bluuebunny/crossref_metadata_2025_split huggingface dataset:
Elevated interleukin-6 levels correlation with anemia, symptom burden, and neurocognitive deficit in cancer patients receiving chemotherapy: Effects of darbepoetin-alfa administered once per cycle for prevention of anemia
Authors: Vadhan-Raj S. , Bueso-Ramos C. , Trent J. , Patel S. , Zhou X. , Benjamin R. S. , Meyers C. A. 
Published: March 2020

19505 Background: Chemo-naïve sarcoma pts experience severe anemia during chemotherapy (CT) with adriamycin and ifosfamide (AI) resulting in PRBC transfusions (Tx) in >90% of pts. Anemia has a negative impact on quality of life (QOL) and neurocognitive (NC) functions (fx). Preclinical studies suggest that treatment with erythropoietic stimulating agent (ESA) may protect NC fx. The purpose of this study was to evaluate the effects of darbepoetin (Initial dose 500mcg) administered once per cycle on prevention of anemia, transfusions, symptom burden and NC fx. Methods: Pts underwent assessment for neuropsychological tests, symptoms (MDASI), and quality of life (QOL). To determine if NC deficits and Hb were correlated to cytokine levels, serum IL-1, IL-6, and TNF were measured at baseline, after 3 cycles and completion. Results: Baseline median hemoglobin (Hb) was 13.2 g/dL (n=49); however, significantly more NC deficits and symptoms were seen in pts as compared to normal. Interestingly, serum IL-6 levels were significantly elevated as compared to normal at baseline and during treatment (p<0.001), and were negatively correlated with baseline Hb (p=0.003) and significantly associated with NC deficits, QOL and symptoms. Of 45 pts that received > 1 cycle of CT, 38% avoided PRBC Tx. Pts with higher baseline Hb had less sadness and shortness of breath (p<0.01). Pts with higher Hb nadir had lower tingling/numbness (p=0.006). Pts who avoided transfusions had less distress (p=0.032), less sadness (p=0.01), and better motor fx (p=0.005). Conclusions: These findings suggest that cancer pts can have NC deficits prior to CT. Prevention/early intervention with ESA may avoid transfusions, reduce symptom burden, and NC deficit. Significant correlation of anemia, symptoms, and NC deficit with elevated IL-6 levels suggest that anti-IL-6 treatment may improve response to ESA and NC functions. [Table: see text] No significant financial relationships to disclose.
Clinical outcomes of 203 adult patients receiving highly (H) and moderately (M) emetogenic (E) chemotherapy (C) following an institutional antiemetic guideline update incorporating aprepitant (A) and palonosetron (P)
Authors: Timoney J. P. , Chan W. W. , Culkin A. E. , Flaherty A. M. , Giacalone W. F. , Lucarelli C. D. , Murphy D. J. , Schumann M. L. , Major M. A. , Kris M. G. 
Published: March 2020

19506 Background: A quality improvement project targeted at chemotherapy induced nausea (N) and vomiting (V) was initiated in 2004. The project included an antiemetic guideline update consisting of replacing ASCO 1998 3 tier guidelines with a 4 tier system similar to ASCO 2006. Following implementation of the guidelines an evaluation phase began. Methods: Adult chemotherapy-naïve patients receiving HEC or MEC were asked to participate. HEC patients received P 250 mcg IV each day of chemotherapy, A 125 mg PO day 1 and 80 mg PO days 2 and 3 and dexamethasone (D) 12 mg PO days 1, 2 and 3. MEC patients received P 250 mcg IV and D 12 mg PO on the day of C. Participating patients were asked to complete a 7 question NV tool at least 5 days following C to report on the 5 days following C. Outcomes reported include % of patients without N, % without V and N score using a 0–10 visual analog scale (VAS). Patient satisfaction with the the control of N and V was also assessed using a 0–10 VAS. Results: A total of 151 patients received HEC and 89% and 44% were protected from V and N respectively. A total of 52 patients received MEC and 90% and 56% were protected from V and N respectively The median N score for all patients who reported nausea was 3. The median and mean score for satisfaction with N and V control was 10 and 8.7 respectively. Patient outcomes for the most commonly used C regimens are reported in the table below. Conclusion: Implementation of revised AEG provided patients receiving HEC and MEC a high level of protection from vomiting, low nausea scores and a high level of overall satisfaction with prevention of N and V. Although N scores were low, the incidence of N reported offers an opportunity for further improvement. [Table: see text] No significant financial relationships to disclose.
Ibandronate reduces radiotherapy-resistant metastatic bone pain in patients with solid tumors: A comparison of i.v. and oral formulations
Authors: Mystakidou K. , Stathopoulou E. , Parpa E. , Hatzipli I. , Touroutoglou N. , Vlahos L. 
Published: March 2020

19517 Background: Bisphosphonates are used to treat metastatic bone disease (MBD). However, some bisphosphonates are associated with renal toxicity. Ibandronate (IA) is a single-nitrogen, noncyclic bisphosphonate with a renal safety profile similar to placebo in phase III trials. This study compares the effects of i.v. IA 6mg and oral IA 50mg on bone pain, analgesic intake and renal safety. Methods: Recruited patients fulfilled the following criteria: age ≥18, solid tumors with at least one bone lesion, normal renal (serum creatinine ≤1.5mg/dL) and hepatic function, WHO performance status 0, I or II, life expectancy ≥6 months, normal serum calcium or asymptomatic hypercalcemia. Patients were excluded if they were pregnant or lactating, taking nephrotoxic drugs or osteoclast activity modulators. Eligible patients (n=52) were recruited for a two-arm study, with 26 patients per group treated over 6 months. Groups were matched for age, gender, weight, height, blood pressure, site of primary tumor, site and number of bone metastases and number of irradiated sites. Intravenous IA 6mg was administered over 15 minutes every 4 weeks. Oral IA 50mg was administered as a single, daily tablet before breakfast. Studies were ceased on occurrence of new bone events. Primary endpoint was reduction in bone pain and reduced analgesic use. Results: There were no significant differences in patient demographics between the two treatment arms. The percentage of patients receiving i.v. IA that achieved stable or progressive disease was 15.4%; those receiving oral IA attained 11.5% stable or progressive disease. Pain (Brief Pain Inventory questionnaire) and analgesic intake were assessed at baseline, 3 and 6 months. Both i.v. and oral IA caused a significant and sustainable decrease in each of the pain indices (p<0.0005) with no significant difference between i.v. and oral groups. Both i.v. and oral IA treatment led to a trend in decrease of analgesic use. Conclusions: Oral and i.v. ibandronate have comparable efficacy for palliation of bone pain in MBD patients. No significant financial relationships to disclose.
Association of physical and psychological symptom burden with time to death among palliative cancer outpatients
Authors: Zimmermann C. , Barmala N. , Zarinehbaf S. , Le L. W. , Cheung W. Y. 
Published: March 2020

19523 Background: Patients with terminal cancer have a high symptom burden, which tends to increase as death approaches. Previous studies have assessed the association of symptom burden with time to death (TTD) among inpatients or using baseline data for patients enrolled in a trial. Our purpose was to determine the association of symptom burden with TTD in patients who were followed by an outpatient palliative oncology clinic (OPOC). Methods: Cancer patients seen in the OPOC between January 2005 to June 2006 and who subsequently died were identified from the palliative care database. The last outpatient Edmonton Symptom Assessment Scale (ESAS) score completed in clinic was compared among patients in the last 4 months of life. Multiple linear regression was used to determine the association of ESAS total symptom distress score (SDS), physical subscore (PHS), psychological subscore (PSS) and individual symptom scores with demographic parameters, disease characteristics and TTD. Results: In total, 198 patients were identified. All patients had stage IV cancer, the mean age was 63.8 years (SD 12.9) and 55% were male. Median survival time from initial assessment was 6.6 weeks (range 0.3 to 16.7) and mean SDS was 46.0 (SD 18.0). Sites of cancer included gastrointestinal (36%), lung (12%), genitourinary (10%), hematological (8%), gynecological (8%), breast (7%) and others (19%). There was no significant association between symptom burden and gender, age or cancer site. TTD was significantly associated with SDS (p<0.001) and PHS (p<0.001), but not with PSS (p=0.19). Individual symptoms most strongly associated with TTD were fatigue (p=0.001), appetite (p=0.001), drowsiness (p=0.0005) and shortness of breath (p=0.0008). There was no significant association between TTD and depression (p=0.24) or anxiety (p=0.20). Conclusions: In this outpatient palliative cancer population, the association between TTD and symptoms held true only for physical symptoms, particularly constitutional symptoms and shortness of breath which are amenable to therapy. Symptoms in palliative patients should be rigorously assessed and treated, regardless of prognosis and especially at end-of-life. No significant financial relationships to disclose.
Randomized trial of acupuncture versus sham control for prevention of myelosuppression in patients with gynecologic malignancies
Authors: Matulonis U. , Lee H. , Lu W. , Goodman A. , Rosulek A. , Doherty A. , Kornblith A. , Atkinson T. , Gibson C. , Dean-Clower E. , Penson R. 
Published: March 2020

19524 Background: CIM is a significant toxicity that is treated with cytokine growth factors, dose reductions and/or delays. Preliminary uncontrolled Chinese studies suggest that acupuncture lessens CIM. Methods: Patients (pts) with newly diagnosed or recurrent gyn cancers receiving chemotherapy were eligible. Trial design was a double blinded, randomized trial of active acupuncture or sham for 5 weeks (administered 3x per week). Primary endpoints were first nadir WBC and ANC levels at chemo cycle 2; other endpoints were recovering counts following the cycle 2 nadir, QOL, G-CSF levels, and feasibility. Results: >460 patients were screened. 21 pts were randomized to either active acupuncture (n=11) or sham control (n=10). Median age of the pts was 55 yrs (range: 28–81). 15 pts have completed the acupuncture treatment to provide the baseline and nadir WBC and ANC. Toxicities related to either sham or active acupuncture were minimal. The active pts group showed higher baseline WBC (median: 3,600 vs. 2,600, NS) and ANC (median: 2,269 vs. 1,922, NS) values. The nadir WBC was higher in the pts receiving acupuncture (median 3,600 vs. 2,300) but the difference was not statistically significant after adjusting for the baseline difference (p=0.16). Nadir ANC was higher among the pts receiving acupuncture (median: 2,424 vs. 1,274) but the difference was not statistically significant after adjusting for the baseline difference (p=0.1107). Recovering WBC in the pts receiving acupuncture was higher (median: 8,600 vs. 4,400) after adjusting for the baseline difference (p=0.045). The recovering ANC in the pts receiving acupuncture was higher (median: 6,530 vs. 4,038) but this difference was not statistically significant after adjusting for the baseline difference (p=0.0919). QOL and G-CSF data will be presented at ASCO. Conclusions: Although a larger randomized trial is necessary to determine the effects of acupuncture on CIM, there were consistent trends, and recovering WBC counts were significantly higher in patients receiving acupuncture. Formal evaluation of CAM is vital to confirm potentially clinically meaningful benefits. No significant financial relationships to disclose.
Adherence to anemia treatment guidelines in U.S. community oncology practices
Authors: Friedman L. , Naeim A. , Pasta D. J. , Elkin E. P. , Viswanathan H. , Kallich J. , Glaspy J. 
Published: March 2020

19525 Background: Adherence to anemia guidelines may improve patient outcomes including health-related quality of life. This analysis presents baseline guideline adherence among community-based oncology practices prior to an educational intervention targeted to health care providers to improve adherence to anemia guidelines. Methods: Medical records of a sequential sample of adult cancer patients receiving chemotherapy from 47 participating sites during the year prior to site randomization to an educational intervention were abstracted. Each chart was analyzed to determine (1) whether or not the patient met the criteria for anemia treatment with an erythropoiesis- stimulating agent (ESA) or a blood transfusion, and (2) whether the patient received anemia treatment. A complex algorithm was developed to evaluate whether treatment adhered to guideline recommendations. Results: This baseline analysis included 2463 patient charts. Most patients were female (66%); with a mean duration of cancer of 14.5 months and a mean age of 61.8 years. According to guidelines, 523 patients (21%) met the criteria for anemia treatment and of these, 286 (55%) received an ESA or transfusion. In 1103 patients (45%), guidelines suggested that anemia treatment may be inappropriate. However, 216 (20%) of the 1103 patients for whom guidelines recommend against treatment received an ESA or transfusion. For 837 patients (34%), the guidelines did not provide a definitive recommendation and 242 (29%) of such patients received an ESA or transfusion. Conclusions: Baseline assessment found that many patients did not receive treatment consistent with anemia guidelines. This study will evaluate whether a year long educational intervention can improve clinician adherence to guideline recommendations, thereby improving patient outcomes. No significant financial relationships to disclose.
Cost-effectiveness of darbepoetin alfa (DA) 500 mcg every three weeks (Q3W) with IV iron compared to DA Q3W alone in cancer patients (pts) with chemotherapy-induced anaemia (CIA)
Authors: Demarteau N. , Annemans L. , Mossman T. , Bracco A. 
Published: March 2020

19531 Background: IV iron supplementation during erythropoiesis-stimulating agent treatment in anaemic cancer pts may help to optimize anaemia management. We assessed the cost-effectiveness of DA Q3W with IV iron (net 200 mg Q3W; DA+IV iron) to DA Q3W without IV iron (standard practice [SP]= oral iron allowed; DA+SP) from a French societal perspective. Methods: A prospective 16-week, randomized, open-label, multicenter study in 396 pts with non-myeloid malignancy and CIA (hemoglobin [Hb] < 11g/dL) was conducted to evaluate the safety and efficacy of DA+IV iron vs. DA+SP. Data collected include: cumulative doses (IV iron, oral iron, and DA), number of transfusions, and Hb values. Quality adjusted life years (QALY) weights were obtained using the EQ-5D at baseline and at end of treatment. The medical resources used for one DA administration and one transfusion, including pts’ time, were determined by a panel of 20 French clinical experts. Costs were applied to both time (valued at the gross hourly wage) and medical resources (extracted from official sources: AMELI; INSEE). Effectiveness was expressed in average Hb values over the treatment period and the change from baseline in QALY weights. A 5,000- replication probabilistic sensitivity analysis was performed with RISK® after applying distributions to medical resources used and effectiveness parameters. Results: Compared to DA+SP, DA+IV iron showed higher average Hb values (+0.2 g/dL [95% CI: -0.0, 0.4]; 10.9g/dL [10.8, 11.1] vs. 11.1g/dL [11.0, 11.3] respectively), higher QALY weights (+0.017 [-0.028, 0.064]; 0.016 [-0.019, 0.050] vs. 0.033 [0.002, 0.064]) and lower cost (-647.5€ [-938.0, -352.4]; 4,788.3€ [4,561.2, 5,018.2] vs. 4,140.8€ [3,955.4, 4,319.8]). Probabilistic sensitivity analysis revealed that DA+IV iron had a 94% chance of a higher average Hb value and lower costs and 73% chance of a higher QALY level and lower costs. Conclusions: DA Q3W with IV iron is a cost effective alternative to Q3W without IV iron. Further studies in this patient population are needed to determine whether systematic administration of IV iron with DA Q3W will demonstrate cost savings, higher average Hb values, and more QALYs. No significant financial relationships to disclose.
Risk factors for severe anemia requiring red blood cell transfusions in lymphoma patients receiving chemotherapy
Authors: Zhou X. , Teegala S. R. , Huen A. , Ji Y. , Fayad L. E. , Romaguera J. E. , Hagemeister F. B. , Vadhan-Raj S. 
Published: March 2020

19537 Background: Anemia is a frequent complication in lymphoma pts receiving chemotherapy (CT). However, the exact incidence of anemia with the current regimens and risk factors for severe anemia are not well established. Methods: A retrospective cohort study was conducted to determine the incidence of anemia requiring transfusions (Tx). Medical records of all newly referred lymphoma pts (n=1046) in 2003 were reviewed. Logistic regression analysis was performed to identify the clinical and laboratory features correlated with anemia in lymphoma pts during initial regimen received. Results: 425 pts who received ≥ 1 cycle of treatment at MDACC were included in this analysis. Median age was 57 (range 17–87) with 262 (62%) newly diagnosed. Most common first regimens were CHOP (29%), Hyper-CVAD ± Ara-c-MTX (23%), and ABVD (8%) (± rituxan- R).The total number of cycles 1638 (median 3, range, 1–10). The incidence of anemia requiring PRBC Tx was 32 % (136/425) of pts and 14% (231/1638) of cycles (median cycle-2 for Tx). The incidence of PRBC Tx ranged from 8% to 17 % in each cycle. The incidence of PRBC Tx among most common regimens were Hyper-CVAD/ Ara-c/MTX 69 %( 66/95), CHOP 23% (29/125), and ABVD 6% (2/34). In the univariate regression analysis, CT, stage, extranodal/BM involvement, histology, Hb, Ca, β2M, LDH, WBC/lymphocyte counts, were significantly associated with the Txs. Using multivariate logistic regression, baseline Hb (< 12 g/dL vs. ≥ 12 g/dL: OR 2.659, 95% CI 1.670 to 4.232, p< 0.0001), extra nodal involvement (± : OR 2.578, 95% CI 1.609 to 4.133, p<0.0001), and CT (high vs low risk: OR 3.889, 95% CI 2.446 to 6.183, p<0.0001) were the most important baseline risk factors for PRBC Txs. Conclusions: The incidence of anemia in this population is high in early cycles. Baseline pt characteristics including Hb (<12g/dL), extra nodal involvement, and high risk CT were found to be significant risk factors predictive for anemia and Txs. These findings could be useful to identify high risk pts for consideration of prophylaxis with erythropoietic agents for prevention of anemia. No significant financial relationships to disclose.
Reporting of clinical trial data: Are we fully utilizing the current clinical trial data to help manage the older adult cancer population?
Authors: Tam-McDevitt J. T. , Tew W. , Klapper S. , Hauser R. , Lichtman S. 
Published: March 2020

19546 Background: The number of older cancer patients will continue to increase as the population ages. Thus the demand for information on how to manage this population will continue to increase in importance. Clinical trials provide pertinent information to clinicians on treatment options, however, are the current available results matching the needs for the older cancer population? Methods: An evaluation was performed of published clinical trials to determine whether the data was analyzed, reported and discussed using age related criteria. Prospective studies involving 50 or more patients published from 01/2005–12/2006 in the Journal of Clinical Oncology (JCO), Cancer, and the Journal of the National Cancer Institute (JNCI) were reviewed. Results: There were 258 JCO, 58 Cancer, and 17 JNCI articles with the prespecified criteria. The median number of patients enrolled per trial is 212 (JCO), 77.5 (Cancer), and 954 (JNCI). The mean age of patients enrolled for all studies was 59.4 years (range 16 to 93 years). The number (%) of studies which stratified for age is 54 (20.9%) for JCO, 17 (29.3%) for Cancer, and 7 (41%) for JNCI. The number (%) of studies which included age in their analyses is 75 (29%) for JCO, 14 (24%) for Cancer, and 6 (35.3%) for JNCI. Age was mentioned in the discussion section in 40 (15.5%), 8 (13.8%), and 6 (35.3%), JCO, Cancer, and JNCI articles, respectively. Conclusions: The current clinical trials fail to provide ample data which clinicians need to best manage the older cancer population. Since there was a lack of age related analyses, valuable data may have gone unreported. ASCO and other organizations recognize the lack of data on the management of older cancer patients. The underrepresentation of this population in clinical trials certainly contributes to this lack of data. Data mining of these existing studies involving large numbers of patients may provide valuable age related information for clinicians. The continued development of trials involving the older cancer population will aid in increasing our knowledge. We would also like to put forth that journal reviewers and editors should require the incorporation and reporting of age related analyses in studies, especially those involving large number of patients. No significant financial relationships to disclose.
Polypharmacy in elders with cancer: An analysis of the Ohio medicaid population
Authors: Koroukian S. M. , Owusu C. , Madigan E. , Diaz M. 
Published: March 2020

19550 Background: Polypharmacy in the elderly complicates therapy, increases cost of treatment and is a challenge to healthcare agencies. However, the impact of polypharmacy on the care of the older cancer patient has been poorly described. The objective of this study was to characterize the use of pharmacy drugs in the month preceding cancer diagnosis among Ohio Medicaid beneficiaries 65 years of age or older, and diagnosed with incident breast, prostate, or colorectal cancer during the study period 1997–2001. Methods: Medicaid beneficiaries were identified by linking data from the Ohio Cancer Incidence Surveillance System (OCISS) with Medicaid enrollment and claims files on a year-by-year basis. Because of potentially incomplete claims history, the study was limited to patients who were enrolled in Medicaid continuously in the year preceding initial cancer diagnosis. Additionally, those with spenddown or nursing home stay in that time frame were excluded from the analysis. Demographics, anatomic cancer site and stage were retrieved from the OCISS, and all non-pharmacy claims for services received in the year prior to cancer diagnosis were accounted for in deriving the Charlson comorbidity score. Results: The study population included 652 patients: 282 with incident breast cancer, 111 with prostate cancer, and 259 with colorectal cancer. The median age was 73, 74, and 75 years among breast, prostate, and colorectal cancer patients, respectively. Nearly 45% were prescribed at least one type of medication in the month preceding cancer diagnosis. Of those with any prescription in that time period, nearly 49% were prescribed 5 or more types of medications. The most commonly prescribed types of medication were narcotic analgesics, diuretics and potassium replacement, anti- hypertensive agents, laxatives, antianxiety drugs, and antidpressants. No significant variations in the use of medications were observed across the different subgroups of the study population. Conclusions: Polpypharmacy (5 or more types of medication) was present in more than 22% of patients in this study population. The effects of polpypharmacy above and beyond that of comorbidities, disability, and other geriatric syndromes, relative to cancer-related outcomes should be determined. No significant financial relationships to disclose.