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1.
BMJ Case Rep ; 15(1)2022 Jan 17.
Article in English | MEDLINE | ID: covidwho-1627521

ABSTRACT

Granulocyte colony stimulating factor (G-CSF) is used to prevent febrile neutropenia post chemotherapy. Usually well tolerated with minimal side effects but aortitis is an extremely rare side effect previously reported. A 64-year-old woman treated with adjuvant chemotherapy including G-CSF for left breast cancer was admitted with fevers, neutropenia and markedly raised inflammatory markers after 7 days of her first cycle. Initially diagnosed with neutropenic sepsis, she did not respond to broad spectrum antibiotics with subsequent CT imaging revealing marked periaortic inflammatory changes consistent with aortitis and periaortitis. Extensive investigations for other causes of large vessel vasculitis were negative and G-CSF was the only causative factor. She rapidly responded to steroids with almost complete resolution of inflammatory changes on repeat imaging within 4 weeks and no recurrence on tapering of steroids. This diagnosis must be considered in patients presenting with fever and raised inflammatory markers post G-CSF treatment.


Subject(s)
Aortitis , Breast Neoplasms , Neutropenia , Antineoplastic Combined Chemotherapy Protocols , Aortitis/chemically induced , Aortitis/diagnostic imaging , Aortitis/drug therapy , Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant , Female , Granulocyte Colony-Stimulating Factor/therapeutic use , Humans , Middle Aged , Neutropenia/drug therapy
2.
Breast Dis ; 41(1): 1-3, 2022.
Article in English | MEDLINE | ID: covidwho-1604128

ABSTRACT

During the first hit of SARS-COVID pandemic, an important reorganization of Healthcare Services has been done, and new protocols and pathways to protect frail patients like oncological patients were designed. The second hit of pandemic had stressed these new pathways and suggests to health-workers some improvements for safer management of patents.We reported our experience in organizing the clinical pathway of neoadjuvant therapy candidate patients based on the execution of sentinel lympho-node biopsy and the placement of implantable venous access port in the same access to operating room before neoadjuvant chemotherapy suggesting a possible organizational model. In the period October-December 2020 we have included in this new type of path twelve patients and we have not registered any cases of COVID among the patients included. We think this new path, adopted amid the second hit, will be useful for all Breast Units that are facing the challenge of guaranteeing the highest standards of care in a historical moment where the health emergency occupies the efforts of health workers and the economic resources of health systems.


Subject(s)
Antineoplastic Agents/administration & dosage , Breast Neoplasms/drug therapy , COVID-19/prevention & control , Catheterization, Central Venous/methods , Infection Control/methods , Patient Safety , Sentinel Lymph Node Biopsy/methods , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/standards , Central Venous Catheters , Chemotherapy, Adjuvant , Critical Pathways , Female , Humans , Infection Control/standards , Mastectomy , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Sentinel Lymph Node Biopsy/standards
3.
BMJ ; 375: e066588, 2021 12 08.
Article in English | MEDLINE | ID: covidwho-1560914

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. DESIGN: Pragmatic, cluster randomised trial. SETTING: 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. PARTICIPANTS: All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. INTERVENTIONS: Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. MAIN OUTCOME MEASURES: The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. RESULTS: Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. CONCLUSIONS: Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. TRIAL REGISTRATION: ClinicalTrials.gov NCT02485678.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Monitoring, Ambulatory/methods , Outpatients , Telemedicine , Telephone , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/psychology , COVID-19 , Chemotherapy, Adjuvant/adverse effects , Drug-Related Side Effects and Adverse Reactions , Emergency Service, Hospital/statistics & numerical data , Female , Humans , Middle Aged , Ontario , Pandemics , Quality of Life , SARS-CoV-2 , Surveys and Questionnaires , Treatment Outcome
4.
BJS Open ; 5(6)2021 11 09.
Article in English | MEDLINE | ID: covidwho-1510889

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has had a global impact on cancer care but the extent to which this has affected the management of colorectal cancer (CRC) in different countries is unknown. CRC management in Denmark was thought to have been relatively less impacted than in other nations during the first wave of the pandemic. The aim of this study was to determine the pandemic's impact on CRC in Denmark. METHODS: The Danish national cancer registry identified patients with newly diagnosed with CRC from 1 March 2020 to 1 August 2020 (pandemic interval) and corresponding dates in 2019 (prepandemic interval). Data regarding clinicopathological demographics and perioperative outcomes were retrieved and compared between the two cohorts. RESULTS: Total CRC diagnoses (201 versus 359 per month, P = 0.008) and screening diagnoses (38 versus 80 per month, P = 0.016) were both lower in the pandemic interval. The proportions of patients presenting acutely and the stage at presentation were, however, unaffected. For those patients having surgery, both colonic and rectal cancer operations fell to about half the prepandemic levels: colon (187 (i.q.r. 183-188) to 96 (i.q.r. 94-112) per month, P = 0.032) and rectal cancers (63 (i.q.r. 59-75) to 32 (i.q.r. 28-42) per month, P = 0.008). No difference was seen in surgical practice or postoperative 30-day mortality rate (colon 2.2 versus 2.2 per cent, P = 0.983; rectal 1.0 versus 2.9 per cent, P = 0.118) between the cohorts. Treatment during the pandemic interval was not independently associated with death at 30 or 90 days. CONCLUSION: The initial wave of the COVID-19 pandemic reduced the number of new diagnoses made and number of operations but had limited impact on technique or outcomes of CRC care in Denmark.


Subject(s)
COVID-19 , Colorectal Neoplasms/epidemiology , Colorectal Neoplasms/therapy , Pandemics , Aged , Aged, 80 and over , Chemotherapy, Adjuvant/statistics & numerical data , Cohort Studies , Colectomy/statistics & numerical data , Colorectal Neoplasms/pathology , Denmark/epidemiology , Female , Humans , Male , Postoperative Complications/epidemiology , Registries
5.
Scand J Immunol ; 94(5): e13101, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1501497

ABSTRACT

The coronavirus disease-19 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) challenged globally with its morbidity and mortality. A small percentage of affected patients (20%) progress into the second stage of the disease clinically presenting with severe or fatal involvement of lung, heart and vascular system, all contributing to multiple-organ failure. The so-called 'cytokines storm' is considered the pathogenic basis of severe disease and it is a target for treatment with corticosteroids, immunotherapies and intravenous immunoglobulin (IVIg). We provide an overview of the role of IVIg in the therapy of adult patients with COVID-19 disease. After discussing the possible underlying mechanisms of IVIg immunomodulation in COVID-19 disease, we review the studies in which IVIg was employed. Considering the latest evidence that show a link between new coronavirus and autoimmunity, we also discuss the use of IVIg in COVID-19 and anti-SARS-CoV-2 vaccination related autoimmune diseases and the post-COVID-19 syndrome. The benefit of high-dose IVIg is evident in almost all studies with a rapid response, a reduction in mortality and improved pulmonary function in critically ill COVID-19 patients. It seems that an early administration of IVIg is crucial for a successful outcome. Studies' limitations are represented by the small number of patients, the lack of control groups in some and the heterogeneity of included patients. IVIg treatment can reduce the stay in ICU and the demand for mechanical ventilation, thus contributing to attenuate the burden of the disease.


Subject(s)
Antiviral Agents/therapeutic use , Autoimmune Diseases/prevention & control , COVID-19 Vaccines/immunology , COVID-19/complications , COVID-19/drug therapy , Immunoglobulins, Intravenous/therapeutic use , SARS-CoV-2/physiology , Adult , Autoimmune Diseases/etiology , Autoimmune Diseases/immunology , COVID-19/etiology , COVID-19/immunology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Chemotherapy, Adjuvant , Critical Illness , Humans , Italy , Length of Stay , Respiration, Artificial , Treatment Outcome
6.
Medicine (Baltimore) ; 100(43): e27586, 2021 Oct 29.
Article in English | MEDLINE | ID: covidwho-1494091

ABSTRACT

BACKGROUND: Corona virus disease 2019 (COVID-19) is spreading fast and it brings great pressure to the social economy. Many reports revealed that ginseng can develop immunity for respiratory disease, but there is no evidence to prove its effects on COVID-19. This protocol of systematic review and meta-analysis will clarify the safety and effectiveness of ginseng adjuvant therapy on COVID-19 patients. METHODS: Different databases (Web of Science, Cochrane Library, PubMed, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, Chinese Scientific Journal Database, Wan fang Database, ClinicalTrials, World Health Organization Trials, and Chinese Clinical Trial Registry) will be retrieved to search related articles according to pre-defined inclusion and exclusion criteria. Clinical recovery time and effective rates will be assessed as the primary outcomes and any changes of patient's condition will be considered as the secondary outcomes. Subgroup analysis and sensitivity analysis will be conducted to explore sources of heterogeneity. Endnote X9.3 will be used to manage data screening. The statistical analysis will be completed by RevMan5.3 and Stata/SE 15.1 software. RESULTS: This study will assess the effects and safety for ginseng adjuvant therapy on COVID-19 patients. CONCLUSION: The discussion will be considered to determine whether sufficient evidence exists to prove the effects of ginseng adjuvant therapy for COVID-19 patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (ID: CRD42021277843).


Subject(s)
COVID-19/therapy , Chemotherapy, Adjuvant/methods , Panax , Humans , Randomized Controlled Trials as Topic , Research Design , SARS-CoV-2
7.
Obstet Gynecol ; 135(5): 1070-1083, 2020 05.
Article in English | MEDLINE | ID: covidwho-1455363

ABSTRACT

OBJECTIVE: To perform a systematic review and meta-analysis evaluating the efficacy of adjuvant human papillomavirus (HPV) vaccination in preventing recurrent cervical intraepithelial neoplasia (CIN) 2 or greater after surgical excision. DATA SOURCES: Electronic databases (Cochrane, PubMed, EMBASE, MEDLINE, Scopus, and ClinicalTrials.gov) were searched for studies comparing surgical excision alone to surgical excision with adjuvant HPV vaccination for CIN 2 or greater. Studies published from January 1990 to January 2019 were included. METHODS: A total of 5,901 studies were reviewed. The primary outcomes evaluated included: recurrence of CIN 2 or greater, CIN 1 or greater, and HPV 16,18 associated CIN within 6-48 months. We used Covidence software to assist with screening, and meta-analysis was performed using Review Manager. TABULATION, INTEGRATION, AND RESULTS: Six studies met inclusion criteria and were included in the final analysis. In total 2,984 women were included; 1,360 (45.6%) received adjuvant HPV vaccination after surgical excision, and 1,624 (54.4%) received either placebo or surgical management alone for CIN 2 or greater. Recurrence of CIN 2 or greater occurred within 6-48 months in 115 women (3.9%) overall; however, recurrence was significantly lower for vaccinated women: 26 of 1,360 women (1.9%) vs 89 of 1,624 unvaccinated women (5.9%) (relative risk [RR] 0.36 95% CI 0.23-0.55). The risk of CIN 1 or greater was also significantly lower with adjuvant HPV vaccination, occurring in 86 of 1,360 vaccinated women (6.3%) vs 157 of 1,624 unvaccinated women (9.7%) (RR 0.67 95% CI 0.52-0.85). Thirty-five women developed recurrent CIN 2 or greater lesions specific to HPV 16,18; nine received adjuvant vaccination (0.9%) vs 26 who were unvaccinated (2.0%) (RR 0.41 95% CI 0.20-0.85). CONCLUSION: Adjuvant HPV vaccination in the setting of surgical excision for CIN 2 or greater is associated with a reduced risk of recurrent cervical dysplasia overall and a reduction in the risk of recurrent lesions caused by the most oncogenic strains (HPV 16,18). Human papillomavirus vaccination should therefore be considered for adjuvant treatment in patients undergoing surgical excision for CIN 2 or greater. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42019123786.


Subject(s)
Cervical Intraepithelial Neoplasia/drug therapy , Neoplasm Recurrence, Local/prevention & control , Papillomavirus Infections/complications , Papillomavirus Vaccines/therapeutic use , Uterine Cervical Neoplasms/drug therapy , Adult , Cervical Intraepithelial Neoplasia/surgery , Cervical Intraepithelial Neoplasia/virology , Chemotherapy, Adjuvant , Female , Humans , Middle Aged , Neoplasm Recurrence, Local/virology , Papillomavirus Infections/virology , Treatment Outcome , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/virology , Young Adult
8.
Cell Cycle ; 20(22): 2321-2336, 2021 11.
Article in English | MEDLINE | ID: covidwho-1442952

ABSTRACT

Multifunctional nature of phytochemicals and their chemical diversity has attracted attention to develop leads originated from nature to fight COVID-19. Pharmacological activities of chelerythrine and its congeners have been studied and reported in the literature. This compound simultaneously has two key therapeutic effects for the treatment of COVID-19, antiviral and anti-inflammatory activities. Chelerythrine can prevent hyper-inflammatory immune response through regulating critical signaling pathways involved in SARS-CoV-2 infection, such as alteration in Nrf2, NF-κB, and p38 MAPK activities. In addition, chelerythrine has a strong protein kinase C-α/-ß inhibitory activity suitable for cerebral vasospasm prevention and eryptosis reduction, as well as beneficial effects in suppressing pulmonary inflammation and fibrosis. In terms of antiviral activity, chelerythrine can fight with SARS-CoV-2 through various mechanisms, such as direct-acting mechanism, viral RNA-intercalation, and regulation of host-based antiviral targets. Although chelerythrine is toxic in vitro, the in vivo toxicity is significantly reduced due to its structural conversion to alkanolamine. Its multifunctional action makes chelerythrine a prominent compound for the treatment of COVID-19. Considering precautions related to the toxicity at higher doses, it is expected that this compound is useful in combination with proper antivirals to reduce the severity of COVID-19 symptoms.


Subject(s)
Anti-Inflammatory Agents/administration & dosage , Antiviral Agents/administration & dosage , Benzophenanthridines/administration & dosage , COVID-19/drug therapy , Chemotherapy, Adjuvant/methods , SARS-CoV-2/drug effects , Animals , COVID-19/metabolism , COVID-19/pathology , Chemotherapy, Adjuvant/trends , Drug Therapy, Combination , Humans , SARS-CoV-2/physiology
9.
Biomed Pharmacother ; 143: 112228, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1432983

ABSTRACT

Coronavirus disease 2019 (COVID-19), which is a respiratory illness associated with high mortality, has been classified as a pandemic. The major obstacles for the clinicians to contain the disease are limited information availability, difficulty in disease diagnosis, predicting disease prognosis, and lack of disease monitoring tools. Additionally, the lack of valid therapies has further contributed to the difficulties in containing the pandemic. Recent studies have reported that the dysregulation of the immune system leads to an ineffective antiviral response and promotes pathological immune response, which manifests as ARDS, myocarditis, and hepatitis. In this study, a novel platform has been described for disseminating information to physicians for the diagnosis and monitoring of patients with COVID-19. An adjuvant approach using compounds that can potentiate antiviral immune response and mitigate COVID-19-induced immune-mediated target organ damage has been presented. A prolonged beneficial effect is achieved by implementing algorithm-based individualized variability measures in the treatment regimen.


Subject(s)
Antiviral Agents/immunology , Antiviral Agents/therapeutic use , COVID-19/diagnosis , COVID-19/drug therapy , Chemotherapy, Adjuvant/methods , Medical Informatics/methods , Algorithms , COVID-19/immunology , Disease Management , Disease Progression , Gastrointestinal Tract/immunology , Humans , Immunity, Cellular , Immunity, Humoral , Severity of Illness Index
10.
Cancer Treat Res Commun ; 28: 100445, 2021.
Article in English | MEDLINE | ID: covidwho-1368630

ABSTRACT

INTRODUCTION: Over half of the 1.5 million individuals globally who are diagnosed with colorectal cancer (CRC) present with stage II-III disease. Understanding clinician attitudes towards treatment for this group is paramount to contextualise real-world outcomes and plan future trials. The aim of this study was to assess clinician awareness of trials assessing the optimal duration of CRC adjuvant therapy, their attitudes towards shorter treatment and their self-reported practice. METHODS: A survey was developed using OnlineSurveys® and distributed to clinicians in April 2019, with a follow-up survey disseminated to a subset of respondents in August 2020. Microsoft Excel® and Stata® were used for analysis. RESULTS: 265 clinicians replied to the first survey, with the majority aware of findings from the International Duration Evaluation of Adjuvant Therapy collaboration and contributory trials. Practice change was greatest for patients under 70 with low-risk stage III CRC, with most uncertainty around using 3-months of doublet chemotherapy for high-risk stage II disease. In August 2020, clinicians (n = 106) were more likely to use 3-months of FOLFOX for low-risk stage III disease and 3-months of CAPOX for stage II disease compared to April 2019. There was no indication that the COVID-19 pandemic had enduring changes on treatment decisions beyond those made in response to trial evidence. DISCUSSION: Clinicians use a risk-stratified approach to treat CRC the adjuvant setting. Lower utilisation of doublet chemotherapy for older and stage II patients has affected the extent of trial implementation. Active dialogue regarding how trial results apply to these groups may improve consensus.


Subject(s)
Clinical Trials as Topic , Colorectal Neoplasms/drug therapy , Practice Patterns, Physicians' , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , COVID-19 , Chemotherapy, Adjuvant , Colorectal Neoplasms/pathology , Fluorouracil/therapeutic use , Humans , Leucovorin/therapeutic use , Longitudinal Studies , Oncologists , Organoplatinum Compounds/therapeutic use , Practice Guidelines as Topic , Self Report , Surveys and Questionnaires , Time Factors
11.
BMJ ; 374: n1647, 2021 07 21.
Article in English | MEDLINE | ID: covidwho-1320441

ABSTRACT

OBJECTIVE: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations. DESIGN: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. SETTING: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. PARTICIPANTS: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years. INTERVENTION: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. MAIN OUTCOME MEASURES: The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ). RESULTS: For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group. CONCLUSIONS: Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic. TRIAL REGISTRATION: Clinicaltrials.gov NCT02356081.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Cell Phone , Drug-Related Side Effects and Adverse Reactions/diagnosis , Quality of Life , Telemedicine/methods , Adult , Aged , Austria , Breast Neoplasms/psychology , Breast Neoplasms/therapy , Chemotherapy, Adjuvant/adverse effects , Colorectal Neoplasms/psychology , Colorectal Neoplasms/therapy , Drug-Related Side Effects and Adverse Reactions/etiology , Drug-Related Side Effects and Adverse Reactions/psychology , Female , Greece , Hodgkin Disease/psychology , Hodgkin Disease/therapy , Humans , Ireland , Lymphoma, Non-Hodgkin/psychology , Lymphoma, Non-Hodgkin/therapy , Male , Middle Aged , Norway , Telemedicine/instrumentation , Treatment Outcome , United Kingdom
12.
Cancer Sci ; 112(7): 2915-2920, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1294969

ABSTRACT

Adjuvant chemotherapy has reduced the risk of tumor recurrence and improved survival in patients with resected colorectal cancer. Potential utility of circulating tumor DNA (ctDNA) prior to and post surgery has been reported across various solid tumors. We initiated a new type of adaptive platform trials to evaluate the clinical benefits of ctDNA analysis and refine precision adjuvant therapy for resectable colorectal cancer, named CIRCULATE-Japan including three clinical trials. The GALAXY study is a prospectively conducted large-scale registry designed to monitor ctDNA for patients with clinical stage II to IV or recurrent colorectal cancer who can undergo complete surgical resection. The VEGA trial is a randomized phase III study designed to test whether postoperative surgery alone is noninferior to the standard therapy with capecitabine plus oxaliplatin for 3 months in patients with high-risk stage II or low-risk stage III colon cancer if ctDNA status is negative at week 4 after curative surgery in the GALAXY study. The ALTAIR trial is a double-blind, phase III study designed to establish the superiority of trifluridine/tipiracil as compared with placebo in patients with resected colorectal cancer who show circulating tumor-positive status in the GALAXY study. Therefore, CIRCULATE-Japan encompasses both "de-escalation" and "escalation" trials for ctDNA-negative and -positive patients, respectively, and helps to answer whether measuring ctDNA postoperatively has prognostic and/or predictive value. Our ctDNA-guided adaptive platform trials will accelerate clinical development toward further precision oncology in the field of adjuvant therapy. Analysis of ctDNA status could be utilized as a predictor of risk stratification for recurrence and to monitor the effectiveness of adjuvant chemotherapy. ctDNA is a promising, noninvasive tumor biomarker that can aid in tumor monitoring throughout disease management.


Subject(s)
Circulating Tumor DNA/blood , Colorectal Neoplasms/blood , Neoplasm Recurrence, Local/blood , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Capecitabine/administration & dosage , Chemotherapy, Adjuvant , Colonic Neoplasms/blood , Colonic Neoplasms/genetics , Colonic Neoplasms/pathology , Colonic Neoplasms/therapy , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Colorectal Neoplasms/therapy , Double-Blind Method , Humans , Japan , Neoplasm Recurrence, Local/genetics , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/therapy , Oxaliplatin/administration & dosage , Prospective Studies , Pyrrolidines/administration & dosage , Thymine/administration & dosage , Trifluridine/administration & dosage
13.
J Surg Oncol ; 124(3): 261-267, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1272214

ABSTRACT

OBJECTIVE: At the end of 1 year of the coronavirus disease (COVID-19) pandemic, we aimed to reveal the changes in breast cancer cases in the context of cause and effect based on the data of surgically treated patients in our institution. PATIENTS AND METHODS: Patients with breast cancer were divided into two groups. Group 1 consisted of patients who were operated in the year before the COVID-19 pandemic, and Group 2 consisted of patients who were operated within the first year of the pandemic. Tumor size, axillary lymph node positivity, distant organ metastasis status, neoadjuvant chemotherapy, and type of surgery performed were compared between the two groups. RESULTS: The tumor size, axillary lymph node positivity, and neoadjuvant chemotherapy were higher in Group 2 than in Group 1 (p = .005, p = .012, p = .042, respectively). In addition, the number of breast-conserving surgery + sentinel lymph node biopsy were lower, while the number of mastectomy and modified radical mastectomy were higher in Group 2 than in Group 1 (p = .034). CONCLUSION: Patients presented with larger breast tumors and increased axillary involvement during the pandemic. Moreover, distant organ metastases may increase in the future.


Subject(s)
Breast Neoplasms/diagnosis , COVID-19 , Delayed Diagnosis/trends , Health Services Accessibility/trends , Patient Acceptance of Health Care/statistics & numerical data , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Chemotherapy, Adjuvant , Female , Humans , Lymph Node Excision/trends , Lymphatic Metastasis , Mastectomy/methods , Mastectomy/trends , Middle Aged , Neoadjuvant Therapy , Retrospective Studies , Tumor Burden , Turkey
14.
Ann Surg Oncol ; 28(13): 8651-8662, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1268205

ABSTRACT

BACKGROUND: National medical/surgical organizations have recommended the use of neoadjuvant endocrine therapy (NET) to bridge surgery delay of weeks to months for patients with hormone receptor positive (HR+) breast cancer during the ongoing coronavirus disease 2019 (COVID-19) pandemic. The effects of NET of varying durations on pathologic response are unclear. Using the National Cancer Database (NCDB), we evaluated objective response to short (< 9 weeks), moderate (9-27 weeks), and long (> 27 weeks) duration of NET. PATIENTS AND METHODS: The study cohort included female patients diagnosed with nonmetastatic invasive HR+ breast cancer, stratifying by those who received NET versus no NET between 2004 and 2016. Pathologic response was grouped into four categories (complete, downstaged, stable, upstaged) by comparing clinical and pathologic staging data. Objective response to NET included complete, downstaged, and stable pathologic response. Clinical characteristics were compared using χ2 and analysis of variance (ANOVA) tests. Multivariable logistic regression was used to determine factors associated with NET use and objective response according to NET duration. RESULTS: A minority (1.2%) received NET in our cohort. Factors associated with NET use included older age, non-Black patients, more advanced clinical stage, higher comorbidity score, government insurance, and lobular histology. Objective response rate (ORR) was 56.7%, 52.1%, and 49.0% after short, moderate, and long NET duration, respectively. CONCLUSION: Short NET duration did not result in an inferior ORR. Future study to evaluate the interaction between surgery delay and NET use on clinical outcome will provide insights into the safety of NET to bridge potential surgery delay in patients with HR+ breast cancer.


Subject(s)
Breast Neoplasms , COVID-19 , Aged , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Female , Humans , Neoadjuvant Therapy , Neoplasm Staging , Receptor, ErbB-2 , SARS-CoV-2
15.
Dig Surg ; 38(4): 259-265, 2021.
Article in English | MEDLINE | ID: covidwho-1247450

ABSTRACT

BACKGROUND: The first COVID-19 pandemic wave hit most of the health-care systems worldwide. The present survey aimed to provide a European overview on the COVID-19 impact on surgical oncology. METHODS: This anonymous online survey was accessible from April 24 to May 11, 2020, for surgeons (n = 298) who were contacted by the surgical society European Digestive Surgery. The survey was completed by 88 surgeons (29.2%) from 69 different departments. The responses per department were evaluated. RESULTS: Of the departments, 88.4% (n = 61/69) reported a lower volume of patients in the outpatient clinic; 69.1% (n = 47/68) and 75.0% (n = 51/68) reported a reduction in hospital bed and the operating room capacity, respectively. As a result, the participants reported an average reduction of 29.3% for all types of oncological resections surveyed in this questionnaire. The strongest reduction was observed for oncological resections of hepato-pancreatico-biliary (HPB) cancers. Of the interviewed surgeons, 68.7% (n = 46/67) agreed that survival outcomes will be negatively impacted by the pandemic. CONCLUSION: The first COVID-19 pandemic wave had a significant impact on surgical oncology in Europe. The surveyed surgeons expect an increase in the number of unresectable cancers as well as poorer survival outcomes due to cancellations of follow-ups and postponements of surgeries.


Subject(s)
COVID-19/epidemiology , Hospital Bed Capacity/statistics & numerical data , Neoplasms/surgery , Oncology Service, Hospital/statistics & numerical data , Surgical Oncology/statistics & numerical data , Adult , Ambulatory Care/statistics & numerical data , COVID-19/diagnosis , Chemotherapy, Adjuvant/statistics & numerical data , Cross-Sectional Studies , Europe/epidemiology , Female , Humans , Male , Middle Aged , Neoplasms/diagnosis , Neoplasms/drug therapy , Operating Rooms/statistics & numerical data , Surveys and Questionnaires , Survival Rate , Time-to-Treatment/statistics & numerical data
16.
Int Immunopharmacol ; 96: 107743, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1226294

ABSTRACT

OBJECTIVE: Ozone therapy has tremendous therapeutic potential owing to its antiviral, anti-inflammatory and antioxidant properties, and potential to improve oxygenation. A pilot clinical trial was conducted to evaluate the safety and efficacy ofintravenous ozonised saline treatment in patients with moderate COVID-19 pneumonia. PATIENTS AND METHODS: 10 patients were administered 200 ml freshly prepared ozonised saline intravenously over 1 h once a day for 8 days along with standard medical treatment. Clinical symptoms were monitored everyday and laboratory biomarkers, radiological findings at 1,3,6,10 days. Telephonic follow up was done for all after discharge till Day 14. 7 out of 10 patients required oxygen supplementation at recruitment. RESULTS: There was severe adverse event recorded in the study group.All patients improved from moderate to mild category in average 8 days and were discharged in average 9.7 days. None deteriorated to severe stage. All clinical symptoms resolved within 6 days and oxygen supplementation requirement reduced to none within 4.1 days. There wasstatistically significant reduction inCRP (p = 0.003), D-Dimer (p = 0.049), IL6 (p = 0.002)and statistically significant improvement (p = 0.001) in SpO2/FiO2 ratio. Change in LDH was borderline statistically not significant (p = 0.058).All patients showed significant resolution of bilateral interstitial infiltrates at the end of 10 days. CONCLUSION: Resolved clinical symptoms, improved oxygenation, clearance of infiltrates on Chest X-ray and improvement in biomarkers in a short period with non-progression of the disease showed that IV ozonised saline therapy was safe and effective to prevent disease progression in COVID-19, making it an effective novel therapeutic tool.


Subject(s)
COVID-19/drug therapy , Ozone/therapeutic use , Administration, Intravenous , Adult , Chemotherapy, Adjuvant , Female , Humans , Male , Middle Aged , Pilot Projects , SARS-CoV-2 , Treatment Outcome
17.
BMJ ; 373: n1038, 2021 05 11.
Article in English | MEDLINE | ID: covidwho-1223582

ABSTRACT

OBJECTIVE: To investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents. DESIGN: Multinational network cohort study. SETTING: Hospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea. PARTICIPANTS: 303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020. MAIN OUTCOME MEASURES: Prescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19. RESULTS: Of the 303 264 patients included, 290 131 were from the US, 7599 from South Korea, 5230 from Spain, and 304 from China. 3455 drugs were identified. Common repurposed drugs were hydroxychloroquine (used in from <5 (<2%) patients in China to 2165 (85.1%) in Spain), azithromycin (from 15 (4.9%) in China to 1473 (57.9%) in Spain), combined lopinavir and ritonavir (from 156 (<2%) in the VA-OMOP US to 2,652 (34.9%) in South Korea and 1285 (50.5%) in Spain), and umifenovir (0% in the US, South Korea, and Spain and 238 (78.3%) in China). Use of adjunctive drugs varied greatly, with the five most used treatments being enoxaparin, fluoroquinolones, ceftriaxone, vitamin D, and corticosteroids. Hydroxychloroquine use increased rapidly from March to April 2020 but declined steeply in May to June and remained low for the rest of the year. The use of dexamethasone and corticosteroids increased steadily during 2020. CONCLUSIONS: Multiple drugs were used in the first few months of the covid-19 pandemic, with substantial geographical and temporal variation. Hydroxychloroquine, azithromycin, lopinavir-ritonavir, and umifenovir (in China only) were the most prescribed repurposed drugs. Antithrombotics, antibiotics, H2 receptor antagonists, and corticosteroids were often used as adjunctive treatments. Research is needed on the comparative risk and benefit of these treatments in the management of covid-19.


Subject(s)
COVID-19/drug therapy , Chemotherapy, Adjuvant/methods , Drug Repositioning/methods , Administrative Claims, Healthcare/statistics & numerical data , Adolescent , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Aged, 80 and over , Azithromycin/therapeutic use , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , Ceftriaxone/therapeutic use , Child , Child, Preschool , China/epidemiology , Cohort Studies , Drug Combinations , Electronic Health Records/statistics & numerical data , Enoxaparin/therapeutic use , Female , Fluoroquinolones/therapeutic use , Humans , Hydroxychloroquine/therapeutic use , Infant , Infant, Newborn , Inpatients , Lopinavir/therapeutic use , Male , Middle Aged , Republic of Korea/epidemiology , Ritonavir/therapeutic use , SARS-CoV-2/drug effects , SARS-CoV-2/genetics , Safety , Spain/epidemiology , Treatment Outcome , United States/epidemiology , Vitamin D/therapeutic use , Young Adult
19.
J Adolesc Young Adult Oncol ; 10(3): 355-358, 2021 06.
Article in English | MEDLINE | ID: covidwho-1174870

ABSTRACT

Choriocarcinoma is an aggressive malignant trophoblastic neoplasm. The rapid growth of neoplastic tissue and myometrial invasion can cause uterine perforation. It is important to quickly diagnose the disease and plan treatment because these tumors are nearly always curable, and fertility can be preserved in most cases with proper management. The outbreak of novel coronavirus disease has affected the whole world since January 2019 and caused delays in treatment and follow-up of patients all over the world. In this study, we report a case of choriocarcinoma who postponed her admission to the hospital after diagnosis because she was afraid of the pandemic and lost her fertility due to uterine rupture and massive intra-abdominal hemorrhage.


Subject(s)
COVID-19 , Choriocarcinoma/complications , Refugees , Time-to-Treatment , Uterine Hemorrhage/etiology , Uterine Neoplasms/complications , Uterine Rupture/etiology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , COVID-19/epidemiology , Chemotherapy, Adjuvant , Choriocarcinoma/drug therapy , Choriocarcinoma/surgery , Female , Humans , Hysterectomy , Pandemics , SARS-CoV-2 , Uterine Hemorrhage/surgery , Uterine Neoplasms/drug therapy , Uterine Neoplasms/surgery , Uterine Rupture/surgery , Young Adult
20.
Anticancer Res ; 41(4): 2193-2195, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1168334

ABSTRACT

BACKGROUND/AIM: Since January 2020, coronavirus disease (COVID-19) cases have been confirmed in Japan, and the number of patients with COVID-19 has been increasing. Two emergency declarations have been made previously and one is currently in effect. Based on our experience of a situation that could affect cancer treatment, this study retrospectively examined the correlation between perioperative anticancer therapy and COVID-19 incidence in patients with breast cancer. PATIENTS AND METHODS: Patients who underwent perioperative anticancer therapy for breast cancer at our hospital from February 2020 to February 2021 were included in this study. The presence or absence of COVID-19, timing of anticancer drug initiation, and clinical data were collected. RESULTS: No cases of COVID-19 were diagnosed in patients receiving perioperative anticancer therapy at our hospital. CONCLUSION: Regimen modification, active use of supportive care, and patient lifestyle were factors reducing the incidence of COVID-19.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms , COVID-19/epidemiology , Perioperative Care/methods , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Chemotherapy, Adjuvant/statistics & numerical data , Combined Modality Therapy , Female , Humans , Immunocompromised Host , Incidence , Japan/epidemiology , Middle Aged , Neoadjuvant Therapy/statistics & numerical data , Perioperative Care/adverse effects , Perioperative Care/statistics & numerical data , Retrospective Studies , Risk Factors , SARS-CoV-2/physiology
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