bluuebunny/crossref_metadata_2025_split huggingface dataset:
Amino acid mixture (enterade) as a new approach to reducing cancer therapy-induced gastrointestinal toxicity: A retrospective study.
Authors: Chauhan Aman , Patel Reema Anil , Luque Laura , Chitwood Holly , Siddiqui Fariha , Tarter Zachary , Mitchell Katherine , Cloud James , Miller Rachel C. , Anthony Lowell Brian 
Published: May 2020

e24107 Background: Gastrointestinal toxicity is a common side effect of cancer therapy. Pre-clinical studies using a proprietary mixture of amino acids, demonstrated a reduction in mucositis and gastrointestinal toxicity following irradiation via tightening of the mucosal barrier, increasing proliferation of crypt cells, increasing villous height and increasing absorption of fluid, electrolytes and nutrients. A novel 5-amino acid mixture “enterade” was previously evaluated in a Phase II clinical trial for anti-diarrheal effects in post bone marrow transplant patients at Dana Farber Cancer Institute (NCT02919670). Signs of anti-diarrheal efficacy were found in treatment-compliant patients.Enterade is currently being tested in two prospective Phase II studies (NCT03722511 and NCT04073017) in neuroendocrine tumor patients with quality of life limiting diarrhea. We conducted a pilot study to evaluate early antidiarrheal signals in oncologic treatment-induced diarrhea. Methods: An IRB-approved retrospective chart review was conducted at Markey Cancer Center between Sept 2019 and Dec 2019. Medical records were retrospectively reviewed for all solid tumor patients who received enterade for chemotherapy or immunotherapy-induced diarrhea. Patients were instructed to consume one 8-oz bottle of enterade twice a day for at least one week in addition to standard of care antidiarrheal medications. Results: A total of 46 patients were offered enterade. Antidiarrheal efficacy data was available on 17 patients. 11 were female and the mean age of the cohort was 64 years. Six out of 17 patients had a previous history of bowel resection. Four patients had immune checkpoint induced colitis. Three patients developed diarrhea from TKI use and rest were on cytotoxic chemotherapy at the time of the diarrheal episode. Eighty-eight percent (15/17) of patients reported a reduction in diarrhea frequency after consuming enterade. On average, patients noticed an improvement in diarrhea frequency after 3.6 days of enterade consumption, with 86% (13/15) of responders reporting at least 50% reduction in diarrhea frequency. Conclusions: Patient-reported diarrheal improvement after enterade consumption is consistent with pre-clinical data. Results suggest the amino acid mixture may alleviate symptoms of cancer therapy-induced gastrointestinal toxicity (i.e. diarrhea). A prospective clinical trial is warranted to substantiate the observed improvement in chemotherapy and immunotherapy induced diarrhea.
The effectiveness of a non-physician provider-led palliative care intervention to improve outcomes in patients with cancer.
Authors: Ready Audrey , Knee Alexander , Rastegar Vida , Stefan Mihaela 
Published: May 2020

e24110 Background: Palliative care (PC) improves symptom burden, patient and family distress and quality of life of patients with advanced illnesses. Previous evidence has shown that non-physician providers (NPP) can be effective in delivering care with minimal physician support. NPP-led PC interventions could potentially address gaps in the workforce and provide access to PC services. The overall objective of this systematic review is to evaluate the effectiveness of NPP-led PC interventions in the management of adults with cancer. Methods: We searched ten electronic databases up to October 2018 for randomized or cluster control trials that evaluated NPP-led interventions in both adults receiving end of life care for advanced malignancies and/or their caregivers. NPPs included nurses, advanced practitioners, social workers or case-worker. Interventions included symptom management, hospice care, advance care planning (ACP) or decision support. We recorded the following outcomes: quality of life, patient symptoms (anxiety, depression, pain or distress), satisfaction with care and ACP. Study quality was assessed using the Cochrane risk of bias tool version 2.0. Results: Overall 5,241 publications were screened, resulting in 207 publications that underwent full text review. 13 studies (n = 2,007 participants) included only patients with diagnoses of cancer and an additional 2 studies (n = 396 participants) focused on mixed diagnoses of advanced illness, including cancer. Only 2 studies focused on both caregivers and patients. A nurse was the lead provider in 13 studies, and an advance practitioner in 2 studies. The NPP-led interventions were mostly psychosocial with four also providing symptom management. Interventions mostly consisted of education, care coordination information and support. A total of 3 studies focused solely on ACP, while 2 additional studies addressed this as part of the planned intervention. Nine studies reported quality of life outcomes and seven studies reported on anxiety and depression. There was considerable heterogeneity among the studies with respect to the nature of the intervention and the diagnoses of the study participants. All but one of the studies examined had high risk of bias, mostly due to issues related to missing outcome data or measurement of the outcome. Conclusions: In the setting of changing models of population health care delivery, the results of this systematic review could provide evidence for implementation of non-physician-led palliative care services outside of clinical trials.
Integrating pharmacogenomics panel testing for supportive care medications in patients with solid tumors.
Authors: Kekic Adrijana , Seetharam Mahesh , Singh Parminder , Kunze Katie , Golafshar Michael A , Azevedo Cindy , Welp Sydney , Bofferding Anne , Koep Tyler , Ross Jason , Nelson Eric , Grilli Christopher , Samadder Jewel 
Published: May 2020

e24114 Background: Pharmacogenomics (PGx) testing is used increasingly in cancer supportive care for drug and dose selection, and side effects prediction with antidepressants, antiemetics, and pain medications. Genetic variants in genes that encode for drug metabolizing enzymes (CYPs), transporters (SLC6A4) and drug receptors (HTR2A, OPRM1, etc) are well known for these medications. They contribute to inter-individual differences in medication safety and efficacy. We report on their frequency and effect on supportive care drugs in patients with solid tumors. Methods: Between 06/06/19 and 12/18/19, solid tumor cancer patients at Mayo Clinic Arizona were enrolled in a PGx prospective study. They were genotyped using a multi-gene panel, OneOme RightMed. The panel assessed 27 genes, including CYP2C9, CYP2C19, CYP2D6, CYP3A4, COMT, OPRM1, GRIK4, HTR2A, SLC6A4, associated with pain medications, antidepressants, and antiemetics. PGx pharmacist provided medication recommendations and dose adjustments based on PGx test results and concurrent medications. Results: 200 patients were swabbed and 196 patients were genotyped. The results were available within 5 days. All patients were also assessed for pheno-conversion (drug-drug-gene interactions) by a pharmacist. Recommendations were made based on predicted phenotype. Various solid tumor types were represented, including prostate (19.9%), colorectal (17.9%), melanoma (14.8%), and others (47.4%). Median age was 65 with 59.2% patients being male and 40.85% female. All had at least one actionable polymorphism related to these medications. The most significant findings were related to CYP2C19 and CYP2D6 genes. Of 196 patients, a total of 132 (67.3%) had other than normal CYP2D6 metabolizer phenotype and 112 (57.1%) had other than normal CYP2C19 metabolizer phenotype. Based on these genotypes, alternatives to pain medications were recommended for 37 patients, to ondansetron in 9 patients, and to anti-depressants in 51 patients. Conclusions: Genetic variants were commonly found that affect supportive care medications used in oncology practice and contribute to inter-individual differences associated with increased risk of adverse drug effects and reduced efficacy. PGx guided recommendation may help physicians in individualizing medication treatment outcomes for patients with different cancer types and with polypharmacy. PGx trained pharmacist can serve as a valuable asset in optimizing personalized medication management.
Aprepitant in weekly cisplatin with radiation in head and neck cancer: Is it required?
Authors: D'souza Hollis , Noronha Vanita , Patil Vijay Maruti , Joshi Amit , Menon Nandini Sharrel , Prabhash Kumar 
Published: May 2020

e24122 Background: Weekly cisplatin below 50 mg/m2 has lower emetogenic potential than 100 mg/m2 3weekly regimen. There is limited data on the utility of Aprepitant with weekly cisplatin used in radiation in head and neck squamous cell cancer (HNSCC). Methods: We conducted a phase 3 randomized trial in locally advanced HNSCC patients who were treated with definitive chemoradiation either with cisplatin or cisplatin-nimotuzumab. 5HT3 inhibitor and steroids +/- aprepitant were used as antiemetic prophylaxis as per physician discretion. The current analysis is focussed on studying the impact of aprepitant on nausea and vomiting. Fischer’s exact test was used to compare the chemotherapy induced nausea vomiting (CINV) rates between aprepitant and non-aprepitant groups. Binary logistic regression analysis was used to calculate the odds of CINV with the use of aprepitant. Results: Data on CINV is available for 524/536 patients. Nausea was present in 251 (47.9%) patients while vomiting was seen in 155 (29.6%) patients. Aprepitant, 5HT3 antagonist and dexamethasone were administered to 265 (50.86%), while 256 received 5HT3 antagonist and dexamethasone. Among patients receiving aprepitant, nausea was present in 112 (42.3%), while there was no nausea in 153 (57.7%) patients (p = 0.011). Vomiting with aprepitant was seen in 71 (26.8%) patients while 194 (73.2%) had no vomiting (p = 0.151). Adjusted odds ratio for use of aprepitant containing antiemetic prophylaxis in prevention of CINV were 1.585 (1.116-2.249;p = 0.010) and 1.328 (0.904-1.951;p = 0.149) as depicted in the table. Conclusions: Use of aprepitant significantly decreases nausea and is needed for weekly cisplatin regimens used in radiation in head and neck cancers. [Table: see text]
Incidence of 5-fluorouracil related in cardiotoxicity in patients with head and neck cancer.
Authors: Rajendra Akhil , Noronha Vanita , Patil Vijay Maruti , Joshi Amit , Menon Nandini Sharrel , Prabhash Kumar 
Published: May 2020

e24123 Background: Combination chemotherapy with cisplatin-fluoropyrimidine backbone is the standard of care for locally advanced head and neck cancer in the neoadjuvant setting. 5-Fluorouracil (5FU) is administered as a continuous intravenous infusion over 5 days. However, 5-FU may induce acute cardiotoxicity preventing its subsequent use. Incidence of 5-FU-induced cardiotoxicity ranges from 0.99 to 19.9% in published studies, which have been assessed predominantly in gastrointestinal malignancies. In the pivotal TAX323 and TAX324 trials, utilizing 5FU (750 mg/m2 continuous infusion for 5 days), docetaxel and cisplatin (TPF) as neoadjuvant chemotherapy, no cardiotoxicity was reported. We evaluated the development of cardiotoxicity from the use of the TPF regime in our patients with locally advanced head and neck cancer. Methods: Post-hoc analysis of patients treated on the TPF arm of a randomized controlled trial in our institution for locally advanced head and neck cancer in the neoadjuvant setting from 2016 to 2019. Results: 246 patients received TPF neoadjuvant chemotherapy for locally advanced head and neck cancer. Cardiotoxicity occurred in 16 patients; thus, the incidence was 6.5% (95% CI, 3-10%). Two-thirds of the cardiac events occurred in the 1st cycle. Mean time to onset of symptoms was 109.5 hours (4th day of the infusion). The most common events were chest pain (9 patients [56%]), asymptomatic bradycardia (5 patients [31%]) and syncope (2 patients [12%]). Dynamic ECG changes were seen in 5 patients with ST-segment elevation myocardial infarction occurring in one patient. Most common rhythm abnormality identified was bradycardia (7 patients) and in most cases, patients were asymptomatic (5 patients) for the same. Only 2 patients had LV dysfunction detected on echocardiography after the event. Cardiotoxicity resolved in 12 patients (75%). Conclusions: 6.5% of patients treated with 5-FU developed cardiotoxicity with most patients developing symptoms by day 4 of the 1st cycle; chest pain was the most common symptom.
Compatibility of topical agents with tumor treating fields (TTFields) for treatment of associated skin events in glioblastoma (GBM).
Authors: Giladi Moshe , Lacouture Mario E. , Weinberg Uri , Bomzon Zeev , Palti Yoram 
Published: May 2020

e24126 Background: TTFields are low intensity, intermediate frequency, alternating electric fields applied continuously using 2 pairs of skin-affixed transducer arrays. TTFields are FDA-approved in GBM and mesothelioma. The most common TTFields-related adverse event (AE) is mild-to-moderate dermatitis (beneath arrays), via long-term irritant exposure and local hyperhidrosis and occlusion exacerbation. Skin reaction mitigation strategies may improve quality-of-life (QoL) and ensure usage, as maximal survival benefits have been correlated with duration of use. Not all skin care products are TTFields compatible and may increase electrical impedance and lead to beneath array temperature increases. The aim of this in vivo study was to investigate the effects of 62 commercially available skin care products on electrical impedance during TTFields treatment. Methods: TTFields (200 kHz; optimal GBM frequency) were applied to rats using transducer arrays made of the same ceramic disks and hydrogels used in patients with GBM. To test electrical impedance effects, skin care products were applied to the skin immediately before array placement. The change in impedance relative to naïve skin was measured using the Optune device. Sixty-two commercially available products from 8 groups (adhesive removers, antibiotics, antiperspirants, antiseptics, cleansers, moisturizers, skin barriers, and topical corticosteroids) were evaluated. Results: Most lotions, soaps, foams, and solutions had minimal effect on electrical impedance, while petrolatum-based ointments significantly increased electrical impedance. Conclusions: TTFields compatible skin care products that did not affect electrical impedance were identified from each of the 8 groups and could be considered for further evaluation. All petrolatum-based ointments that were tested led to an increase in electrical impedance and are thus not recommended. Local application of TTFields compatible skin care products should be prospectively investigated in the clinical setting for their potential role in minimizing TTFields–related skin AEs. The randomized, double-blind PROTECT (PROphylactic skin Toxicity thErapy with Clindamycin and triamcinolone in GBM patients Treated with TTFields) study, should help establish which products best reduce skin AEs in patients with GBM and assess impact on QoL.
Efficacy of WC03 in treating radiotherapy-induced oral mucositis (RIOM): A multicenter nonrandomized controlled clinical trial.
Authors: Chen Dongmei , Gu Tian , Jia Liqun 
Published: May 2020

e24127 Background: RIOM is a common side effect of radiotherapy for head and neck cancer patients, however, no standard and effective treatment existed so far. WC03 is an oily Traditional Chinese Herbal Medicine recipe for external-use in mouth, which had been utilized to treat RIOM in China-Japan Friendship Hospital for more than ten years. This trial aimed to investigate the safety and efficacy of WC03 in treating RIOM. Methods: Between May 2017 and June 2018, we conducted a multicenter, non-randomized controlled trial within 7 hospitals in China. Inclusion criteria included head and neck cancer patients who developed RIOM (≥ grade II) undergoing radiotherapy or after radiotherapy (within 6 months). They were assigned to different groups based on their willingness. Patients in treatment group were treated by WC03, which was daily applied to the oral mucosa for 30 min twice a day. Patients in control group were treated with Kangfuxin (Periplaneta americana) Lotion combined with conventional treatment such as vitamin B12 and rhGM-CSF. The interventions lasted for 2 weeks. The primary outcome was overall effective rate, which was calculated through changes of radio-induced oral mucositis grade before and after interventions (according to National Cancer Institute Common Toxicity Criteria). Secondary outcome was oral pain which was measured by Numeric Pain Rating Scale. Results: 48 eligible participants were enrolled, 24 in treatment group and 24 in control group, respectively. 2 patients in treatment group were withdrawn from the study in the first week because of developing secondary infection and treatment got changed. Thus, 22 were included at the terminal of the study. All the 24 participants in control group were included. After the intervention, the overall effective rate was 95.45%(21/22) in the treatment group, which was significantly higher than that of 70.83% (17/24) in the control group (p = 0.049). Similarly, 86.36%(19/22) of the participants in treatment group got cured, which was significantly higher than that of 45.83%(11/24) in the control group(p = 0.007). There is a trend that oral pain relief rate in the treatment group was higher than that of the control group, but not statistically significant (100.00% vs. 87.50%, p = 0.210). Patients in treatment group used less time to get relieved from RIOM than control group (5 vs. 8 days, p < 0.001). No adverse event had been observed in both two groups. Conclusions: WC03 is safe and effective in treating radiotherapy-induced oral mucositis. RCT is necessary in future studies.
Appropriateness of opioid prescribing in cancer patients.
Authors: Matera Robert M. , Duffy Christine M. , Robbins James , Higel-Mcgovern Camille , Chartier Ashley , Dizon Don S. 
Published: May 2020

e24129 Background: The American Cancer Society estimates 48% people with cancer and 34% of cancer survivors report issues with chronic pain and 43 and 10% report taking an opioid, respectively. We sought to further examine the indications for pain medications in people with cancer and whether they were related to cancer, treatment, or neither. Methods: Retrospective chart review was conducted on 122 cancer patients treated at a single American academic cancer center. Authors created criteria to categorize whether patients’ pain was attributable to their malignancy or treatment regimen. Two trained coders reviewed each case with a third to resolve coding differences. Pain due to disease was further subdivided into pre-determined categories (tumor site, fracture, surgery, neuropathy, disease progression). The relationship between demographic, disease and pain type were examined in relation to inappropriate opioid prescribing using Chi-square analysis and Fischer’s exact test. Results: 55% of patients were male, 39% had metastatic disease, and 33% NED. 95% had received chemotherapy 69% radiation and 43% surgery. Factors associated with inappropriate opioid prescribing included increased age and female sex. Appropriateness of opioid prescribing was not associated with a specific cancer type or pain indication subset. Conclusions: As survivorship among cancer patients increases this may result in a cohort of patients in which opioid pain medication may not be indicated and in whom the risks may outweigh the benefits.
Work loss and activity impairment due to duration of nausea and vomiting in patients with breast cancer receiving CINV prophylaxis.
Authors: Schwartzberg Lee S. , Navari Rudolph M. , Ruddy Kathryn Jean , LeBlanc Thomas William , Clark-Snow Rebecca Anne , Wickham Rita S. , Binder Gary , Bailey William , Turini Marco , Potluri Ravi C. , Schmerold Luke M. , Roeland Eric 
Published: May 2020

e24133 Background: The impact of chemotherapy-induced nausea and vomiting (CINV) on work loss and activity impairment is important to patients yet not well described in literature. We sought to evaluate CINV-related work loss and activity impairment and their associations with CINV duration. Methods: In a prospective CINV prophylaxis trial of oral or intravenous netupitant/palonestron (NEPA) + dexamethasone (DEX) (12mg day 1 only) for patients with breast cancer receiving anthracycline + cyclophosphamide (AC), we defined CINV as vomiting or use of rescue medication during days 1-5 after AC. Pre-specified endpoints included CINV duration (0-5 days), patient reported CINV-associated work loss (Work Productivity and Activity Impairment survey), and CINV-related impaired activity [0 (none) - (worst) Likert scale] for chemotherapy cycles 1 and 2. CINV-related work loss and activity impairment could involve nausea with or without vomiting or rescue medication use. We categorized CINV duration as 1-2 days (d) or ≥3 d, and compared results using the chi-squared test. We report here on the first 2 cycles. Results: Survey data was captured for 792 cycles in 402 female patients including 132 (32.8%) employed patients. Mean age was 55.4. CINV was observed in 173 (21.8%) of total cycles. CINV-related work loss was reported in 26 (3.3% of all cycles, 15.0% of cycles with CINV, 38.2% of employed patient cycles with CINV) while 142 had related activity impairment. When we categorized cycles by CINV duration, CINV-related work loss was seen in 25.9% of 81 cycles with ≥3 d CINV duration vs. 5.4% for 92 cycles of 1-2 d of CINV (p < 0.001); mean scores of CINV-related impaired activity were 5.0 for ≥3 d CINV vs 3.0 for 1-2 d CINV (p < 0.001). Conclusions: Despite guideline recommended prophylaxis, CINV occurred in > 20% of AC cycles. In cycles with CINV, CINV-related work loss occurred in 38.2% for employed patients while activity impairment occurred in 82.1% for all patient cycles. The majority of CINV lasted 1-2 d. Notably, ≥3 d of CINV was associated with considerably higher levels of work loss and activity impairment suggesting that duration may be a meaningful measure of CINV impact. Clinical trial information: NCT03403712 . [Table: see text]