bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized double-blind pilot study comparing cetirizine with diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions.
Authors: Bouchard Philippe , Beaucage-Charron Johannie , Gaudet Laurence , Lamothe Sarah , Pelletier Cloé , Pépin Anne-Sophie , Roy Valérie , Charpentier Frédéric , Lordkipanidzé Marie , Projean Denis , Picard Matthieu 
Published: June 2021

e24080 Background: Cetirizine is a less sedative alternative to diphenhydramine for the prevention of infusion-related reactions (IRR) to paclitaxel. However, there is no prospective data to support its use in this context. In this study, we conducted a feasibility study for a future definitive non-inferiority trial comparing cetirizine with diphenhydramine as premedication to prevent paclitaxel-related IRR. Methods: This was a single center randomized double-blind parallel-group prospective pilot study. Participants were paclitaxel-naive cancer patients scheduled to start paclitaxel chemotherapy, alone or in combination. They were assigned to receive either intravenous diphenhydramine 50 mg + oral placebo (diphenhydramine group) or intravenous placebo + oral cetirizine 10 mg (cetirizine group) for their first two paclitaxel treatments. To assess the feasibility of a larger study, the percentage of eligible patients completing a first paclitaxel treatment and the recruitment rate were calculated. IRR events were documented. Change in drowsiness compared with baseline was assessed using the Stanford Sleepiness Scale (SSS). Results: Among 37 eligible patients, 27 were recruited and randomized (control 13; intervention 14) and 25 completed the study. The recruitment rate was 4.8 participants/month, meeting the primary feasibility target of 4 participants per month. One participant had an IRR (cetirizine group, CTCAE grade 2) and no unexpected serious adverse events occurred. Drowsiness was the main adverse effect associated with the premedication. The increase in drowsiness compared to baseline (ΔSSS) was greater in the diphenhydramine group compared to the cetirizine group (median ΔSSS 2 (IQR 3.25) vs median ΔSSS 0 (IQR 1), p < 0.01) when measured one hour after the administration of the premedication. Patient self-assessed moderate or intense discomfort caused by drowsiness was exclusively reported in the diphenhydramine group, by 4 out of 13 participants. Conclusions: The trial methods were feasible in terms of recruitment rate, retention and patient safety. IRR were infrequent and a larger trial is warranted to confirm non-inferiority for IRR prevention. Cetirizine was significantly less sedating than diphenhydramine when administered as premedication to prevent paclitaxel-associated IRR. Clinical trial information: NCT04237090. [Table: see text]
Prediction of the breakthrough cancer pain using deep learning model.
Authors: Bang Yeong Hak , Choi Yoon Ho , Park Mincheol , Lee Geon Hee , Shin Soo-yong , Kim Seok Jin 
Published: June 2021

e24085 Background: Breakthrough cancer pain (BTcP), a transitory flare of pain that occurs on a background of relatively well-controlled baseline pain, is a challenging clinical problem in managing cancer pain. We hypothesized that the BTcP could be predictable according to the patients’ previous observed patterns. In this study, we report on the development of a deep learning model that predicts hourly individual-level breakthrough pain for patients with cancer. Methods: We defined the BTcP as the pain with numerical rating scale (NRS) score 4 or above and developed models predicting the onset time of BTcP with the temporal resolution of 1 hour. The datasets which have more than 20 records of NRS score during hospitalization were included in our study. All the pain records were obtained from patients hospitalized on the wards of hematology-oncology in Samsung Medical Center between July 2016 to February 2020. The model used the time windows of 3 days to predict NRS scores over the next 24 hours. To capture irregular pain patterns, we created the sequence of average pain patterns over 24 hours from the previous 3 days and used it for normalization. We trained a Bi-directional long-short term memory (LSTM) based deep learning model. The model was validated using the holdout method with 20% of the datasets. Its performance was assessed with the area under the receiver operating characteristic curve (AUROC) and the area under the precision-recall curve (AURPC). Results: We included pain log data containing 2,905 admissions from 2,176 patients with solid cancer and 1,755 admissions from 1,082 patients with hematologic cancer in the analysis. The median age was 57 (interquartile range (IQR), 47-64), the most frequent type of cancer was lung cancer (18.0%), and most patients had stage 4 (60.7%). Among the 103,948 hours from patients in whole datasets, 1,091 (4.7%) hours were labeled as the period of BTcP. The patients have the records of NRS score with a median of 3 (IQR, 2.0-4.5) and BTcP with a median of 1.1 (IQR, 0.5-2.0) per day. We allocated approximately 20% of patients (653 patients with 932 admissions) to the holdout test dataset. Our model showed the AUROC 0.719 and AUPRC 0.680 for predicting the BTcP in the test dataset. Conclusions: Our study showed that cancer pain could be predictive by using a deep learning model. Though our exploratory study has a limitation of generalizability, future warranted subgroup analysis and verification research could make our model more applicable in a real-world setting.
ICES (International Carboplatin Emesis Survey) for the evaluation of the emetogenicity of continuous cycles of carboplatin-based chemotherapy with focus on nausea: A MASCC emesis study group, prospective, observational, real-world multi-centric study.
Authors: Rapoport Bernardo Leon , Chan Alexandre , Chasen Martin Robert , Smit Teresa , Heyman Liezl , Tan Chia Jie , Bhargava Ravi , Bosnjak Snezana , Zilic Ana , Jabbar Adnan Abdul , Zhang Yaxiong , De Necker Margreet , Mhazo Tina V 
Published: June 2021

e24086 Background: Chemotherapy induced nausea and vomiting (CINV) following carboplatin containing chemotherapy regimen remains a considerable problem for cancer patients (pts) despite standard antiemetic prophylaxis. This study was undertaken to prospectively evaluate the incidence of CINV in pts undergoing carboplatin-based chemotherapy receiving guidelines consistent CINV prophylaxis (GCCP). All sites did not prescribe NK1-RA as it is not included in all institutional guidelines. Methods: The study enrolled 207 pts undergoing carboplatin-based chemotherapy, the final analysis evaluated cycle 1 - 6 with a total of 183 evaluable pts from 6 countries. Pt diaries were used to collect data from day 1-10 beginning with cycle 1. Nausea was reported by the pts using a visual analog scale (VAS) with the end-point being no nausea. Vomiting episodes were recorded in the pts’ diaries. Demographic, occurrence and severity of emesis, numbers of emetic episodes and time to the onset of emesis, were summarized using descriptive statistics. Results: There were 129 females and 54 males. The overall incidence of acute and delayed nausea for was 17% and 25% respectively. The incidence of nausea of entire population was significantly higher than vomiting (58% vs. 14%; Chi2 22.271 p<0.000). The use of NK1-RA was associated with a significant decrease in time to first vomiting for cycle 1 (p<0.041) and subsequent cycle 2-6 (p<0.0075). Additional results are reported in the Table. In a logistic regression model factors associated with acute nausea in cycle 1 included history of motion sickness (p< 0.0090), comorbidities (p< 0.0084), history of morning sickness (p< 0.0090), previous chemotherapy (p< 0.0096), anemia (p< 0.0209). A separate logistic regression analysis for delayed nausea in cycle 1 showed that prior radiotherapy (p<0.0093) and a history of morning sickness (p<0.0195) were also significant. During subsequent cycles (1 – 6), the incidence of nausea remained higher than vomiting and was documented in the acute and delayed phases ranging from 6% to 25%. The use of NK1-RA was associated with a lower incidence of vomiting during cycle 1-6 with 91% patient receiving NK1-RA experiencing no vomiting vs 78% of patients not receiving NK1-RA with no vomiting (log rank = 0.0287). Conclusions: Despite GCCP and the usage of NK1-RA, carboplatin induced nausea remains a major unmet medical need in cancer pts. Further research should focus on management of nausea, risk factors and the impact of nausea on quality of life and in pts undergoing carboplatin-based treatment.[Table: see text]
Implementation of virtual mentoring to optimize collection of patient-reported data in the COVID-19 era: A prospective cohort study with adaptive design.
Authors: Kazazian Karineh , Bogach Jessica , Johnston Wendy , Swallow Carol Jane 
Published: June 2021

e24091 Background: Prior to the COVID-19 pandemic, all patients attending ambulatory clinic at cancer centers in Ontario, Canada completed the Edmonton Symptom Assessment Scale (ESAS), as per governmental cancer agency mandate. At our center, completion was via touch pad, with assistance by clinic volunteers. As of mid-March 2020, clinic appointments were conducted virtually whenever possible, and touch pads removed from clinic. Our purpose here was to explore how these changes impacted the collection of patient-reported outcomes, in particular the recognition of severe symptoms. Methods: We performed a prospective cross-sectional cohort study to test the feasibility of remote completion of the ESAS by patients scheduled for appointments at a weekly surgical oncology clinic at a major cancer center. Patients were identified serially based on date of clinic appointment. Patients in the initial study cohort were asked to complete and return the ESAS virtually (V). Given low completion rates, the ensuing study cohort was asked to complete a hard-copy (HC) ESAS. For the final cohort, we used an adaptive approach, providing remote, personal mentoring by a member of the health care team to support virtual ESAS completion (virtual-mentored, VM). Results: Between May-July 2020, a total of 174 patients were included in the study: 53% were female, and median age was 62 (19-90) yrs. Age, gender and tumor site did not differ between the three cohorts. For the V cohort, 20/43 patients successfully completed and returned the ESAS electronically (completion rate 44%). For the HC cohort, 49/50 completed the form (98%). For the VM cohort (n=78), the completion rate was 74%. Questionnaire completion was not predicted by age, gender or tumor site, although patients who completed the ESAS were more likely to be under active investigation/treatment vs. surveillance (p=.04). Of the 127 ESAS forms completed in all patient cohorts, 117 reported at least 1 symptom score ≥1. There were no significant differences in individual symptom scores (e.g. tiredness, wellbeing-see Table) reported between cohorts. Of all completed forms, 42% had a depression score ≥2 and 27% an anxiety score ≥4, indicating significant psychosocial distress. Conclusions: We have identified significant barriers to the virtual completion of ESAS forms, with lack of predictive variables. The severe degree of psychological distress reported by ̃50% of respondents demonstrates the need for ongoing regular collection and review of these data.[Table: see text]
Granisetron extended-release subcutaneous injection versus palonosetron infusion for preventing chemotherapy-induced nausea and vomiting: A cost analysis.
Authors: Kumar Vikas , Barnes Martin , Calcanes George , Mosier Michael , Virgilio Danille , Vacirca Jeffrey L. 
Published: June 2021

e24093 Background: Unscheduled hydrations (UHs) can significantly increase the cost of care in patients receiving moderately or highly emetogenic chemotherapy (MEC or HEC). Granisetron extended-release subcutaneous injection (GERSC) is a unique formulation of granisetron for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Limited data are available regarding the impact of GERSC on cost of UHs compared to other antiemetics. Objective: Assess costs of an UHs associated with breakthrough CINV following GERSC or palonosetron (PALO) for preventing CINV in patients receiving MEC or HEC. Methods: Retrospective analysis of medical records from a single multicenter community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen (neurokinin-1 receptor antagonist, dexamethasone, and either GERSC or PALO). Cost of care analysis for GERSC and PALO was based on maximum per-unit Medicare reimbursement for UHs, rescue antiemetic drugs and administration, laboratory, and office evaluations. Results: 182 patient records (n = 91 GERSC; n = 91 PALO) were evaluated. A lower number of median UHs per-patient were observed following GERSC versus PALO (HEC, 3 vs 5) and (MEC, 2 vs 3). Mean cost of care related to UHs was significantly lower per-patient following GERSC ($296, n=91) versus palonosetron ($837, n=91) ( P < 0.0001), including when the subset analysis was restricted to those patients requiring hydration (Table).When analyzing individual components of care, hydration (CPT codes 96360 and 96361) costs per-patient receiving HEC or MEC were lower following GERSC ($62, n=91) versus PALO ($253, n=91) ( P < 0.0001). Lower per-patient costs were observed following GERSC in all components of care except rescue antiemetic drug costs in MEC patients. Conclusions: GERSC reduced total per-patient costs of care associated with UHs visit relative to PALO in patients receiving HEC or MEC.[Table: see text]
Brain correlates of chemotherapy-induced peripheral neuropathy (CIPN) during somatosensory and interoceptive attention: A functional MRI (fMRI) study.
Authors: Kleckner Ian , Kleckner Amber , Belcher Elizabeth , Xu Huiwen , Lin Po-Ju , Dunne Richard Francis , Janelsins Michelle Christine , Kesler Shelli R. , Mustian Karen Michelle 
Published: June 2021

e24095 Background: Over half of patients receiving neurotoxic taxane, platinum, or bortezomib chemotherapy experience CIPN—a dose-limiting toxicity involving numbness and pain in the extremities. There are limited biomarkers and treatments for CIPN partly due to lack of knowledge of its pathophysiology. Here, we studied whether CIPN involves changes in the brain’s sensory processing circuitry to inform novel brain-based biomarkers and brain-based treatments for CIPN. Methods: Eleven patients scheduled to receive taxane, platinum, or bortezomib rated CIPN severity (CIPN-20) and completed an fMRI scan before starting neurotoxic chemotherapy and/or 12 weeks later. The 7-min fMRI task involved alternating 20-sec trials of distinct attentional focus: (1) their left fingertips (somatosensory attention), (2) their heart (interoceptive attention), and (3) a flashing word “target” (visual attention; the reference condition). We found an activation cluster in primary somatosensory cortex (S1) comparing somatosensory vs. visual attention and another cluster in primary interoceptive cortex (mid/posterior insula) comparing interoceptive vs. visual attention. We tested for associations between CIPN severity and task-based activations in S1 and the insula. Because this is a pilot study, we present effect sizes (ESs) using Cohen’s d and Pearson’s r, not p-values. Results: The 11 patients were 63±12 years old, 54% women, and 54% had breast cancer with high-quality fMRI data (16 scans; 8 pre-chemotherapy). As expected, somatosensory attention increased activation in S1 compared to visual attention (ES = 1.46), and interoceptive attention increased activation in the insula compared to visual attention (ES = 0.94). Patients with worse CIPN had smaller increases in S1 activation during somatosensory vs. visual attention (ES = 0.38), suggesting reduced S1 activation during somatosensory attention (i.e., failure to activate S1) and/or increased S1 activation during visual attention (i.e., S1 chronically activated). Similarly, patients with worse CIPN had smaller increases in insula activation during interoceptive vs. visual attention (ES = 0.57). Individual differences in S1 or insula activity were not significantly explained by age, anxiety, or problems remembering (all ESs < 0.12). Conclusions: CIPN severity was associated with changes in brain activity during a simple attentional task during fMRI scanning, implicating the brain’s somatosensory and interoceptive processing in CIPN. Future work should test for replication and develop biomarkers and treatments for CIPN that target somatosensory and interoceptive processing, perhaps using this attention task. NCT03021174. Funding: NIH R25CA102618, UG1CA189961, K07CA221931. Clinical trial information: NCT03021174.
Prognostic disclosure: A scoping review on communication guidelines and their application in oncology.
Authors: Bloom Julie R , Marshall Deborah Catherine , Rodriguez-Russo Carlos , Martin Emily J , Jones Joshua Adam , Dharmarajan Kavita Vyas 
Published: June 2021

e24107 Background: Prognostic disclosure is essential to informed decision making in oncology, yet many oncologists are unsure how to successfully facilitate this discussion. This scoping review determines what prognostic communication guidelines exist, compares and contrasts these guidelines and explores the supporting evidence. Methods: A protocol was created using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols extension for Scoping Reviews. Comprehensive literature searches of MEDLINE, EMBASE, PsychINFO, and Cochrane CENTRAL were performed to identify relevant publications between 1971 and 2020. Results: In total, 1532 articles were identified, of which 78 met inclusion criteria and contained 5 communication guidelines. Three guidelines have been validated in randomized control trials (Serious Illness Conversation Guide (SICG), The Four Habits Model and ADAPT) and demonstrated improved patient reported outcomes and objective communication measures. Among guidelines’ core principles, 3 concepts are common to all: patient’s understanding and preference, prognosis, and responding to emotion. Conclusions: Communicating prognosis is a core competency skill in cancer care, yet remains underprioritized in training and practice. This review highlights available models and acknowledges areas in need of further understanding including how to maintain learned communication skills for lifelong practice.[Table: see text]
The influence of clinical stage, race, and gender on factors which impact quality of life in multiple myeloma.
Authors: Luhowy Meghan , Binion Katrina , Warfield Tiffany , Bosley Rebecca , Krauss Elizabeth , Badros Ashraf 
Published: June 2021

e24126 Background: Multiple myeloma (MM) is unique among hematologic malignancies as an incurable disease. Patients are affected long-term by the disease symptoms as well as psychological, financial burden, and social impact, which may affect overall quality of life (QOL). The current literature related to QOL in MM is largely limited to a single clinical stage, impact concurrent with a specific treatment regimen, or focused on a single QOL factor. Changes in impact on QOL based on longitudinal follow up during the disease course have not been readily assessed. Here, we evaluated patient-reported QOL measures utilized by one time validated questionnaires. Methods: The study enrolled 100 participants in a sequential manner from the Myeloma Clinic at UMGCC with a diagnosis of plasma cell disorders at various stages: MGUS, smoldering myeloma, or multiple myeloma: newly diagnosed, maintenance, relapsed. Participants provided verbal responses to a series of questions listed in Table. Questions aligned with three main domains: physical symptoms and function, mental health, and social systems. The following is an interim analysis of the first 50 patients. Results: This sample of myeloma patients (N=50; males n=26), felt their QOL was impacted by myeloma symptoms (70%). More African American participants reported impact from financial burden (6, 50%) in comparison to Caucasian and other races (10, 26%). Interestingly, males reported less impact on sexual intimacy (3, 15%) than females (6, 43%). Females also reported more impact from financial burden (10, 42%) compared to males (6, 23%). Conclusions: Changes to impact on QOL as a function of clinical MM stage, race, and/or gender will be fully evaluated. Planned analyses include correlation statistics by age and social demographics to determine patterns in patient-reported outcomes. Finally, second interviews with current participants will be conducted to determine changes to impact across the same QOL variables over time.[Table: see text]
Revamping the delivery of cancer support, education, and wellness programming during the COVID-19 pandemic.
Authors: Capparella Lisa , Lopez Ana Maria , Naputo Kristine , O'Hayer C. Virginia Virginia , Garber Gregory D. , Leader Amy , Pomerantz Miriam 
Published: June 2021

e24127 Background: Supportive care is considered essential to standard care for patients with a history of cancer. The interdisciplinary team at Sidney Kimmel Cancer Center (SKCC) of Thomas Jefferson University, an NCI-designated cancer center in Philadelphia, offers a robust variety of supportive care services including support groups, educational and wellness programs. SKCC includes four academic hubs across the Greater Philadelphia region. With the onset of the COVID-19 pandemic and the subsequent statewide shutdown of services, SKCC quickly pivoted to virtual offerings, to address patients’ supportive care needs. Recent research has shown patients self-reporting higher incidence of anxiety and loneliness due to the pandemic. Direct patient feedback identified programs of greatest need, the preferred times and format. Methods: At the beginning of the pandemic SKCC offered a program “Coping with Cancer and Covid-19: as You Navigate Cancer Treatment.” This program helped patients understand their risk of COVID-19 and provided emotional support as patients and caregivers began facing loneliness. Additional virtual offerings included Mindfulness Sessions, Yoga, Stretching for Stress Relief, Healing through Humor. SKCC began evaluating the impact of the programming beginning in June 2020. Attendees completed surveys evaluating the presentation, their level of psychological distress, perceived quality of life, and feelings of hope, loneliness, and connection. Participants were asked if they would attend another program and were asked to rate the program on a Likert scale. Results: In 2019 SKCC offered 273 programs and attracted 984 participants. Only 90 of the 984 participants attended virtually prior to the pandemic. Since the start of the pandemic, SKCC has hosted 334 programs, all virtually, with 3,346 participants. Surveys were sent electronically and completed immediately after the completion of all support programs offered at SKCC. 40% of program participants’ completed an evaluation form and 94% rated the program exceptional or very good. Overall, 88% of participants in virtual wellness, support groups and educational programs indicated they would attend another program offered by SKCC. Conclusions: Virtual supportive care offerings have engaged more patients and caregivers than ever across SKCC hubs and have proven an effective means to continue to support patients during the pandemic. It is important to continue to evaluate and create meaningful programs to match the ongoing needs of patients and caregivers.[Table: see text]