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1.
Contemp Clin Trials ; 108: 106482, 2021 09.
Article in English | MEDLINE | ID: covidwho-1427719

ABSTRACT

BACKGROUND: 20-60% of patients with initially locally advanced Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. Adjuvant strategies have been tested in RCC including cytokines, radiotherapy, hormones and oral tyrosine-kinase inhibitors (TKIs), with limited success. The predominant global standard-of-care after nephrectomy remains active monitoring. Immune checkpoint inhibitors (ICIs) are effective in the treatment of metastatic RCC; RAMPART will investigate these agents in the adjuvant setting. METHODS/DESIGN: RAMPART is an international, UK-led trial investigating the addition of ICIs after nephrectomy in patients with resected locally advanced RCC. RAMPART is a multi-arm multi-stage (MAMS) platform trial, upon which additional research questions may be addressed over time. The target population is patients with histologically proven resected locally advanced RCC (clear cell and non-clear cell histological subtypes), with no residual macroscopic disease, who are at high or intermediate risk of relapse (Leibovich score 3-11). Patients with fully resected synchronous ipsilateral adrenal metastases are included. Participants are randomly assigned (3,2:2) to Arm A - active monitoring (no placebo) for one year, Arm B - durvalumab (PD-L1 inhibitor) 4-weekly for one year; or Arm C - combination therapy with durvalumab 4-weekly for one year plus two doses of tremelimumab (CTLA-4 inhibitor) at day 1 of the first two 4-weekly cycles. The co-primary outcomes are disease-free-survival (DFS) and overall survival (OS). Secondary outcomes include safety, metastasis-free survival, RCC specific survival, quality of life, and patient and clinician preferences. Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART). TRIAL REGISTRATION: ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39, CTA #: 20363/0380/001-0001, MREC #: 17/LO/1875, ClinicalTrials.gov Identifier: NCT03288532, RAMPART grant number: MC_UU_12023/25, TransRAMPART grant number: A28690 Cancer Research UK, RAMPART Protocol version 5.0.


Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Carcinoma, Renal Cell/surgery , Chronic Disease , Humans , Kidney Neoplasms/surgery , Quality of Life , Recurrence
3.
BJU Int ; 128(6): 752-758, 2021 12.
Article in English | MEDLINE | ID: covidwho-1219502

ABSTRACT

OBJECTIVE: To analyse the impact of the COVID-19 pandemic on a centralized specialist kidney cancer care pathway. MATERIALS AND METHODS: We conducted a retrospective analysis of patient and pathway characteristics including prioritization strategies at the Specialist Centre for Kidney Cancer located at the Royal Free London NHS Foundation Trust (RFH) before and during the surge of COVID-19. RESULTS: On 18 March 2020 all elective surgery was halted at RFH to redeploy resources and staff for the COVID-19 surge. Prioritizing of patients according to European Association of Urology guidance was introduced. Clinics and the specialist multidisciplinary team (SMDT) meetings were maintained with physical distancing, kidney surgery was moved to a COVID-protected site, and infection prevention measurements were enforced. During the 7 weeks of lockdown (23 March to 10 May 2020), 234 cases were discussed at the SMDT meetings, 53% compared to the 446 cases discussed in the 7 weeks pre-lockdown. The reduction in referrals was more pronounced for small and asymptomatic renal masses. Of 62 low-priority cancer patients, 27 (43.5%) were deferred. Only one (4%) COVID-19 infection occurred postoperatively, and the patient made a full recovery. No increase in clinical or pathological upstaging could be detected in patients who underwent deferred surgery compared to pre-COVID practice. CONCLUSION: The first surge of the COVID-19 pandemic severely impacted diagnosis, referral and treatment of kidney cancer at a tertiary referral centre. With a policy of prioritization and COVID-protected pathways, capacity for time-sensitive oncological interventions was maintained and no immediate clinical harm was observed.


Subject(s)
COVID-19/prevention & control , Carcinoma, Renal Cell/therapy , Kidney Neoplasms/therapy , Patient Care Team/statistics & numerical data , Referral and Consultation/statistics & numerical data , COVID-19/epidemiology , Cancer Care Facilities/organization & administration , Cancer Care Facilities/statistics & numerical data , Carcinoma, Renal Cell/pathology , Disease Progression , Hospitals, High-Volume/statistics & numerical data , Humans , Kidney Neoplasms/pathology , Neoplasm Staging , Nephrectomy/statistics & numerical data , Patient Selection , Retrospective Studies , Tertiary Care Centers/organization & administration , Tertiary Care Centers/statistics & numerical data , Time-to-Treatment , Watchful Waiting/statistics & numerical data
5.
Eur Urol Open Sci ; 25: 39-43, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1014483

ABSTRACT

COVID-19 has resulted in the deferral of major surgery for genitourinary (GU) cancers with the exception of cancers with a high risk of progression. We report outcomes for major GU cancer operations, namely radical prostatectomy (RP), radical cystectomy (RC), radical nephrectomy (RN), partial nephrectomy (PN), and nephroureterectomy performed at 13 major GU cancer centres across the UK between March 1 and May 5, 2020. A total of 598 such operations were performed. Four patients (0.7%) developed COVID-19 postoperatively. There was no COVID-19-related mortality at 30 d. A minimally invasive approach was used in 499 cases (83.4%). A total of 228 cases (38.1%) were described as training procedures. Training case status was not associated with a higher American Society of Anesthesiologists (ASA) score (p = 0.194) or hospital length of stay (LOS; p > 0.05 for all operation types). The risk of contracting COVID-19 was not associated with longer hospital LOS (p = 0.146), training case status (p = 0.588), higher ASA score (p = 0.295), or type of hospital site (p = 0.303). Our results suggest that major surgery for urological cancers remains safe and training should be encouraged during the ongoing COVID-19 pandemic provided appropriate countermeasures are taken. These real-life data are important for policy-makers and clinicians when counselling patients during the current pandemic. PATIENT SUMMARY: We collected outcome data for major operations for prostate, bladder, and kidney cancers during the COVID-19 pandemic. These surgeries remain safe and training should be encouraged during the ongoing pandemic provided appropriate countermeasures are taken. Our real-life results are important for policy-makers and clinicians when counselling patients during the COVID-19 pandemic.

6.
Int J Surg ; 84: 57-65, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-893960

ABSTRACT

BACKGROUND: Two million non-emergency surgeries are being cancelled globally every week due to the COVID-19 pandemic, which will have a major impact on patients and healthcare systems. METHODS: During the peak of the pandemic in the United Kingdom, we set up a multicentre cancer network amongst 14 National Health Service institutions, performing urological, thoracic, gynaecological and general surgical urgent and cancer operations at a central COVID-19 cold site. This is a cohort study of 500 consecutive patients undergoing surgery in this network. The primary outcome was 30-day mortality from COVID-19. Secondary outcomes included all-cause mortality and post-operative complications at 30-days. RESULTS: 500 patients underwent surgery with median age 62.5 (IQR 51-71). 65% were male, 60% had a known diagnosis of cancer and 61% of surgeries were considered complex or major. No patient died from COVID-19 at 30-days. 30-day all-cause mortality was 3/500 (1%). 10 (2%) patients were diagnosed with COVID-19, 4 (1%) with confirmed laboratory diagnosis and 6 (1%) with probable COVID-19. 33/500 (7%) of patients developed Clavien-Dindo grade 3 or higher complications, with 1/33 (3%) occurring in a patient with COVID-19. CONCLUSION: It is safe to continue cancer and urgent surgery during the COVID-19 pandemic with appropriate service reconfiguration.


Subject(s)
COVID-19/mortality , Hospital Mortality , Oncology Service, Hospital/organization & administration , Surgery Department, Hospital/organization & administration , Adult , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Pandemics , Postoperative Complications/epidemiology , SARS-CoV-2 , State Medicine , United Kingdom/epidemiology
7.
Urol Oncol ; 38(12): 929.e1-929.e10, 2020 12.
Article in English | MEDLINE | ID: covidwho-838829

ABSTRACT

OBJECTIVE: Ad-hoc guidelines for managing the COVID-19 pandemic are published worldwide. We investigated international applications of such policies in the urologic-oncology community. METHODS: A 20-item survey was e-mailed via SurveyMonkey to 100 international senior urologic-oncology surgeons. Leaders' policies regarding clinical/surgical management and medical education were surveyed probing demographics, affiliations, urologic-oncologic areas of interest, and current transportation restrictions. Data on COVID-19 burden were retrieved from the ECDC. Statistical analyses employed non-parametric tests (SPSS v.25.0, IBM). RESULTS: Of 100 leaders from 17 countries, 63 responded to our survey, with 58 (92%) reporting university and/or cancer-center affiliations. Policies on new-patient visits remained mostly unchanged, while follow-up visits for low-risk diseases were mostly postponed, for example, 83.3% for small renal mass (SRM). Radical prostatectomy was delayed in 76.2% of cases, while maintaining scheduled timing for radical cystectomy (71.7%). Delays were longer in Europe than in the Americas for kidney cancer (SRM follow-up, P = 0.014), prostate cancer (new visits, P = 0.003), and intravesical therapy for intermediate-risk bladder cancer (P = 0.043). In Europe, COVID-19 burden correlated with policy adaptation, for example, nephrectomy delays for T2 disease (r = 0.5, P =0.005). Regarding education policies, trainees' medical education was mainly unchanged, whereas senior urologists' planned attendance at professional meetings dropped from 6 (IQR 1-11) to 2 (IQR 0-5) (P < 0.0001). CONCLUSION: Under COVID-19, senior urologic-oncology surgeons worldwide apply risk-stratified approaches to timing of clinical and surgical schedules. Policies regarding trainee education were not significantly affected. We suggest establishment of an international consortium to create a directive for coping with such future challenges to global healthcare.


Subject(s)
COVID-19/epidemiology , Medical Oncology/trends , Urologists/statistics & numerical data , Urology/trends , COVID-19/prevention & control , Forecasting , Humans , Medical Oncology/education , Medical Oncology/standards , Practice Guidelines as Topic , SARS-CoV-2 , Surveys and Questionnaires , Urologic Neoplasms/diagnosis , Urologic Neoplasms/therapy , Urologists/trends , Urology/education , Urology/standards
8.
Urology ; 145: 73-78, 2020 11.
Article in English | MEDLINE | ID: covidwho-695345

ABSTRACT

OBJECTIVE: To assess the outreach and influence of the main recommendations of surgical governing bodies on adaptation of minimally invasive laparoscopic surgery (MIS) procedures during the coronavirus disease 2019 (COVID-19) pandemic in an anonymized multi-institutional survey. MATERIALS AND METHODS: International experts performing MIS were selected on the basis of the contact database of the speakers of the Friends of Israel Urology Symposium. A 24-item questionnaire was built using main recommendations of surgical societies. Total cases/1 Mio residents as well as absolute number of total cases were utilized as surrogates for the national disease burden. Statistics and plots were performed using RStudio v0.98.953. RESULTS: Sixty-two complete questionnaires from individual centers performing MIS were received. The study demonstrated that most centers were aware of and adapted their MIS management to the COVID-19 pandemic in accordance to surgical bodies' recommendations. Hospitals from the countries with a high disease burden put these adoptions more often into practice than the others particularly regarding swabs as well as CO2 insufflation and specimen extraction procedures. Twelve respondents reported on presumed severe acute respiratory syndrome coronavirus 2 transmission during MIS generating hypothesis for further research. CONCLUSION: Guidelines of surgical governing bodies on adaptation of MIS during the COVID-19 pandemic demonstrate significant outreach and implementation, whereas centers from the countries with a high disease burden are more often poised to modify their practice. Rapid publication and distribution of such recommendation is crucial during future epidemic threats.


Subject(s)
COVID-19/epidemiology , Guideline Adherence/statistics & numerical data , Laparoscopy/standards , Robotic Surgical Procedures/standards , SARS-CoV-2 , Urologic Surgical Procedures/standards , Health Care Surveys , Humans , Internationality , Laparoscopy/statistics & numerical data , Minimally Invasive Surgical Procedures/standards , Practice Guidelines as Topic , Practice Patterns, Physicians' , Robotic Surgical Procedures/statistics & numerical data , Societies, Medical , Urologic Surgical Procedures/methods , Urologic Surgical Procedures/statistics & numerical data , Urology
9.
Eur Urol ; 78(2): 276-280, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-598133

ABSTRACT

Preliminary data suggest that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is associated with higher mortality among cancer patients, particularly in those on systemic therapy. It is unclear whether this applies to patients receiving immune checkpoint inhibitors (ICIs). In this case series, 74 patients from a single institution with genitourinary (GU) cancer on ICI were followed up during a 12-wk period. During this period, 11 patients (15%) developed symptoms consistent with coronavirus disease 2019 (COVID-19) and four (5%) tested positive. Two patients had metastatic urothelial cancer (treated with atezolizumab) and two had metastatic renal cancer (treated with ipilimumab and nivolumab). All had additional risk factors associated with COVID-19 mortality and two received steroids within 1 mo of infection. Two patients developed symptoms requiring hospitalisation. All four are alive 32-45 d after their first symptoms and 28-38 d after testing positive. These patients all had multiple risk factors associated with severe COVID-19. These data suggest that the higher risk of COVID-19 death associated with systemic therapy in cancer may not apply to patients on ICIs. Assessment of COVID-19 severity in these patients can be complicated by the underlying cancer and its treatment.


Subject(s)
Betacoronavirus , Coronavirus Infections/complications , Immunologic Factors/therapeutic use , Kidney Neoplasms/drug therapy , Pneumonia, Viral/complications , Aged , COVID-19 , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Female , Follow-Up Studies , Humans , Kidney Neoplasms/complications , Kidney Neoplasms/epidemiology , Male , Middle Aged , Pandemics , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Retrospective Studies , Risk Factors , SARS-CoV-2 , Treatment Outcome
10.
Eur Urol ; 78(1): 29-42, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-155387

ABSTRACT

CONTEXT: The coronavirus disease 2019 (COVID-19) pandemic is leading to delays in the treatment of many urologic cancers. OBJECTIVE: To provide a contemporary picture of the risks from delayed treatment for urologic cancers to assist with triage. EVIDENCE ACQUISITION: A collaborative review using literature published as of April 2, 2020. EVIDENCE SYNTHESIS: Patients with low-grade non-muscle-invasive bladder cancer are unlikely to suffer from a 3-6-month delay. Patients with muscle-invasive bladder cancer are at risk of disease progression, with radical cystectomy delays beyond 12 wk from diagnosis or completion of neoadjuvant chemotherapy. Prioritization of these patients for surgery or management with radiochemotherapy is encouraged. Active surveillance should be used for low-risk prostate cancer (PCa). Treatment of most patients with intermediate- and high-risk PCa can be deferred 3-6 mo without change in outcomes. The same may be true for cancers with the highest risk of progression. With radiotherapy, neoadjuvant androgen deprivation therapy (ADT) is the standard of care. For surgery, although the added value of neoadjuvant ADT is questionable, it may be considered if a patient is interested in such an approach. Intervention may be safely deferred for T1/T2 renal masses, while locally advanced renal tumors (≥T3) should be treated expeditiously. Patients with metastatic renal cancer may consider vascular endothelial growth factor targeted therapy over immunotherapy. Risks for delay in the treatment of upper tract urothelial cancer depend on grade and stage. For patients with high-grade disease, delays of 12 wk in nephroureterectomy are not associated with adverse survival outcomes. Expert guidance recommends expedient local treatment of testis cancer. In penile cancer, adverse outcomes have been observed with delays of ≥3 mo before inguinal lymphadenectomy. Limitations include a paucity of data and methodologic variations for many cancers. CONCLUSIONS: Patients and clinicians should consider the oncologic risk of delayed cancer intervention versus the risks of COVID-19 to the patient, treating health care professionals, and the health care system. PATIENT SUMMARY: The coronavirus disease 2019 pandemic has led to delays in the treatment of patients with urologic malignancies. Based on a review of the literature, patients with high-grade urothelial carcinoma, advanced kidney cancer, testicular cancer, and penile cancer should be prioritized for treatment during these challenging times.


Subject(s)
Betacoronavirus , Coronavirus Infections/complications , Disease Management , Pandemics , Pneumonia, Viral/complications , Time-to-Treatment/organization & administration , Triage/organization & administration , Urogenital Neoplasms/therapy , COVID-19 , Combined Modality Therapy/methods , Coronavirus Infections/epidemiology , Humans , Pneumonia, Viral/epidemiology , Risk Factors , SARS-CoV-2 , Urogenital Neoplasms/complications , Urogenital Neoplasms/diagnosis
11.
Eur Urol ; 78(1): 21-28, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-125264

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic is unlike anything seen before by modern science-based medicine. Health systems across the world are struggling to manage it. Added to this struggle are the effects of social confinement and isolation. This brings into question whether the latest guidelines are relevant in this crisis. We aim to support urologists in this difficult situation by providing tools that can facilitate decision making, and to minimise the impact and risks for both patients and health professionals delivering urological care, whenever possible. We hope that the revised recommendations will assist urologist surgeons across the globe to guide the management of urological conditions during the current COVID-19 pandemic.


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Disease Management , Pneumonia, Viral/epidemiology , Practice Guidelines as Topic , Societies, Medical , Urologic Diseases/therapy , Urology/standards , COVID-19 , Coronavirus Infections/complications , Europe , Humans , Pandemics , Pneumonia, Viral/complications , SARS-CoV-2 , Urologic Diseases/complications , Urologic Diseases/diagnosis
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