonist, in the management of DCINV associated with HCT. Methods: Pilot phase I-II RCT, adult patients undergoing ablative HCT. Eligibility Criteria: Presence of DCINV (>1 episode of vomiting/24 hrs or >25 mm on nausea visual analogue scale (VAS) on day 2–14 post- HCT). Control arm: ondansetron + metoclopramide. Aprepitant arm: Same regimen + aprepitant 125 mg on d1 and 80 mg d2–3. Controls with DCINV persisting >72 hours were crossed to treatment arm. Safety endpoints: Primary: myeloid engraftment (ANC>500/μL by d15.) Secondary: platelet engraftment (plts >20,000/μL by d21.) Efficacy endpoints: Primary: no episodes of emesis. Secondary: VAS reduction ≥ 25 mm Results: 12 pts, ages 23–62 yrs, were randomized, 9 to treatment arm. Two of 3 controls crossed over. The study was interrupted prior to completion of accrual to control arm. Results are summarized as median ± SD in the table below. Treatment arm showed no delay in granulocyte and platelet engraftment, less emesis, and little difference in VAS compared to control. No patients in either group developed unexpected grade III-IV toxicities, including VOD or IPS. Conclusions: The use of aprepitant for control of DCINV after myeloablative HCT decreased the frequency of DCINV and had no adverse effect on granulocyte and platelet engraftment. This pilot study supports the safety and efficacy of aprepitant for DCINV in the setting of HCT. [Table: see text] [Table: see text]
Survival prediction and frequency of anticancer treatment (ACT) near the end of life in patients hospitalized due to acute conditions (AC)
Authors: Numico G. , Occelli M. , Fea E. , Granetto C. , Di Costanzo G. , Colantonio I. , Gasco M. , Garrone O. , Polla V. , Merlano M. 
Published: August 2020

e20558 Background: Recent literature suggests that ACT near the end of life is increasingly common. Although the reason is complex, we hypothesize that AC impair the formulation of prognosis. The PaP score was shown to predict 1-month survival for terminally ill pts. Its application to pts with AC is object of debate. We evaluated the frequency of ACT near the end of life and assessed the value of PaP score and of other clinical parameters in predicting survival in pts with AC. Methods: All pts admitted due to AC in a Department of Medical Oncology in a 9-month period were included. Pts and disease features (site of primary, stage of disease, disease control), previous and current ACT, cause of admission (diagnosis without a previous history of cancer; treatment-related toxicity; cancer- related symptoms) were assessed. The PaP score was calculated using physicians’ survival prediction, Performance Status (PS), anorexia and dyspnea, total WBC and lymphocyte percentage. Results: 208 pts were evaluated: local disease 24%, advanced 76%; ACT 60%, off-treatment 40%; disease controlled 9%, non controlled 91%; cause of admission: diagnosis 19%, toxicity 17%; symptoms 64%. PaP score: group A 78%, B 18%, C 4%. Overall, median survival was 19 weeks (95% I.C. 13,3 to 24,6) and 12-week survival was 59,6%. Of the pts admitted during ACT 11% died within 4 weeks and 32% within 12 weeks. Among the 39 pts died within 4 weeks, 33% were on ACT. Cause of admission, disease control, treatment, and PaP score predicted 12-week survival in the multivariate analysis. However, only PS < 30, and PaP group B and C identified pts with a 12-week survival lower than 30%. Conclusions: ACT in the last period of life is common. During AC only a minority of pts has such a dismal prognosis that treatment withdrawal is justified. The potential reversibility of AC renders prognostic measures inadequate to make treatment decisions. No significant financial relationships to disclose.