bluuebunny/crossref_metadata_2025 huggingface dataset:
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.
Efficacy of an oncology palliative care clinic for improving symptom management and patient satisfaction
Authors: Follwell M. , Burman D. , Wakimoto K. , Seccareccia D. , Bryson J. , Sirianni G. , Le L. , Rodin G. , Zimmermann C.
Published: March 2020

19552

Background: Previous studies to assess symptom control in a palliative care clinic setting have largely been retrospective. This study prospectively assesses the efficacy of an Oncology Palliative Care Clinic (OPCC) for improving symptom management and satisfaction with cancer care. Methods: All consenting patients newly referred to the OPCC completed the Edmonton Symptom Assessment System (ESAS) and the FAMCARE Scale (modified for patient use) at baseline, one week, and one month. The primary outcomes were the ESAS distress and FAMCARE total scores, for which one-week analyses are presented (paired t-test). Individual ESAS symptom scores were also assessed in an exploratory analysis, with the p-value set at 0.01 to provide some protection from multiple comparisons. Results: 118 patients, all with metastatic cancer, have completed the one-week assessment. The mean ESAS symptom distress score at baseline was 38.31±18.34. One week after the initial OPCC assessment there was a mean decrease in the distress score of 7.94 units (95%CI 5.11–10.76, p<0.0001). The mean baseline score for patient satisfaction was 66.31±13.23, with a mean increase of 7.22 points at one week (95%CI 4.51–9.94, p<0.0001). Individual symptom scores that showed the greatest improvement were anxiety (improved 1.40 units; p<0.0001), nausea (1.16 units, p = 0.0001), dyspnea (1.08 units; p = 0.0003), insomnia (0.97 units, p = 0.0003), pain (1.01 units, p = 0.0018), drowsiness (0.93 units, p = 0.0083), appetite (0.86 units, p = 0.0023) and fatigue (0.77 units p = 0.0039). The only symptoms that did not reach statistical significance were constipation (improved by 0.71, p = 0.053) and depression (0.6 units, p = 0.018). Conclusions: One week after assessment in an OPCC, there were significant improvements in symptom distress and satisfaction with care. It remains to be determined whether or not these results will be sustained at one month. Randomized controlled trials of the effectiveness of an OPCC are needed.

No significant financial relationships to disclose.
Epoetin delta in the management of anaemia in cancer patients
Authors: Zajda K. , Krzakowski M.
Published: March 2020

19555

Background: Cancer is often associated with anaemia. Epoetin delta (Shire plc) differs from recombinant erythropoietins as it is produced in a human cell line using gene-activation technology. We report data from a controlled trial of epoetin delta (ED) and an extension study. Methods: Cancer patients with anaemia (haemoglobin [Hb] = 10.5 g/dL) were randomized to 12-weeks’ treatment with ED (150 or 300 IU/kg) or placebo (double blind). Treatment was given subcutaneously, three-times weekly. Patients were included if they were receiving chemotherapy and had at least two cycles remaining when randomized. Primary objective was to demonstrate a difference between ED and placebo in Δ Hb from baseline and the number of patients requiring blood transfusions. Target sample size was 100 patients per arm (99% power for a 1.6 g/dL difference in Δ Hb and a 29% difference in the percentage of patients requiring transfusions). Patients completing the study entered an open-label, 12-week extension in which all initially received ED 150 IU/kg. Dose could be increased to 300 IU/kg if Hb levels were < 12 g/dL after 4 weeks. Results: In total, 313 patients were randomized (100, 103 and 99 to ED 150 and 300 IU/kg, and placebo, respectively). Mean change ± SD in Hb from baseline was 2.47 ± 2.39, 2.46 ± 2.56 and 0.57 ± 1.7 in the ED 150 and 300 IU/kg, and placebo groups respectively (P < 0.0001 for both comparisons). There was no difference in the proportion of patients requiring transfusions (26.0, 21.9 and 26.9%, respectively). In the second study, Hb levels were maintained in those previously on ED and increased in those previously on placebo (2.55 g/dL). In those previously on ED, transfusion requirements were lower. ED was well tolerated. Conclusions: Epoetin delta was effective in increasing Hb levels in patients with anaemia related to cancer and longer treatment was associated with fewer transfusions.

No significant financial relationships to disclose.
A randomized control study on the effects of prescriptive exercise on lean mass and fatigue in breast cancer patients undergoing treatment
Authors: Battaglini C. , Dennehy C. A.
Published: March 2020

19560

Background: Loss of lean mass during cancer treatment has been correlated with increases in fatigue (F) levels. Exercise is related to decreases treatment related fatigue and has been shown to thwart muscle loss. Methods: Twenty female subjects, ages ranging from 35 to 70 years, were recruited for the 21 week study. A randomized two-group (exercise and control) design with multiple measurements [Pre-surgery (PS), Post-surgery (POS), 1st assessment during Chemotherapy (Chemo1), 2nd assessment (Chemo 2), 3rd assessment (Chemo 3), and at the end of the experiment (FA)] was used. Percent of lean body mass (%LBM) and F levels were measured as dependent variables. Also, creatine kinase (CK) and total caloric intake (TCI) were measured to explain changes in %LBM and F. Data were analyzed using a two-way mixed model ANOVA with repeated-measures. Results: No significant difference in %LBM from PS to FA (p = 0.82) was observed. However, a significant interaction effect between groups and %LBM from PS to FA was observed (p<0.000). Post hoc analyses revealed significant difference in %LBM between groups at the FA (p = 0.004). Significant differences in F scores were observed between PS and FA (p=0.008). Post hoc analyses revealed significant difference in F scores between groups at Chemo 1, (p=0.001), Chemo 2, (p=0.005), and FA (p=0.000). No differences in CK were noted, however significant differences were noted between groups at PS (p=0.000) and FA (p=0.000) for TCI. Conclusions: The results suggest that initiating a regular individualized prescriptive exercise immediately following surgical recovery and continuing through at least 12 weeks during chemotherapy treatment positively impacts %LBM and deceases F when compared to patients not involved in any exercise.

No significant financial relationships to disclose.
Safety of transdermal scopolamine in pediatric patients for chemotherapy-induced nausea and vomiting (CINV)
Authors: Weber L. M. , Alexander D. , Finkelstein M. , Chen S.
Published: March 2020

19568

Background: Transdermal scopolamine has been used for over 25 years in the treatment of nausea and vomiting, but little information is available on its safety in pediatric patients. The antiemetic guidelines established at our hospital allow children between 8 and 15kg to receive a ½ patch every 3 days and children greater than 15 kg to receive 1 patch every 3 days as an adjunct agent for CINV. The goal of this study was to assess the safety of transdermal scopolamine in hospitalized pediatric patients during chemotherapy treatment. Methods: A retrospective chart review was conducted at Children’s Hospital and Clinics of Minnesota from April to September 2005. A total of 82 hospital admissions (41 patients) were reviewed for adverse effects specific to scopolamine using the National Cancer Institute’s Common Terminology Criteria for Adverse Events. Results: Mean patient age was 8 years (1–20 years) and the average length of patch use was 6 days (2–31 days). Of the 82 admissions reviewed, a total of 20 adverse events occurred (24%) in 14 patients. Median weight was significantly greater for patients experiencing the following adverse events compared to patients that did not: headaches (p=0.009), mental status changes (p=0.01) and hallucinations (p=0.003). Age > 12 years (p<0.001) and use of the patch > 4 days (p<0.01) were significantly correlated with the incidence of an adverse event. 75% of patients did not experience an adverse effect from transdermal scopolamine therapy when used 4 days or less. Conclusions: Transdermal scopolamine is a safe adjuvant for treatment of CINV in pediatric patients; however, as many as 1 in 5 may suffer adverse events. When used for more than 4 days the risk of adverse events increases. Older children and adolescents are more prone to adverse events.

No significant financial relationships to disclose.
Human recombinant erythropoietic agents (rHuEPO) do not induce changes in circulating levels of endoglin and vascular endothelial growth factor (VEGF) in anaemic cancer patients
Authors: Ocana A. , Rodríguez-Barbero A. , Pericacho M. , Bellido L. , Fonseca E. , Delgado C. , Soto de Prado D. , Cruz- Hernández J. J. , López-Novoa J. M.
Published: March 2020

19569

Background: The expression of Erythropoietin (EPO) receptors on cancer cells and the correlation of EPO receptor levels with angiogenesis and progression in some cancers have suggested that EPO could acts directly as an angiogenic factor. The purpose of this study was to assess the effect of treatment with human recombinant erythropoietic agents (rHuEPO) in cancer patients with chemotherapy-induced anaemia on Endoglin and Vascular Endothelial Growth Factor (VEGF) circulating levels as a possible marker of angiogenesis. Methods: Endoglin and VEGF were measured in serum samples from 25 cancer patients with chemotherapy-induced anaemia before and after 3 to 4 weeks of treatment with rHuEPO (Epoetin alfa 150 UI/Kg three times per week; darbepoetin alfa 150 mcg/weekly). A group of 28 healthy voluntaries were used as control. Endoglin and VEGF were analyzed using an ELISA commercial Kit (R&D Systems; Ciudad-Pais). T- student test was used to study the association between variables. Paired comparisons before and after treatment were performed using the Wilcoxon rank-sum test. Results: VEGF serum levels were significantly higher in cancer patients than in controls (476,66±72,56 pg/ml versus 227,34±24,58 pg/ml, p<0.001, respectively). Endoglin levels were significantly higher in patients than controls, although this difference did not reach statistical significance (4.75±0.30ng/ml versus 4.18±0.12 ng/ml, p=0.075). Similar results were found in the different subgroups of patients (Breast cancer, endoglin p=0.019; VEGF p=0.009; Colon cancer, endoglin p=0.084; VEGF p<0.001). Using the Wilcoxon rank-sum test no statistically significant differences in endoglin (p=0.510) and VEGF (p=0.313) serum levels were found between samples obtained before and after treatment with rHuEPO agents. When considering the type of rHuEPO, no differences were observed. In a similar manner, no difference was observed depending on chemotherapy regimen or cancer type. Conclusions: Although the follow up is short and the number of patients is small, our exploratory results do not support that rHuEpo treatment in anaemic cancer patients induce angiogenic serum markers.

No significant financial relationships to disclose.
Pulmonary toxicity of cytotoxic agents: A meta-analysis
Authors: Takiguchi Y. , Tada Y. , Kurosu K. , Sakao S. , Tatsumi K. , Nagao K. , Kuriyama T.
Published: March 2020

19573

Background: Pulmonary toxicity is one of the most serious adverse effects of cytotoxic agents, and affected patients require discontinuation of the anti-cancer therapy, and it even proves fatal in many cases. Its incidence, however, may be considerably biased, as it may be influenced by many factors such as intercurrent medications or co-morbidities. The purpose of our study was to evaluate the incidences of pulmonary toxicity by cytotoxic agents in published data relating to prospective randomized comparative studies. Methods: A Medline literature search was conducted to extract prospective randomized comparative studies (either phase II or III) that included docetaxel, paclitaxel, irinotecan, vinorelbine and gemcitabine. Comparisons had to be performed between regimens with and without one of these agents, in addition to best supportive care with or without other common agent(s), so as to be able to clearly attribute the toxicity to the agent. Reports lacking detailed toxicity data were excluded. Results: The table below summarizes the results of the finally evaluated 47 studies (5 to 12 per agent) fulfilling the criteria. As many studies showed no pulmonary toxicity, standard statistical methods for meta-analysis were not applicable. Conclusions: The present study analyzing data in prospective randomized comparative studies might minimize bias of the relative incidence of pulmonary toxicity. Pulmonary toxicity was rarely encountered in randomized comparative studies. No increase in frequency was shown by the inclusion of any of the five cytotoxic agents.

[Table: see text]

No significant financial relationships to disclose.
The protective effect of proanthocyanidin on the methotrexate-induced intestinal damage
Authors: Gulgun M. , Erdem O. , Oztas E. , Kismet E. , Koseoglu V. , Balamtekin N. , Kesik V. , Ozcan O.
Published: March 2020

19576

Background: Methotrexate (MTX) induced mucositis is an important dose-limiting side effect for which there is no definitive prophylaxis or treatment. This study was designed to investigate whether proantocyanidin, grape seed extract from Vitus Vinifera, had a protective effect on the small intestine of rats with MTX-induced damage. Methods: Thirty two albino rats were randomized into experimental and control groups and divided into four groups. To the first group, MTX was applied as a single dose (20 mg/kg) intraperitoneally. To the second group, in addition to MTX application, proanthocyanidin (100 mg/kg) was given orally every day by gavage until the rats were killed. To the third group, proanthocyanidin only was administered. The fourth group was the control. All animals were sacrificied 4 days after the intraperitoneally injection of MTX for histopathologic examination and tissue malonaldehyd (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GPx) levels. Results: MTX was found to lead to injury in the jejunal tissues and to increase the MDA levels. Administration of the proantocyanidin decreased the jejunal damage and MDA level which was caused by MTX treatment and increased SOD an GPx levels. Conclusions: These results suggest that proanthocyanidin may protect the small intestine of rats from MTX-induced damage. The effects of proanthocyanidin could be resulted from antioxidant properties of the proanthocyanidin.

No significant financial relationships to disclose.
Treatment of colorectal cancer in elder patients
Authors: Piga A. , Miscoria M. , Aprile G. , Cozzi M. , Iaiza E. , De Pauli F. , Zanon E. , Fasola G. , Sacco C.
Published: March 2020

19595

Background: Tumor-related mortality is higher in elder patients worldwide. This may be due to comorbidities associated with age but also, at least in part, to a cautious approach by the attending physician(s) which might result in inadequate or even denied treatment. This approach is purportedly justified by scarcity of literature reports on effectiveness, tolerance and side effects of chemotherapy and other treatments on this category of patients. Methods: We have reviewed clinical records of patients of 70 years of age or older with colorectal cancer who came to our first observation between January 2004 and April 2006. We have correlated the appropriateness of therapeutic decisions, based on adherence to clinical standards, to the clinical characteristics of the patients and in particular to number and degree of coexisting morbidities. Chi square test was used for analysing the association between variables. Results: We have reviewed the records of 193 patients with colorectal cancer, to a total of 215 events, including 22 relapses in the same patients, in which a new therapeutic decision was involved. Adjuvant treatment was omitted in 40% of patients with stage III colon cancer, and 38% of patients with stage III rectal cancer. Chemotherapy was also omitted in 34% of patients with stage IV colon cancer and 35% of patients with stage IV rectal cancer. Even when patients received treatment, preference was given to drugs and regimens of low toxicity. Therapeutic decisions appeared in most cases based on age rather than number and severity of comorbidities. On the other hand, once the decision to treat was taken, the treatment was given as programmed, although 21% of patients received drug doses lower than 75% of projected dose; reasons for abandoning the treatment were progression and toxicity in stage IV, and more often patient's refusal in stage III. Conclusions: In a disease where standards of treatment are well defined, elder patients often receive inadequate treatment or no therapy at all. Although the justification for inadequate treatment is or should be poor clinical conditions of patients, this is not apparent from review of clinical records. Efforts should be made to have in elder patients standardised evaluation of physical status and comorbidities on a regular basis.

No significant financial relationships to disclose.
Technology exchange for cancer health network
Authors: Yunus F. , Teresa W. , Jahanzeb M. , Karen F. , Minhaus S. , Yunus R. , Sydow P. , Merkel M. , Kersey R. , Gray S.
Published: March 2020

19598

Background: The Technology Exchange for Cancer Health Network (TECH-Net) is a collaborative, multi-state effort to implement a systematic care program to improve cancer management in the rural communities of west Tennessee, north Mississippi and east Arkansas. This Health Information Technology (HIT) project uses a two-pronged approach to total clinical decision support: (1) provide access to oncology, hematology, and other specialists through the dedicated telehealth network of the University of Tennessee's Health Science Center in conjunction with the University of Tennessee Cancer Institute; and (2) rely on a distributed electronic health record (EHR) with integrated decision support systems for online management of cancer protocols, electronic orders, and medication management. Methods: Patients with a cancer diagnosis requiring treatment for at least one year are eligible to participate. The ultimate goal for this project is to enroll 250 patients (125 rural, 125 urban) and compare quality, safety, and cost outcomes for patients receiving rural Telehealth care versus “routine” urban care. Telehealth patients see their oncologist in person at the rural sites for initial care, and see their physician via telemedicine for approximately one-half of their subsequent visits. This approach allows the clinician to make in-person clinical assessments on a regular basis while still taking advantage of the time savings associated with telemedicine. Results: 163 patients have been enrolled in the study (127 rural, 36 urban) over 18 months. Patient satisfaction has been high - 95 % of patients indicated their telemedicine visit was as good as or better than an in-person office visit. Cost analysis comparing cost savings (physician travel time) with telemedicine costs (equipment, high speed lines) indicates that the cost-benefit depends critically on distance to the rural facility and number of physician trips avoided. Initial cost data indicate that telemedicine must save at least 5 hours of physician travel time per month to break even. Conclusions: Telemedicine offers a feasible method for increasing access to oncology care in rural areas that is well-accepted by both patients and clinicians.

No significant financial relationships to disclose.
The impact of intra-operative high field magnetic resonance imaging on clinical decision making during oncologic neurosurgical procedures
Authors: Weinberg J. S. , Shah K. , Rao G. , Jackson E. F. , Suki D. , Sawaya R. , Schellingerhout D.
Published: March 2020

19599

Background: Existing image guided surgical (IGS) technology used during resection of brain tumors is based on preoperative imaging modalities and are limited by their inability to demonstrate extent of resection (EOR) and compensate for anatomical changes which occur as a result of surgical manipulation (e.g. brain shift, tumor resection, spinal fluid loss). Having the ability to perform MRI during brain tumor surgery obviates many of these limitations. The purpose of this study was to determine the impact of intra-operative imaging with a high field MRI on brain tumor resection. Methods: Since September 2006, a total of 23 patients with brain tumors underwent resection at The University of Texas M. D. Anderson Cancer Center with intra-operative MR guidance (BrainLAB IGS system integrated with a 1.5T Siemens Espree scanner). For each patient, appropriate imaging was performed prior to craniotomy. Resection was then performed using image guidance. Surgeons completed a questionnaire documenting the reason for the scan and provided an estimation of EOR prior to and after the intraoperative scan. Multiple intraoperative scans were performed at the discretion of the operating surgeon. Results: In 23 patients, 25 scans were performed. The patients had a diagnosis of glioma (21), lymphoma (1), and schwannoma (1). Reasons for performing a scan included: evaluate EOR in 23 (92%) or update the IGS system in 2 (8%). Surgeons indicated in 21/23 (91%) scans performed to evaluate the extent of resection that they would have terminated the surgery prior to the scan. In 9/21 cases (43%), further surgery was performed after the scan to maximize EOR. In 10/24 (42%) cases, the pre-scan estimate of residual tumor matched the post-scan amount. The amount of residual tumor was correctly assessed (within 10%) prior to review of the MRI in 19/24 cases. The correlation between the pre-scan estimation of residual tumor and actual post-scan tumor was high (correlation coefficient 0.81, p<0.05). Conclusions: High field intra- operative MRI with high spatial resolution is a useful adjunct to a neurosurgical oncology practice and alters surgical decision making in a significant number of cases.

[Table: see text]
Role of epoetins in beta-thalassemia minor patients with solid tumors undergoing chemotherapy: Results of a retrospective analysis
Authors: Soto Parra H. J. , Medula E. , Latteri F. , Lavenia G. , Amadio P. , Cordio S. , Magnano C.
Published: March 2020

19600

Background: β-Thalassemia minor (β-Tm) is the most common hereditary disorder in the Mediterranean region with a prevalence of 6% in Sicily. β-Tm is characterised by mild anemia (A). Therefore, we performed a retrospective analysis to evaluate the course of A in β-Tm pts with solid tumors (ST) undergoing chemotherapy (CT). Methods: β-Tm pts with ST were identified from our clinical record database [history and/or hemoglobin (Hb) A2 level > 3.3%]. Inclusion criteria were first-line or second-line CT after a CT-free interval of 6 mos. Exclusion criteria:concomitant radiotherapy (RT) , or previous RT to pelvic region, or active bleeding. Results: From July 2004 until the present day, 26 β-Tm pts with ST have been observed, and 23 fulfil the criteria of this analysis. The pt demography was as follows: median age, 56 years (range, 38–76 years); Males: 9 pts; PS 0/1: 19/4; stage IV: 10; types of cancers: breast 7, gastrointestinal 7, others 9; platinum containing regimen: 7. A was evaluated during first and second-line treatments in 19 and 4 pts, respectively. The mean values of Hb and the incidence of pts (%) with mild (from ≥10 and <12 gr/dl) or moderate (<10 gr/dl) A during CT, were as follows. No paradoxical effect of CT on the Hb level was observed. One pt received transfusions (Hb level, 7.8 gr/dl). Nine pts were treated with epoetin (darbepoetin alfa, 7 pts) and iron supplements due to worsening A (mean Hb value = 9 gr/dl ± 0.6): five pts experienced a ≥2 gr/dl increase in the Hb level at 8 weeks, one had >1 gr/dl, one had stable values = 9 gr/dl, and two pts had decreased values, i.e. < 8 gr/dl, and required transfusions. Conclusion: This analysis demonstrates that 70% of β-Tm pts with ST have mild or moderate A prior to CT. The A of β-Tm patients is worsened by CT and results in moderate A in 55% of the pts. Epoetins, particularly effectively ameliorate A when administered to pts with Hb levels of <10 gr/dl. This data suggests that epoetin treatment during CT may benefit β-Tm pts; however, prospective trials are required.

No significant financial relationships to disclose.

[Table: see text]
Feasibility of group follow-up visit for breast cancer survivors
Authors: Ruud C. O. , Francis K. , Stephens C. , Rajab M. H.
Published: March 2020

19603

Background: The ASCO 2006 guidelines specify that regularly scheduled follow-up care of breast cancer survivors should be the standard. Follow up care is a “teachable moment” to train survivors in positive habits. A group visit model at the Cleveland Clinic proved feasible and improved patient satisfaction for other diseases. Our objectives include assessing the feasibility of an adapted group follow-up visit for the care of breast cancer patients and patient satisfaction. Methods: A feasibility study targeting breast cancer patients who completed primary therapy and were scheduled for a routine appointment. We mailed letters inviting patients to a follow-up group visit. Patients were divided into 3 groups, each scheduled for a separate (90–120 minute). During the first half of the visit, participants were divided into three groups; 5-minute physician exam, nurse review of medications and vital signs, and instruction by a social worker. Groups were rotated. During the second half the doctor, nurse, and social worker met with all participants in one room starting with an educational presentation about fatigue and exercise. Each participant was subsequently interviewed by the physician in the presence of their peers. Shared complaints were investigated first. Patients rated their satisfaction with the different parts of the visit on a scale of 1–5. Participants were surveyed pre- and post- education session and asked if they would participate again. Participants were allowed to bring a family member or friend. Results: 29 (29.6 %) out of 98 consented and 22 (22.5%) attended;10 in first visit, 5 in second visit and 7 in last visit. Average age 61±8, ranged from 46–72 years. Most participants were satisfied with all parts of the group visit, except two in the first group were less satisfied with the check in process and moving between rooms. Comparing the pre- vs. post- educational session surveys showed an improved understanding of the importance of fatigue or exercise. 17 (77%) out of 22 participants agreed to participate in another group visit. Conclusion: Group visit format is feasible and provides patient satisfaction.

No significant financial relationships to disclose.
Pilot study of dronabinol for adult patients with primary malignant gliomas
Authors: Vredenburgh J. J. , Bohlin C. H. , Reardon D. A. , Desjardins A. , Quinn J. A. , Rich J. N. , Bota D. A. , Goli K. J. , Friedman H. S. , Allen D. H.
Published: March 2020

19607

Background: Chemotherapy-induced nausea and vomiting (CINV) are common adverse effects from chemotherapy. While most treatments administered in patients with primary gliomas are not highly emetogenic, up to 50% of neuro-oncology patients report CINV despite 5HT3 or steroid therapies. Adjuvant benzodiazepines frequently alter mental status. Dronabinol may provide a safe alternative option without compromise of neurological status. his study seeks to describe toxicities (TOX) associated with dronabinol administration in neuro-oncology patients. A secondary aim is to describe the impact that dronabinol has on their quality of life (QOL). Methods: This is an exploratory study of adult patients with WHO Grade III/IV primary gliomas on adjuvant chemotherapy. Power analysis determined a sample size of 34 subjects for 0.80 effect size. Enrollment is ongoing with 18/34 adult patients accrued. Patients take dronabinol 5 mg BID 24 hours prior to, during, and 48 hours after completion of oral/IV chemotherapy. Patients continue their established antiemetic regimen. Between chemotherapy doses, dronabinol is reduced to 2.5 mg daily. Intolerance of dronabinol is defined as 2 or more Grade 3 or greater non-hematologic TOX according to the CTC v.3 definition handbook. Modified Functional Living Index-Emesis (FLIE), Functional Assessment of Cancer Therapy-Brain Tumor (FACT-Br), Mini Mental Status Exam (MMSE), and CINV visual analog scales are collected at specific points for 2 cycles for TOX and QOL data. Results: Subjects are predominately male (n=10); mean age of 45.2 years. Four withdrew due to Grade 3 neurologic TOX of cognitive changes (n=3) despite decreasing dosages; Grade 3 persistent CINV (n=1) despite increasing dronabinol dosage. Increased dosages were required in 4 subjects to better manage CINV. Two required decreased doses for Grade 2 neurologic TOX. Most subjects (n=14) reported stable or improved QOL by FACT-Br and FLIE while the 4 withdrawn subjects reported worsening QOL related to TOX. Conclusions: Dronabinol is safe and effective for administration as an adjunct to standard antiemetic therapy during treatment for primary glioma. The dose may be titrated with minimal toxicities and improvement in QOL.

No significant financial relationships to disclose.
Defining the pathophysiology of the paclitaxel-acute pain syndrome
Authors: Wolf S. L. , Loprinzi C. L. , Maddocks-Christianson K. , Rao R. D. , Dyck P. B. , Mantyh P. , Dyck P. J.
Published: March 2020

19613

Background: Paclitaxel therapy often results in a unique sub-acute pain syndrome, whose pathophysiology is unknown. While this syndrome is often termed as a ‘myalgia’ or ‘arthralgia’, it has not been demonstrated to be associated with any structural injury of muscles or joints. Identifying the pathophysiology mechanisms that result in the paclitaxel-acute pain syndrome might be a positive step in the development of effective prevention and/or treatment strategies. With the hypothesis that the paclitaxel-acute pain syndrome occurs as a result of nerve injury, an observational study to clarify the clinical characteristics of this syndrome was initiated. Methods: Oncology patients who were treated with at least one dose of paclitaxel and reported developing sub-acute pain were questioned using a detailed structured interview. Various aspects of the pain, including the time of onset, duration, location, severity, and exacerbating factors were evaluated. Data were tabulated descriptively. Results: Eighteen patients were interviewed. The onset of pain typically occurred 1–2 days after therapy and lasted for a median of 4–5 days. Pain was most commonly located in the back, hips, shoulders, thighs, legs and feet, with the most common descriptors used being ‘aching’ or ‘deep pain’. Commonly used adjectives to describe the pain were: ‘radiating’, ‘shooting’, ‘aching’, ‘stabbing’ and ‘pulsating’. Some patients described increased pain with weight bearing or walking. Fifteen of 18 patients specifically denied localization of pain to either joints or muscles. Conclusions: The nature of the pain, i.e. , generalized, deep aching pain, the notation of increased sensitivity with weight bearing (mechanical hyperalgesia) and the lack of localization to joints or muscles, support the hypothesis that the paclitaxel-acute pain syndrome results from a hyperalgesic dysfunction of nociceptive receptors, their fibers, or the spinothalamic system. These clinical conclusions are supported by the recent findings that markers of cellular injury can be identified in peripheral nerve tissues shortly following paclitaxel administration in an animal model (Peters CM, et al., Exp Neurol. 2007 Jan;203(1):42- 54).

No significant financial relationships to disclose.
Anemia management with erythropoietic stimulating therapies (ESTs) in patients (pts) with gastrointestinal (GI) malignancies: Results from a prospective observational study
Authors: Chen E. , Larholt K. , Wang Q. , Bookhart B. , McKenzie R. , Tak Piech C.
Published: March 2020

19614

Background: Chemotherapy-induced anemia is a common problem for pts with GI malignancies. To assess dosing patterns and outcomes in GI malignancy pts treated with ESTs (epoetin alfa (EPO) and darbepoetin alfa (DARB), a subset analysis of an ongoing registry was conducted. Methods: Data drawn between1/04 and 10/06 from 41 U.S. oncology clinics from the Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (D.O.S.E.) registry were assessed. Pts were included in this analysis if they were diagnosed with a GI malignancy (colon, rectal, gastric, esophageal, or pancreatic), = 18 years, and received = 2 doses of either EPO or DARB. Outcomes assessed included mean baseline (BL) characteristics, transfusion utilization, hemoglobin (Hb) at Weeks 4, 8, and 12 after initiation of EPO or DARB, and cumulative EST doses with associated cost (based on 9/2006 wholesale acquisition cost). Results: 186 pts (82 EPO, 104 DARB) were identified. BL characteristics were similar between treatment groups: age 64 years, 45% women, and Hb 10.5g/dL. Both groups had a similar treatment duration (7 weeks) and number of Hb determinations (7.6); however, the DARB group had significantly more office visits (EPO 7, DARB 9.8, p=.0006). The proportion of pts transfused from Week 5 to end of study and number of units transfused/pt were similar between both groups. Hb values were similar at Weeks 4 (11.1 g/dL), 8 (11.1 g/dL), and 12 (11.0 g/dL). The mean administered dose per injection was 42,143 Units for EPO and 225 mcg for DARB. Mean cumulative administered dose during the treatment episode was 296,476 Units for EPO and 1,131 mcg for DARB, resulting in a dose ratio of 262:1 (Units EPO:mcg DARB). Overall EST cost was significantly lower in the EPO group compared to the DARB group (EPO $3,608, DARB $5,028, p=.0024). Conclusions: Similar hematological outcomes for EPO- and DARB-treated pts with GI malignancies were observed. Based on observed dosing patterns and cumulative EST utilization from this prospective observational study, EST costs were 28% lower in the EPO group than the DARB group. The observed dose ratio is consistent with previously reported clinical studies.

No significant financial relationships to disclose.
Risk factors for neutropenic fever in lymphoma patients receiving chemotherapy
Authors: Teegala S. R. , Zhou X. , Huen A. , Ji Y. , Fayad L. E. , Romaguera J. E. , Vadhan-Raj S.
Published: March 2020

19616

Background: Neutropenic fever (NF) can be a serious complication of chemotherapy (CT) in lymphoma patients (pts), however the exact incidence with the current regimens and risk factors for NF are not well known. Methods: A retrospective cohort study was conducted to determine the incidence of NF, and logistic regression analysis were performed to identify the clinical and laboratory features correlated with NF in lymphoma. Medical records of all newly referred lymphoma pts (n=1046) in 2003 were reviewed. Results: 425 pts who received ≥ 1 cycle of treatment at MDACC were included in the analysis. Median age was 57 (range 17–87) with 262 (62%) newly diagnosed. Most common first regimens were (± rituxan) CHOP (29%), Hyper-CVAD ± Ara-c-MTX (23%), and ABVD (8%), with the total number of cycles were 1638 (median 3, range, 1–10). NF was observed in 23 % (97/425) of pts and 8 % (123/1638) of cycles, with the highest number in cycle 1 (49/123). The NF incidence among most common regimens were (± rituxan) Hyper-CVAD/ Ara-c/MTX 53% (31/58), Hyper-CVAD 24% (9/37), CHOP 22% (27/125), and ABVD 6% (2/34), and most common subtypes were MCL (33%), LCL (23%), HD (16%), and FL (13%). In the univariate regression analysis, CT, Hb, Ca, LDH, lymphocyte (ALC) and neutrophil (ANC) counts, were significantly associated with the NF. Using multivariate logistic regression, baseline ALC count (=1000 vs. >1000/μL: OR=2.251, 95% CI, 1.194 to 4.244, p=0.0121), Hb (<12 g/dL vs. ≥ 12g/dL: OR=2.117, 95% CI, 1.122 to 3.996, p=0.0207), age (>60 vs. ≤60: OR=2.035, 95% CI, 1.066 to 3.884, p=0.0312), CT (high vs. low risk: OR=2.913, 95% CI, 1.520 to 5.583, p=0.0013) were the most important baseline risk factors for NF in cycle-1. Conclusions: The incidence of NF in this population is high in cycle 1. Baseline pt characteristics including old age, high risk CT, low ALC and Hb were found to be significant risk factors predictive for NF in cycle-1. These findings could be useful to identify high risk pts for consideration of treatment approaches for prevention of NF.

No significant financial relationships to disclose.