bluuebunny/crossref_metadata_2025 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]
M-palliative care link: Improving symptom control and information exchange among specialists and local health workers treating late-STAGE Tanzanian cancer patients.
Authors: Miesfeldt Susan , Ngoma Twalib Athumani , Mushi Beatrice , Ngoma Mamsau , Mahuna Habiba , Morse Robert , Ho Yun Xian , Quinn Erin , Lambden Kaley Xian , Sagan Sarah , Mmari Joshua , Mmbaga Elia , Lucas Frances L
Published: May 2020

e24146

Background: Lack of effective end-of-life symptom control among late-stage cancer patients is a Tanzanian public health priority, calling for innovative community-based solutions. Mobile health technology holds promise; however, existing resources are limited and access to palliative care specialists is poor. This work aimed to develop a secure mobile-/web-based symptom assessment/control communication system (m-Palliative Care Link; mPCL) that extends access to a limited number of palliative care specialists (hereafter, specialists). mPCL is based on the existing patient-focused African Palliative care Outcome Scale (POS), adapted for mobile symptom assessment, and is designed to support end-of-life care coordination among specialists, patients/caregivers, and local health workers (LHWs) (i.e., user groups). Methods: In partnership with Tanzanian specialists, mPCL was developed following a user-centered design process. mPCL prototype usability testing was conducted with 5-7 participants per user group and included a combination of hands-on observations as well as collection of feedback on ease-of-use and recommendations for modifications. User input was incorporated into the mPCL prototype iteration, tested via field study with 45 late-stage cancer patients discharged from Ocean Road Cancer Institute in Dar es Salaam. A brief mPCL usability/utility survey, including closed- and open-ended survey items, was conducted with field study participants from user groups at six weeks. Results: Prototype usability test participants successfully used the application and indicated that it would be very helpful. Recommendations from usability testing included redesign data collection tools, simplify patient/caregiver application, and broaden clinical data access. Six-week field study survey data showed that a significant majority (range: 68-100%) of specialists and patients “definitely agreed” that mPCL improved patient-provider communication, symptom-based care, care access, both quality of life and care, and reduced need for travel. Nearly all specialists and patients (93% and 98%, respectively) reported that mPCL was easy to use. Conclusions: mPCL promises to assess and address the symptom-control needs of late-stage cancer patients. Due to its reliance on existing technology/personnel, mPCL should be sustainable and scalable among cancer patients and those with other chronic diseases in low resource settings.
A single-arm, prospective, multicenter study on the efficacy and safety of low-dose transdermal fentanyl patch in opioid-naive patients with moderate to severe cancer pain.
Authors: Liu Yong , Li Qing , Yu Yang , Wang Jie Jun , Shi Han Ping
Published: May 2020

e24149

Background: The efficacy and safety of low-dose fentanyl transdermal patch (TDF) in the treatment of opioid-naive patients with moderate-to-severe cancer pain has no tyet been confirmed. There are little international studies, and none in mainland China. The aim of this study was to explore the effect and tolerability of low dose of TDF in opioid-naive patients with Chinese moderate-to-severe cancer pain, and evaluate the influence on quality of life and cognitive function. Methods: A prospective, single-arm, non-randomized, open-label, multicenter trial was conducted with 285 opioid-naivepatients with moderate-to-severe cancer pain in 14 tertiary hospitals in mainland China. The initial analgesic dose of TDF was 12.5 µg/h, pain assessment (pain score, pain relief and pain response rate) was performed every 3 days for a total of 9 cycles.Adverse reactions and events were monitored over 24 days. In the meantime, quality of life and cognitive function of patient were evaluated with EORTC QLQ-C30 and MMSE. Results: 285 patients with 267(92.00%) completed the trial were enrolled. The average age was 60 (range 28-87) and the average effective therapeutic dose was 6.3±6.08mg.The total pain relief rate was 98.12% (mean pain score ±SD, 5.7±0.89 vs 3.9±1.28; P < 0.001). The efficacy of low-dose TDF on pain relief was consistent in groups separated by gender (p < 0.001), age (p < 0.001), types of cancer (p < 0.001), and baseline pain intensity (p < 0.001). There were 79 patients (29.59%) in the low-dose subgroup, and the pain response rate of the low-dose subgroup was better than other dose groups within one week (p = 0.0018).The adverse effects were mild. The most common adverse reactions are constipation 7.87%, followed by nausea 11.24%, vomiting 4.12%, drowsiness 1.87% and urine retention 1.5%.There was no difference in the incidence of adverse reactions between the low-dose subgroup and the other groups (p > 0.05). Meanwhile, TDF improved the quality of life of patients with moderate-to-severe cancer pain (mean± SD: 46.44±16.96 vs. 67.04±18.02;p < 0.05), without impairing cognitive function(mean ±SD, 29.13±1.54 vs. 28.98±1.99; p > 0.05). Conclusions: Low-dose TDF is effective for opioid-naive patients with moderate-to-severe cancer pain. Adverse reactions are mild and the quality of life of patients is improvedwith little losson cognitive function. Further randomized controlled studies are warranted to investigate the value of low-dose TDF in the treatment of opioid intolerant cancer pain. Clinical trial information: ChiCTR-ONC-17014080 .
Concomitant limb cryocompression and scalp cooling to reduce paclitaxel-induced neuropathy and alopecia.
Authors: Sundar Raghav , Magarajah Gayathiri , Ow Samuel Guan Wei , Chan Gloria , Choo Joan , Eng Lim Siew , Wong Andrea , Vijayan Joy , Hairom Zarinah , Ang Emily , Paxman Richard , Wilder-Smith Einar , Thakor Nitish , Lee Soo-Chin , Bandla Aishwarya
Published: May 2020

e24157

Background: Scalp cooling is an FDA approved method to mitigate chemotherapy-induced alopecia (CIA) caused by paclitaxel. Chemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting toxicity of paclitaxel. Several recent randomized studies have suggested limb hypothermia as a mechanism to ameliorate paclitaxel-induced neuropathy. The safety, tolerability and feasibility of concomitant limb hypothermia and scalp cooling to prevent these two common adverse effects of paclitaxel has not been previously studied. Methods: A proof-of-concept study was conducted in breast cancer patients receiving weekly paclitaxel chemotherapy. Each subject underwent concomitant scalp and four-limb cryocompression with each chemotherapy infusion (3 hours) for a maximum of 12 cycles. Limb cryocompression was administered at cyclic pressure (5-15 mmHg) and temperatures starting at 11°C (established as lowest tolerable temperature in a separate healthy volunteer study) and adjusted according to patient tolerability. Skin surface temperature and tolerance scores were recorded. CIPN was assessed via EORTC Quality of Life Questionnaire-CIPN before (QOLpre), after completion (QOLpost) and 3-months post chemotherapy (QOL3m). Results: Fifteen patients enrolled in the study, of which 14 completed all 12 cycles of concomitant scalp cooling and limb cryocompression during chemotherapy without any side effects barring transient erythema over the limbs. None had intolerance to scalp cooling. Eight patients safely tolerated 12 cycles of cryocompression at 11°C. Of the remaining, 6 completed all 12 cycles at device temperatures ranging from 14-25°C. One patient withdrew at the 6th cycle, finding 25°C intolerable. Median QOLpre was 19 (range 17-19), QOLpost 20 (18-29) (p = 0.04, Wilcoxon signed-rank) and QOL3m was 19 (18-21) (vs QOLpre; p = 1). QOL showed no significant differences from pre-chemotherapy to 3 months post-chemotherapy suggesting preservation of nerve function. Conclusions: Delivery of concomitant scalp cooling and limb cryocompression is feasible, safe and generally well-tolerated. Future limb hypothermia trials should not preclude patients from undergoing scalp-cooling concomitantly to reduce CIA. Clinical trial information: NCT03248193 .
Evaluation of immune-related adverse events (irAE): Utilizing the patient-reported outcomes of the common terminology criteria for adverse events (PRO-CTCAE) in a phase II study of ipilimumab (ipi) in men with castration-sensitive prostate cancer (CSPC).
Authors: Vargas Pivato de Almeida Daniel , Anderson Justine , Danila Daniel Costin , Morris Michael J. , Slovin Susan F. , Abida Wassim , Dayan Erica Simone , Curley Tracy , Arauz Gabrielle , Baser Raymond E , Scher Howard I. , Autio Karen A.
Published: May 2020

e24174

Background: Incorporation of the PRO-CTCAE during chemotherapy is associated with fewer ER visits and improved survival. Limited data exist using this tool to capture irAE in immunotherapy trials. We collected select PRO-CTCAEs in a clinical trial evaluating an immune checkpoint inhibitor (ICI) in patients (pts) with CSPC. Methods: Cohort A (Coh A) enrolled de novo metastatic CSPC; Cohort B (Coh B) enrolled recurrent CSPC after radical prostatectomy (RP). Treatment consisted of 4 doses of ipi and 8 months of androgen deprivation therapy (ADT) in Coh A & B, and RP in Coh A. PRO-CTCAEs were collected at each ipi or ADT administration, and during follow-up. PRO-CTCAE items included abdominal pain, diarrhea, fatigue, anorexia, nausea, vomiting, rash and pruritus, with the correspondent attributes of frequency (freq), severity (sev), interference (int), and presence. Results: 16 pts were treated (Coh A: 7; Coh B: 9) with 181 matched pairs of PRO-CTCAE and CTCAE. The study was terminated early for an unfavorable risk:benefit ratio. PRO-CTCAE completion at required visits was 85.4% in Coh A and 98.1% in Coh B. Cohen’s kappa coefficients was lowest for pruritus (k = 0.10, slight agreement) and highest for rash (k = 0.64, moderate agreement). CTCAE captured diarrhea in 10 pts, 4 of whom received steroids. 75% (3/4) of pts receiving steroids graded diarrhea as ‘frequently’ or ‘almost constantly’ on the PRO-CTCAE while 66.7% (4/6) of those who did not receive steroids reported the same frequency. Conclusions: IrAE were more commonly reported and of higher grade by patients using the PRO-CTCAE as compared to clinician reporting, consistent with existing literature in non-ICI studies. Diarrhea as reported by the PRO-CTCAE did not associate with steroid use in this small trial. Further studies are needed to evaluate irAE using PRO-CTCAEs and the potential role in management of these toxicities. Clinical trial information: NCT02020070 . [Table: see text]
Cannabis and cancer: Examining the use and perceived benefits in an Irish cancer cohort.
Authors: coyne zac , Cowzer Darren , Hennessy Maeve , Linehan Anna , Hennessy Bryan T. , Grogan William , Breathnach Oscar S. , Morris Patrick G.
Published: May 2020

e24178

Background: Medicinal cannabis is currently approved for symptom control in cancer patients. There is limited evidence to suggest cannabis is efficacious in the treatment of cancer. In this study we aim to characterise the extent of cannabis use in patients receiving anti-cancer therapies and what impact they think cannabis use has on their cancer. Methods: An anonymous survey was distributed to patients with cancer attending the Beaumont Hospital Oncology Day Unit for anti-cancer therapy over a period of 4 weeks. Results: 175 patients completed the survey. 166 (95%) of patients said they would be comfortable talking to their oncologist about cannabis use. 161 (92%) felt their oncologist should prescribe cannabis as part of their cancer treatment. 17% thought cannabis would cure their cancer. 38% thought cannabis would slow the growth of their cancer and 33% thought cannabis would treat cancer related symptoms. 42 (24%) of all patients had tried some form of cannabis at least once in their life. 26 (15%) were actively taking CBD (Cannabidiol) oil as part of their treatment independently of any healthcare professional guidance. More females (15) were taking CBD compared to males (11). A higher proportion of patients < 50 years (14) were taking CBD during their treatment. 30% of patients using CBD had breast cancer and 23% had a primary CNS malignancy. Of the patients taking CBD, 20 (77%) patients felt it would cure or slow cancer growth and 10 (38%) patients believed it would help with cancer related symptoms. Conclusions: Patients with cancer appear to have a positive attitude towards cannabis as part of their treatment despite limited evidence to support this. With the increasing availability of cannabis-based products globally, medical oncologists must now take into consideration patient’s attitude towards cannabis while treating their cancer. [Table: see text]
Streamlining survivorship care plan (SCP) creation and delivery to primary care providers in poor, rural, and minority patients.
Authors: Tawfik Bernard , Jaffe Shoshana Adler , Oomen-Hajagos Jamina , Mohler Lisa , San Gil Inigo , Kano Miria Adler , Ryan Shawnia R , Abernathy Janet , Wiggins Charles , Sussman Andrew , Dayao Zoneddy R.
Published: May 2020

e24181

Background: The number of cancer survivors is rapidly climbing due to increased screening and improved treatment. Survivorship Care Plans (SCPS) summarize the patients’ treatment and is a communication tool between oncologists and primary care physicians (PCP)s. Creation and delivery of the SCPs has been labor intensive and costly for many healthcare systems and a previous paper based system at our institution was ineffective. The University of New Mexico Comprehensive Cancer Center (UNMCCC) treats a unique population of lower socioeconomic status (SES) (poverty rate 19.7%), rural (22.6%) and minority (Native Americans and Hispanics constitute 10.4% and 48% of the population respectively) patients in a large rural state. Methods: Beginning March 2019, UNMCCC initiated a process for creation and delivery of SCPs through the Electronic Medical Record (EMR). EMRs are not designed to delivery SCPs to patients and PCPs, so EMR functions were creatively repurposed. Upon identification of eligible patients, providers would place an electronic SCP order through the EMR. Designated staff then partially completes the SCPs based on medical record review while the EMR imports demographics, PCP, cancer and stage. Then the EMR flags SCPs ready for delivery and the provider edits, approves and prints the SCP for the patient at the next encounter. Once printed, the EMR alerts medical records to send the SCP to the PCP via mail or EMR routing. Results: 282 SCPs were ordered, 222 (78.7%) were created and 86 (38.7%) given to patients after definitive therapy of Breast (77.9%), Colorectal (7.0%), Gynecological (9.3%) and Prostate Cancer (5.8%). Of 72 SCPs eligible to be sent to PCPs, 48 (66.7%) were successfully mailed or sent via EMR, 13 (18.1%) had PCP discrepancies, 6 (8.3%) had no PCP and 5 (6.9%) had PCPs in systems which do not accept unsolicited records. Conclusions: The UNMCCC cares for low SES, rural and minority patients and was able to create and deliver SCPs to a significant number of patients and PCPs. Future process steps will involve creating tailored SCPs for other diagnoses, resolving PCP discrepancy issues and creating an EMR alert for PCPs when they receive an SCP. Additionally, assessment of both patient and PCP perceptions is ongoing.
Effect of adolescent and young adult cancer placements on advanced communication skills.
Authors: Hatcher Helen , Magrath Cameron , Hatcher Debbie Critoph
Published: May 2020

e24182

Background: Communication with adolescent and young adult cancer (AYA) patients and their families can be challenging and requires extensive skills, often developed over time. Medical students can be afraid to encounter such challenges and treating teams can be protective of these vulnerable patients. Therefore, medical students can have little contact and experience communicating with AYA putting them at a disadvantage. We have developed a special study module (SSM) for students with the AYA multi-disciplinary team to promote student awareness of the unique challenges of communicating with AYA patients and provide essential skills for later practice. We present the findings from the first year of this module. Methods: Students at the University of Cambridge were offered a 6-week placement with the AYA cancer service. This involved shadowing members of the multi-professional cancer team and time on the AYA ward to talk with patients and their families in order to practice triadic communication skills. Mid-placement, an experiential learning experience with simulated patients focused on triadic interviews was also offered in line with our local clinical communication skills courses. After the module students were questioned about how they felt this had affected their practice and knowledge of communicating with AYA with cancer. Results: 12 students enrolled for the SSM over the year. All students found the placement widened their communication skills as well as their knowledge of AYA cancers and treatments. 4 main areas of learning were evident. 1.The problems faced by AYA patients as they try to establishing independent adult identities in the midst of severe illness or at the end of life and the implications for the triadic interview. 2. Information sharing during patient denial. 3. The AYA perspective: desire for control and their difficulty of communicating. 4.Challenges of communicating well in emotionally-charged situations. Conclusions: Experiential learning during the placement highlighted techniques for balancing both patient and parental involvement during consultations to maximise efficacy of information gathering. AYA cancer placements provide opportunities to develop advanced communication skills and can be augmented with experiential learning.
Individual and community respite as supportive care for adult cancer patients, their caregivers and their families.
Authors: Schankweiler Marcella
Published: May 2020

e24183

Background: When a young adult (ages 24 to 55) is diagnosed with cancer, the entire family is traumatized. The psychosocial, emotional, economic and spiritual concerns become forefront and often, the family unit is unable to cope with a potentially devastating outcome. Respite becomes helpful in in addressing these traumas by providing a haven for honest, open dialogue about coping with today and preparing for an uncertain future. Each patient and family are provided a seven-day respite experience to a mutally selected destination suitable for travel and congruent with the family's psychosocial needs at the time with limited programming and schedule flexibility. Methods: Respite impact will be presented with qualitative and quantitative outcome measures provided by the treating clinicians. Using a multidisciplinary approach as outlined by a FPS program committee comprised of nominating oncologists, nurses, social workers and patient coordinators, these measurements are gathered both pre and post respite and gauge the patient/caregivers/children ability to cope with cancer after respite experiences. Further, the treating clinician observes and assesses said parties' ability to cope upon respite completion and return to clinic. Results: See table below. Conclusions: Studies support that respite is critical as complementary therapy in treatment protocol in the adult population segment with young families. Care-free, cost-free organized respite helps improve one's overall coping with a cancer diagnosis, improves the families' psychosocial health, results in increased communication and strengthened relationships as a family unit, reduces anxiety and improves patient compliance with future treatment protocol. FPS has also studied the impact of group respite v. individual respite and documents that a group setting lessens anxiety, strengthens relationships and promotes communication with peer support. Best practices from this respite program can assist in both short term and long term psychosocial and mental health of patients and their families so to optimize coping and healing related to cancer. [Table: see text]
Quality assessment of online hepatocellular carcinoma patient education materials.
Authors: Li Jim (Zhang Hao) , McLeod Jane , Ingledew Paris-Ann
Published: May 2020

e24184

Background: Hepatocellular carcinoma (HCC) is the fourth-leading cause of cancer-associated death in the world, claiming nearly 800,000 lives each year globally. Concurrently, an increasing number of patients are using the Internet as a source of health information. However, limited research has been done on assessing the quality of HCC websites. Therefore, we aim to systematically evaluate the quality of online HCC information to illuminate its current strengths and limitations. Methods: The term “hepatocellular carcinoma” was searched using Google, Dogpile, and Yippy. The overall highest-ranked 100 (“top 100”) websites were extracted based on pre-specified inclusion and exclusion criteria. A validated, evidence-based tool was used to evaluate their quality based on several benchmarks such as website affiliation, accountability, interactivity, structure & organization, readability, and content quality. Results were evaluated using descriptive and inferential statistics. Results: The search yielded over 1,100 websites. Of the top 100 websites, 53% were commercial in nature. Although 95% disclosed ownership, other measures of accountability were poor – only 30% identified their author(s), 42% cited sources, and 33% were updated within the past two years. Average readability was judged to be at a grade 11.8 level using the Flesch-Kincaid grading system, and 10.4 using the SMOG index. Both estimates were significantly higher than the traditionally recommended grade-six level ( p < 0.0001 for both). Prognosis, prevention, and incidence were the least commonly covered topics (33%, 46%, and 50% respectively). All other topics were covered with “mostly accurate” or “completely accurate” information by over 70% of websites (Table). Overall, non-commercial websites were higher in quality compared to their commercial counterparts ( p < 0.002). Conclusions: Content accuracy is generally high. However, authorship disclosure, attribution, currency, and coverage in certain topics are deficient among many HCC websites. Additionally, difficult readability may pose a barrier for patient comprehension. Healthcare professionals should be aware of the limitations of online HCC information, in order to proactively guide patients to suitable resources and advocate for improvements in patient education materials. [Table: see text]
A phase I study of CX-4945 administered orally twice daily to patients with advanced basal cell carcinoma.
Authors: Eroglu Zeynep , Cowey Charles Lance , Soong John , McCormick Daniel , Fan Phoebe , Chen Jimmy , Elgendy Mohamed , Jang Sekwon , Chang Anne Lynn S.
Published: May 2020

TPS10080

Background: Smoothened inhibitors (SMOi) targeting the Hedgehog (Hh) pathway have been approved for the treatment of patients with locally advanced Basal Cell Carcinoma (laBCC) or metastatic BCC (mBCC). Unfortunately, resistance against SMO inhibitors (SMOi) can develop. Targeting the signaling cascade downstream of SMO, in this case via a novel small molecule inhibitor, could obviate this issue. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting Gli2 stability and Gli2’s interaction with target genes. Given the interplay between CK2 and GLI-2 and the importance of Hh signaling activation, CX-4945, a potent CK2 inhibitor, may provide benefits for the BCC patients with resistance or intolerance to SMOi. Methods: A phase I trial (NCT03897036) to explore various treatment durations of CX-4945 was designed for patients with laBCC or mBCC; with endpoints include safety (CTCAE v5) and objective response rate by RECIST 1.0 for mBCC and composite response for laBCC. Major eligibility criteria include progression or intolerability to SMO inhibitors; laBCC patients must not be surgical candidates and must have received prior radiation unless contraindicated, and basosquamous histology is excluded. The first phase of the trial uses a 3+3 design to test the tolerance of a CX-4945 dose of 1000 mg bid for a duration of 28 days continuously. If 2 out of 3, or 2 out of 6 patients experience a DLT, the regimen of 1000 mg bid for 21 days followed by 7 days off (already tested in prior CX-4945 Phase I trials in other tumor types) will be selected as the recommend phase 2 dose (RP2D). Upon determining the RP2D, a dose-expansion phase will further evaluateCX-4945 in two cohorts (laBCC & mBCC), with 10 patients enrolled in each. Currently, we are enrolling patients and collecting sufficient data for the determination of RP2D in this patient population; thus, further assessments are required to determine the safety, tolerability, and efficacy of CX-4945 in advanced BCC. Clinical trial information: NCT03897036.