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1.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009660

ABSTRACT

Background: CSCC is the second most common skin cancer with an estimated incidence of 1 million cases per year in the US. While the surgical cure rate for CSCC is > 95%, some pts have high risk of recurrence as assessed by immune status, primary disease stage, extent of nodal involvement, presence of extracapsular extension (ECE), and prior treatment. Postoperative RT is recommended for these pts but relapse with locoregional recurrence or distant metastases may still occur. C-POST is evaluating the efficacy of cemiplimab as adjuvant therapy for pts with high-risk CSCC. Here, we provide summary of the most recent study protocol amendment. Methods: C-POST is a randomized, placebo-controlled, double-blind, multicenter Phase 3 study to evaluate cemiplimab as adjuvant treatment for pts with high-risk CSCC, based on surgical and clinicopathologic findings, who completed surgery and postoperative RT (minimum total dose 50Gy, within 10 weeks before randomization) (NCT03969004). Pts with at least one of the following high-risk features are eligible: (1) nodal disease with (a) ECE and at least one node ≥20 mm or (b) at least three lymph nodes positive on surgical pathology report, regardless of ECE;(2) in-transit metastases;(3) T4 lesion;(4) perineural invasion;and (5) recurrent CSCC with at least one other risk factor. Pts with CSCC involvement in at least three lymph nodes (feature 1b) were added to the eligibility criteria, as this group was found to be at similar risk of CSCC recurrence as the initially planned study population. Protocol amendment now allows patients with chronic lymphocytic leukemia (CLL) who are not on active treatment to be enrolled. The study has two parts. In Part 1 (blinded), pts are randomly assigned 1:1 to receive cemiplimab 350 mg or placebo intravenously every 3 weeks for 12 weeks, followed by cemiplimab 700 mg or placebo every 6 weeks for 36 weeks. In optional Part 2 (unblinded), pts in the placebo arm who experience disease recurrence and pts in the cemiplimab arm who experience disease recurrence ≥3 months after completion of 48-week treatment in Part 1 are eligible to receive open-label cemiplimab for up to 96 weeks. The trial is expected to enrol 412 pts from about 100 sites in North and South America, Europe, and Asia-Pacific regions. Key primary objective is to compare disease-free survival;secondary objectives include evaluating overall survival, freedom from locoregional relapse, and distant relapse with adjuvant cemiplimab versus placebo in patients with high-risk CSCC. This study is once again open for enrolment following interruptions owing to the COVID-19 pandemic.

2.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009658

ABSTRACT

Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicenter randomized trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumors (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomized 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Coprimary end-points are: (1) Non-inferiority comparison of the requirement for a second procedure. (2) Single-arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. The DMC will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimize recruitment and informed consent. Recruitment challenges are identified by analyzing recruiter/ patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted for 5 months due to COVID-19. At 11th February 2022, 91 patients had been recruited from 22 centers, with an approached/consented ration of 50%. Drawing from preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomization). Individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion: Despite pandemic-related challenges, SMALL has excellent recruitment to date and is expected to have a global impact on treatment of screen-detected breast cancer.

3.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005695

ABSTRACT

Background: During the first year of the COVID-19 pandemic there was global disruption in the provision of healthcare, causing significant pressure on hospital resources. High-grade gliomas (HGG) are rapidly progressive tumors, so patients with delays in diagnosis or treatment due to COVID-19-related disruptions might have poor outcomes. Therefore, we retrospectively evaluated the impact of the COVID- 19 pandemic on treatment patterns and outcomes of patients with HGG in British Columbia (BC). Methods: A case cohort with a pathologic diagnosis of HGG (grade 4 astrocytoma and glioblastoma) treated at BC Cancer centers with radiotherapy between March 1, 2020 - March 1, 2021 (“COVID era”), and a control cohort treated between March 1, 2018 - March 1, 2019 (“pre-COVID era”) were identified. Patient demographics, tumor characteristics, treatment details, and dates of radiographic progression and death were included in the chart review. Analyses were performed with one-way ANOVA and Chi-squared tests for comparisons between eras. The Kaplan-Meier method was used to assess progression-free survival (PFS) and overall survival (OS) and differences in outcome between eras were investigated using the log-rank test. Results: 164 patients were identified: 85 in the pre-COVID era and 79 in the COVID era. There was no statistically significant baseline difference in age, sex, comorbidities, ECOG, tumor diameter, IDH mutation status, or MGMT methylation status between eras. There was also no statistically significant difference between time from symptom onset to first imaging, time from first imaging to surgery, time from surgery to oncologic consultation between eras, and time from surgery to radiotherapy. Significantly more patients were managed with biopsy relative to partial or gross total resection during the COVID era 22% (17/79) than the pre-COVID era 13% (11/85) (p = 0.04). However, radiation treatment (RT) did not differ between eras, with similar rates of conventionally fractionated RT in the pre-COVID era (87%, 74/85) and the COVID era (82%, 65/79) (p = 0.23). Use of concurrent and/or adjuvant temozolomide also was not significantly different between eras (p = 0.27 and p = 0.19, respectively). Median PFS was 7.0 months in both eras (CI95 = 5.5 - 8.5 months for pre-COVID era, CI95 = 5.8 - 8.2 months for COVID era, p = 0.3), and median OS was 13 months in the pre-COVID era (CI95 = 10.3 - 15.7 months) and 16 months in the COVID era (CI95 = 11.5 - 20.5 months), though this difference was not significant (p = 0.09). Conclusions: To our knowledge, this is the first study to assess outcomes of patients treated for HGG during the COVID-19 pandemic. We found that, despite less use of surgery in the COVID era, the outcomes of patients with HGG were not affected.

4.
Cancer Manag Res ; 14: 2299-2304, 2022.
Article in English | MEDLINE | ID: covidwho-1978913

ABSTRACT

The COVID-19 pandemic has opened several new disease scenarios, yielding novel syndromes that have never been seen before and resurrecting old inflammatory phenomena that are no longer recorded, such as radiation recall (RR) syndromes. Radiation recall syndrome is a limited field inflammatory reaction that occurs in a volume that was irradiated several months or years previously before being induced by a triggering factor. The most frequently reported phenomena are skin reactions; however, other organs could be involved, such as the lungs in radiation recall pneumonitis (RRP). It is a well-described inflammatory reaction that occurs within a pulmonary volume that was irradiated several months or years previously via radiotherapy (RT), triggered by factors such as drugs, including chemotherapy agents, immunotherapy, or vaccination. Indeed, during the COVID-19 pandemic, RRP following anti-COVID-19 vaccination or SARS-CoV2 infection was recently reported. ACE receptor-rich tissues such as lung or skin tissues were mainly involved. Herein, we present a case of RRP triggered by COVID-19 pulmonary infection in a woman who previously underwent adjuvant breast cancer radiotherapy. Although symptoms were typical, pulmonary CT findings depicted a unique distribution of ground-glass opacities (GGOs) throughout the previous radiation portals and mirror-like the radiation fields. Anamnesis and radiation plan evaluation were crucial in the diagnosis of RRP.

5.
Radiotherapy and Oncology ; 170:S652-S653, 2022.
Article in English | EMBASE | ID: covidwho-1967465

ABSTRACT

Purpose or Objective Clinical trials are essential to improve cancer treatment. Trials rely on wide-ranging patient (pt) participation to gain adequate sample sizes and externally applicable results. The Danish Breast Cancer Group (DBCG) develops national guidelines for breast cancer therapy, and this is preferably through clinical trials. During 2015-2021 moderately hypofractionated adjuvant loco-regional breast cancer (BC) radiation therapy (RT) was tested in an international trial, the DBCG SKAGEN Trial 1, testing 50Gy/25 fr (standard) versus 40Gy/15fr (experimental). The trial inclusion criteria were broad, thus any pt with indication for loco-regional RT (LR-RT) for unilateral early high-risk BC with no prior cancer and willing/able to participate in the 10-year follow up was a candidate.Recently, the inclusion of pts in trials may have been particularly challenged due to difficulties imposed by the COVID 19 pandemic. Hitherto, the DBCG has had no evidencebased knowledge about trial participation rates (TPR). These are important for evaluating the applicability of the trial results and planning of future RT trials. We present annual trial participation rates during the inclusion period. Materials and Methods The international DBCG SKAGEN Trial 1 randomized patients from 2015 to July 1st 2021, and the 17 participating institutions from 7 countries accrued 2,963 patients. Eight of these institutions accruing 2,184 pts in all delivered data on the total number of pts treated with LR-RT during the inclusion period. We calculated annual TPRs per institution and overall as TPR (number pts enrolled per year/ number pts treated with LR-RT per year). Results From 6,929 pts receiving LR-RT, 2,184 pts were enrolled, corresponding to an overall TPR of 31.5% (figure 1). In all eight institutions, accrual was running from 2016 (figure 2). From 2016, the average single institution TPR per year ranged from 14.4% to 50.4%. Annual TPRs varied with time: most institutions experienced a modest decline in TPR during 2019-2020, while in 2021 TPR seemed to stabilize. In one institution, accrual was terminated during 2020 due to COVID 19 related restrictions.(Figure Presented)(Figure Presented)Conclusion TPRs displayed considerable variation across institutions and time and were vulnerable to COVID 19 related restrictions. Even with a straight-forward trial design and the prospect of a shortened LR-RT course, only one institution succeeded in accruing more than half of the patients likely to be trial candidates. The results indicate, that a TPR around 50% was feasible for the best performing department, thus implying a large potential for better trial accrual in most centres. In future trials, systematic monitoring of TPRs and reasons for not participating should be undertaken to optimize trial designs and accrual procedures

6.
Neuro-Oncology ; 24:i74-i75, 2022.
Article in English | EMBASE | ID: covidwho-1956572

ABSTRACT

INTRODUCTION: High-grade gliomas account for <5% of all pediatric brain tumors with a 20% 5-year overall survival even with maximal safe resection followed by concurrent radiotherapy and chemotherapy. Patients in low-and middle-income countries already face delays and barriers to the treatment they require. The current COVID pandemic has added unique challenges to the delivery of complex, multidisciplinary health services to these patients. METHODOLOGY AND RESULTS: We retrospectively reviewed the records of four patients, ages 2-18 years old, with histologically confirmed high-grade glioma managed in a tertiary government institution from 2020-2021. Three of the patients had a supratentorial tumor and one patient had multiple tumors located in both supra-and infratentorial compartments. Neurosurgical procedures performed were: gross total excision (1), subtotal excision (2), and biopsy (1). The tissue diagnoses obtained were glioblastoma (3) and high-grade astrocytoma (1). Two patients survived and are currently undergoing adjuvant radiotherapy and chemotherapy. The remaining two patients expired: one from hospital-acquired pneumonia and the other from COVID-19 infection. DISCUSSION: Decreased mobility due to lockdowns, the burden of requiring negative COVID-19 results before admission for surgery, reduced hospital capacity to comply with physical distancing measures, the postponement of elective surgery to minimize COVID-19 transmission, physician and nursing shortages due to infection or mandatory isolation of staff, cancellation of face-to-face outpatient clinics, and hesitation among patients and their families to go to the hospital for fear of exposure were found to be common causes of delays in treatment. Also, the redirection of health resources and other government and hospital policies to handle the COVID-19 pandemic resulted in an overall delay in the delivery of health services. In particular, the management of pediatric patients with cancers, especially high-grade gliomas, was significantly disrupted.

7.
International Journal of Radiation Oncology Biology Physics ; 113(4):A12-A15, 2022.
Article in English | EMBASE | ID: covidwho-1926991
8.
Neurology ; 98(18 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1925422

ABSTRACT

Objective: NA Background: Glioma classification evolved over the years but remains a diagnostic challenge. Primary spinal cord (PSC) glioblastoma is extremely rare and represents fewer than 1.5% of all spine tumors in adults. Presentation may mimic demyelinating or inflammatory disorders, but prognosis is significantly worse. We present two aggressive cases of extensive, total spinal cord gliomas with early metastases to brain. Design/Methods: NA Case #1: A 44-year-old woman with a diagnosis of demyelinating disorder with paraplegia, bladder and bowel incontinence presented with new appendicular ataxia. Previous MRI revealed unremarkable brain and hyperintensity in T7-10 concerning for multiple sclerosis. Empiric methylprednisolone and cyclophosphamide showed no improvement. Repeat MRI showed extensive intramedullary cystic lesions throughout cervical, thoracic, and lumbar spine, hyperintensities in the brainstem, and enhancing lesions in the corpus callosum and R frontal lobe. Biopsy revealed brain Glioblastoma, WHO grade IV, IDH wildtype. H3K27M test was not performed. Patient expired 13 months after initial symptom onset. Case #2: A 49-year-old man with a recent COVID-19 infection presented with 2 weeks of bilateral lower extremity numbness and weakness. MRI brain was unremarkable, and spine revealed intra-dural, extra-medullary nodular enhancing lesions throughout cervical and thoracic spine, and the cauda equina. Infectious, inflammatory, and rheumatologic causes were investigated until repeat imaging in 1 week (after a course of empiric methylprednisolone) demonstrated the rapid development of a non-enhancing expansile mass in the R temporal lobe. Biopsy revealed spinal Glioblastoma, WHO grade IV, IDH wildtype, negative for H3K27M mutation, and brain low grade glioma. The patient remains on palliative radiation with concurrent temozolomide and adjuvant temozolomide. Conclusions: Primary spinal cord glioblastomas are rare and devastating. Timely diagnosis remains a challenge since clinical and radiographic findings mimic demyelinating or inflammatory disorders. Our cases highlight the diagnostic challenge and importance of early suspicion in the diagnosis of malignant spinal glioma.

9.
Libri Oncologici ; 50(SUPPL 1):108-109, 2022.
Article in English | EMBASE | ID: covidwho-1894066

ABSTRACT

Introduction: The COVID-19 pandemic has a significant impact on the primary, secondary and tertiary levels of the health system. In a low-middle income countries such as Bosnia and Herzegovina, ensuring optimal oncology care was challenging even before the COVID-19 pandemic. Since the beginning of the COVID-19 pandemic, there was a warning of the possible impact of worsening mortality and/ or morbidity due to delayed diagnosis and suboptimal treatment.1 The COVID 19 pandemic has impact on reducing the number of patients treated with radiotherapy.2 The aim of our study was to analyze the impact of the COVID-19 pandemic on radiotherapy in a patient with head and neck cancer who were treated with radiotherapy in a tertiary health care facility. Methods: We analyzed data from the institutional databases for radiotherapy of the Oncology Department at University Clinical Hospital Mostar, Bosnia and Herzegovina. We performed data extraction for patients with head and neck cancer who were treated with primary or adjuvant radiotherapy with or without chemotherapy from January 2018 to December 2021. Results: A total of 114 patients were treated with radiotherapy for head and neck cancer in the pre- COVID-19 period (2018-2019) and COVID-19 period (2020-2021). There were more patients treated with radiotherapy in the preCOVID19 period, 64 (56%) compared to the COVID19 period, 50 (44%). In the COVID 19 period, the number of patients treated with radiotherapy was reduced by 22% compared to the preCOVID19 period. Conclusion: A decline innumber of patients treated with radiotherapy in the COVID 19 period was detected. Health system optimization and education of the general population about the negative indirect impact of COVID 19 on the health system, diagnosis and treatment of cancer is needed.

10.
Cancer Research ; 82(4 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1779451

ABSTRACT

Background: The COVID-19 pandemic strained healthcare systems worldwide, delaying breast cancer screening and surgery. In 2019, approximately 80% of breast cancers in the U.S. were diagnosed on screening examinations, with 76.4% of eligible Medicare patients undergoing screening at least every two years. Since the start of the pandemic, many women have been reluctant to seek elective screening mammography, even with the lifting of "lock-down". We describe the effect of the COVID-19 pandemic on breast cancer presentation at an academic medical center in a city hit hard by the pandemic. Materials and Methods: The institutional IRB-approved Breast Cancer Registry Database was queried for patients enrolled during two time periods, those undergoing first surgical procedure before the start of the pandemic (4/1/2019-3/31/2020) to those the year after the pandemic started (4/1/2020-3/31/2021). Elective cancer surgery was paused for 3 weeks, ending 4/20/2020, and access to routine breast care was limited for 3 months. Variables included age, method of detection, palpability, histologic subtype and staging, neoadjuvant systemic therapy, cancer specific treatments, and radiation uptake. Results: 349 patients were in the 2019 cohort;246 in the 2020 cohort. No differences in baseline characteristics, including age at presentation, nodal status, or operation type. Fewer cancers were detected on routine mammography post-COVID vs. pre-COVID. Increase in detection of breast cancer through self-Sexams in 2020 was seen compared to 2019. Palpability on presentation also increased. More patients were treated with neo-adjuvant therapy chemotherapy, and 36 of 45 (80%) eligible early-stage breast cancer patients accepted neoadjuvant hormonal therapy during the period that elective cancer surgery was on hold. Patients received radiation therapy less frequently during the pandemic. The proportion of patients diagnosed with invasive ductal cancers was higher in the 2020 cohort and the proportion of patients diagnosed with ductal carcinoma in situ (DCIS) and for invasive lobular cancers (ILC) was lower. Conclusions: Patients at an academic New York City medical center presented with more palpable and invasive breast cancers during the COVID-19 pandemic compared to the preceding year, and fewer patients with DCIS and ILC, cancers typically detected following screening mammography. While stage migration with an increase in diagnosis of late stage cancers has been described, in our population the stage shift occurred in early stage breast cancer, with decreases in DCIS and increases in Stages I-II, with the higher stages III-IV essentially unchanged. This reflects the effect of delay in our previously highly-screened population, with an average screening delay of 3 + months, and many patients missing their yearly screening altogether. While many medical interactions during COVID-19 were via telemedicine, radiation therapy requires daily office visits, and fear of exposure contributed to the lower rate of radiation. Given the increase in invasiveness and stage of breast cancers diagnosed during the COVID-19 pandemic, this study emphasizes the importance of screening for diagnosis and treatment of breast cancer, even in the face of a concurrent health crisis.

11.
Cancer Research ; 82(4 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1779443

ABSTRACT

Background:. Mammographic screening programmes have been shown to reduce breast cancer mortality. However, they detect many small tumours with favourable biological features which may not progress during a woman's lifetime. These are treated with standard surgery and adjuvant therapies, which have associated morbidities. Thus, there is a need to reduce overtreatment of good prognosis tumours found by screening. Minimally invasive treatment approaches have been described but there is no prospective randomised evidence to support their routine use. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Methods:. SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected good prognosis breast cancers. The main eligibility criteria are age ≥47 years, screen-detected unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in S the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are:1.Non-inferiority comparison of the requirement for a second procedure following excision2.Single arm analysis of local recurrence (LR) at 5 years following VAE. Recruitment of 800 patients over 4 years will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results:. SMALL opened in December 2019, but recruitment halted in 2020 due to suspension of the NHS BSP for 5 months due to COVID-19. As of 1st July 2021, 55 patients had been approached in 10 centres, with 33 patients randomised (randomisation rate 60%). A further 23 centres are in set-up, with 8 suspended due to the pandemic. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on introducing and discussing SMALL, providing balanced information. on treatment options and explaining randomisation). individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion:. Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme, award 17/42/32.

12.
Cancer Research ; 82(4 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1779442

ABSTRACT

The optimal timing of commencing adjuvant endocrine therapy (ET) relative to adjuvant radiotherapy (RT) (i.e. concurrent with or sequential to radiotherapy) remains unknown. A systematic review performed by our team was unable to answer this question due to a lack of high quality, randomized data on concurrent versus sequential ET and RT. Surveys of physicians confirmed this uncertainty and highlighted theoretical concerns for increased side effects with concurrent treatment. Respondents showed keen interest in obtaining real world, randomized data to guide clinical practice. REaCT-RETT is a pragmatic, randomized, non-inferiority trial comparing concurrent and sequential ET and RT in early breast cancer (EBC). The primary endpoint will assess the change in ET side effects at baseline and 3 months post radiation, using the Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES), with primary analysis based on an analysis of covariance (ANCOVA). With a sample size of 176 patients (88 per arm), an ANCOVA would have 80% power (α=0.05) to detect effect sizes as small as 0.25 regardless of the correlation with covariates. It is hypothesized that concurrent therapy will be non-inferior to sequential therapy in terms of ET side effects. Secondary endpoints will examine RT toxicity, ET compliance, quality of S life, and cost-effectiveness. Patients with HR positive EBC planned to receive both adjuvant ET and RT were eligible. Patients who previously received ET for invasive breast cancer, or RT in the same breast, were excluded. The trial is conducted by The Ottawa Hospital's (TOH) innovative Rethinking Clinical Trials (REaCT) program (https://react.ohri.ca/) which strives to improve access to patient-centered, pragmatic clinical trials by removing barriers for patients and researchers. Integral features of the program include broad eligibility criteria, a verbal consent model, and pragmatic data collection and assessment procedures. REaCT is the largest pragmatic cancer clinical trials program in Canada, with over 3, 200 patients randomized in 18 clinical trials at 15 sites across Canada. REaCT-RETT accrued patients from September 2019 to January 2021. Data collection is ongoing, with final patient follow up expected April 2022. The timing of accrual provided a unique opportunity to adapt in response to restrictions due to the COVID-19 pandemic, which began to impact trial sites in March 2020. The target sample size was met with 262 patients randomized (1:1) across 3 sites in Ontario, 98% from TOH. A mean of 19 patients/month were accrued prior to the pandemic, compared to a mean of 13 patients/month after March 2020. Twenty-two patients were removed due to withdrawal of consent, ineligibility, or physician choice, and the pandemic was not a significant contributing factor. Since March 2020 there have been 772 patient follow ups, of which 47% (364/772) have been virtual. Only 10% (102/1028) of trial mandated appointments have been missed to date. Compliance with baseline and 3-month FACT-ES questionnaires for the primary endpoint in evaluable patients was 90% (215/240) and 83% (198/240), respectively. The pandemic posed several challenges to the REaCT-RETT study including a decline in patient accrual, poor accrual at peripheral sites due to delayed opening, and a rapid switch to virtual patient care. However, the nimble REaCT methodology enabled virtual patient consent and data collection during the pandemic, allowing the trial to continue successfully, with final data expected for presentation summer 2022. Finally, despite the challenges of COVID-19 we have seen that patients and physicians remain interested in research, and we are applying valuable lessons learned to forthcoming REaCT trials to strengthen their performance during and beyond the ongoing pandemic.

13.
Breast ; 56:S8, 2021.
Article in English | EMBASE | ID: covidwho-1735074

ABSTRACT

The increasing use of pre-operative systemic therapy has resulted in more limited information about axillary lymph node status, both from the impact of systemic therapy itself as well as from less extensive axillary surgery. Decisions about the use of adjuvant endocrine therapy have not been majorly affected, but information on the presence and number of involved lymph nodes can have a significant influence on the use of adjuvant chemotherapy and HER-2 targeted therapies. In addition, lymph node information can also impact decisions around radiation therapy, making multidisciplinary discussions highly relevant when planning therapy. Patients with hormone receptor positive breast cancer may be treated with pre-operative endocrine therapy. This strategy was often used in early stage breast cancer during the COVID pandemic due to delays in surgery. Although an effective approach, pre-operative endocrine therapy may impact nodal status at surgery, information which is important when deciding on the use of OncotypeDX testing in premenopausal women. Similarly, in postmenopausal women, the presence and number of lymph nodes involved is a critical factor in determining the appropriateness of OncotypeDx testing. This nodal information may be lost in the setting of pre-operative therapy and would alter decisions regarding adjuvant chemotherapy. For patients with HER2 positive breast cancer, the presence of nodal disease remains critical for adjuvant decision making. In the situation of small (up to 3 cm) node negative cancers, up front surgery is preferred, because pathologic confirmation of the tumor size and node negative status may make patients eligible for a de-escalated approach of adjuvant paclitaxel and trastuzumab. Patients with more advanced HER2 positive disease are good candidates for preoperative chemotherapy and HER2 targeted therapy. If they have residual disease at surgery, they can be offered trastuzumab emtansine, which was shown in the KATHERINE trial to improve outcomes. In both situations, accurate information about the presence of disease in the axillary lymph nodes determines the most effective treatment approach. Finally, accurate information about nodal status is also relevant to decisions in patients with triple negative breast cancer. Patients who are treated with pre-operative chemotherapy and have residual disease in either the breast or axillary lymph nodes may be offered adjuvant capecitabine, based on the CREATE-X study, which indicated improved survival outcomes in those patients with residual disease who received adjuvant capecitabine. As in HER2 positive breast cancer, the presence of residual disease (including in the lymph nodes) after preoperative therapy will influence the adjuvant therapy recommendation. Thus, when considering de-escalation approaches in axillary management, the impact on systemic therapy decision making must be carefully considered, as these additional adjuvant therapies may improve survival for patients. Conflict of Interest: No significant relationships.

14.
Journal of Radiotherapy in Practice ; : 6, 2022.
Article in English | Web of Science | ID: covidwho-1665661

ABSTRACT

Background: During the SARS-CoV-2 virus pandemic, University Hospital Birmingham NHS Trust Oncology Department incorporated the ultrahypofractionated regime of 26Gy/5 fractions alongside the moderate hypofractionated regime of 40Gy/15 fractions as part of local adjuvant breast radiotherapy treatment (RT) for eligible patients. We conducted a local study to assess the real-life experience of patients undergoing ultrahypofractionated schedule to compare feasibility and toxicity to the fast-forward trial during the COVID - 19 pandemic. Methods: A single institution, retrospective, qualitative study. Patients included had early-stage breast cancer and received adjuvant radiotherapy between 23 March 2020 and 31 May 2020, a total of 211 patients. Inclusion was irrespective of any other neoadjuvant/adjuvant treatments. Data were collected retrospectively for treatment dose, boost dose and toxicity. Results: Of the total 211 patients, 85 were treated with 26Gy in 5# and 19 patients received a boost as per the fast-forward protocol. Of these 85 patients, 15.9% did not report any skin toxicity post-treatment. 63.5% of patients reported RTOG Grade 1, 15.9% had RTOG Grade 2, and 1.6% reported RTOG Grade 3 skin toxicity. 3.2% of the patients could not be contacted for follow-up. Of the 19 patients who received a breast boost, 10.53% reported no skin changes. 78.9% reported Grade 1 skin toxicity. Both Grades 2a and 2b skin toxicity were reported by 5.26% each. The patient demographics and tumour characteristics in our study cohort were comparable to those within the fast-forward trial. In terms of post-RT skin toxicity, fewer patients reported any toxicity in the UHB patient cohort versus those in the trial, and the number of Grade 2/3 toxicities reported was also low. A delay in toxicity reporting from 2 weeks for 40Gy/15 to 3 weeks for 26Gy/5 was observed. Conclusion: Our study concluded that offering ultrahypofractionation was convenient for patients;reducing the number of hospital visits during the SARS-CoV-2 virus pandemic appeared safe in terms of acute post-RT-related skin toxicity. The reduced hospital visits limited exposure of patients and staff to the SARS-CoV-2 virus while also ensuring efficient use of Radiotherapy Department resources. Local follow-up protocols have been amended to ensure review at 3 weeks for the 26Gy/5 schedule to acknowledge the delay in acute toxicity development. To date, there is only 5-year toxicity and relapse data available from the fast-forward trial;therefore, hypofractionation schedules should be offered to patients as long as they fulfil the criteria and understand the limitations of the study as well as accelerated peer review processes in the face of the pandemic.

15.
Revista de Senologia y Patologia Mamaria ; 2022.
Article in English, Spanish | Scopus | ID: covidwho-1641660

ABSTRACT

The current pandemic due to the new Coronavirus (SARS-CoV-2) requires the health systems to rapidly adopt measures aimed at mitigating the crisis, which implies redistributing economic and social resources and the workforce, so that those sectors of the population most affected can be cared for in an optimal and timely manner. In patients with low-risk invasive breast cancer and low-risk ductal carcinoma in situ, postoperative radiation therapy does not offer any benefit in overall survival, making the idea of omitting this oncological resource attractive. In this second article, we conducted a review of the literature on the criteria for omitting adjuvant radiotherapy in patients with low-risk breast neoplasms. In addition, the recommendations issued during the current contingency made by some international scientific societies are summarized, and certain reasons why physicians refuse to change clinical behaviors that offer limited advantages are analyzed, many times outweighed by the associated risks and adverse effects. © 2021

16.
Anticancer Res ; 41(9): 4407-4410, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1395530

ABSTRACT

BACKGROUND/AIM: Many patients with gynecological malignancies receive postoperative radiotherapy, which can lead to fear and sleep disorders. We aimed to identify the prevalence of and risk factors for sleep disorders. PATIENTS AND METHODS: Sixty-two patients assigned to radiotherapy for gynecological malignancies were retrospectively evaluated. Seventeen characteristics were analyzed for associations with pre-radiotherapy sleep disorders including age, Karnofsky performance score, Charlson comorbidity index, history of additional malignancy, family history of gynecological cancer, distress score, emotional, physical or practical problems, tumor site/stage; chemotherapy, treatment volume, brachytherapy, and the COVID-19 pandemic. RESULTS: The prevalence of pre-radiotherapy sleep disorders was 46.8%. Sleep disorders were significantly associated with Charlson comorbidity index ≥3 (p=0.012), greater number of physical problems (p<0.0001), and advanced primary tumor stage (p=0.005). A trend was found for greater number of emotional problems (p=0.075). CONCLUSION: Pre-radiotherapy sleep disorders are common in patients with gynecological malignancies, particularly in those with specific risk factors. Patients should be offered early psychological support.


Subject(s)
Genital Neoplasms, Female/radiotherapy , Genital Neoplasms, Female/surgery , Radiotherapy, Adjuvant/methods , Sleep Wake Disorders/epidemiology , Adult , Brachytherapy , COVID-19/epidemiology , Female , Genital Neoplasms, Female/pathology , Genital Neoplasms, Female/psychology , Humans , Middle Aged , Neoplasm Staging , Prevalence , Retrospective Studies , Risk Factors , Sleep Wake Disorders/etiology , Treatment Outcome
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