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1.
Journal of Clinical Urology ; 15(1):93-95, 2022.
Article in English | EMBASE | ID: covidwho-1957026

ABSTRACT

Introduction: The Covid-19 pandemic in the UK led to much un-certainty about the delivery of cancer services. A shift from established therapy (and its timing) in patients with Muscle invasive Bladder Cancer (MIBC) has potential deleterious consequences. To understand outcomes, we formed a collaborative to measure overall and diseasefree survival at 3-years in patients with non-metastatic MIBC (Figure 1) treated during the UK's first wave of Covid-19. Secondary aims included comparison between treatment modalities and pre-Covid controls. Patients and Methods: The collaborative included clinicians from 13 major centres, representing 3 UK nations. A prospective clinical audit, endorsed by the National Cancer Research Institute, was started to collect comprehensive data. MIBC patients discussed at the multidisciplinary meeting (MDM) between 1/3/2020-30/06/2020 were included. Results: At submission, data were available from 12 centres for 299 patients. The mean age was 69.3 years (27- 90), and there were 72 female and 227 male patients. Mean Charlson Co-morbidity Index was 5 (1-12). Preliminary analysis of available data indicate the following: MDM recommendations for (at least) 1 in 4 patients were deemed as being modified from standard practice. Twenty six patients received neoadjuvant chemotherapy. In total (from available data), 99 received radical radiotherapy and 146 underwent radical cystectomy (65 and 74 specified as open and robotic assisted, respectively). Preliminary analysis suggests that 1 in 3 patients had died within 1 year. Conclusions: Preliminary Results indicate that recommendations for MIBC patients were significantly altered consequent to the pandemic and mortality was high. Analyses towards endpoints are awaited.

2.
Neuro-Oncology ; 24:i145, 2022.
Article in English | EMBASE | ID: covidwho-1956576

ABSTRACT

INTRODUCTION: Surgery in patients diagnosed with COVID-19 is associated with increased risk of morbidity and mortality, especially within 6 weeks of SARSCoV- 2 infection. Furthermore, most studies have focused on adults, and little is known about perioperative outcomes in children with COVID-19. METHODS: We reviewed the operative census of the Division of Neurosurgery of Philippine General Hospital from March 2020 until December 2021. We identified all pediatric patients with brain tumors and confirmed COVID-19 infection within two weeks of their neuro-oncologic surgery. Their clinical course and outcomes are described herein. RESULTS: Four patients were included in this case series: three had tumors in the cerebellum, one in the pineal region. All of them were boys, with ages ranging from 4 months to 13 years. All tumors were malignant, and two were confirmed to be medulloblastoma after tumor resection. COVID-19 infection was diagnosed by the presence of SARS-CoV-2 RNA through a nasopharyngeal swab. Three patients acquired the virus post-operatively, likely from nosocomial transmission. In the remaining patient, it was community-acquired. All the patients had chest radiographs consistent with pneumonia but none had marked elevation of serum inflammatory markers. No patient received remdesivir or tocilizumab. At the time of their presentation, either the COVID-19 vaccine was not yet available in the country, or the patient was not yet eligible for vaccination. One patient died because of brain herniation from tumor progression, two were discharged and eventually underwent adjuvant therapy, and one remained in-hospital as of this writing. DISCUSSION: COVID-19 infection resulted in delays in the management of patients with pediatric CNS tumors. Given the high risk of these patients for potential complications, consensus guidelines must be established to achieve good outcomes and prolong survival.

3.
Annals of Oncology ; 33:S375-S376, 2022.
Article in English | EMBASE | ID: covidwho-1936046

ABSTRACT

Background: Despite the occurrence of HER2 amplification/overexpression (HER2+) in ~3% to 5% of all patients with metastatic colorectal cancer (mCRC) and up to ~10% of patients with RAS/BRAF wild-type mCRC, there are currently no FDA- or EMA-approved HER2-directed therapies for HER2+ mCRC. Patients with mCRC who progress on early lines of chemotherapy regimens receive limited clinical benefit from current standard-of-care treatments. Tucatinib is a highly selective, HER2-directed, tyrosine kinase inhibitor. The MOUNTAINEER trial (NCT03043313) was initiated to evaluate the efficacy and safety of the investigational combination of tucatinib with trastuzumab in patients with HER2+ mCRC. Here we present results from the primary analysis of MOUNTAINEER. Methods: MOUNTAINEER is a multi-center, open-label, randomised, phase 2 trial conducted in the US and Europe. Eligible patients had HER2+ (one or more local tests: 3+ immunohistochemistry, 2+ immunohistochemistry with amplification by in situ hybridization, or amplification by next‑generation sequencing of tumor tissue) and RAS wild-type mCRC with progression on or intolerance to fluoropyrimidine, oxaliplatin, irinotecan, and an anti-VEGF antibody. Measurable disease and an ECOG performance status of 0–2 were required. Previous HER2-directed therapies were not permitted. The trial initially consisted of a single cohort (Cohort A) to be treated with tucatinib (300 mg PO BID) and trastuzumab (8 mg/kg IV then 6 mg/kg IV every 3 weeks). The trial was expanded to include patients randomised 4:3 to receive tucatinib + trastuzumab (Cohort B) or tucatinib monotherapy (Cohort C). The primary endpoint is confirmed objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) in Cohorts A+B. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety and tolerability. Results: MOUNTAINEER enrolled 117 patients between 08Aug2017 and 22Sept2021. Data cutoff was 28Mar2022. The median age was 56.0 years (range, 24, 77), and baseline characteristics were balanced across cohorts. Eighty-six patients received at least 1 dose of study treatment in Cohorts A+B, and 30 patients received tucatinib monotherapy in Cohort C (total, 116). The overall median duration of follow-up was 16.3 months (IQR, 10.8, 28.2). In Cohorts A+B, the confirmed ORR by BICR was 38.1% (95% CI, 27.7, 49.3). The median DOR was 12.4 months (95% CI, 8.5, 20.5). The median PFS was 8.2 months (95% CI, 4.2, 10.3), and the median OS was 24.1 months (95% CI, 20.3, 36.7). The most common adverse events (AEs) in Cohorts A+B were diarrhoea (64.0%), fatigue (44.2%), nausea (34.9%), and infusion-related reaction (20.9%);the most common AE of grade ≥3 was hypertension (7.0%). Adverse events leading to tucatinib discontinuation in Cohorts A+B occurred in 5.8% of patients and included alanine amino transferase increase (2.3%), COVID-19 pneumonia (1.2%), cholangitis (1.2%), and fatigue (1.2%). No deaths resulted from AEs. Conclusions: In patients with chemotherapy-refractory HER2+ mCRC, tucatinib in combination with trastuzumab was well tolerated with clinically meaningful antitumor activity including durable responses and a median overall survival of 2 years. Tucatinib in combination with trastuzumab has the potential to become a new standard of care for patients with HER2+ mCRC. Clinical trial identification: NCT03043313. Editorial acknowledgement: The authors thank Joseph Giaconia of MMS Holdings, Michigan, USA for providing medical writing support/editorial support, which was funded by Seagen Inc., Bothell, WA, USA in accordance with Good Publication Practice (GPP3) guidelines. Legal entity responsible for the study: Seagen Inc. Funding: Seagen Inc. Disclosures: J. Strickler: Advisory / Consultancy: Seagen, Bayer, Pfizer;Research grant / Funding (institution): Amgen, Roche/Genentech, Seagen. A. Cercek: Advisory / Consultancy: Bayer, Merck, Seagen;Research grant / Funding (institution): Seagen, GSK, Rgenix. T. André: Honoraria (self : Amgen, Astra-Zeneca, Bristol-Myers Squibb, Gritstone Oncology, GlaxoSmithKline, Haliodx, Kaleido Biosciences, Merck & Co., Inc., Pierre Fabre, Sanofi, Servier, Merck & Co., Inc, Servier;Advisory / Consultancy: Astellas Pharma, BMS, Gritstone Oncology, Transgène, Roche/Ventana, Seagen, Merck & Co., Inc, Servier;Research grant / Funding (institution): BMS, Seagen, GSK;Travel / Accommodation / Expenses: BMS, Merck & Co., Inc. K. Ng: Advisory / Consultancy: Seattle Genetics, Bicara Therapeutics, GlaxoSmithKline;Research grant / Funding (institution): Pharmavite, Evergrande Group, Janssen. E. Van Cutsem: Advisory / Consultancy: AbbVie, Array, Astellas, AstraZeneca, Bayer, Beigene, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Daiichi, Halozyme, GSK, Helsinn, Incyte, Ipsen, Janssen Research, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Pierre Fabre, Roche, Seattle Genetics, Servier, Sirtex, Terumo, Taiho, TRIGR, Zymeworks;Research grant / Funding (institution): Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, Servier. C. Wu: Research grant / Funding (institution): Seagen. A. Paulson: Research grant / Funding (institution): Seattle Genetics. J. Hubbard: Research grant / Funding (institution): Seattle Genetics. H. Lenz: Honoraria (self): BMS, Bayer, Roche;Advisory / Consultancy: Bayer, Merck, Roche;Travel / Accommodation / Expenses: BMS, Bayer, Merck KG;Shareholder / Stockholder / Stock options: Fulgent. M. Stecher: Full / Part-time employment: SeaGen. W. Feng: Full / Part-time employment: Seagen. T. Bekaii-Saab: Honoraria (self): Royalties: Uptodate;Advisory / Consultancy: Consulting (to institution): Ipsen, Arcus, Pfizer, Seattle Genetics, Bayer, Genentech, Incyte, Eisai and Merck., Consulting (to self): Stemline, AbbVie, Boehringer Ingelheim, Janssen, Daichii Sankyo, Natera, TreosBio, Celularity, Exact Science, Sobi, Beigene, Kanaph, Astra Zeneca, Deciphera, MJH Life Sciences, Aptitude Health, Illumina and Foundation Medicine, IDMC/DSMB: Fibrogen, Suzhou Kintor, Astra Zeneca, Exelixis, Merck/Eisai, PanCan and 1Globe;Research grant / Funding (institution): Agios, Arys, Arcus, Atreca, Boston Biomedical, Bayer, Eisai, Celgene, Lilly, Ipsen, Clovis, Seattle Genetics, Genentech, Novartis, Mirati, Merus, Abgenomics, Incyte, Pfizer, BMS.;Licensing / Royalties: WO/2018/183488: HUMAN PD1 PEPTIDE VACCINES AND USES THEREOF – Licensed to Imugene, WO/2019/055687: METHODS AND COMPOSITIONS FOR THE TREATMENT OF CANCER CACHEXIA – Licensed to Recursion. All other authors have declared no conflicts of interest.

4.
Annals of Oncology ; 33:S331, 2022.
Article in English | EMBASE | ID: covidwho-1936045

ABSTRACT

Background: Colorectal cancer (CCR) is the third most common and the second most deadly cancer with 1.9 million new diagnoses worldwide in 2020. COVID-19 pandemic placed an unprecedented burden on health systems worldwide, directly impacting cancer patients’ management. Health-care systems reorganization led to a decrease on all non-urgent surgical and medical procedures, delaying cancer screening protocols. This study aims to access the impact of COVID-19 on Colorectal Cancer management in a Portuguese Oncology Department. Methods: A retrospective cohort study comparing the new colorectal cancer diagnosis between March/2019 and March/2022. New diagnosis between March/2019 and March/2020 were assigned to Cohort 1 “Before COVID-19 Pandemic” and new diagnosis between March/2020 and March/2022 assigned to Cohort 2 “During COVID-19 Pandemic”. Data was collected from digital medical records and statistical analysis performed using SPSS V.25 IBM®. Results: Between March/19 and March/22 were diagnosed 313 new colorectal cancers, 116 (37%) assigned to Cohort 1 “Before COVID-19 Pandemic” and 197 (63%) to Cohort 2 “During COVID-19 Pandemic”. Analysing the new diagnosis in Cohort 2, 105 (34%) occurred between March/20-21 and 92 (29%) between March/21-22. Mean age at diagnosis of 69 (30-96) years for Cohort 1 and 68 (32-94) years for Cohort 2. 42% (n=49) females and 58% (n=68) males in Cohort 1 compared to 38% (n=77) females and 62% (n=123) males in Cohort 2. Colorectal cancer screening diagnosed 36% (n=42) patients in Cohort 1 and 35% (n=69) in Cohort 2. Clinical presentation with bowel obstruction was seen in 25% (n=29) in Cohort 1 and 37% (n=74) in Cohort 2 (p=0.02). Metastatic disease at diagnosis in 13% (n=14) for Cohort 1 and 26% (n=52) for Cohort 2 (p=0.07). Regarding management, 39% (n=46) underwent adjuvant systemic treatment in Cohort 1 compared to 28% (n=55) in Cohort 2 (p=0.03). Palliative systemic treatment was agreed for 7% (n=10) in Cohort 1 and 17% (n=36) in Cohort 2 (p=0.02). At diagnosis, best supportive care was decided for 2% (n=2) in the first Cohort and 15% (n=30) (p=0.03). Overall survival of 25 (1-36) months for Cohort 1 and 10 (1-23) months for Cohort 2. Conclusions: Comparison between pre-pandemic and in-pandemic periods revealed a numeric reduction on new cases of colorectal cancer in each 12 months period. Despite similar rate of diagnosis by colorectal cancer screening, statistical significance was found when comparing clinical presentation with bowel obstruction or metastatic disease. Despite that, less patients underwent adjuvant systemic treatment in cohort 2 and more were evaluated for best supportive care at diagnosis. These findings may be explained by more advanced disease in more fragile patients in the Cohort 2 population. The results of our study contribute to the evidence on the impact of COVID-19 pandemics on colorectal cancer with fewer diagnosis, more advanced disease, and lack of re-establishment of pre-pandemic rate of new diagnosis. Legal entity responsible for the study: The author. Funding: Has not received any funding. Disclosures: All authors have declared no conflicts of interest.

5.
Annals of Oncology ; 33:S400, 2022.
Article in English | EMBASE | ID: covidwho-1936039

ABSTRACT

Background: Malignant bowel obstruction (MBO) is common in advanced ovarian cancer (AOC). Treatment options are limited as majority of cases present with widespread, multilevel peritoneal dissemination and platinum-resistant disease. The benefit of Parenteral Nutrition (PN) in MBO is debated, given the limited overall survival (OS) of this patient group. Aim: to identify which clinical features correlate with improved survival in AOC and MBO, to support clinical decision-making. Methods: Retrospective review of patients admitted with MBO between April 2019 and October 2021 to a single tertiary cancer centre. Those with AOC established on PN with the aim to discharge home on PN were included. Univariate analysis for survival after commencing PN was performed using log-rank test. Results: 103 patients with MBO were identified with 33 patients excluded (PN not initiated, 15;PN withdrawn: covid service constraint, 5, acute medical event, 13). 70 patients were successfully established on PN and 49 discharged on PN;16 patients clinically deteriorated;5 returned to enteral diet. Median OS of patients that did not receive PN was 19 days, PN stopped due to general deterioration 39 days and 100 days (range 18-807) for those established on PN (p<0.0001). Clinical features associated with improved OS: no prior systemic therapy (p=0.0067), platinum sensitivity (p=0.043), ECOG performance status (PS) 1 vs 2-3 (p=0.004), falling modified Glasgow Prognostic Score (mGPS) during admission (p=0.0027). In the treatment naïve group, chemotherapy resolved MBO in 6/9 cases. In the pre-treated group, 60% of patients received subsequent chemotherapy (median duration 8 weeks), with early cessation due to toxicity and no clinical benefit. Only 1 patient achieved resolution of MBO on chemotherapy. Conclusions: PN may improve survival of patients with AOC in MBO. ECOG PS, platinum sensitivity and mGPS trend may be useful to select patients for PN. In those presenting with MBO at AOC diagnosis, PN can enable safe delivery of chemotherapy, which usually will resolve MBO. In pre-treated patients, PN is a life-long commitment and chemotherapy is largely ineffective in resolving MBO. Further research should focus on quality of life in patients receiving PN. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

6.
Supportive Care in Cancer ; 30:S26, 2022.
Article in English | EMBASE | ID: covidwho-1935807

ABSTRACT

Introduction COVID19 cancelled in-person breast cancer support in Australia. Text messages are effective at providing health support. Aim: Evaluate cost, uptake, reach and utility of a 3-month co-designed (consumers/clinicians/ researchers) lifestyle-focused text message program 'EMPOWER-SMS'. Methods Participants were recruited (Apr'20-Feb'21) via breast cancer organisations' social media and emails. Inclusion: Adults, finished active breast cancer treatment (surgery/chemotherapy/radiotherapy), lived in Australia, owned a mobile phone, sufficient English for e-consent. Exclusion: metastatic breast cancer. Online survey at baseline: Demographics and postcode (coded to Index of Relative Socio-economic Advantage and Disadvantage [IRSAD];1 least to 5 most advantaged). At 3-months: program feedback for ease-of-understanding, utility, perceived health management (5-Point Likert Scale;strongly [dis]agree), open-text feedback (coded thematically). Results Ads cost $2641. Participants' (N=845) mean age: 59±10yrs (range 30-87yrs), 48% resided in less advantaged areas (IRSAD 1-3). Survey participants (n=452) agreed/strongly agreed EMPOWERSMS was easy-to-understand (99%), useful (83%), helpful for managing health (69%), exercise (70%), healthy diet (70%). Key themes: 'feeling supported/less lonely', 'friendly reminders', 'sad it ended', 'some messages too simple'. Conclusions With low cost ($3.1/enrolment), 845 diverse participants enrolled and found it useful, overcoming support barriers during COVID19.

7.
Supportive Care in Cancer ; 30:S31, 2022.
Article in English | EMBASE | ID: covidwho-1935797

ABSTRACT

Introduction Telehealth-based supportive care has proliferated, particularly during COVID-19. However, research on the use of these resources among older adults, who are the majority of cancer survivors, is limited. This study utilized online semi-structured interviews to gather older cancer survivors' use and perceptions of telehealth-based supportive care. Methods Participants were recruited through ResearchMatch. Content analyses were conducted by two independent coders for identification of common themes. SPSS IBM 27.0 was used for descriptive analyses. Results The majority of participants (n=21;mean age=73.5±4.9) were female (57%), White (90%), and had a variety of cancer diagnoses. Ten (47.6%) survivors had prior experience with telehealth use. More than half (52.3%) of survivors reported interest in using telehealth for symptom management. One-third of survivors were interested in telehealthbased supportive care for nutrition, exercise, screening, and stress management. Older cancer survivors noted the convenience of telehealth, yet expressed feelings of disconnect with supportive care providers and preference for in-person appointments. Conclusions These findings suggest that older cancer survivors are divided in their use and perceptions of telehealth for supportive care. Additional efforts to establish the most appropriate uses and distribution of telehealth-based supportive cancer care for older cancer survivors post-COVID-19 are warranted.

8.
Supportive Care in Cancer ; 30:S159-S160, 2022.
Article in English | EMBASE | ID: covidwho-1935776

ABSTRACT

Introduction Our objective was to compare the quality of life (QOL) in residents according to their cancer status, using questionnaires adapted to potential neurocognitive disorders (NCD) presence. Methods This multicenter cross-sectional study included residents aged 70 years and older able to communicate, with an estimated necessary number of subjects of 352. The study was conducted in two steps: first including residents with cancer and next a control group randomly selected among residents without any history of cancer matched on NCD and dependence status. QoL was assessed with different scales: QolAD if NCD, otherwise WHOQOL-OLD and QLQC30+ELD14 in the cancer group. Results Due to the COVID pandemic, the study was terminated early, and only 70 included residents had complete analyzable data. The participants had a median age of 85 years [70-99] and 20 were male. Regarding dependence status, 20 had an ADL between 0-2, 15 an ADL between 2.5-4.5, 34 an ADL between 5-6. Among the 42 residents in the cancer group, mostly cancer survivors. 13/42 residents in the cancer group had NCD (vs. 7/28 in the control group), 19/42 in the cancer group reported pain (vs. 16/28 in the control group). Conclusions Various obstacles have prevented from completing the study: low resident eligibility, difficulty in obtaining written consent, and finally the COVID pandemic which limited the availability of the nurse investigators and had impacted residents' QOL. This study could be redone at a distance from this pandemic if possible.

9.
Supportive Care in Cancer ; 30:S158-S159, 2022.
Article in English | EMBASE | ID: covidwho-1935775

ABSTRACT

Introduction Older (65+) cancer survivors have unique complications after chemotherapy, including physical and cognitive impairments and geriatric syndromes. Survivorship research has generally focused on younger and urban populations. We explored the survivorship needs of rural older adult survivors. Methods Thirteen rural older adults who finished curative-intent chemotherapy completed open-ended interviews and health surveys. Transcripts were coded independently by two coders using thematic analysis. Results Mean age was 74 (SD=5.1). Most participants were non-Hispanic White (92.3%), female (69.2%), and married (46.2%). All had health insurance and 76.9% had an annual income <$50k. Most were diagnosed with colon (46.2%) or lung (23.1%) cancer. Themes (Table 1) included: 1) No survivorship care plan developed (100%), 2) No coordination between primary and oncology team (100%), 3) Symptomatic toxicities present (100%), 4) No discussion on long-term chemotherapy effects (61.4%);5) Financial challenges (53.8%), 6) Isolation due to COVID19 pandemic (38.5%), 7) Organizational barriers to care (30.8%), 8) Patient does what doctor says (23.1%), and Recommendations included: 1) referral to support groups (23.1%), 2) discussion on survivorship care (23.1%), and 2) information on exercise (15.4%) Conclusions Rural older survivors have unmet survivorship needs. Aging-sensitive interventions may lead to improved survivorship health post-treatment among rural older adult survivors.

10.
Annals of Surgical Oncology ; 29(SUPPL 2):S443, 2022.
Article in English | EMBASE | ID: covidwho-1928242

ABSTRACT

INTRODUCTION: Time from diagnosis to treatment initiation for many cancers is lengthening. During the COVID pandemic, many institutions were forced to postpone cancer treatment to reallocate resources, despite the unclear impact of treatment delays. This study sought to investigate the association between time to treatment initiation (TTI) and overall survival in patients with hepatopancreatobiliary (HPB) cancers. METHODS: The National Cancer Database (NCDB) was queried for patients diagnosed with de novo cancers of the pancreas, liver, and intrahepatic and extrahepatic bile ducts between 2004 and 2017. Kaplan-Meier survival analysis and Cox regression were used to investigate the association between TTI and overall survival for each cancer type, stratified by stage. Multivariable linear regression identified factors associated with longer TTI. RESULTS: Of 318,931 patients with HPB cancer, median TTI across all cancers was 31 days, ranging from 26 days for pancreas cancer to 48 days for liver cancer. Longer TTI was associated with increased mortality in patients with stages I, II, and III extrahepatic bile duct (EHBD) cancer (Figure 1), and stage I pancreatic adenocarcinoma. Compared to TTI of 3 to 30 days, the risk-adjusted hazard ratios for stage I EHBD cancer for TTI 31 to 60, 61 to 90, and ≥90 days were 1.17 [95% CI 1.07-1.29], 1.39 [1.21-1.59], and 1.63 [1.40-1.90], respectively. For the same time frames, hazard ratios in stage I pancreatic cancer were 1.08 [1.03-1.13], 1.19 [1.11-1.28], and 0.99 [0.90-1.09], respectively. Factors most strongly associated with increased TTI for all cancers included treatment with radiation only (β = +14.1 days, p< 0.001), early stage disease (+13.8 days for stage I vs. stage IV, p< 0.001), Black race (+4.4 days, p< 0.001), Hispanic ethnicity (+4.2 days, p< 0.001), and treatment in the West (+3.9 days vs. Northeast, p< 0.001). CONCLUSIONS: Delayed initiation of definitive therapy leads to increased mortality in stage I-III EHBD and stage I pancreatic cancer. Some patients, including Blacks and Hispanics, are more likely to experience delayed care. Treatment initiation for these cancers should be expedited, and pandemic-related postponements should be avoided if possible.

11.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927835

ABSTRACT

Invasive aspergillosis is a rapidly progressive, fatal infection that usually occurs in immunocompromised patients. The spectrum of clinical presentation ranges from non-invasive, invasive, destructive and allergic aspergillosis. It is rare to see overwhelming aspergillosis in an immunocompetent host. Nevertheless, certain risk factors such as underlying fibrotic lung disease, suppurative infection, long-term corticosteroid use and uncontrolled diabetes mellitus (DM) have been described. We hereby present a case of invasive pulmonary aspergillosis in a patient with uncontrolled DM. A 60-year-old man with a history of heavy smoking (50- pack-year), poorly controlled DM presented to the hospital with a large area of erythema with eschar over his left posterior thigh. Clinical examination and CT abdomen pelvis confirmed necrotizing fasciitis involving his perineum and left thigh. Admission CT abdomen showed a small left lower lobe infiltrate (Day 1, Panel A). He underwent urgent debridement and intraoperative tissue cultures grew coagulase-negative staphylococcus, Proteus Vulgaris and anaerobic gram-positive rods. He received piperacillintazobactam, vancomycin, and clindamycin for 16 days which was subsequently narrowed to ceftriaxone and metronidazole. He had worsening leukocytosis but all his blood cultures have been negative. Tracheal aspirate gram stain on day 5 showed moderate yeast, and cultures grew Candida albicans and Aspergillus fumigatus. CT scan of his chest showed bilateral reticulonodular opacities with a new loculated right pleural effusion (Day 16, Panel B). Trans-esophageal echocardiogram did not show any right-sided heart valve vegetation. He received intravenous voriconazole for disseminated aspergillosis. Despite of new prophylactic antifungal strategies, more sensitive and rapid diagnostic tests, as well as various efficacious treatments, survival of invasive disseminated aspergillosis remains poor. High clinical suspicion with a proactive investigation approach is the key to minimizing mortality. Various risk factors such as hematopoietic-cell transplantation, neutropenia, solid-organ transplantation, chemotherapy, prolonged ICU stay, structural lung disease, impaired mucociliary clearance after a recent pulmonary infection (including SARS-CoV-2) have been well described. Our case highlights the importance of recognizing uncontrolled DM as a crucial risk factor for disseminated aspergillosis. (Figure Presented).

12.
International Journal of Radiation Oncology Biology Physics ; 113(4):A12-A15, 2022.
Article in English | EMBASE | ID: covidwho-1926991
13.
European Journal of Obstetrics and Gynecology and Reproductive Biology ; 270:e119, 2022.
Article in English | EMBASE | ID: covidwho-1926417

ABSTRACT

Introduction and aims of the study: In early vulvar cancer, lymph node status is the most important prognostic factor. Sentinel lymph node biopsy (SLNB) is the minimally invasive procedure that lead to the most significant reduction in the classical high morbidity associated with the sistematic inguinal-femoral lymphadenectomy. Besides quality control, the aim of this study is to document the overall experience around SLNB at this referral Centre before the Covid pandemic, in order to monitor and possibly prevent future related changes. Methods: Retrospective analysis of patient files in cases where SLNB was performed as part of the treatment for vulvar cancer at the authors’ Department, from January, 2016 to December, 2019. A single surgeon performed the SLNB with the combined technique (technetium and patent blue). Data collected included demographics, pathology, accuracy, surgery and perioperative results, feasibility and survival. Results: 18 patients with vulvar squamous cell cancer were enrolled in the study. Median age was 68 years, average BMI 27.5kg/m2, 61.1% were married and Charlson score ≥5 was 55.6%. Primary site was labia majora in 44.4% and mid-line was affected in 27.8%. FIGO stage IB in 72.2% of cases, mean tumour diameter was 20.2 (7-39)mm. SLNB was bilateral in 27.8%, 1 out of 38 nodes removed was positive and average number of nodes per patient was 2.1. Mean hospital stay was 13.2 days, blood loss 72ml and no surgical complications. There was a single case of groin recurrence in 45.1 months mean follow-up time and 2 cases of non-related deaths. 33.3% and 5.6% patients had short and long-term postoperative complications, respectively, mostly infectious. Conclusions: SLNB is a reliable and safe minimally invasive technique that should be performed by experienced gynaecological oncologists in well-equipped and multidisciplinary Centres. The Covid pandemic is believed to be causing severe difficulties in the management of patients with vulvar cancer, from diagnosis to follow-up and treatment of recurrences. This study allows a future comparison with positive results at this Centre, possibly reflecting other similar scenarios in Europe.

14.
Palliative Medicine ; 36(1 SUPPL):47, 2022.
Article in English | EMBASE | ID: covidwho-1916793

ABSTRACT

Background/aims: Palliation of painful bone metastases encompasses a significant portion of radiation treatments. The COVID-19 pandemic has led us to consider shorter courses and hypofractionation. The purpose of this study is to analyze our practice: efficacy of single-fraction vs standard multifraction radiotherapy for alleviation of pain in patients with bone metastases. Methods: 178 patients who receive radiation treatment for painful bone metastases from March 2020 to March 2021 were reviewed. We analyze rate of re-irradiation and how the treatment line has been modified throughout the 1 year of the pandemic. Results: Median age was 68 years (range 36-93), 67% males, 33% females. Main primary tumors were 40% lung, 13% prostate and 32% breast. . Advanced disease was detected in 11% as debut. Treatment provided was: Only 8 patients required reirradiation, 75% of them had received single fraction. Currently, 62% died. Conclusions: Painful bone metastases is not an oncologic emergency but requires Radiotherapy for symptom management. Radiotherapy has improved quality of life in patients with advanced disease in the midst of the COVID-19 pandemic, when short radiation therapy cycles prevailed over the long ones. Almost single-fraction has shown to be an effective treatment option for patients with painful bone metastases, conventional multifraction should be considered for patients expected to have relatively long survival. (Table Presented).

15.
HemaSphere ; 6(SUPPL 2):15, 2022.
Article in English | EMBASE | ID: covidwho-1915866

ABSTRACT

Introduction: Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell (CAR-T) therapy expressing two B-cell maturation antigen (BCMA)-targeting, single-domain antibodies. The multicohort, open-label, phase 2 CARTITUDE-2 study (NCT04133636) is assessing cilta-cel in patients (pts) with multiple myeloma (MM) under various clinical settings and evaluating the suitability of outpatient administration. Updated results of CARTITUDE-2 cohort A are presented here. Methods: Cohort A pts had progressive MM after 1-3 prior lines of therapy (LOT;included proteasome inhibitor [PI] and immunomodulatory drug [IMiD]), were lenalidomide-refractory, and had no previous exposure to BCMA-targeting agents. A single cilta-cel infusion at a target dose of 0.75×106 CAR+ viable T cells/kg was given 5-7 d after start of lymphodepletion (cyclophosphamide [300 mg/m2] and fludarabine [30 mg/m2] for 3 d). The primary endpoint was minimal residual disease (MRD) negativity at 10-5 at any time point. Secondary endpoints were overall response rate (ORR), duration of response (DOR), time and duration of MRD negativity, and incidence and severity of adverse events (AEs). Response was assessed per International Myeloma Working Group criteria and AEs were graded by Common Terminology Criteria for Adverse Events version 5.0 (cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS] by American Society for Transplantation and Cellular Therapy). Results: As of April 15, 2021 (median follow-up of 9.7 mo), 20 pts (65% men;median age 60 y [range 38-75]) received cilta-cel, with 1 pt treated in an outpatient setting. Pts had a median of 2 prior LOT (range 1-3);60% had 1-2 prior LOT and 40% had 3 prior LOT. All pts were exposed to a PI, IMiD, and dexamethasone;95% were exposed to alkylating agents and 65% to daratumumab. 95% of pts were refractory to last LOT;40% were triple-class refractory. ORR was 95% (95% CI 75.1-99.9);85% (95% CI 62.1-96.8) had ≥complete response (CR), and 95% (95% CI 75.1-99.9) had ≥very good partial response (Figure). Median time to first response was 1.0 mo (range 0.7-3.3) and median time to ≥CR was 2.6 mo (range 0.9-7.9). Median DOR was not reached;progression-free survival (PFS) at 6 mo was 90% (95% CI 65.6-97.4). Of 13 MRD-evaluable pts, 92.3% (95% CI 64.0-99.8) were MRD-negative at 10-5. Hematologic AEs (≥20% of pts) were neutropenia (95%;grade [gr] 3/4: 95%), thrombocytopenia (80%;gr 3/4: 35%), anemia (75%;gr 3/4: 45%), lymphopenia (65%;gr 3/4: 60%) and leukopenia (55%;gr 3/4: 55%). 95% of pts had CRS (gr 3/4: 10%);median time to onset was 7 d (range 5-9) and median duration was 4 d (range 2-11). Four pts (20%) had CAR-T neurotoxicity (all gr 1/2). Three pts (15%) had ICANS (all gr 1/2);median time to onset was 8 d (range 7-10) and median duration was 3 d (range 1-3). One pt had facial paralysis (gr 2) with time to onset of 29 d and duration of 51 d. No movement and neurocognitive treatment-emergent adverse events (TEAEs) were reported. One death due to COVID-19 was assessed as treatment-related. Safety was manageable in the pt treated in an outpatient setting. Conclusions: A single cilta-cel infusion led to early and deep responses in pts with MM who had 1-3 prior LOT and were lenalidomide-refractory. No movement and neurocognitive TEAEs occurred, suggesting successful implementation of monitoring and pt management strategies across phase 2/3 studies in the CARTITUDE program.

16.
Nephrology Dialysis Transplantation ; 37(SUPPL 3):i63, 2022.
Article in English | EMBASE | ID: covidwho-1915661

ABSTRACT

BACKGROUND AND AIMS: Renal failure severe enough to require dialysis is an independent predictor of poor survival outcomes in multiple myeloma (MM). Significant early mortality (EM) was also determined in patients with MM infected by COVID-19. To evaluate the EM rate and investigate the risk factors associated with EM in MM patients. METHOD: Medical records of patients from the hematology unit of UHC 'Mother Teresa' with MM between January 2020 and March 2021 were reviewed. Out of 183 patients, 33.3% have in presentation myeloma-related kidney disease (MRKD). The statistical methods consisted of Kaplan-Meier survival curves, the log-rank test, logistic regression analysis and the ROC curve for mortality analysis. RESULTS: We evaluated 61 patients with MRKD, with 67.2% men;the mean age was 66.2+ (8.7) years. The incidence of MRKD was 41%, and 19.7% of MRKD patients underwent haemodialysis treatment. The 1-year mortality rate was found 29.5% (P < .01), where the EM rate was 13.1%, from which 62.5% needed dialysis. During follow-up, 10% of patients with MRKD had confirmed positive SARS-COV2 tests, associated with a high mortality rate of around 67%. AUC for creatinine value was 0.828, while it had a specificity of 88.37% and a sensitivity of 77.78% at a cut-off value >4 mg/dL (Figure 1). Multivariate logistic regression found creatinine >4 mg/dL, haemodialysis and COVID-19 remained independent predictors of high mortality in MRKD patients after being adjusted for cofounders (Figure 2). CONCLUSION: High incidence of MRKD indicates under recognition of MM. Mortality from COVID-19 infection in MRKD was relatively high, 22.2%. Renal failure is the second most common cause, after infection, of EM in MM patients. It is potentially reversible, so it is of high-interest early diagnosis and management of MRKD for more prolonged survival. Prophylactic measures in patients with preexisting-kidney failure may further reduce this risk.

17.
European Heart Journal, Supplement ; 24(SUPPL C):C60, 2022.
Article in English | EMBASE | ID: covidwho-1915556

ABSTRACT

Development of endomyocardial biopsy for acute rejection monitoring in the early Seventies, and above all use of cyclosporine in the clinical practice starting from 1980, introduced the modern era of heart transplantation. Following the initial positive outcomes, the first Italian transplant was performed in Padua by V.Gallucci on November 15th 1985. This pioneering success was rapidly repeated in Pavia, where M.Viganò performed the second transplant on Novembre 17th. Recipient was 20 years old man, suffering from dilated cardiomyopathy, on urgent transplant list. Cardiac index was 1.38 l/min/m2 and pulmonary vascular resistance 1.6 WU. Donor was a 14 years old boy died of brain injury. Total ischemic time was 125 minutes. Induction immunosuppression consisted of horse anti-lymphocyte immunoglobulins, whereas maintenance therapy included cyclosporine, azathioprine and steroids. Postoperative course was complicated by pericardial effusion and cholestatic jaundice. Later pulmonary aspergillosis occurred and due to the profound immunodepression was complicated by fungal localization at L2 vertebral body. The infection was treated with surgical removal of the secondary localization and amphotericin B administration. On December 6th severe acute rejection was found at biopsy and treated with i.v. steroid pulse. Length of ICU and hospital stay was 28 and 72 days, respectively. In 1998 HCV infection was detected and eradicated in 2017 with elbasvir/grazoprevir therapy. Complications of long term immunosuppressive treatment included dyslipidemia, myeloma and basal cell carcinoma. Due to long-term calcineurin inhibitors therapy progressive chronic renal failure occurred, leading to replacement therapy in 2015 and kidney transplantation in 2016. In 2015 the patient underwent percutaneous coronary intervention with stents implantation in two marginal branches and in the anterior descending artery in 2021. Everolimus was introduced to slow down progression of cardiac allograft vasculopathy. In 2020 he suffered from Covid-19, but the course of infection was uneventful being cough the only symptom. We report the eldest survivor after heart transplant in Europe. Our case demonstrates that despite early and long-term complications of immunosuppressive therapy, a careful and patient tailored management allowed an amazing outcome. Nowadays heart transplant remains the best treatment for end stage heart failure and allows to resume a nearly normal quality of life.

18.
Diseases of the Esophagus ; 35(SUPPL 1):20-21, 2022.
Article in English | EMBASE | ID: covidwho-1915547

ABSTRACT

Background and aim: Covid-19 has had a devastating global impact and resulted in over 4.4 million directly attributed deaths. The UK entered lockdown in March 2020, redistributing its medical workforce and resources. Early estimations suggested at least 4700 extra cancer deaths at 5 years if there was a 3-month delay to surgery. Delays to diagnosis and treatment for esophagogastric (EG) cancers can be particularly detrimental to survival. The aim of this study is to assess the impact of Covid-19 on new cancer referrals to a centralised UK EG cancer centre, including presentation, decision making and treatment. Methods: Patients with EG cancer referred to a tertiary, high-volume centre between March 2019 and March 2021 were reviewed. Patients were stratified into Pre-covid (March 2019-March 2020) and Covid (March 2020- 2021) cohorts. Number of new referrals, clinical stage, treatment decision, and time to treatment were compared for gastric adenocarcinoma (GA), esophagogastric-junction adenocarcinoma (EGJA), esophageal adenocarcinoma (EA) and esophageal SCC (ESCC). Results: There was an 11% reduction in new cancer referrals (485 vs 431). GA, EGJA and EA did not have significant change in treatment intent, although there was a significant increase in the decision for definitive nonsurgical treatment of EA (P = 0.046). GA and EA patients had a small, but significant increase in average clinical stage at presentation (P < 0.05). There was no increase in time to treatment for GA, EGJA and EA. A significantly higher proportion of ESCC patients were given curative intent treatment in the Covid-19 cohort (P = 0.0006) however, this was accompanied with an increased time to treatment (35.8 days vs 27.9 days P = 0.0198). Conclusion: This high-volume centre has seen a reduction in new cancer referrals since the first UK lockdown. This was associated with a small, but significant, increase in clinical stage of GA and EA at presentation. This may represent an early indication of excess esophagogastric cancer deaths due to the impact of Covid-19. This data also confirms initial results showing that oncological decisions were not compromised, although Covid-19 remains a dynamic challenge.

19.
Journal of Mental Health Policy and Economics ; 25(SUPPL 1):S23, 2022.
Article in English | EMBASE | ID: covidwho-1913132

ABSTRACT

Background: Cancer is one of the leading causes of death and has been found to have a significant associated economic burden. That cancer diagnosis comes with a financial burden on patients and survivors is known but little is known about the psychological and social impact of COVID-19 or how the resulting economic environment has exasperated this further. Aims of the Study: This systematic review examines the impact of COVID-19 on cancer patients and survivors from an economic, social and psychological perspective. Methods: A systematic review of the literature published between January 2020 and March 2021 was completed by searching electronic databases. The review protocol was registered on the PROSPERO database. Results were analysed using a thematic analysis approach. Results: A total of 55 articles were identified. Approximately 93% of the psychological studies reviewed reported increased anxiety, depression, psychological distress and worry in cancer patients. Evidence in 50% of social studies reviewed, showed that national stayat- home guidelines compounded and contributed to feelings of increased loneliness and social isolation. While the underlying economic conditions were found to impact health systems both positively and negatively with reports of a modified workflow and transitioning to telemedicine. Discussion and Limitations: National stay-at-home guidelines implemented to stop the spread of the virus and protect vulnerable populations were found to have a negative social effect on patients. Increased anxiety, depression, psychological distress and worry among cancer patients was found. Furthermore, there is evidence of socio-economic inequalities with certain subgroups more vulnerable to the economic strain caused by Covid-19 than others. Psychological strain and financial distress are side effects associated with cancer treatment but COVID-19 exasperated these side effects further. Many of the papers reviewed were reliant on single institutions and lack long term follow-up and in some cases data were only available for short periods which had negative implications on sample size. Implications for Healthcare Provision and Use: COVID-19 has reduced healthcare capacity, adversely impacting delivery and access to healthcare and causing a re-distribution of resources to meet with demand. In addition environmental considerations such as national and institutional COVID-19 guidelines and the reaction/ behaviour of patients to these guidelines will influence both demand and supply behaviour. The underlying economic conditions were found to impact health systems both positively and negatively with reports of a modified workflow and transitioning to telemedicine. Implications for Health Policy: The results provide reflections on how care for cancer patients undergoing treatment were affected by the pandemic. This informs continued plans for the implementation of the National Cancer Strategy and operationalisation plans for Ireland's blueprint for universal health care, Sláintecare. Implications for Future Research: Before COVID-19, studies were already shown to be lacking particularly on the financial burden of cancer on patients. The need for more studies in this area is paramount in order to fully understand the challenges that cancer patients face particularly because of COVID. The systematic review revealed few papers on survivors (two years post treatment)of cancer. The late effects of cancer and its treatment are well documented and extend further than active treatment and with only a few studies reporting on the psychological effects the true impact and risk to survivors is not yet fully understood.

20.
Libri Oncologici ; 50(SUPPL 1):148-149, 2022.
Article in English | EMBASE | ID: covidwho-1894114

ABSTRACT

Introduction: Nivolumab is a PD-1 checkpoint inhibitor that restores the pre-existing antitumor immune response by selectively blocking the interaction between PD-1 receptors on T-cells and PD-1 ligands, PD-L1 and PD-L2, on tumor cells and antigen presenting cells. Nivolumab prolongs survival in patients with metastatic kidney cancer with a good safety profile as demonstrated in the CheckMate 025 clinical trial. Material And Methods: This retrospective data involved prospectively monitored patients (named patient programm) treated with second-line nivolumab for mRCC at the University Hospital Centre Zagreb from 2016 to 2018 and the treatment continued to be funded by the Croatian Health Insurance. Patients with metastatic kidney cancer (mRCC) received tyrosine kinase inhibitors (TKI), (29/30), one patient received mTOR inhibitor as first line therapy, and subsequently they initially received nivolumab 3 mg kg NPP every 2 weeks. Later we applied a monthly dose 480 mg. Nivolumab treatment was continued in patients who did not have disease progression or grade 3 and 4 toxicity. Patients were monitored every three momths with CT of the chest, abdomen and pelvis and laboratory tests (hemathology, biochemistry, T4, TSH). We also respected patients' preference in regard to cycle dynamic by stopping nivolumab therapy or introducing SBRT during nivolumab therapy. Results: We treated a total of 30 patients (22 men and 8 women) with mRCC, who initially received TKI or mTOR therapy with median age 60.2 ± 9.79 years at diagnosis of kidney cancer. Most patients belonged to intermediate-risk groups. Majority of patients (23/30) were treated with sunitinib as the first line treatment after nephrectomy. Six patients had CR (20%) but two of them died in 2021, one of COVID- 19 and one of haed and neck cancer. Currently, 6 (20%) are alive, ECOG=0, 4 (13.3%) have CR without therapy, expressed in months-23, 33, 35 and 53 (treatment-free survival). Median OS first line with TKI therapy was 34 months while median OS second line with nivolumab was 17 months. Patients with sarcomatoid component in pathohistology report have longer survival. Patients with bone metastases have shorter survival to patients with other metastases. Conclusion: Nivolumab demonstrated clinical efficacy in the CheckMate 025 clinical trial and in clinical practice as second line treatment after patients had previously received TKI. Our results show that six years after first cycle of nivolumab as second line therapy 6 out of 30 patient (20%) are alive, ECOG=0. Further research should show which sequence therapy would be the best for each patient. Research about potential immunotherapy biomarkers which would indicate who responds to the therapy and who does not is ongoing.

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