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BACKGROUND: Herbal medicine and its derived products have been used in the medicine and nutraceutical sectors for the treatment of human disorders and associated secondary complications. Plant-derived products play an important role in our daily life due to their medicinal properties and pharmacological activities. The attention of scientists to natural products has increased due to their significant biological activities. Flavonoids represent one of the most important phytocompounds present in the higher plants, common fruits, vegetables, herbs, wine, juices, and dried fruits. Flavonoids exert potent antioxidant activity by blocking and scavenging free radicals. Cirsilineol, also called 4',5-dihydroxy-3',6,7-trimethoxyflavone, is an active phytochemical of Artemisia vestita, Artemisia monosperma, Artemisia asiatica, and Agrostis gigantea. METHODS: Medicinal importance and pharmacological activities of cirsilineol have been investigated in the present work with their analytical aspects in order to know the biological importance of cirsilineol in medicine. Literature data on cirsilineol were collected and analyzed in the present work to study its therapeutic potential against various human disorders and associated secondary complications. Scientific data were collected from Google, Google Scholar, PubMed, Science Direct, and Scopus and analyzed in the present work using the term herbal medicine, flavonoid and cirsilineol. RESULTS: Medicinal plants containing a significant amount of cirsilineol have biological applications in medicine due to their pharmacological activities. This present work signifies the biological importance of cirsilineol in medicine as it has anti-proliferative, gastroprotective, anti-Helicobacter pylori, anti-diabetic and anti-oxidant activities. Further therapeutic effectiveness of cirsilineol against different types of cancers, including breast carcinoma and lung carcinoma, has been discussed in the present work. The biological importance of cirsilineol against allergic rhinitis, inflammation, coronavirus, immune system, renal cellular membrane and protein glycation has also been discussed in the present work. However, the importance of analytical methods for the isolation and identification of cirsilineol in medicine has also been analyzed. CONCLUSION: This work aimed to summarize the health-beneficial aspects of cirsilineol in medicine which will be beneficial to explore the further therapeutic effectiveness of cirsilineol for the treatment of various forms of human disorders.
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Background: Breats cancer is a major health problem in elderly ( >= 70 years) women. Increase incidence with age and the progressive increase in life expectancy mean that the numbers in elderly breast cancer diagnosis are increasing. These patients do not always receive the proper treatment and despite this the survival of this population is not always depends on cancer, there are other competing causes of death typical of the aging population. Method(s): A retrospective observational analysis of women >= age 70 diagnosed with breast carcinoma in HUPHM between 2014 and 2020 was made. Clinical, pathological data and stages at diagnosis were analyzed. We checked our patients with the national death center (official national registry) thus obtaining an exact date of death and the cause of death. Data updated in January 2023 , ensuring a minimum follow-up of 24 months. We excluded deaths from Covid or of unknown cause to avoid bias. Result(s): A total of 421 patients were analyzed, mean age of 78.6 years and median follow-up of 48 months. 28% of patients had died at the time of analysis, 11% due to cancer and 17% from other causes. If we analyze the population deceased by cancer, no deaths are detected in patients diagnosed with carcinoma in situ (4% of the population), in stage I (30% of the population) the cumulative incidence of cancer death at 5 years is 3%, 7% In stage II (30% of the population), 15% in stage III (16%) and 70% in stage IV (12%). Death by other causes are more frequent in early breast cancer, the cumulative incidence at 5 years are 10% in stage I, 22% in stage II, 44% in satge III and just 10% in stage IV. The most frequent causes of death in this population were caridovascular events and infections. There are no differences in 5-year mortality according to histological subtypes 20%, 12%, 25% and 12% for triple negative, Rh+/HER2-, RH+/her2+ and RH-/HER2+ respectively. Conclusion(s): Although elderly patients do not receive optical treatments, mortality from cancer in early stages is incidental at 5 years, a different scenario is seen in metastatic disease in which the patient's prognosis depends mainly on the oncological disease, Therefore, an effort should be made in the treatment of these patients with metastatic breast cancer since adequate treatments can have a clearly positive impact on the survival of patients. Legal entity responsible for the study: The authors. Funding(s): Has not received any funding. Disclosure: All authors have declared no conflicts of interest.Copyright © 2023
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Background: In India, less than 5% of women get routine screening for breast cancer due to lack of awareness and the absence of a coordinated national breast cancer screening programme. A community health initiative was launched by Niramai in collaboration with City Health officials in Bangalore as a pilot to increase awareness and make breast health screening available to all. Free breast cancer screening using AI powered Thermalytix test is being offered to all the underprivileged women walking into Bruhat Bengaluru Mahanagara Palike (BBMP) government hospitals from November 14, 2017 till today (after a break for 15 months during COVID). Material(s) and Method(s): This observational study was conducted in 22 BBMP-affiliated primary health centers where outpatient women over the age of 18 years and not pregnant were enrolled. The procedure included a briefing on camp procedures, taking patient consent, identification of eligible candidates, general health education, and conducting the Thermalytix test by a healthcare worker who was trained to use the Thermalytix software tool. Women were triaged using the output generated by Thermalytix 180. Those triaged as red were referred for further detailed imaging investigation in a district hospital using mammography, ultrasound and FNAC/biopsy. Result(s): A total of 6935 women underwent Thermalytix screening in 22 BBMP hospitals during Nov 2017 to July 2022. A total of 1687 participants were excluded from the analysis as they did not meet the eligibility criteria. The median age of the 5248 eligible participants was 42 years (range 18-86). Among them, 90 women (1.71%) had previously noticed a lump in their breast, 431 women (8.12%) had breast pain, 16 women had complained of nipple discharge, and 5 women had noticed skin discoloration. When screened, 62 (1.2%) women were detected with abnormalities and triaged positive by Thermalytix. Among them 11 women have so far gone through diagnostic investigations, of which 8 were radiologically positive and were recommended for histopathology correlation. The overall test positivity rate of Thermalytix in this cohort was 1.2% and positive predictive value with radiological positivity as reference was found to be 9/11 = 81.81%. Furhter histological analysis reported 1 DCIS and 8 benign fibroadenoma. The tests were conducted in screening camps and the average cost of conducting the test in the field came to around 6.5 USD per person. Conclusion(s): Thermalytix could be a potential automated screening tool for population-level screening in resource constrained settings. The portable equipment enabled easy movement across different PHCs. Since it is a privacy-aware test, there was less refusal to participate in the test. Community mobilization with the help of the local government health officials was crucial to ensure walk-ins. Conflict of interest: Ownership: yes Board of Directors: yes Corporate-sponsored Research: yesCopyright © 2022 Elsevier Ltd. All rights reserved
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Introduction. The SARS-CoV-2 infection rate and the COVID-19 death rate were relatively high in the Netherlands during the first wave of the COVID-19 pandemic (2.7 and 7.2 times higher than in Norway, respectively). Moreover, social measures differed between the two countries. This study aimed to compare the effect of the pandemic on breast cancer incidence and stage between the Netherlands and Norway. Methods. Women diagnosed with DCIS or invasive breast cancer between January 2017 and December 2021 were selected from the Netherlands Cancer Registry and from the Cancer Registry of Norway. The COVID-19 period was divided in three approximately equal periods: March-September 2020 (first wave), October 2020-April 2021 (second wave), May-December 2021 (post-second wave). Breast cancer incidence during the COVID-19 periods was compared with averaged data of the corresponding reference period: March-September 2017, 2018, 2019 (first wave-ref), October-April 2017, 2018, 2019 (second wave-ref), May-December 2017, 2018, 2019 (post-second wave-ref). Incidences were compared by age group, clinical tumor stage, and method of detection. Results. The number of breast cancer diagnosis and the breast cancer incidence are shown in Table 1. Compared to the reference period, breast cancer incidence was lower during the first wave in the Netherlands and Norway (IRR: 0.72;95%CI: 0.70-0.75;IRR: 0.83, 95%CI 0.78-0.88, respectively), and was higher post-second wave in Norway (IRR: 1.10, 95%CI: 1.04-1.16) (Table 1). During the first wave, breast cancer incidence was lower in all age groups in the Netherlands (age < 50 IRR: 0.85, 95%CI: 0.79-0.91;50-69 IRR: 0.64, 95%CIL 0.61-0.67;70-74 IRR: 0.61, 95%CI: 0.56-0.67;>74 IRR: 0.86, 95%CI: 0.80-0.93, respectively). During the first wave, incidence was lower in women aged 50- 69 in Norway (i.e., women eligible for screening;IRR: 0.68, 95%CI: 0.62-0.74). Post-second wave incidence was higher in women aged 50-69 and >74 in Norway (IRR: 1.09, 95%CI: 1.01-1.17;IRR: 1.13, 95%CI: 1.00-1.28, respectively). In the first wave the incidence of DCIS, stage I tumors, and screen-detected tumors was lower in the Netherlands (IRR: 0.55, 95%CI: 0.50-0.61;IRR: 0.62, 95%CI: 0.59-0.65, IRR: 0.36, 95%CI: 0.33-0.38, respectively) as well as Norway (IRR: 0.66, 95%CI: 0.54-0.79;IRR: 0.73, 95%CI: 0.66-0.81, IRR: 0.46;95%CI: 0.40-0.52, respectively). Conclusion. The current study showed that the incidence of early-stage tumors mainly decreased. Moreover, during the first wave of the pandemic breast cancer incidence decreased in all age groups in the Netherlands but only in women aged 50-69 in Norway. The relatively high infection and death rate in the Netherlands might have increased the fear of patients to visit the general practitioner (GP) and/or to overburden the healthcare system at the start-up of the pandemic. In addition, it might have reduced the capacity at the GP. As a result, appointments with the GP might have been postponed, resulting in a decrease in the number of breast cancer diagnoses in all age groups. A catch-up in breast cancer diagnoses was seen post-second wave in Norway, but not in the Netherlands. Incidence rates should therefore be monitored in the coming period. (Table Presented).
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Sinonasal cancer accounts for roughly only 3% of upper respiratory tract malignancies and generally presents as a primary malignancy. Although extremely rare, the sinonasal cavity is also a known location for metastasis, with 8% of these cases originating from primary breast cancer. When attempting to differentiate primary disease from metastasis, immunohistochemical analyses play a crucial role in reaching the correct diagnosis. To date, there are a handful of reports describing metastasis involving the paranasal sinuses but even fewer reporting primary sinonasal cancer with coexisting primary malignancy. Here we present a case of primary sinonasal adenocarcinoma in the setting of a long-standing history of breast cancer. The patient, a 73-year-old female, was diagnosed with T1cN1aM0, progesterone receptor positive and estrogen receptor negative ductal carcinoma in situ of the left breast in November 2019. She subsequently underwent bilateral mastectomy and treated with 3 cycles of chemotherapy and anastrozole, which were both discontinued due to intolerance. Of note, in March 2019, MRI of the head incidentally found a 3 x 2 cm mass in right nasal cavity extending into ethmoid sinus. One year later, she presented with mild right sided nasal obstruction and drainage, and biopsy revealed squamous and respiratory mucosa with chronic inflammation. The patient elected to cancel initial surgical resection of the mass due to the COVID-19 pandemic. The patient returned in March 2022 with complaints of eye pressure, double vision, headaches, and worsening nasal obstruction. PET/CT scan was negative for distant metastasis but demonstrated increased uptake in sinus cavity. MRI showed a larger 5 x 3.7 cm mass impressing on medial inferior margins of orbit. Imaging also suggested evidence of dehiscence of lamina and irregular neo-osteogenesis of the skull base. She underwent approach and resection of the mass with histology demonstrating a well differentiated, low grade non-intestinal mucinous adenocarcinoma. Immunohistochemistry was positive for pankeratin and CK7, favoring a primary sinonasal origin. It was estrogen receptor negative and negative for GATA3, a sensitive and fairly specific stain in mammary carcinoma. Adjuvant radiation was recommended postoperatively, however the patient declined this therapy. This case highlights the role of immunohistochemistry to discriminate a new primary cancer from metastasis in patients with a history of breast cancer. Clinically, patients with sinonasal metastasis can present with symptoms ranging from unilateral nasal obstruction, facial pain, diplopia, and decreased vision. On imaging, suspicion of malignancy is raised when there is evidence of destruction of bony boundaries and invasion of surrounding tissues such as the orbit and anterior skull base, as found in our patient. Notably, metastasis to the paranasal sinuses can mimic a primary cancer of the nasal cavity, with both tumors showing epithelial differentiation. However, primary tumors often show neoplastic changes in the overlying respiratory epithelium and do not express estrogen receptor, progesterone receptor, or HER2 positivity, which are known to be correlated with breast cancer. In this setting, GATA3 and estrogen receptor negativity allowed us to diagnose primary nasal cancer more confidently. Therefore, clinicians should be aware of metastatic disease and expand immunohistochemistry panels when appropriate.
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Background: Dermatomyositis is a type of systemic inflammatory autoimmune disorder characterised by muscle inflammation and skin rashes. We present a rare adult onset refractory Nxp2 dermatomyositis following COVID 19 infection Methods: 36-year- old male came with the complaints of: Redness of right eye, Easy fatgiuability ,dysphagia of 3 months duration * Patient had uncomplicated COVID-19 1 month prior to onset of present complaints * On examination he had anasarca proximal muscle weakness and muscle tenderness and had neck and pharyngeal muscle weakness dysphagia and nasal regurgitation.He also had malar rash and periribital rash and swelling (Figure 1) * Investigations revealed biochemical radiological and Electrophysiological evidence of myositis (Table 1) * He was managed with pulse sterids ivig rituximab and tacrolimus with gradual but definite resolution Conclusion(s): Auto-antibodies against NXP2 are detected in 15% to 25% cases of Juvenile dermatomyositis and in only 1% of adult cases. This form of DM is characterized by accompanying calcinosis and severe and chronic disease course and is often carcinoma-associated (breast, uterine or pancreatic carcinoma). Post COVID NXP2 DM has not yet been reported. (Figure Presented).
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Aims: COVID-19 has had much publicised impacts on cancer diagnosis within Victoria. Statewide there are thought to be over 2000 undiagnosed malignancies since the start of the pandemic, particularly in men andwithin melanoma, prostate cancer and head and neck malignancies. Regional and local patterns of presentation may differ from statewide data and local data suggesting under diagnosis may assist in regional service planning. Method(s): Prior statistical analysis using Victorian Cancer Registry (VCR) data has been used to identify a shortfall in cancer diagnoses. VCR notifications for 2019-2021 inclusive for the Barwon southwest region were utilised for this review. Notifications for the five most common cancers were assessed for major variations in notifications, taking a pragmatic approach to classify a major variation where notifications changed by more than 10% from 2019 levels in either or both of 2020/2021. Result(s): Total notifications did not change significantly from 2019- 21 (3676, 3777, 3731, respectively). Likewise, there were no obvious reductions in notification by sex or in older patients. While breast cancer notifications dropped in 2021 but rebounded in 2022 (424, 348, 453), diagnoses of DCIS increased each year (36, 55, 68). Lung cancer notifications dropped in 2021-22 (336, 249, 269) as did notifications of colorectal cancer (452, 418, 361), while prostate cancer notifications rose (531, 662, 654) and melanoma notifications were fairly consistent (145, 158, 141). Conclusion(s): Using a pragmatic approach to identifying major variations in cancer notifications during the COVID-19 pandemic, regional data suggests a reduction in lung cancer and colorectal cancer diagnoses in our region. Unlike reported statewide data, there was not an obvious drop in notifications of prostate cancer or melanoma. Further analysis of this data may help better identify cohorts with under diagnosis in our region.
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Background: Nutrition and lifestyle interventions are instrumental in modifying cancer risk. These changes are often challenging for patients to make due to residual side effects from active treatment and/or ongoing toxicities from current treatment. The SHINE (Survivorship and Health Interventions in Nutrition and Exercise) Program is a wellness program for patients with breast cancer focusing on three pillars of nutrition, exercise and community in order to improve overall health outcomes and decrease the risk of cancer recurrence. Methods: Participants in SHINE have either been diagnosed with ductal carcinoma in situ (DCIS) and/or stage I-IV breast cancer. They are referred to the program at the threemonth breast surgery post-operative follow-up appointment or any time after that. All patients are referred to meet with a registered dietitian (RD) and integrative health coach, who provides counseling and education on how to reduce risk through diet and lifestyle, using evidence-based recommendations. Patients are provided with support and accountability. A collaborative program, the Physician Referred Exercise Program (PREP), was established with our health system's medical fitness center, Valley Health LifeStyles. Patients undergo a fitness assessment that focuses on aerobic fitness, muscle strength and endurance, flexibility, & functional activity. Each patient then receives an exercise prescription developed by a degreed exercise specialist, taking into account both the physician's & patient's recommendations & goals. Results: Each component of the SHINE Program has been developed in various stages due to the COVID-19 pandemic. 336 patients with either DCIS or stage I-IV breast cancer have been seen by the RD from December 2020 through January 2022. Mean number of visits/ patient: 1.89 (range 1-8). N = 48 were participants in a 12-week study on the feasibility of nutrition counseling and impact on quality of life (QOL) which is still in progress. 76 patient referrals have been placed to the PREP program from August 2021-February 2022. Multiple community programs (Table) have been created for patients to help them develop shared experiences & camaraderie with each other so that they can better integrate new ideas and lifestyle modifications. Conclusions: The SHINE Program addresses care for the whole person, empowering individuals to live their healthiest lifestyle. Future work will focus on clinical trials to evaluate the benefits of these individual and collective interventions on overall QOL, QOL subscales (physical, psychological, social & spiritual well-being), & survivorship symptoms.
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Background: Disparities in cancer screening have been well documented during the Covid-19 pandemic. However, there are limited patient-reported data describing the prevalence and drivers of patient hesitancy towards cancer screening and willingness to resume screening. As health systems continue to experience pandemic-related capacity strain, there is an urgent need for innovative models of re-engaging patients in preventive screening. To address this issue, we developed a medical student-led, high-touch outreach model to re-engage primary care patients at Brookside Community Health Center in cancer screening. Methods: We iteratively optimized semi-structured call scripts and surveys in English and Spanish to contact patients overdue for mammography screening. Student callers included medical and pre-medical students with native Spanish fluency. Using the call script, students identified patient-reported barriers and facilitated mammogram scheduling for consenting patients. For consenting patients, student callers placed a telephone encounter with a pended screening mammogram order in the electronic medical record. PCP confirmation of the order triggered outreach by the radiology department for mammogram scheduling. Patients also received reminder calls from students the week of their appointment. Primary outcomes include screening consent rates, mammogram scheduling and completion rates, and screening results. Patient survey responses were securely recorded using the REDCap survey platform. Results: 198 patients were eligible for the intervention. 60% are primarily Spanish-speaking and 81% are insured by Medicaid. 145 patients (73%) have successfully been contacted, of which 129 (89%) consented for mammogram screening. 74 (57%) of the consenting patients have scheduled their mammogram and 38 (29%) have completed their mammogram. 36% of consenting Spanish-speaking patients with active mammogram orders did not have a mammogram scheduled, compared to 9% of consenting English-speaking. To date, 6 patients had abnormal mammograms requiring subsequent diagnostic imaging, and 1 patient was diagnosed with ductal carcinoma in situ requiring oncologic care. Qualitative analysis of patient surveys found that primary barriers to screening included factors associated with the Covid-19 pandemic (32.9% of contacted patients), lack of awareness of overdue status (25.9%) and patient unavailability (e.g. outside of country) (20%). Conclusions: In this single-center quality improvement study, we found that patients had a high willingness to engage in cancer screening during the pandemic and that trainees can play a vital role in re-engaging patients in preventative care. The disparity between Spanish and English-speaking patients' ability to schedule a mammogram after the consent process suggests that patients with limited English proficiency face additional challenges in accessing screenings.
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Background: Significant challenges exist in recruiting newly diagnosed ductal carcinoma in situ (DCIS) patients to participate in presurgical intervention trials. Perceived motivators and barriers to participation have not been formally studied from the patient or healthcare provider (HCP) perspective. Based on our experience in the Promise Study (NCT02694809), we hypothesized that delaying surgery and concern for side effects are barriers to trial participation and that access to new treatments and financial benefits are motivators. To improve recruitment, we conducted focus groups to better understand barriers and motivators for trial participation in our patient population. Methods: Three focus groups with post-menopausal women (PMW) without history of DCIS, one focus group with patients previously treated for DCIS, and two HCP focus groups were conducted. Due to COVID-19, the focus groups took place online via videoconferencing and included participants from across the United States. A thirdparty facilitator generated discussion on predetermined topics including knowledge of DCIS, clinical trial recruitment materials, hormone replacement therapy, healthcare delivery and clinical trials during COVID-19, and perceived motivators and barriers to trial participation in general and specifically for women with DCIS. Here, we focus on comparing perceived influential factors for patient participation in DCIS clinical trials in PMW and HCP focus groups. Qualitative thematic analysis was completed on focus group transcripts in NVivo. Results: PMW had no knowledge of DCIS prior to the focus groups and believed DCIS should be removed promptly. PMW believed barriers to DCIS clinical trial participation included the potential for the study drug to cause harm, distrust of medicine, and the fact that DCIS is not life-threatening. PMW identified helping future DCIS patients, accessing better treatment, and easing anxiety as motivators for DCIS trial participation. HCPs believed patients were motivated by increased monitoring by the medical team, financial incentive, and access to newer treatment. HCPs believed that delays in DCIS surgery, the potential for the intervention to be harmful or ineffective, and the trial causing patient anxiety were barriers. Neither group emphasized time commitment as a barrier to DCIS trial participation. PMW were not motivated by financial incentives. Conclusions: Knowledge about DCIS is lacking in PMW. PMW and HCPs agreed that the risk of harm caused by study interventions is a deterrent to trial participation and that access to superior treatment is a motivator. However, PMW and HCPs did not agree on other motivators and barriers which could lead to missed recruitment opportunities. Providing educational materials on DCIS and addressing motivators and barriers to clinical trial participation may increase recruitment to presurgical DCIS trials.
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Background: SB5, a biosimilar to reference adalimumab (ADL), received EU marketing authorisation in 2017, based on pre-clinical and clinical phase I and III studies that demonstrated bioequivalence and comparable efficacy, safety and immunogenicity to ADL. Objectives: The real-world study 'PROPER' is designed to provide insights into outcomes of the transition from ADL to SB5 outside the randomised, controlled, clinical trial setting. Methods: Under an umbrella design, 1000 patients with immune-mediated infammatory disease were enrolled at centres in Belgium, Germany, Ireland, Italy, Spain and the UK, and followed for 48 weeks post-transition. Eligible patients with a diagnosis of rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), ulcerative colitis or Crohn's disease had been transitioned to SB5 as part of routine treatment following a minimum of 16 weeks' treatment with ADL. Data were captured from patient charts retrospectively for 24 weeks prior to and prospectively and/or retrospectively up to 48 weeks after SB5 initiation. This analysis of the rheumatology cohort reports clinical characteristics, disease scores, persistence on SB5, clinical management and safety up to the closing date of November 30th, 2021. Results: Of the 496 patients included in this analysis, the majority were enrolled in UK (n=174), Germany (n=145) and Spain (n=73);Italy, Ireland and Belgium enrolled 45, 44 and 15 patients respectively. At study close, 487 patients had completed 48 weeks of follow-up;397 of those remained on SB5 throughout. Methotrexate was received as concomitant therapy by 37% of patients and 20% had received a biologic therapy prior to reference ADL. Most patients (89.3% of RA, 92.1% of axSpA, 97.3% of PsA) transitioned to SB5 at the same dose regimen received for ADL. Clinical characteristics, SB5 dose and fare are detailed in Table 1, disease scores in Figure 1. Fifteen patients each experienced one unrelated Serious Adverse Event (SAE): 2 in the axSpA cohort [tachycardia, intracranial haemorrhage];6 in the PsA cohort [myocardial infarct (2), breast carcinoma, COVID-19, gallbladder calculus, dyspnoea];7 in the RA cohort [facial numbness, depression, COVID-19, pneumonia, diverticulitis, parvovirus, coronary occlusion]. Tw o patients reported SAEs considered causally related to SB5: Herpes zoster and pneumonia (RA cohort), and ALS with worsening (PsA cohort). Conclusion: This analysis of a large, contemporary cohort of EU patients with established RA, axSpA or PsA shows treatment effectiveness maintained at 48 weeks after switching from ADL to SB5, with most patients continuing on SB5 Q2W throughout. Episodes of fare were uncommon, and the importance of patient-reported symptoms in recognition of fare is evident. No new safety signals were observed.
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Background: Fatigue is common in patients undergoing radiotherapy (RT). Melatonin, an inexpensive natural supplement, may improve symptoms and attenuate the side effects of RT. The effect of melatonin for prevention of fatigue and other symptoms was evaluated in a double-blind placebo-controlled trial. Methods: Early-stage or ductal carcinoma in-situ breast cancer patients ≥ 18 years, female, Eastern Cooperative Oncology Group performance status (ECOG PS) < 3, hemoglobin ≥9 g/dL. RT with curative intent, randomized 1:1 to melatonin 20 mg or oral placebo, starting night before RT initiation until 2 weeks post-RT. Sample size of 142 evaluable patients in each arm for 80% power and interim analysis at mid recruitment using the unified family method rho = 0.3. Randomization stratified to RT duration (< 3 weeks, ≥3 weeks) and prior chemotherapy. Primary outcome : Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale after completion of RT with additional scores measured at baseline, 2 and 8 weeks post-RT. Secondary outcomes : FACIT-F subscales, Edmonton Symptom Assessment System (ESAS) and Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Form 8a. Secondary analyses reported using an F-test at a 5% significance level. Results: For this interim analysis, 85 patients screened;80 randomized;39 received melatonin and 38 placebo. 72 included in the analysis as 5 patients had no post baseline FACIT score. Characteristics of age, race, and ECOG PS similar in both arms. Treatment X time for FACIT-Fatigue not significant for melatonin compared to placebo (p .83). FACIT physical, emotional, and functional wellbeing scores not significantly different (p .35, .62, and .71) but showing a trend for social well-being (p .06). PROMIS scores not changed over time (p .34). ESAS individual symptoms of anxiety, well-being, drowsiness, poor appetite, nausea, pain, shortness of breath, sleep and tiredness not significant, except for depression (p.04). However, a decrease of 0.01 unit in depression score is not considered clinically significant. No grade 3 or 4 adverse events. No participants died during study, 2 died after study completion from breast cancer recurrence. 16 withdrew prior to study completion because of adverse events, unrelated hospitalizations, RT discontinuation, and COVID-19 precautions. Trial was stopped based on statistical analysis demonstrating no difference for primary outcome and imminent expiry of available drug. Discontinuation was approved by Data Safety Monitoring Committee. Conclusions: Melatonin did not prevent fatigue in patients with early stage breast cancer undergoing RT. Melatonin also demonstrated no benefit for other symptoms, except depression. Analysis showed little evidence of an effect, and the trial was terminated early.
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STATEMENT OF PROBLEM/QUESTION: The COVID-19 pandemic has caused marked declines in cancer screenings and exacerbated preexisting disparities in cancer screening among vulnerable patient populations. DESCRIPTION OF PROGRAM/INTERVENTION: Despite the availability of robust quantitative data reporting disparities in cancer screening during the COVID-19 pandemic, there is a dearth of patient-reported data available describing prevalence and drivers of patient hesitancy towards cancer screening and patient willingness to resume cancer screening. Additionally, as health systems continue to experience pandemic-related bandwidth strain, there is an urgent need to develop innovative models of re-engaging patients in preventive screening that can successfully be implemented in the current healthcare environment. To address this issue, we developed a medical student-led, high- touch outreach model to re-engage primary care patients of the Brookside Community Health Center (BCHC) in cancer screening. We iteratively optimized semi-structured call scripts and surveys in English and Spanish to contact patients overdue for mammography screening. Student callers consisted of medical students and premedical students with native Spanish fluency. Call script language allows students to identify patient-reported barriers and facilitates re-scheduling of mammograms for consenting patients. For consenting patients, student callers input a telephone encounter with a pended screening mammogram order in the electronic medical record;the note is then routed to the patient's PCP for signing. Patients additionally receive reminder calls from students the week of their mammography appointment. MEASURES OF SUCCESS: Primary outcomes include screening consent rates, rates of mammogram scheduling and completion, and screening results. Patient response to survey prompts and student call summaries were securely recorded and analyzed utilizing the REDCap survey platform. FINDINGS TO DATE: 198 patients eligible for the intervention have been identified, of which 60% are primarily Spanish-speaking and 81% are enrolled in MassHealth (MA Medicaid). 145 patients (73%) have successfully been contacted, of which 129 (89%) consented for mammogram screening. 74 (57%) of the consenting patients have scheduled their mammogram, and 38 (29%) have completed their mammogram. Of note, 6 patients had abnormal mammograms requiring subsequent diagnostic imaging, and one patient was diagnosed with ductal carcinoma in situ requiring establishment of oncologic care. A preliminary qualitative analysis of patient surveys has found that primary barriers to screening included factors associated with the COVID-19 pandemic, lack of awareness of overdue status, and patient unavailiability (e.g. temporarily out of the country), and miscommunication between patients and the clinic. KEY LESSONS FOR DISSEMINATION: In this single-center quality improvement study, we found willingness to engage in cancer screening during the pandemic remains high and trainees can play a vital role in mitigating screening disparities during the pandemic.
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Radiotherapy is an essential treatment in the local control of breast cancer. Standard treatment is currently carried out in 15 daily sessions. At present, following the results of the phase III Fast-Foward trial and in view of the situation triggered by COVID-19, the number of sessions has been reduced to 5. We present the data of our series to evaluate the results of the extreme hypofractionation scheme as a radiotherapy treatment for breast cancer at the Multihospital Clinical Unit of Radiation Oncology of Aragón (UCMORA). Materials and Methods After implantation, 115 patients were treated with 3D conformal radiotherapy between April 2020 and May 2021 at UCMORA using the extreme hypofractionation scheme (26 Gy at 5.2 Gy per fraction in 5 fractions). Demographic, tumor, dosimetric and toxicity characteristics were analyzed. Results The mean age was 63.5 years. 53 patients were treated at the Lozano Blesa Clinical Universitary Hospital and 62 at the Miguel Servet Universitary Hospital, in total 59 right and 56 left breasts. The predominant histology was infiltrating ductal carcinoma (84.3%), followed by infiltrating lobular carcinoma (10.4%), ductal carcinoma in situ (4.3%) and mucinous (0.9%). 51.7% were luminal A, 39.1% luminal B, 1.8% Her2 positive and 7.8% triple negative. In relation to staging, we found 4pTis, 8pT1a, 45pT1b, 58pT1c, 2Nx, 8N0, 1Nmi and 13N1a. Only 45% had acute toxicity at one month after the end of treatment, predominantly G1 radiodermatitis (86.6%), followed by G2 (11.2%) and G3 (2.2%). When analyzing the dose-volume histograms, values were obtained for ipsilateral lung V8 between 1.32 and 21.2%, for the heart, in case of left breast a median for V1.5 of 8.2% and 1.05% for V7;in case of right breast the median Dmed for the heart was 0.5Gy (Figure Presented) Conclusion Ultra-hypofractionated whole breast radiotherapy as a radiation treatment for breast cancer is well tolerated, reduces costs and number of sessions, while increasing comfort for patients.
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Mucormycosis is a rare, but potentially fatal, fungal infection which is caused by mucormyctes. These forms of fungi are typically known to infect immuno-compromised individuals but are rare in immunocompetent individuals. Herein, we report the case of a 52 year-old female who was diagnosed with right breast carcinoma in Manipal Hospital, a tertiary cancer care center. The patient was a known diabetic and hypertensive and who had recently recovered from coronavirus disease-2019 (COVID-19) pneumonia. In the due course of management, she developed mucormycosis infection at the operative site in her right breast where she had a radiation therapy-induced wound. This patient was successfully treated with an aggressive regimen of early surgical debridement along with administration of systemic amphotericin B.
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INTRODUCTION: The COVID-19 pandemic peaked in New York City in Spring 2020. From March 20-May 4, all elective operations were suspended due to the number of hospitalized Covid-19 patients. In this study, we sought to describe patterns of care for surgical patients during this time. METHODS: An IRB approved retrospective review was performed of patients who presented to our hospital system from March-May 2020, diagnosed with breast cancer or atypia. RESULTS: We identified 75 patients with breast cancer and 19 patients with atypia. According to standard of care, 55/75 (73%) cancer patients would have undergone upfront surgery. 2/55 (4%) instead were treated with neoadjuvant chemotherapy (NCT), 34/55 (62%) with neoadjuvant endocrine therapy (NET), and 19/55 (34%) had no immediate treatment. 12/19 (63%) with no immediate treatment had DCIS only. 7 had invasive disease, and mean days from diagnosis to surgery was 63 days (range 47-79). One patient had a positive node. A total of 20/75 (27%) patients needed NCT based on advanced stage or molecular profile and had no delay in starting treatment. Of the 34 NET patients, 5 (14.7%) were treated for approximately 6 months and 24 (70.6%) were treated for approximately 6 weeks as a bridge to surgery only. Of the 34 patients who received NET, 5 (14.7%) had an apparent decrease in T stage: 3 patients with clinical T1 disease had no residual disease. 2 had clinical T2 and ultimately had pathological T1 disease. Of the 19 patients with atypia, 6 (31.6%) started chemoprevention preoperatively and 1 patient was already receiving it for a previous LCIS diagnosis. All underwent subsequent surgery and 1/19 (5.3%) patients was upstaged to DCIS. CONCLUSIONS: During the peak of Covid-19, with delay of surgery, we observed an increased utilization of NET when compared to usual treatment patterns, with no apparent adverse effects. While further studies are needed to validate our results, we may see more wide spread use of NET in the future to temporize patients as needed.
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Background: Atypical axillary lymph nodes identified on breast cancer screening often result in axillary lymph node core biopsy (ALNB). However, similar changes may occur after vaccination. Recent trends of mass vaccination for SARS-CoV-2 have resulted in new guidelines, specifically delay to biopsy following vaccination to avoid false positives and unnecessary biopsy, with notable exceptions in the context of breast cancer. We aimed to evaluate ALNB pathology, clinical and imaging features in patients who had received SARS-CoV-2 vaccination. Design: We evaluated ALNB specimens from patients who received SARS-CoV-2 vaccine before biopsy (1/2021 - 6/2021) at our enterprise (1 academic and 2 community hospital sites). Clinicopathologic features were assessed by chart and slide review, with pathology review by a dedicated hematopathologist and imaging review by dedicated breast radiologists. Results: Of 135 patients with ALNB, 48 (35.6%) had vaccination prior to biopsy. Patients were predominantly female (47/48;97.9%), with a mean age of 55.1 years (range 19.9-91.3). 34 of 48 (70.8%) were benign, 12 (25%) had metastatic carcinoma, 1 (2.1%) hematologic malignancy (CLL/SLL), and 1 (2.1%) metastatic melanoma. In non-vaccinated patients, the rate of malignancy was similar (24/87;27.6%) (p=0.73). All ALNB with metastatic carcinoma were from patients with concurrent breast carcinoma and the patient with metastatic melanoma had a history of melanoma. Of patients with benign ALNB, 10 (29.4%) had concurrent, 1 (2.9%) recent (within 2 years) and 3 (8.8%) remote (>2 years) history of breast cancer. Most (37/48;77.1%) ALNB specimens could be traced to abnormal breast imaging (Table 1). SARS-CoV-2 vaccine was ipsilateral in 18 (37.5%), contralateral in 14 (29.2%) and side was not documented in 16 (33.3%). Median time from 1st dose to ALNB was 10.6 weeks (range 1.9-23.9) and from 2nd dose to ALNB was 7.7 weeks (range 0-20.9). 16 (33.3%) had a dose within the prior 6 weeks. Benign ALNB in patients who underwent vaccination prior to biopsy comprised: 21 (61.8%) without specific features, 10 (29.4%) reactive follicular hyperplasia, 2 (5.9%) dermatopathic change and 1 (2.9%) tattoo pigment. Reactive follicular hyperplasia was significantly less frequent (4/63;6.3%) in patients who did not undergo vaccination prior to biopsy (p<.01). Conclusions: Some patients who underwent SARS-CoV-2 vaccination with reactive changes may have avoided ALNB if there were more time between imaging, vaccination and breast cancer diagnosis. (Table Presented).
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Introduction: The burden of the COVID-19 pandemic forced the Dutch health care services to discontinue their national screening programs on 16 March 2020 (week 12). For breast cancer, the program invites women aged 50-74 years for biennial screening mammography. From mid-June 2020 (week 25) the breast cancer screening program was resumed, albeit with reduced capacity (max 60%). We aimed to investigate the impact of resuming the screening program on incidence, tumor-, and T-stage of screen- and non-screen-detected ductal carcinoma in situ (DCIS) and invasive breast cancer (IBC) in the Netherlands. Methods: Women, 50-74 years of age, diagnosed with DCIS or IBC in weeks 2-35 of 2018, 2019 and 2020 were selected from the Netherlands Cancer Registry. Weekly incidence of screen- and non-screen-detected tumors was calculated and expressed per 1 million women aged 50-74 years living in the Netherlands. Weeks 2-35 were divided in seven periods, representing separate phases of the pandemic. For each period, incidence of screen- and non-screen-detected tumors was stratified by clinical tumor stage (TNM) and clinical T-stage. Incidence in each period of 2020 was compared with the incidence in the same period of 2018/2019 (averaged). Results: In weeks 2-35, 7,250 patients were diagnosed in 2018, 7,299 in 2019, and 5,300 in 2020. During weeks 2-12 2020 the weekly average incidence of screen-detected tumors was 42/1 million women aged 50-74. In week 13 incidence dropped to 19, and was almost zero during weeks 14-25. Incidence increased to 4 in week 26, when the screening was gradually restarted, and increased to an weekly average of 24 tumors/1 million in weeks 30-35, when screening had restarted in most of the Netherlands. During weeks 14-16, 17-25, 26-29, and 30-35 2020 incidence of screen detected DCIS, stage I-II tumors and T0-2 tumors was lower than in the same period of 2018/2019. Distribution of tumor- and T-stage in newly diagnosed tumors did not differ between the periods (24% DCIS, 57% stage I, 18% stage II, 1% stage III, 1% stage IV;24% T0, 59% T1, 15% T2, 2% T3, 0% T4). During weeks 2-11 2020 the weekly average incidence of non-screen-detected tumors was 38/1 million women aged 50-74. Incidence dropped to 16 in week 14, and increased to an average of 37 tumors per week in weeks 17-35. During weeks 17-25, 26-29, and 30-35 the incidence and distribution of non-screen-detected DCIS, stage I-IV and T0-4 tumors was comparable with 2018/2019 (weekly incidence (distribution): 3 DCIS (9%), 15 stage I (40%), 13 stage II (36%), 3 stage III (7%), 3 stage IV (8%);3 T0 (9%), 17 T1 (45%), 12 T2 (34%), 3 T3 (8%), 2 T4 (5%)). Conclusion: The temporary suspension of the breast cancer screening program reduced the incidence of breast cancer. After resuming screening the incidence did not raise above the incidence in 2018/2019, therefore it is expected that the incidence will rise during the next months. The results to date did not show a shift towards a higher tumor stage or T-stage.