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Background: During the coronavirus disease 2019 (COVID-19) pandemic, established best practices in cancer care were modified to diminish the risk of COVID-19 infection among patients and health-care workers. Objective(s): We aimed to study the modifications in cancer-directed therapy during the first wave of the COVID-19 pandemic. Material(s) and Method(s): A cross-sectional study of patients with cancers of the head and neck, thoracic, urologic, and central nervous systems who visited the medical oncology department of the Tata Memorial Hospital, Mumbai, India, between April 22, 2020 and June 01, 2020, was conducted. Data were prospectively collected in an online pro forma and supplemented from the electronic medical records. Result(s): Of a total of 514 patients, 363 (71%) were men. The most common malignancy was lung cancer in 234 patients (46%). Cancer-directed therapy was modified in 83 patients (16%). Deviations consisted of modification of the chemotherapy regimen (48%), temporary discontinuation of chemotherapy in 37%, and interim chemotherapy to delay surgery in 5%. Changes in the chemotherapy regimen included a shift to a less intensive regimen in 45%, changing from intravenous to oral in 40%, and less frequent dosing of immunotherapy in 7%. Considering missed appointments as a deviation from planned cancer therapy, 68% of patients had a deviation in the standard planned cancer care. Conclusion(s): Almost two-thirds of the patients could not reach the hospital during the COVID-19 pandemic lockdown in India. Of those who could reach the hospital, one of out every six patients with cancer had a change in their cancer-directed treatment, half of which consisted of a modification in the standard chemotherapy regimens. The effects of these therapy deviations are likely to be long-lasting. (Clinical Trials Registry-India, CTRI/2020/07/026533).Copyright © 2023 Neurology India, Neurological Society of India Published by Wolters Kluwer - Medknow.
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Introduction: Surgical treatment of rectal cancer depends on clinical stage, size and location of primary tumor. A sphincter preserving technique such as low anterior resection (LAR) is the preferred method if negative distal margin can be achieved. If an adequate distal margin cannot be obtained, an abdominoperineal resection (APR) is required. A proctosigmoidectomy (Hartmann's procedure) is performed in patients with potentially curable obstructing rectal cancer after neoadjuvant chemoradiotherapy, or as a palliative treatment for locally advanced rectal cancer. Aim(s): The aim of this retrospective study was to investigate the impact of COVID 19 pandemic on the number and type of surgeries performed for the treatment of rectal cancer in UHC Zagreb, Department of Surgery. Material(s) and Method(s): Collected data were extracted from medical records of the patients who underwent surgery at the Department of Surgery from 1st of January 2016 to 31st of December 2022 with prior Ethics Committee approval. Total of 688 patients were included. Retrospective analysis of number and type of surgery was done consecutively by years for the period of interest. Result(s): In 2016 total of 75 patients underwent elective surgery for rectal cancer. LAR was performed in 64% (N=48) of patients, Hartmann's procedure in 20% (N=15), and APR in 16% (N=12). In 2017, 94 surgeries were performed. LAR accounted for 64% (N=60), Hartmann's procedure 17% (N=16), and APR 19% (N=18). In 2018, 115 surgeries were performed. LAR accounted for 69% (N=79), Hartmann's procedure 10% (N=12), and APR 21% (N=24). In 2019, 80 surgeries were performed. LAR accounted for 67% (N=54), Hartmann's procedure 9% (N=80), and APR 24%. In 2020, 78 surgeries were performed. LAR accounted for 59% (N=46), Hartmann's procedure 14% (N=11), and APR 27% (N=21). In 2021, 124 surgeries were performed. LAR accounted for 66% (N=82), Hartmann's procedure 14% (N=17), and APR 20% (N=25). In 2022, 122 surgeries were performed. LAR accounted for 64% (N=78), Hartmann's procedure 15% (N=18), and APR 21% (N=26). Conclusion(s): Our results show steady growth in numbers of performed surgeries in the years prior to the pandemic, with exception of the year 2019 when our department underwent organizational changes. In 2020, significant decrease in number of surgeries was observed as a result of restrictive epidemiological measures established to reduce the spread of COVID 19 infection. COVID 19 pandemic measures also resulted in delayed diagnosis and treatment of rectal cancer which is indirectly shown through the increasing share of Hartmann's procedure. In the years following the relaxation of measures, significant increase in number of performed surgeries that exceeded all the pre-pandemic years was recorded. Constant elevated share of Hartmann's procedure was noted as possible consequence of post COVID delay in diagnosis and confirmation of rectal cancer in more advanced stages of disease.
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Introduction: Achalasia is a motility disorder of the esophagus characterized by impaired relaxation of the lower esophageal sphincter and loss of peristalsis in the distal esophagus. It is a rare condition with an annual incidence of 0.5-1.2 per 100,000 individuals. The etiology of primary achalasia is unknown, however secondary achalasia can be attributed to malignancy, infections or systemic diseases such as amyloidosis. An infrequent complication of achalasia is esophageal squamous cell carcinoma which has a prevalence of 26 in every 1,000 cases. We present a case of interval locoregionally advanced esophageal squamous cell carcinoma only 2 years after a normal upper endoscopy. Case Description/Methods: A 67-year-old female with known achalasia and previous pneumatic dilation in her 30s presented to our outpatient clinic in 2019 with complaints of worsening chronic dysphagia. EGD was performed which revealed a significantly dilated esophagus with candida esophagitis. Despite completing antifungal therapy, she continued to experience dysphagia to solids and liquids. Barium swallow demonstrated absent peristalsis with pooling of contrast within the esophagus. High-Resolution Manometry testing demonstrated absent peristalsis. She opted for surgical myotomy, however due to COVID restrictions, the procedure was delayed. Repeat EGD was performed in 2022 for pre-surgical evaluation and showed a large obstructing friable esophageal mass in the lower third of the esophagus. Pathology was consistent with invasive poorly differentiated squamous cell carcinoma. PET scan showed locoregional disease with FDG-avid esophageal and gastrohepatic node lesions. She was started on chemoradiation with Paclitaxel and Carboplatin (Figure). Discussion(s): The risk of esophageal squamous cell carcinoma in achalasia has significantly increased with incidence of approximately 1 in 300 patients. The presumed mechanism of malignancy in achalasia is poor emptying resulting in food stasis, bacterial overgrowth and inflammation leading to dysplasia and development of carcinoma. Given the relatively low incidence, there are currently no guidelines on routine endoscopic screening to assess for malignancy in patients with achalasia. Survival rates are poor as patients are often diagnosed at advanced stages. This case aims to illustrate the importance and need for interval screening in individuals with long standing achalasia to improve outcomes.
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Introduction: Incidental elevations in Carbohydrate Antigen 19-9 (CA19-9) can trigger extensive medical evaluations for malignancy. Though classically associated with pancreatic cancer, CA19-9 is a nonspecific manifestation of multiple benign and malignant disease processes. Case Description/Methods: An asymptomatic, healthy 50-year-old female presented to primary care for an elevated CA19-9 level obtained for pancreatic cancer screening in Asia in 2019. Her evaluation in 2019 included abdominopelvic CT and magnetic retrograde cholangiopancreatography, which were normal. She was offered endoscopic ultrasonography to further evaluate pancreaticobiliary etiologies but was lost to follow-up amid the COVID-19 pandemic. She returned to the US in 2021, and basic laboratory testing and routine cervical cancer screening were performed. She was referred to Gastroenterology (GI) for further evaluation. Cervical cytology revealed atypical endometrial cells, and endometrial biopsy by gynecology was concerning for gastric-type endocervical adenocarcinoma. Transvaginal ultrasound revealed a thickened endometrial stripe, and pan CT revealed duodenal thickening, for which GI performed bidirectional endoscopy without significant abnormalities and no pancreatic or metastatic disease. Repeat CA19- 9 increased. She was referred to gynecologic oncology, where cervical biopsy and pelvic MRI confirmed an endocervical mass. She was diagnosed with Stage IIB gastric-type endocervical adenocarcinoma and underwent hysterectomy and left salpingectomy with adjuvant chemoradiation. Discussion(s): CA19-9 is synthesized in multiple organ systems. Elevations in asymptomatic patients are rarely predictive of pancreatic cancer but may expose patients to unnecessary testing and inadvertent harms without identifying malignancy. Thus, CA19-9 is not recommended for pancreatic cancer screening. Incidental elevations do warrant repeat testing. Benign processes will yield stable or decreasing levels, while rising levels suggest progressive or malignant processes. If concern for pancreatic malignancy is low, a reasonable investigation includes chest X-ray or CT, metabolic studies, hemoglobin A1c, liver and thyroid function panels, abdominopelvic CT or gynecologic cancer evaluation, and any other age-indicated cancer screening. In this case, prior imaging studies suggested low concern for pancreatic cancer. Her subsequent evaluation aligned with this suggested work-up and revealed gynecologic cancer as the ultimate etiology for her elevated CA19-9.
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Objective. To comparatively assess the early toxicity of treatment, its tolerability, 1-, 2-, 3-year overall survival, and local regional control rates in a group of patients receiving a radical cycle of accelerated or conventional fractionation chemoradiotherapy. Subjects and methods. The paper presents the interim results of a prospective study that included 115 patients with locally advanced cancer of the oropharynx, tongue root, and larynx who received a radical cycle of conformal chemoradiotherapy using accelerated (the single focal dose (SFD) was 2.4 Gy for 25-26 fractions) or conventional (SFD was 2.0 Gy for 32-33 fractions) fractionation in the period from 2015 to 2020. Results. An analysis comparing the study group with the control one revealed no statistically significant differences in the level of early toxicity of treatment (p=0.41). Complete tumor reversal was achieved in 57 (86.3%) patients in the study group and in 39 (79.5%) in the comparison group (p=0.23). The 1-, 2-, and 3-year local regional control rates in the accelerated fractionation group was 78.3+/-5.3%;65.9+/-6.8%, and 54.5+/-9.2%, respectively. The 3-year overall survival rate was 80.4+/-7.4%. These rates did not differ statistically from those in the conventional radiotherapy group (p=0.12-0.82);53 (80.3%) patients in the study group and 37 (75.5%) in the standard fractionation group received a radiation cycle without a forced interval. The treatment interval in the patients of both groups reduced the 2-year local regional control rates by 30.2% compared to that in the continuous cycle group (p=0.02). Conclusion. Accelerated fractionation chemoradiotherapy (SFD was 2.4 Gy for 25-26 fractions, the daily focal dose was 60.0- 62.4 Gy) is a procedure comparable with conventional radiation in its direct efficiency and safety. During the COVID-19 pandemic, this regimen can be considered to be a mainstay for patients with locally advanced oropharyngeal cancer in order to preserve the previous volumes of specialized healthcare.Copyright © A.V. SEMENOV I.A. GULIDOV O.G. LEPILINA M.U. RADZHAPOVA F.E. SEVRYUKOV K.B. GORDON.
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Introduction & Objectives: Bladder preservation is routinely used as an alternative to radical cystectomy in the UK and is becoming more accepted elsewhere globally. The gold standard is for patients to receive radiotherapy with a radiosensitiser most commonly concurrent chemotherapy e.g. 5FU/mitomycin C, gemcitabine or cisplatin. Patients with poor performance status or comorbidities may be unable to be offered concurrent treatment with chemotherapy but alternative treatment with concurrent carbogen +/- nicotinamide as a hypoxic modifier may be of benefit. Our aim therefore was to retrospectively review patients with bladder TCC treated with radical radiotherapy alone in the last 5 years who may have benefited from carbogen +/- nicotinamide radiosensitisation at a large cancer centre in the north of England. Material(s) and Method(s): In this single institution retrospective case note review, electronic records were reviewed for 175 patients who had received radiotherapy to the bladder for TCC between 2017-2022. Patients who had radical radiotherapy (RT) alone without radiosensitisation were scrutinised to ascertain whether they would have been candidates for carbogen and nicotinamide using the inclusion/exclusion criteria previously defined in the Bladder Carbogen Nicotinamide (BCON) Randomised Phase 3 trial. Result(s): We analysed 175 patients. Of these, 133 received had radical RT without radiosensitisation. The most common reason for not offering radiosensitisation was the presence of co-morbidities (27.8%). Of interest, the proportion of patients having chemotherapy radiosensitisation did not change after COVID19 in March 2020 (21.5% pre- vs 27.5% post;p=0.32 chi2). Conversely, the proportion of patients receiving neo-adjuvant chemotherapy reduced though failed to reach significance (12.6% pre- vs 5% post;p=0.08 chi2). After review of the notes and criteria from the original BCON trial, 106 patients (79.6%) could have benefited from carbogen +/- nicotinamide. Of these, 14 patients (13.2%) could have been offered carbogen alone due to poor renal function. The most common reason for not being eligible for BCON was respiratory disease with reduced respiratory drive (44%). Conclusion(s): The National Institute for Health and Care Excellence (NICE) state that all radical RT for bladder TCC should be with a radiosensitiser. Due to logistical and departmental issues, the BCON regimen is not currently offered as a standard alternative to radiosensitisation with chemotherapy. BCON has been demonstrated to be tolerable and, whilst updated follow-up data failed to demonstrate statistical significance for overall survival (OS), meta-analysis of hypoxia modification has shown significant improvement in OS compared to RT alone. Hypoxia modification with carbogen +/- nicotinamide should be considered for all patients unsuitable for chemotherapy radiosensitisation.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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INTRODUCTION: Many landmark trials have challenged the need for extensive axillary surgery and radiation in breast cancer patients. De-escalation of axillary treatment could potentially result in less breast cancer-related lymphedema (BCRL). Our study aims to define the incidence and trends of BRCL over the last 15 years. METHOD(S): Since 2005, our institution has prospectively screened breast cancer patients for lymphedema during and after treatment with a Perometer. 2,334 women diagnosed with breast cancer with baseline arm volume measurements and at least 2 follow-up measurements were divided into 3 cohorts based on date of surgery (Cohort 1: 2005-2010, Cohort 2:2011-2016, Cohort 3: 2016-2022). The cohorts were selected to coincide with publications of the landmark trials NSABP B-32, ASCOG Z0011, ASCOG Z1071, and EORTC 10981-22023 AMAROS which demonstrated safety in reducing the number of axillary lymph node dissections (ALND). Lymphedema was defined as a relative volume change of 10% or greater from preoperative baseline at least 3 months post-operatively. In cases of bilateral surgery, the weight-adjusted arm volume change equation was utilized. Cohort, age, BMI, axillary surgery type, chemotherapy timing, radiation type, and surgery type were all included in the multivariate analysis. RESULT(S): The overall incidence of BCRL was 12.8%, with a 29.6% incidence for those undergoing ALND and a 6.4% incidence for those undergoing sentinel lymph node biopsy. While the number of ALND performed decreased between cohorts (Figure 1), there was no significant difference in BCRL between assigned cohorts (HR 1.02 (95% CI [0.69, 1.51], p=0.930 for cohort 3 vs cohort 1). On multivariate analysis, significant associations with development of BCRL were identified with older age (HR 1.02;95% CI [1.01, 1.03], p=0.002), higher BMI (HR 1.05;95% CI [1.04, 1.07], p< 0.0001) and ALND (HR increased the risk of (HR 3.67;95% CI [2.62, 5.13], p< .0001). Regional lymph node radiation was not significantly associated with BCRL. CONCLUSION(S): Despite a reduction in the number of ALND performed over time, we did not see a dramatic reduction in the incidence of BCRL. Interestingly, between cohort 2 and cohort 3 there was a stable incidence of ALND which could be related to the COVID pandemic with an increase in more advanced cancers and a decrease in the ability to screen patients for BCRL during that time period.
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Objectives: To determine if the COVID pandemic affected treatment times for women with locally advanced (FIGO Stages IIb-IVa) cervical cancer. Method(s): Subjects diagnosed with and treated for locally advanced (FIGO Stages IIb-IVa) cervical cancer with chemo/radiotherapy at a large, urban, tertiary hospital between 1/1/19-12/31/21 were identified and the following was collected: Demographics, urban/rural home address, stage, histology, and the dates of diagnostic biopsy, first visit with oncologist, and start and completion of radiotherapy. Result(s): 69 subjects were identified. (59 Black vs 10 white;35 urban vs 34 rural). Median time from biopsy to seeing an oncologist was 14.2 days. Median time from seeing an oncologist to start of radiotherapy was 29.9 days, and median time from start to completion of radiotherapy was 62.9 days. Pre-COVID (P, 2019-2/20) vs during (D, 3/20-), median times in days were: Biopsy until seeing oncologist: 12.7(P) vs 15.2(D);seeing oncologist until start of radiotherapy: 27.3(P) vs 31.6(D);start until completion of radiotherapy: 62.2(P) vs 63.4(D);and biopsy until completion of radiotherapy: 99.9(P) vs 109.3(D). When urban(U) vs rural (R) subjects are compared in the pre-pandemic era, median times were: Biopsy until seeing oncologist: 10.5(U) vs 14.9(R);seeing oncologist until start of radiotherapy: 19.8(U) vs 34.7(R);start until completion of radiotherapy: 58.6(U) vs 65.4(R);and biopsy until completion of radiotherapy: 88.1(U) vs 113.9(R). When urban(U) vs rural (R) subjects are compared in the During-pandemic era, median times in days were: Biopsy until seeing oncologist: 12.9(U) vs 17.8(R);seeing oncologist until start of radiotherapy: 28.3(U) vs 35.4(R);start until completion of radiotherapy: 60.4(U) vs 66.8(R);and biopsy until completion of radiotherapy: 101.0(U) vs 118.9(R). All differences were significant to p<0.001. Conclusion(s): The COVID pandemic was associated with an increased time from diagnosis to completion of treatment for locally advanced cervical cancer. (99.9 vs 109.3 days) Rural subjects experienced longer times in treatment than urban subjects prior to COVID, and this difference was exacerbated by the pandemic: 101(U) v.118.9(R) Rural subjects will require proactive efforts to maintain compliance with treatment.Copyright © 2022 Elsevier Inc.
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Circulating tumor DNA is a liquid biomarker that offers a highly specific method to assess HPV-associated tumor burden via a blood draw. It has the potential for many clinical applications in cancer care, including prognostication, monitoring treatment response, and surveillance for disease recurrence. In this case report, we present a case of recurrent HPV-associated hypopharyngeal squamous cell carcinoma first detected by circulating tumor HPV DNA that demonstrates the role of circulating tumor HPV DNA tests in posttreatment surveillance and the utility of HPV testing in all HPV-mediated tumors, regardless of subsite.Copyright © 2023 Elsevier Inc.
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INTRODUCTION: Reallocation of resources during the COVID-19 pandemic resulted in delays for breast health care. Data are sparse regarding the impact of these delays on psychosocial outcomes. METHOD(S): Women seeking breast health care across a multi-site breast program in a large metropolitan area were assessed for psychosocial outcomes including depression, stress, and anxiety as it related to delays in care. Psychosocial outcomes were evaluated utilizing validated instruments (PROMIS, PHQ-9). Outcomes were stratified by treatment group (healthy, breast cancer, survivor) and Kaplan-Meier curves created for breast cancer patients to evaluate the relationship of time to treatment stratified by dichotomous psychosocial outcomes. Demographic and clinical data was ed from the electronic medical record. RESULT(S): 85 women enrolled in the study including 30 (35%) breast cancer patients, 24 (28%) healthy women, and 31 (36%) breast cancer survivors. Overall, 58% reported a delay in breast health care including surgery, radiation, chemotherapy, medical oncology treatments, clinical appointments, breast imaging and/or biopsies, survivorship follow-up, support groups, and/or screening. Compared to women in the no delay group, a greater proportion of women reporting a delay had high anxiety (78% vs. 58%;p = 0.06), high perceived stress (45% vs. 28%;p = 0.17), high loneliness (67% vs. 32%;p = 0.003), moderate or higher depression (16% vs. 8.3%;p = 0.34), and no or low emotional support (58% vs. 28%;p = 0.008). Among breast cancer patients, the first treatment modality was surgery in 73% and the median time to treatment was 33 days. The median time to treatment was 40 days for breast cancer patients reporting a delay compared to 28 days for patients reporting no delay. Longer time to treatment was observed among breast cancer patients with high versus low anxiety, perceived stress, loneliness, and depression and for patients with low versus high emotional support. CONCLUSION(S): Women with and without breast cancer reporting a delay had worse measures for anxiety, depression, perceived stress, loneliness, and emotional support. Longer time to treatment was experienced by breast cancer patients with worse psychosocial measures. Risk stratification of women seeking breast health care during the COVID-19 pandemic is needed to identify and support those at risk for adverse psychosocial outcomes. (Table Presented).
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Background Graft versus host disease (GVHD) most often occurs 100-365 days after hematopoietic stem cell transplant (HSCT). Manifestations most often are dermatologic, hepatic or pulmonic, and are rarely cardiac. We present a unique case of GVHD inducing cardiogenic shock necessitating advanced heart failure therapies. Case This is a 34 year-old male with a history of acute lymphoblastic leukemia who completed chemoradiation and HSCT from an HLA perfect sibling in 1992. In May 2020, he presented with dyspnea for 6 weeks. An echocardiogram at that time showed an EF of 10% and severe biventricular dilatation. He was originally hospitalized at an outside institution for hypoxia where a left heart catheterization showed normal coronaries and goal directed therapy was initiated. After 2 negative COVID tests, he was discharged with a LifeVest. One month later, despite medication compliance, he returned in cardiogenic shock after his LifeVest was activated for ventricular tachycardia (VT). Decision-making He was started on inotropic therapy and an intra-aortic balloon pump (IABP) was placed 1:1 prior to transfer to our tertiary center. After support was started, a right heart catheterization showed a right atrial pressure of 13 mmHg, a wedge of 17, and a cardiac index of 2.6. His course was complicated by VT storm. Differentials for his non-ischemic cardiomyopathy (NICMO) included myocarditis (viral vs. giant cell) with a possible component of chemotherapy/radiation induced NICMO. Immediate AHFT work-up was started. He was unable to be weaned off his IABP or inotropic support. The decision was made to pursue emergent left ventricular assist device placement (LVAD) and achieve a definitive diagnosis with a core biopsy. Pathology resulted with myocyte hypertrophy, chronic inflammation with eosinophils concerning for chronic GVHD. Conclusion There have only been a handful of case reports describing cardiac manifestations of GVHD, and none with NICMO and cardiogenic shock requiring an LVAD. Despite this, suspicion should remain present for GVHD in HSCT patients regardless of time frame from oncologic therapies or specificity of HLA match when presenting in cardiogenic shock.Copyright © 2023 American College of Cardiology Foundation
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Background: There has been lot of speculation around the possible side effects associated with COVID vaccination and incidence of facial palsy is one of them. Bilateral facial palsy is less likely to be idiopathic as compared to unilateral facial nerve palsy and warrants further investigations to find any secondary cause. COVID 19 infection and the vaccinations for the same are also included in the unique list of differentials. Case report: We report an interesting case of bilateral rapidly sequential facial nerve palsy following the administration of COVID vaccination that showed subsequent improvement. We provide literature review to report the current incidence of same, secondary to the vaccination as well the infection itself Case presentation: Following the introduction of COVID 19 vaccine, there have been reports of various cranial nerve involvement including lower motor neuron type facial paresis. Bilateral facial palsy is less likely to be idiopathic as compared to unilateral palsy(23% vs 70%) and requires further work up to determine the etiology before determining to be idiopathic. Unilateral facial palsy(FP) has been reported in the Phase I and II trials for Pfizer and Moderna vaccine, with a total of 7 cases reported in these initial trials. To date, there is no direct evidence that these vaccines have increased the incidence of facial palsy as compared to adverse events reported with other vaccines or compared to COVID 19 infection itself. We report a unique case of bilateral lower motor neuron type facial palsy noted in a young male within hours of receiving the vaccine that later improved with treatment. Reports of simultaneous bilateral facial palsy after vaccine are rare with only few cases reported to date in literature. Conclusion(s): In conclusion from current available literature, we would like to postulate that though there is a risk of facial nerve palsy following the vaccination, it is comparable to the risks associated with any other vaccinations and not been higher than the non-vaccinated population. The overall risk is higher with the actual COVID 19 infection itself as compared to the vaccine.Copyright © 2022
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Aim: The PINETREE study showed benefit of remdesivir in non-hospitalised COVID patients. This became the evidence base for the NHSE policy on antivirals use in hospital-onset COVID patients. However, there are differences between PINETREE inclusion criteria and NHSE policy eligibility criteria, and PINETREE was conducted when Delta was dominant. We describe attributes, risk stratification and outcomes in hospital-onset COVID patients when Omicron is dominant. Method(s): A retrospective analysis of patients testing COVID +ve post-admission over 30 days at two district hospitals, collecting risk factors as defined by the QCovid model, and outcomes including days on/off oxygen, survival/discharge at 28 days, and whether antivirals were considered/given. Result(s): 68 eligible cases were identified. CV followed by respiratory diseases were the commonest risk factors. In the 28 days after a +ve test, 31% required supplemental oxygen and 16% died. Being male, and having CV disease, active solid malignancy and recent chemo/radiotherapy were over-represented in patients who died. Supplemental oxygen was associated with significantly higher 28-day mortality risk (43% v 4.3%). Average age of those who died was higher than the overall cohort (84 v 75y). 28-day mortality rates for those who received 1, 2 and 3 COVID vaccines were 60%, 21% and 5% respectively. 18 patients met criteria for highest risk group and were eligible for antivirals. Only 11% were considered for antivirals. Conclusion(s): Despite the milder omicron variant and high vaccination rate, hospital-onset COVID is associated with worse outcomes compared to community clinical trials. The lack of antivirals use according to NHSE criteria should push MDTs to consider a validated risk model for antivirals use.
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Introduction: Efficient and comprehensive trial oversight and data management ensures valid, robust outcomes necessary to inform health policy and improve patient outcomes. This is particularly challenging in the context of multicenter trials. The format of this session will include four introductory presentations (15 min each), followed by 30-min panel discussion/Q&A focusing on recent experiences and innovative approaches utilized within the Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB). Since 2017, WF has managed 15 studies with approximately 3000 patient and 1000 provider/stakeholder accruals across 1000 potential participating community oncology practices within the United States and Puerto Rico. These practices often operate differently from academic medical centers, with varying patient capacity, provider number and level of engagement, use of advanced practice providers, and services offered. In addition, practices within this network have heterogeneous utility of electronic health records (EHRs) and display a wide range of clinical research staffing models. The COVID-19 pandemic has highlighted the need for streamlining research visits and maximizing telehealth technologies when applicable, particularly for intervention non-therapeutic clinical trials. As such, research expectations must be standardized to ensure quality trial conduct and data collection across diverse practices. Recently, the WF NCORP RB has taken many steps to improve efficiency and data quality across our studies. This session will discuss a comprehensive approach to data quality and management across the lifespan of a trial. This starts with consent/ recruitment strategies and general oversight/ monitoring of our portfolio of trials. WF RB now utilizes REDCap for all data capture, as this allows direct data entry for site personnel and participant entered patient-reported outcomes using surveys. In addition, REDCap facilitates data monitoring, query, and auditing strategies. We will also introduce a team-based approach to adjudicate complex outcomes. Talk 1 (15 min): Specifically, Karen Craver, our RB administrator, will discuss approaches to obtain robust data as a result of strong screening and recruitment. She will provide an overview on how we survey practice research staff within the Landscape assessment and brief, pre-trial interest surveys to identify optimal target populations during the planning stage. We utilize our internal EHR to create custom screening reports to identify potential participants and generalize these for other practices to customize and use as a screening tool within their clinic. The RB has integrated remote consenting in part due to the pandemic, but we realize the need to continue offering flexibility in consent modality moving forward. Talk 2 (15 min): Emily Dressler, lead Biostatistician, will discuss oversight of the RB portfolio using dynamic reports within Tableau. These reports update daily and provide a comprehensive assessment of all ongoing and completed studies. RB personnel can filter reports to create custom results subset by timeframe, practice or set of practices, trial type, and/or other demographic characteristics. This has greatly reduced the request for study-specific accrual reports and has standardized our reporting across studies. She will also discuss the rationale for transitioning to REDCap, including strengths and weaknesses for integrating in multicenter studies. Talk 3 (15 min): Bill Stanfield, lead data manager, will demonstrate our utilization of the REDCap Data Resolution Workflow and Data Quality modules to efficiently manage data collection, data quality, and audits. He will show how REDCap can be used to seamlessly communicate with research staff to obtain missing or late data, verify out of range values, and then validate and lock responses for analysis. Talk 4 (15 min): Glenn Lesser, WF NCORP multiple principal investigator (mPI), will discuss a team approach to adjudicating cancer treatment information that often consists of combination of surgery, radiation, chemotherapy, or immunotherapy/targeted agents. This remains a particularly challenging problem in large trials enrolling patients with multiple types of cancer who may be treated with a wide spectrum of standard therapeutic regimens. This diversity limits both the effectiveness of automated reviews of remote data entries and the study-specific training of data management staff at sites. Data are pulled in real time from multiple forms within REDCap and collated into participant-level summaries of treatment, starting with the time of baseline assessment and sorted sequentially for each drug administration or event. A multidisciplinary team of data managers, biostatisticians, and clinicians meet to adjudicate each participant as data collection completes. Particularly for trials with multiple cancer types or treatment regimens, our experience with this approach has shown it identifies significant data gaps in treatment, with at least 75% of entries requiring clarification from research staff prior to finalizing and locking data. This process highlighted the challenge of real-time adjudication of treatment data in patients receiving multiple anti-cancer agents, given at varying doses and schedules, and in multiple combinations and/or phases over an individual patient's course of therapy. Panel (30 min): We will conclude with a panel discussion and Q&A. The panel will contribute additional perspective on implications of these strategies in the conduct of multilevel cancer care delivery research studies. We will also incorporate perspectives from NCORP community sites implementing these strategies. Panelists will discuss the broad applicability of these strategies for diverse trials, with attention to size/ complexity, database vendor, and patient population.
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INTRODUCTION: There is concerned that prognosis of cancer-bearing patients is adversely affected by postponement of cancer treatment due to infection with a new type of coronavirus(COVID-19). We report a case of thoracic esophageal cancer treated with COVID-19 pneumonia during preoperative CRT. A 60-year-old female diagnosed as having Stage IV thoracic esophageal cancer(cT3N0M1LYM[104R])started receiving preoperative chemoradiotherapy. On the 12th day, she had a fever and was diagnosed with COVID-19 infection. CRT temporarily interrupted and she was treated for COVID-19 pneumonia preferentially. CRT was resumed promptly after remission. Finally, video-Assisted radical esophagectomy was performed. There were no postoperative complications. Nivolumab was started as an adjuvant therapy on the 2nd postoperative months. CONCLUSION(S): We experienced a case of thoracic esophageal cancer in which COVID-19 pneumonia was treated during preoperative CRT, and CRT and surgery were completed without complications by appropriate treatment.
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INTRODUCTION: There is concerned that prognosis of cancer-bearing patients is adversely affected by postponement of cancer treatment due to infection with a new type of coronavirus(COVID-19). We report a case of thoracic esophageal cancer treated with COVID-19 pneumonia during preoperative CRT. A 60-year-old female diagnosed as having Stage IV thoracic esophageal cancer(cT3N0M1LYM[104R])started receiving preoperative chemoradiotherapy. On the 12th day, she had a fever and was diagnosed with COVID-19 infection. CRT temporarily interrupted and she was treated for COVID-19 pneumonia preferentially. CRT was resumed promptly after remission. Finally, video-Assisted radical esophagectomy was performed. There were no postoperative complications. Nivolumab was started as an adjuvant therapy on the 2nd postoperative months. CONCLUSIONS: We experienced a case of thoracic esophageal cancer in which COVID-19 pneumonia was treated during preoperative CRT, and CRT and surgery were completed without complications by appropriate treatment.
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Objective: To explore the clinical practice of delivering radiotherapy during the outbreak of 2019 novel coronavirus disease(COVID-19). Method(s): During this epidemic period, available method including but not limited to: strict disinfection, body temperature monitoring and staff training of relevant knowledge, were used to ensure the safety of radiotherapy treatment. Statistical analysis was performed to study the relevant data including proportion of patients receiving radiotherapy for different purposes, time from scanning to the first time of radiation delivery and degree of satisfaction in the view of staffs and patients, respectively. Result(s): A total of 60 patients received radiation therapy in the department of radiotherapy of Zhejiang Provincial People's Hospital (2020-02-11). Compared with the same period in 2019 (after the Spring Festival), the total number of patients receiving radiotherapy was decreased from 72 to 60(83.3%). Among them, the number of patients receiving palliative radiation therapy decreased significantly, while the proportion of radical, preoperative and/or postoperative radiotherapy/radiochemotherapy did not significantly decrease. There was significant difference between two years (chi2=6.967, P<0.05). The median time for newly admitted patients to receive radiotherapy was two days, which was not significantly longer than the interval in 2019 (P>0.05). Staff and patients were generally satisfied with the current prevention measures. Conclusion(s): Using a variety of prevention and control method, and taking full account of medical safety and patient benefits, radiation-related activities can be carried out during the epidemic.Copyright © 2020 by the Chinese Medical Association.
ABSTRACT
Purpose/Objectives: Since the COVID-19 pandemic, telemedicine has become an attractive alternative to office visits in routine radiation oncology practice. The purpose of this study was to identify factors associated with patient preference for an initial consult telemedicine visit and correlation with clinical trial enrollment. Materials/Methods: We evaluated breast cancer patients seen during the open enrollment of a prospective randomized controlled non inferiority trial evaluating radiation fibrosis with five versus three fractions from 07/13/2020 to 05/13/2021. Univariate and multivariate logistic regression models were used to identify factors associated with virtual vs inperson initial consultation and enrolled vs not enrolled patients. All statistical tests were two-sided and the null hypothesis was rejected for p< 0.05. Result(s): We identified 476 patient consultations with 259 office visits and 217 telemedicine visits. On multivariate analysis, increased age, unemployment, chemotherapy receipt and radiation at NYU were associated with decreased usage of telemedicine for consultation visit. Out of 217 patients who underwent a telemedicine initial consultation, 10% were eligible to enroll on the trial and of those eligible, 76% enrolled. Out of 259 patients who underwent office visit initial consultation, 14% were eligible to enroll on the trial and of those eligible, 53% enrolled. Among eligible patients, there was no statistically significant difference in clinical trial enrollment between telemedicine and office visits. There was no statistically significant difference in patient characteristics between enrolled vs not enrolled patients. Conclusion(s): Though patient and disease characteristics remained similar between patients undergoing telemedicine and office visits consultations, increased age, unemployment and receipt of chemotherapy were associated with lower usage of telemedicine. Those who underwent in person initial consultation were also more likely to subsequently receive their radiation at our clinic. Further studies are needed to better define underlying reasons for patient selection and impact on care and trial enrollment in order to ensure equal access and benefit from telemedicine, especially in already vulnerable patient populations.