Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 337
Filter
1.
Revista Medica de Chile ; 150(5):625-633, 2022.
Article in Spanish | EMBASE | ID: covidwho-2163842

ABSTRACT

Background: COVID-19 infection can be especially severe in certain risk populations such as patients with hematologic malignancies. Aim(s): To describe the characteristics and clinical outcomes of a population of patients with hematologic malignancies and COVID-19. Material(s) and Method(s): Review of medical records of patients with COVID-19 and hematologic malignancies, treated in Hematology Service of a regional hospital in Chile, between April 1 and October 30, 2020. Demographic characteristics, chronic comorbidities and clinical characteristics related to the underlying disease and COVID-19 infection were recorded. Result(s): Thirty adults aged 17 to 73 years (67% men) with COVID-19 confirmed by RT-PCR, were evaluated. Forty percent had comorbidities, mainly hypertension (30%), obesity (27%) and diabetes (10%). Two thirds of cases came from a nosocomial outbreak and 77% were symptomatic. Half of the cases had mild disease and 20% required mechanical ventilation. Five patients (17%) died from COVID 19. Female sex, the presence of comorbidities and obesity were more common among deceased patients. Only 1 of 5 deceased patients were in complete remission. No differences were found in the mean survival according to requirement for intubation or the presence of complete remission. Conclusion(s): This population with hematologic malignancies and COVID-19 had special characteristics leading to a greater fatality rate which, in this series, does not increase with the use of mechanical ventilation. Copyright © 2022 Sociedad Medica de Santiago. All rights reserved.

2.
Journal for ImmunoTherapy of Cancer ; 10(Supplement 2):A1432, 2022.
Article in English | EMBASE | ID: covidwho-2161960

ABSTRACT

Background Immune checkpoint inhibitors (ICI) revolutionized solid tumor treatment, however, in many tumors only partial response is achieved. Allocetra-OTS has an immune modulating effect on macrophages1 and showed an excellent safety profile in patients including patients with sepsis.2 Here we investigated the anti-tumoral effect of Allocetra-OTS cellular therapy, in solid tumor animal models. Methods Allocetra-OTS is manufactured from enriched mononuclear fractions and induced to undergo early apoptosis. In an immunecompetent model, Balb/c mice were inoculated intraperitoneally (IP) with AB12 (mesothelioma) with pLenti-PGK-V5-Luc-Neo and treated with anti-CTLA4 with or without Allocetra-OTS. Mice were monitored daily for clinical score and weekly using IVIS. Kaplan-Meier log rank test was done for survival. For Allocetra-OTS preparation, enriched mononuclear fractions were collected by leukapheresis from healthy eligible human donors and induced to undergo early apoptosis.To follow tumor growth in vivo, HeLa-CD19 cells were stably transduced with pLenti-PGK-V5-Luc-Neo. For CAR preparation, fresh mononuclear cells (MNC) were transfected with CD19-CAR plasmids. SCID-Bg mice were injected IP with human HeLa-CD19 or HeLa-CD19-luciferase cells, 10x10 allocetraOTS or vehicle, and 10x10 CD19-CAR T cells or mock T cells. Results In immune competent Balb/c mesothelioma model, anti-CTLA4 standalone therapy significantly improved survival from mean 34+/-9 to 44.9 +/-20 days (p<0.05). Similarly, Allocetra- OTS standalone therapy improved survival to 52.3 +/-20 days (p<0.02). However, anti-CTLA4 + Allocetra-OTS combination therapy, ameliorated survival to 86.7+/-20 days (p<0.0001) with complete cancer remission in 60-100% of mice (figure 1 & 2). Similar anti-tumoral effects of Allocetra- OTS were seen in mesothelioma model in a combination therapy with either anti-PD1 or cisplatin. In the CAR-T model, SCID-Bg mice were sacrificed or died from tumor progression in 30+/-5 days (range 27-37). CAR T cell therapy significantly improved survival to 55+/-11 days (p < 0.05 vs MOCK) but Alloctra-OTS further improved survival to 75+/-10 (p < 0.001) with 20-40% complete remission. Conclusions During IP tumor progression, Allocetra-OTS as a standalone therapy or in combination with ICI, cisplatin or CAR-T therapy, significantly reduced tumor size and resulted in complete remission in up to100% treated mice. Based on excellent safety profile in > 40 patients treated in prior clinical trials for sepsis and Covid-19, Phase I/II clinical trial of Allocetra-OTS plus chemotherapy has started and first patient already recruited. A second Phase I/II clinical trial of Allocetra-OTS plus anti-PD1, as a second- and third-line therapy in various cancers, is planned for Q4 2022.

3.
Journal for ImmunoTherapy of Cancer ; 10(Supplement 2):A1353, 2022.
Article in English | EMBASE | ID: covidwho-2161959

ABSTRACT

Background Clonal hematopoiesis (CH) is an age-related phenomenon characterized by the overrepresentation of blood cells arising from a single, mutant clone and is detectable in 10-20% of individuals over 70.1 CH has now been implicated in a variety of non-hematological disorders, such as cardiovascular diseases and Covid-19 infections, by exacerbating the innate inflammatory response.2-4 However, the impact of CH in solid tumors and response to immune checkpoint blockade (ICB) is unknown. Methods To assess the prevalence and role of CH in patients with solid tumors, we analyzed publicly available data from the MSKCC-IMPACT study.5, 6 To mechanistically study CH in solid tumors, we established an orthotopic model of pancreatic adenocarcinoma (PDAC) in mice with Tet2+/- CH. CH and WT mice were treated with either ICB (aCTLA-4 + aPD-1) or vehicle control. Single-cell (sc-) RNAseq was performed on tumor infiltrating lymphocytes (n=3/group) while remaining mice were observed for disease progression and overall survival (n=10/group). Results Analyzing CH frequencies in a cohort of patients with solid tumors, we observed that the prevalence of CH was approximately 5 times higher in patients with cancer when compared to healthy age-matched controls. Further, patients with detectable CH clones had significantly worse overall survival (figure 1A). In vivo, sc-RNAseq data revealed that myeloid cells present within the pancreatic tumors of mice with Tet2+/- CH were significantly enriched for both type I and type II interferon (IFN) signaling (figure 1B). Further, these IFN+ myeloid cells were ablated after ICB therapy in Tet2+/+ WT mice but persisted in mice with Tet2+/- CH (figure 1C). PDAC tumors from mice with Tet2+/- CH had approximately half the total number of infiltrating CD8 T cells at baseline when compared to those from Tet2+/+ WT mice. Upon ICB treatment, CD8 effector cells only expanded in the tumors from Tet2+/+ WT mice. Functionally, this translated to more rapidly progressing tumors, resistance to ICB, and reduced overall survival in mice with Tet2+/- CH (figure 1D). Conclusions CH is present in upwards of 30% of patients with solid tumors and is associated with significantly worsened prognosis. Modeling PDAC in the presence of Tet2+/- CH in vivo revealed distinct alterations in the tumor microenvironment that ultimately influenced tumor progression and response to ICB. This proposed research bridges the fields of solid tumor immunology and clonal hematopoiesis to address novel mechanisms of immunotherapy resistance that will span cancer type and, ultimately, improve patient care.

4.
Journal for ImmunoTherapy of Cancer ; 10(Supplement 2):A959-A960, 2022.
Article in English | EMBASE | ID: covidwho-2161950

ABSTRACT

Background Immunotherapy is one of the most prominent therapies for NSCLC patients. While there is a lot of promise, adverse events (AEs) due to immunotherapies are a concern. Entering the era of COVID-19, the interaction of COVID-19 vaccination status with immunotherapy is not fully understood. 1-2 As most newly diagnosed NSCLC patients will be vaccinated, understanding this interaction is important for managing their treatment. This study aims at determining whether COVID-19 vaccination status has any significant effect on AEs and outcomes of aNSCLC patients treated with immunotherapies in 1st line. Methods This retrospective study leverages ConcertAI's NSCLC Patient360TM dataset, a deeply curated real-world oncology dataset with patients from across the United States. aNSCLC patients who started 1st line treatment containing an immunotherapy at least 30 days after their last COVID-19 vaccine were included in the vaccine-primed cohort (N= 138). 1st line treatment in these patients started between January 2021 - April 2022. Similarly, a cohort of vaccine-naive patients was created by including all patients in the dataset who received their 1st line immunotherapy treatment between January 2019 - April 2020 (N=1537) to ensure none of them received COVID-19 vaccine prior to immunotherapy treatment. Descriptive analysis on these cohorts showed no significant differences in terms of age, race, gender and treatment patterns. AEs for each patient during the course of 1st line immunotherapy treatment were identified. These AEs were categorised into 5 levels (table 1). To normalise the effect of length of treatment, AE/time on immunotherapy was calculated. Progression-Free Survival (PFS) and Overall Survival (OS) from start of L1 was also compared between the two cohorts. Results 56% vaccine-naive and 54% vaccine-primed patients had an AE while on immunotherapy. The distribution of severity of AEs between the two cohorts was also quite similar (table 2). Although the AE/time was higher in the vaccinenaive cohort (p-value=0.03) (figure 1), this effect was mostly driven by 41 (2.6%) outlier patients who had many AEs in a very short span of time after starting immunotherapy. We believe such outliers were not seen in the vaccine-primed cohort primarily due to its smaller sample size. OS and PFS were similar between the two cohorts (figures 2 and 3). Conclusions COVID-19 vaccination status does not affect frequency or severity of immunotherapy related AEs or have a significant impact on patients' outcomes. As more data becomes available on the vaccine-primed cohort the impact on rarer patient sub-populations can be evaluated. (Figure Presented).

5.
Hepatology ; 76(Supplement 1):S1379-S1380, 2022.
Article in English | EMBASE | ID: covidwho-2157786

ABSTRACT

Background: Screening for hepatocellular carcinoma (HCC) is associated with earlier stage at diagnosis and longer HCC-specific survival after diagnosis, but recent studies in Veterans Affairs (VA) cohorts have reached contrasting conclusions regarding this association. Few studies have evaluated screening and overall survival. Direct-acting antivirals (DAAs) for HCV have altered the natural history of HCV cirrhosis. We evaluated screening and overall survival in the post-DAA and pre-COVID era in a national cohort of veterans with cirrhosis largely due to alcohol and HCV. Method(s): All adults in VA care with CTP A or B cirrhosis for at least 1 year prior to January 1, 2015 were followed for incident HCC and all-cause mortality through December 31, 2019. Patients were censored at development of CTP C cirrhosis or maximum follow-up. Percent of time up to date with screening (PTUDS) for eligible follow up was calculated using relevant cross-sectional imaging. Time-updating age, MELD, and comorbidity score were identified for 180-day windows. We used Cox proportional hazards regression to compare survival time after HCC diagnosis by PTUDS and logistic regression to assess 3-year all-cause mortality after HCC diagnosis. Result(s): A total of 21,441 veterans were included, of whom 4.2% developed CTP C cirrhosis, 34.3% died, and 61.6% were censored at maximum follow-up. In all, 30.3% had cirrhosis from alcohol, 24.6% from HCV, 23.4% from alcohol/HCV, and 17.7% from NAFLD. There were 2,021 incident HCCs. Adjusting for time-updating age, MELD, and comorbidities, as well as etiology of cirrhosis, race, tobacco, BMI, CTP class, and GI and PCP visit density per year of follow-up, PTUDS was associated with decreased mortality in veterans diagnosed with HCC (HR for 10% increase in PTUDS 0.90, 95% CI 0.88-0.92). Restricting to those with HCV cirrhosis, PTUDS was associated with decreased mortality in those who cleared HCV (HR=0.88, 95% CI 0.85-0.91) but not in persistently HCV positive patients (HR=0.98, 95% CI 0.95-1.02). Among veterans diagnosed with HCC by December 31, 2016, PTUDS was associated with decreased 3-year overall mortality adjusting for age, MELD, and comorbidities at time of HCC diagnosis (OR for 10% increase in PTUDS 0.76, 95% CI 0.68-0.86). Restricting to those affected by HCV, the association was stronger in those who cleared HCV (OR=0.72, 95% CI 0.62-0.84) than those persistently HCV positive (OR=0.84, 95% CI 0.71-0.99). Conclusion(s): Screening is associated with both longer survival and greater 3-year overall survival in veterans with CTP A and B cirrhosis diagnosed with HCC, in particular among those who have cleared HCV.

6.
Hepatology ; 76(Supplement 1):S1184, 2022.
Article in English | EMBASE | ID: covidwho-2157773

ABSTRACT

Background: Patients with decompensated cirrhosis and ascites are at risk for developing acute kidney injury (AKI), occurring in 20-49% of patients. Those with recurrent or refractory ascites requiring regular large volume paracentesis (LVPs) are at greater risk for AKI because of their advanced cirrhosis, abnormal hemodynamics and frequent fluid shifts from the LVPs. Aim(s): To assess the natural history of renal function in ascitic cirrhotic patients who require regular LVPs. Method(s): A single centre retrospective study including all ascitic cirrhotic patients who attended for outpatient regular LVPs from April 2020 to March 2021, excluding those with COVID infection, hepatocellular carcinoma exceeding Milan's criteria, or extensive non-liver malignancy. Data collected included demographics, paracentesis details, albumin infusions, renal function at baseline and during 3-month (M) follow-up, especially any AKI details, hospital admissions and survival. Result(s): 87 (M:57, F:30;62.0+/-11.3 yrs;MELD-Na: 17.6+/-4.8) mostly alcoholic (47%) and NASH (25%) patients who attended for regular LVPs were included. 14 patients had history of variceal bleed, 26 had a history of encephalopathy (HE). Ascites had been present for 17+/-24M at enrolment, and 12 patients had prior spontaneous bacterial peritonitis. LVP had started 9+/-11M earlier. The mean # of LVPs was 4.2+/-2.6/M with 7.3+/-2.6L of ascites removed/LVP, receiving 90.5+/-38gm/M albumin with the LVPs. The mean serum creatinine (sCr) at enrolment was 100.9+/-50.3mumol/L, with 12 patients fulfilling the KDIGO's criteria for chronic kidney disease (CKD), due to diabetes or hypertension or both. 23 patients were diagnosed to have AKI at enrolment, 3 with background CKD. 5 patients required hospital admission. Table shows the details of AKI at enrolment. During 3M follow-up, 15 episodes of AKI (stage 1: n=9, stage 2: n=6) recurred in 11 patients, with the final sCr at 3M at 113+/-90mumol/L. 17 patients had 26 admissions in 3M, mostly related to cirrhosis complications (AKI/ HRS: n=4, HE: n=4;ascites related: n=4, GI bleed: n=4;infection (n=6). There was 1 liver transplant and 7 liver related deaths. Conclusion(s): CKD is becoming common among ascitic cirrhotic patients requiring LVPs. Irrespective of CKD presence, such patients frequently develop AKI, although mostly stage 1, but recur often, leading to gradual worsening of renal function within 3 M. This subset of patients needs close monitoring and future strategies to prevent AKIs.

7.
Pakistan Journal of Medical and Health Sciences ; 16(10):182-184, 2022.
Article in English | EMBASE | ID: covidwho-2156411

ABSTRACT

Background: A hypersensitivity condition called cytokine storm is the main cause of death in COVID-19 patients. A monoclonal antibody called tocilizumab may be able to suppress the Interleukin-6 receptors (IL-6R) and lessen the likelihood that the body would have a hypersensitive immune response. Aim(s): To evaluate the mortality advantages of tocilizumab in individuals with COVID-19. Study design: Retrospective study. Place and duration of study: Bahria Town International Hospital Lahore from 16th June 2020 to 17th September 2021. Methodology: Patients with 96 confirmed instances of COVID-19 were enrolled. Two groups of patients were created. A single dosage of tocilizumab was administered to 52 participants in the first group, referred to as the survivors, and 44 patients in the second group, who passed away within 14 days. From the patients' medical records, the demographic information, co-morbid conditions, and laboratory values were obtained. The hospital's institutional review board and ethics committee (IRBEC) gave its approval for this study. The permission was ignored because this was a retroactive analysis. Result(s): 54.24 16.58 was the average age, and 54 (56.25%) of the population were men. 52 (54.16%) patients were survivors, compared to 44(45.83%) patients in the non-survivor group. In non-survivors compared to survivors, the older age group was shown to be statistically significant (62.78+/-12.86 vs. 51.65+/-11.68, p=0.003). Additionally, non-survivors had a greater BMI (p=0.006). In our study, hypertension and diabetes were the two co-morbid conditions that were most frequently detected (35.24% and 28.94%, respectively). The mortality rates among patients with diabetes, asthma, COPD, and cancer were all considerably higher (P=0.01, 0.006, and 0.004, respectively). Cancer and type-2 diabetes patients had death rates that were considerably higher (p=0.05 and p=0.01, respectively). C-reactive protein (CRP), D. Dimer, procalcitonin (PCT), and IL-6 were discovered to be the significant predictors of mortality (p 0.0001, 0.05, 0.001, and 0.004 respectively). Conclusion(s): Even though tocilizumab is authorised and has been shown to have positive results, people with diabetes, COPD, and asthma are more likely to experience negative results even after getting a single dosage of the medication. Similar to CRP, D. Dimer levels are reliable indicators of death. Copyright © 2022 Lahore Medical And Dental College. All rights reserved.

8.
HemaSphere Conference: 12th International Symposium on Hodgkin Lymphoma, ISHL ; 6(Supplement 5), 2022.
Article in English | EMBASE | ID: covidwho-2124562

ABSTRACT

The proceedings contain 115 papers. The topics discussed include: FDG-PET and serum TARC levels after one cycle of BV-AVD in advanced stage Hodgkin lymphoma patients: results from the very early pet-response adapted EORTC-COBRA trial;treatment related morbidity in patients with classical Hodgkin lymphoma: results of the ongoing, randomized phase III HD21 trial by the German Hodgkin study group;a retrospective study to evaluate the reliability of staging and risk stratification of adolescent and adult patients with Hodgkin's lymphoma registered in the lymphoma clinic at Tata Memorial Center;advanced stage classical Hodgkin lymphoma (CHL) patients with a positive interim-pet (Pet-2) Deauville Score (DS) 5 after 2 ABVD cycles: a pooled analysis of individual patient data of three multi-center trials;age, histotype and stage iv are associated with a shorter survival in patients with Hodgkin lymphoma, even the pet-adapted era. a single center retrospective study;clinical outcome of classical Hodgkin lymphoma patients receiving systemic anti-lymphoma treatment during SARS-CoV-2 positivity: results from the chemo-covid study on behalf of Fondazione Italiana Linfomi;comparative efficacy of the R-BEACOPP-14 and R-CHOP regimens in the treatment of patients with advanced stages of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) with THRLBCL-like histopathological growth patterns in the tumor biopsy;and improved overall survival with first-line brentuximab Vedotin Plus chemotherapy in patients with advanced stage III/IV classical Hodgkin lymphoma: an updated analysis of ECHELON-1.

9.
Oncogematologiya ; 17(3):119-126, 2022.
Article in Russian | EMBASE | ID: covidwho-2145729

ABSTRACT

Background. Oncohematological patients are more predispose to SARS-CoV-2 infection than healthy individuals and patients with malignant neoplasms, and also they have a worse prognosis, which is because of immune system disorders, both due to the underlying disease and as a result of immunosuppressive therapy. There is limited data regarding the impact of SARS-CoV-2 infection on the survival of patients with chronic myeloid leukemia (CML). Aim. To evaluate the course and outcome of COVID-19 in patients with CML in the Orenburg region during the SARS-CoV-2 pandemic. Materials and methods. All 166 patients with CML over 18 years of age were analyzed during the COVID-19 pandemic between february 2020 and December 2021. The source of information was data from the personalized register of patients with CML and the unified state health information system. Results. The proportion of SARS-CoV-2 infection among patients with CML was 36 %. The risk of infection was not affected by age, gender, work features, place of residence, phase or duration of the disease, and therapy. underwent COVID-19 patients were 1.6 times more likely to be overweight and 2 times more likely to have a second cancer. A significant increase in the number of outpatient visits to polyclinics and number of hospital admissions during the pandemic was revealed in the group of patients who had SARS-CoV-2 infection. underwent COVID-19 patients were over 60 years of age in 48.3 % of cases and had one or more comorbidities in 77.6 % cases. SARS-CoV-2-infected patients with CML had a favorable outcome: a mild course of infection in 75.9 % of cases and a low mortality rate - 6.8 % (4 of 58 patients) were observed. COVID-19 was recognized as the cause of death in only 2 patients with optimal molecular response and comorbidity. In two other patients who underwent COVID-19, the progression of CML to a blast crisis was recognized as the cause of death. There were no significant differences in mortality level in the group of patients who had SARS-CoV-2 infection and those who did not have COVID-19. Conclusion. patients with CML living in the Orenburg region have a low susceptibility to SARS-CoV-2 infection and a mild course of the disease. The mortality rate for CML patients infected with SARS-CoV-2 was 6.8 %. unfavorable factors in the overall survival of patients with CML infected with SARS-CoV-2 were high comorbidity and blast crisis. Reducing the number of outpatient visits during the pandemic and using remote medical consultations is likely to reduce the risk of SARS-CoV-2 infection. Copyright © 2022 ABV-Press Publishing House. All rights reserved.

10.
Russian Journal of Cardiology ; 26(10):86-98, 2021.
Article in Russian | EMBASE | ID: covidwho-2145624

ABSTRACT

Aim. To study the clinical course specifics of coronavirus disease 2019 (COVID-19) and comorbid conditions in COVID-19 survivors 3, 6, 12 months after recovery in the Eurasian region according to the AKTIV register. Material and methods. The AKTIV register was created at the initiative of the Eurasian Association of Therapists. The AKTIV register is divided into 2 parts: AKTIV 1 and AKTIV 2. The AKTIV 1 register currently includes 6300 patients, while in AKTIV 2 - 2770. Patients diagnosed with COVID-19 receiving in-and outpatient treatment have been anonymously included on the registry. The following 7 countries participated in the register: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic, Republic of Moldova, Republic of Uzbekistan. This closed multicenter register with two non-overlapping branches (in-and outpatient branch) provides 6 visits: 3 in-person visits during the acute period and 3 telephone calls after 3, 6, 12 months. Subject recruitment lasted from June 29, 2020 to October 29, 2020. Register will end on October 29, 2022. A total of 9 fragmentary analyzes of the registry data are planned. This fragment of the study presents the results of the post-hospitalization period in COVID-19 survivors after 3 and 6 months. Results. According to the AKTIV register, patients after COVID-19 are characterized by long-term persistent symptoms and frequent seeking for unscheduled medical care, including rehospitalizations. The most common causes of unplanned medical care are uncontrolled hypertension (HTN) and chronic coronary artery disease (CAD) and/or decompensated type 2 diabetes (T2D). During 3-and 6-month follow-up after hospitalization, 5,6% and 6,4% of patients were diagnosed with other diseases, which were more often presented by HTN, T2D, and CAD. The mortality rate of patients in the post-hospitalization period was 1,9% in the first 3 months and 0,2% for 4-6 months. The highest mortality rate was observed in the first 3 months in the group of patients with class II-IV heart failure, as well as in patients with cardiovascular diseases and cancer. In the pattern of death causes in the post-hospitalization period, following cardiovascular causes prevailed (31,8%): acute coronary syndrome, stroke, acute heart failure. Conclusion. According to the AKTIV register, the health status of patients after COVID-19 in a serious challenge for healthcare system, which requires planning adequate health system capacity to provide care to patients with COVID-19 in both acute and post-hospitalization period. Copyright © 2021, Silicea-Poligraf. All rights reserved.

11.
Asia-Pacific Journal of Clinical Oncology ; 18(Supplement 3):193-194, 2022.
Article in English | EMBASE | ID: covidwho-2136610

ABSTRACT

4The University of the sunshine Coast, Sippy Downs, QLD, Australia Background and Aims: Access to health services and quality of life are important factors for long-term cancer survivorship. The COVID-19 pandemic has significantly impacted cancer care globally. In response to the pandemic, reconfiguration of services and adoption of telehealth have been essential for continuation of services, while also offering an alternative approach to cancer care and support. This study explores the role of telehealth in providing health and supportive services to Australian rural/regional cancer patients during COVID-19 and their attitudes on the quality of these services to inform future practice. Method(s): Rural/regional cancer patients and survivors (n = 66) completed an online survey regarding the transition and delivery of health and support services via telehealth during COVID-19. Data was collected as part of a bi-annual survey on client satisfaction at a rural/regional community cancer wellness centre in Australia. Result(s): Participants included 71% females with 48% younger (under 64 years), and 52% older cancer patients and survivors (65 years and over), with a mix of cancer presentations. Younger participants were significantly (p < 0.05) more likely to use allied health services via video/telehealth during COVID-19 compared to their older counterparts. The preferred format for nursing health services in the future was face-to-face (59% for younger and42%for older participants) telehealth (10% for both groups), and mixed (31% for younger and 48% for older participants). Although not statistically significant (p>.05), it is interesting that the older cohort had a greater preference for a mixed modality of face-to-face and telehealth in meeting their future health service needs. Conclusion(s): Telehealth has benefits for the delivery of health and supportive services to rural/regional cancer patients. Nurses can play a key role in assessing the support needs of cancer survivors and facilitate strategies to ensure that survivors have the skills necessary to access telehealth support.

12.
Asia-Pacific Journal of Clinical Oncology ; 18(Supplement 3):216-217, 2022.
Article in English | EMBASE | ID: covidwho-2136605

ABSTRACT

Aim: The 'Ballet after breast cancer' study sought to investigate the feasibility, acceptability, and participant experiences of a 16-week classical ballet intervention for breast cancer survivors, delivered face-to-face and/or online. Method(s): Breast cancer survivors attended 2 x 1-h weekly ballet classes for 16 weeks. Primary outcomes of feasibility and acceptability were assessed according to rates of enrolment and attendance, and feedback questionnaire. Secondary outcomes included quality of life (QOL), upper-body disability, shoulder range of motion (ROM), muscular strength, aerobic capacity, and physical activity levels. Participants were invited to attend study focus groups. Semi-structured discussions regarding perceived changes following ballet participation, program design and delivery, and recommendations for future implementation were subject to thematic analysis. Result(s): Thirty-one participants (77.5% of target) enrolled in the program. Classes commenced face-to-face and moved online due to COVID-19 restrictions. Twenty-nine commenced the intervention [Female, 53.3 +/- 10.8 yrs (Mean +/- SD)] attending 77.6% [67.6, 87.5] (Mean [95%CI]) of sessions. Seventeen participants (54.4 +/- 11.9yrs;54.2 +/- 43 mnths post-diagnosis [Mean +/- SD]) attended focus groups. Based on rates of enrolment and attendance, and participant feedback, the program was deemed feasible and acceptable. Significant improvements in shoulder ROM and reductions in sedentarity were achieved. Participants reported improved physical capacity and psychological, social, and cognitive wellbeing. In discussing experiences, five themes emerged: Embracing normal;Connection to others;Acceptance without judgement;Engagement;Learning and progress. The characteristics of the ballet instructor emerged as key determinants of program engagement/enjoyment. Recommendations to improve future programs included a hybrid delivery model, facilitated socialisation, and the provision of learning resources. Conclusion(s): Classical ballet delivered face-to-face and/or online is a feasible and acceptable activity after breast cancer, leading to perceived improvements in physical, psychological, social and cognitive wellbeing. The study provided preliminary evidence showing ballet can improve shoulder ROM and reduce sedentarity. Findings invite future research investigating the comparative effectiveness of ballet and honing its implementation after breast cancer.

13.
European Urology Open Science ; 44(Supplement 1):S112, 2022.
Article in English | EMBASE | ID: covidwho-2132862

ABSTRACT

Author of the study: The coronavirus disease 2019 (COVID-19) pandemic is leading to delays in the treatment of several urological malignancies. To determine the impact of COVID-19 pandemic on the outcomes of patients with prostate cancer (PCa) treated with robotassisted radical prostatectomy (RARP) at a single tertiary-care center. Material(s) and Method(s): A retrospective study on patients who underwent a RARP at a single institution in two pre-specified time intervals, namely March-July 2019 (pre-COVID) and March-July 2020 (during-COVID), was conducted. Surgical waiting time (SWT) was defined as the period from prostate biopsy to surgery. All patients in the pre-COVID era underwent a specific pre- rehabilitation program, consisting of preoperative pelvic floor muscle exercises starting at least 1-month before RARP, as well as counselling with a prostate casemanager. After surgery, all patients underwent a structured follow-up both with physiotherapists and andrologists. During the COVID period, this specific program was not guaranteed. Continence recovery was defined as no use of pad, while erectile function (EF) recovery was defined as an erection sufficient for intercourse. Oncological outcomes were defined as biochemical recurrence and/or imaging evidence of progression. Result(s): A total of 249 patientswere eligible for analysis,136 (54.6%) in the pre-COVID and 113 (45.4%) in the COVID time-span. No significant differences in baseline characteristics, clinical and pathological features were observed between the two groups. Median SWT was 2.9 (2.5-3.1) in 2019 and 5.8 (5.0-7.0) in 2020. Median (IQR) follow-up was 25 (15-27) months. At 45 days, 6 months and 1 year follow-up no significant differences were observed in biochemical recurrence and progression- free survival rates. Biochemical recurrence at last followup was observed in 11 (8.1%) patients of pre-COVID and 3 (2.7%) patients during COVID. At the first follow-up visit 45 days after RARP, 49 (36.0%) patientswere continent and 6 (4.4%) patients had preserved EF in the pre-COVID group period, as compared to 8 (7.08%) and 0 (0%) in the COVID group (p < 0.001 and p = 0.072 respectively). At 6 months, 131 (96.3%) patients `were continent and 30 (22.1%) patients had EF recovery in pre-COVID group, as compared to 77 (68.14%) and 9 (8.0%) in the COVID group (p < 0.001). Finally, at 1 year 134 (98.5%) patients were continent and 50 (36.8%) patients were fully potent in the pre- COVID period, compared with 96 (85.0%) and 19 (16.8%) during COVID (p < 0.001). Conclusion(s): The use of a pre-rehabilitation program, which was routinely used in the pre-COVID era, appears to significantly improve the functional outcomes of patients subjected to RARP. On the other side, surgical delay does not appear to significantlyworsen oncological outcomes, even though these findings are limited by the short followup time. Copyright © 2022 European Association of Urology. Published by Elsevier B.V.

14.
Radiotherapy and Oncology ; 174(Supplement 1):S26-S27, 2022.
Article in English | EMBASE | ID: covidwho-2132763

ABSTRACT

Purpose: To report final results of a clinical trial of APBI using intensity modulated radiotherapy (IMRT) to deliver 27 Gy in 5 daily fractions following breast conserving surgery (BCS) prospectively designed to assess the efficacy and cosmetic outcomes of a oneweek, APBI regimen among women with early breast cancer. Material(s) and Method(s): Women >= 50 years, with lymph nodenegative, ER positive, HER-2 negative breast cancer or ductal carcinoma in situ (DCIS), <= 3cm diameter, following BCS with margins >= 2mm, and excellent or good baseline cosmesis received 27 Gy in 5 daily fractions to the seroma plus 1 cm CTV and 0.7 cm PTV margins. Clinical photographs, patient and provider cosmetic scores, breast fibrosis, telangiectasia and pain were collected prospectively, prior to RT and at 6 weeks, 1 and 2 years after RT. The primary endpoint was the proportion of women who retained Excellent or Good cosmesis at 2 years using the EORTC Cosmetic Rating System. Cosmetic failure was deterioration from Excellent or Good to Fair or Poor. A panel of 5 radiation oncologists independently assessed the cosmetic photographs. Secondary endpoints were rates and grades of breast fibrosis, telangiectasia, breast pain, ipsilateral breast tumour recurrence (IBRT), overall (OS), breast cancer-specific survival (BCSS) and subsequent mastectomy. Efficacy outcomes were assessed at clinic visits and by review of charts. ClinicalTrials.gov registration: NCT02681107. Result(s): A total of 298 patients were treated between April 25, 2016, and October 31, 2019. At a median follow-up of 48 months, the four-year OS was 98.5% (95% CI 96.1% - 99.5%) and BCSS was 99.7% (95% CI 97.6% - 99.9%). The four-year IBRT rate was 3.3% (95% CI 1.1% - 6.4%). There were 10 contralateral breast events for a four-year rate of 3.9% (95% CI 2.2% - 6.9%). There were 10 ipsilateral and six contralateral mastectomies. Two patients died of unrelated causes prior to two years;79 patients declined inclinic attendance due to COVID or competing comorbidities and 217 women had two-year cosmetic photographs and clinical assessments performed. Consensus of the photo-panel cosmesis at baseline was: Excellent: n=116 (53%), Good: n=102 (47%), Fair: n=1 (0.5%) and Poor: n=0. Consensus overall cosmesis at two years was: Excellent: n= 141 (65%), Good: n=78 (35%), Fair: n=0 and Poor: n=0. Most patients had either improved (n=168;77%) or no change (n=43;20%) in cosmesis at two years. No patient had cosmetic failure but 6 (3%) had a change from Excellent to Good at two years. Most patients reported either no (79%) or mild (21%) pain, with no moderate or severe pain. Two patients (0.9%) had Grade 2 fibrosis and five patients (2%) had visible telangiectasia that did not detract from overall cosmesis. Conclusion(s): APBI using 27 Gy in 5 fractions using a conformal IMRT technique, achieved excellent two-year cosmesis with minimal toxicity. The IBRT risk was comparable to the contralateral new breast cancer risk and to local recurrence rates of recently published early breast cancer trials. Copyright © 2022 Elsevier Ireland Ltd. This is an open access article under the CC-BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

15.
Annals of Oncology ; 33(Supplement 9):S1503-S1504, 2022.
Article in English | EMBASE | ID: covidwho-2129909

ABSTRACT

Background: In the PAOLA-1/ENGOT-ov25 (NCT02477644) primary analysis, adding ola to maintenance bev after first-line (1L) platinum-based chemotherapy (PBC) + bev led to a significant progression-free survival (PFS) benefit in AOC (HR 0.59, 95% CI 0.49-0.72;P<0.001), particularly in pts with homologous recombination deficiency (HRD+;BRCA1/2 mutation [BRCAm] and/or genomic instability;Ray-Coquard et al NEJM 2019). Here, we report the prespecified final OS analysis. Method(s): Pts with high-grade AOC, in response after PBC + bev, were randomized 2:1 to ola tablets (300 mg bid;up to 24 months [mo]) + bev (15 mg/kg q3w;15 mo total) or placebo [pbo] + bev. OS (intent-to-treat [ITT] population) was a key secondary endpoint, with analysis planned for 3 years after the primary analysis as part of hierarchical testing. Result(s): 537 pts were randomized to ola + bev and 269 to pbo + bev (median follow-up 61.7 and 61.9 mo, respectively;OS data maturity: 55.3%). Median OS in the ITT population was 56.5 mo with ola + bev vs 51.6 mo with pbo + bev (HR 0.92, 95% CI 0.76-1.12;P=0.4118;OS at 5 y, 47.3 vs 41.5%). In HRD+ pts, OS was prolonged with ola + bev (HR 0.62, 95% CI 0.45-0.85;OS at 5 y, 65.5 vs 48.4%), with benefit in HRD+ pts with or without a tumour BRCAm (tBRCAm;Table). No benefit was seen in HRD- pts (HR 1.19, 95% CI 0.88-1.63). Subsequent PARP inhibitor therapy was received by 105 (19.6%) ola + bev pts vs 123 (45.7%) pbo + bev pts. Myelodysplastic syndrome, acute myeloid leukaemia and aplastic anaemia incidence, and new primary malignancy incidence, was respectively: ola + bev, 9 pts [1.6%] and 22 pts [4.1%];pbo + bev, 6 pts [2.2%]) and 8 pts [2.9%]). [Formula presented] Conclusion(s): Despite a high proportion of pts in the control arm receiving a PARP inhibitor post-progression, ola + bev provided a clinically meaningful improvement in OS for 1L HRD+ pts with and without a tBRCAm, confirming ola + bev as standard of care in this setting. Clinical trial identification: NCT02477644. Editorial acknowledgement: Medical writing assistance was provided by Rachel Dodd, PhD, at Cence, funded by AstraZeneca and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Legal entity responsible for the study: AstraZeneca. Funding(s): ARCAGY Research, AstraZeneca, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and F. Hoffmann-La Roche. Disclosure: I.L. Ray-Coquard: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, Mersana, Deciphera, Amgen, Oxnea, Merck Sereno, Agenus, Novartis, Macrogenics, Clovis, EQRX, adaptimmun, Esai, SUTRO;Financial Interests, Institutional, Other, COLIBRI translational research: BMS;Financial Interests, Institutional, Advisory Board, translational research NEOPREMBROV trial: MSD;Non-Financial Interests, Personal, Principal Investigator: PAOLA1;Non-Financial Interests, Personal, Other, President: GINECO. K. Fujiwara: Financial Interests, Personal, Other, Consulting fees and grant support: Pfizer, Eisai, Merck Sharp & Dohme, Taiho, Zeria, Chugai Pharmaceutical, Genmab, Takeda Pharmaceutical;Financial Interests, Personal, Research Grant: Immunogen, Oncotherapy, Regeneron;Financial Interests, Personal, Other, Consulting fees: Novartis, Kyowa Hakko Kirin, Daiichi Sankyo, Mochida Pharmaceutical, NanoCarrier. A. Leary: Financial Interests, Personal, Advisory Board: Zentalis;Financial Interests, Personal, Invited Speaker, Educational: GSK, Medscape, Onko+;Financial Interests, Institutional, Other, Steering committee: MSD;Financial Interests, Institutional, Advisory Board: GSK, AZ, Clovis, Ability Pharma, MSD, Tesaro, Merck Serono, Apmonia, Blueprint;Financial Interests, Institutional, Invited Speaker, Educational: Kephren publishing;Financial Interests, Institutional, Other, Consultancy: Orion;Financial Interests, Institutional, Invited Speaker: Tesaro, AZ, Clovis;Financial Interests, Personal, Other, Consultancy: GLG;Financial Interests, Institutional, Research Grant, PI translational research: ARCAGY-GINECO, Sanofi, A ;Financial Interests, Institutional, Funding, CI clinical trial: AZ;Financial Interests, Institutional, Research Grant, Int CI clinical trial: OSE immuno;Financial Interests, Institutional, Funding, PI clinical trial: Agenus, BMS, Iovance, GSK;Financial Interests, Institutional, Funding, PI 5 clinical trials: Roche;Financial Interests, Institutional, Funding, PI 2 clinical trials: AZ;Financial Interests, Institutional, Funding, PI 3 clinical trials and steering committee: MSD;Non-Financial Interests, Institutional, Other, Academic research project: Owkin, LXRepair;Non-Financial Interests, Personal, Proprietary Information, IDMC member: Clovis;Non-Financial Interests, Personal, Proprietary Information, IDMC chair: Pfizer. S. Pignata: Financial Interests, Personal, Advisory Board: Roche, AZ, MSD, Clovis, GSK, PharmaMar;Financial Interests, Institutional, Funding: Roche, MSD, Pfizer, AZ. A.J. Gonzalez Martin: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Clovis, GSK, Genmab, Alkermes, Sutro, Roche, Sotio, PharmaMar, Oncoinvent, Novartis, Mersana, MSD, Macrogenics;Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, Clovis, Roche, Novocure, MSD;Financial Interests, Institutional, Invited Speaker, PI of ANITA trial: GSK, Roche;Financial Interests, Personal, Invited Speaker, Member of ENGOT ov43-SC: MSD;Financial Interests, Institutional, Invited Speaker, ENGOT PI of EPIK-O trial: Novartis;Financial Interests, Institutional, Invited Speaker, ENGOT PI of AVB-500 phase III trial: ARAVIVE. G. Bogner: Financial Interests, Personal, Advisory Board: AstraZeneca, Roche and GSK;Financial Interests, Personal, Other, Medical conferences: AstraZeneca, Roche and GSK. I.B. Vergote: Financial Interests, Personal, Advisory Board, Consulting: Agenus (2021), Aksebio China (2021), AstraZeneca (2021-2022), Bristol Myers Squibb (2021), Deciphera Pharmaceuticals (2021), Eisai (2021), F. Hoffmann-La Roche Ltd. (2021), Genmab (2021), GSK (2021), Immunogen Inc. (2021-2022), Jazzpharma (2021-2022), Karyopharm (2021), MSD (2021-2022), Novocure (2020-2022), Novartis (2021), Oncoinvent AS (2021-2022), Seagen (2021), Sotio a.s. (2021-2022);Financial Interests, Institutional, Advisory Board, Consulting: AstraZeneca (2019-2020), eciphera Pharmaceuticals (2020), Elevar Therapeutics (2020), F. Hoffmann-La Roche Ltd. (2019-2020), Genmab (2019-2020), GSK (2019-2020), Mersana (2020), MSD (2019-2020), Oncoinvent AS (2019-2020), Sotio a.s. (2019-2020), Verastem Oncology (2020), Zentalis (2020), Amgen (Europe) 2019, Clovis Oncology Inc (2019), Carrick Therapeutics (2019), Millennium Pharmaceuticals (2019);Financial Interests, Institutional, Research Grant, Contracted Research ( via KU Leuven): Oncoinvent AS (2019-2020);Financial Interests, Institutional, Research Grant, Contracted Research (via KU Leuven): Genmab (2019);Financial Interests, Institutional, Research Grant, Corporate sponsored research: Amgen (2019-2020), Roche (2019-2020). N. Colombo: Financial Interests, Personal, Advisory Board, Various: Roche, PharmaMar, AstraZeneca, MSD/Merck, Clovis Oncology, Tesaro, GSK, Pfizer, Takeda, BIOCAD, Immunogen, Mersana;Financial Interests, Personal, Invited Speaker, Congress, Symposia, Lectures: AstraZeneca, Tesaro;Financial Interests, Personal, Invited Speaker, Lectures: Novartis;Financial Interests, Personal, Advisory Board, Lectures: Eisai;Financial Interests, Personal, Advisory Board, Advisory role: Nuvation Bio, Pieris;Financial Interests, Personal, Advisory Board, Advisory Role: Onxerna;Financial Interests, Institutional, Research Grant: AstraZeneca, PharmaMar, Roche;Non-Financial Interests, Personal, Other, Sterring committee member Clinical Guidelines: ESMO;Non-Financial Interests, Personal, Leadership Role, Chair, Scientific Committee: ACTO( Alleanza contro il tumore ovarico). J. Maenpaa: Financial Interests, Personal, Other, Honoraria: AstraZeneca and GSK. F. Selle: Financial Interests, Personal, Other, Honoraria: AstraZeneca, GSK Tesaro, MSD, Sandoz (Novartis), and Clovis Oncology;Financial Int rests, Institutional, Funding: Roche, GSK Tesaro, AstraZeneca, Immunogen, MSD, Incyte, and Agenus. B. Schmalfeldt: Financial Interests, Personal, Other, Honoraria: Roche, AstraZeneca, Tesaro, Clovis, GSK, MSD;Financial Interests, Personal, Advisory Role: Roche, AstraZeneca, Tesaro, Clovis, GSK, MSD;Financial Interests, Personal, Speaker's Bureau: Roche, AstraZeneca, Tesaro, Clovis, GSK, MSD;Financial Interests, Personal, Funding: Roche, AstraZeneca, Tesaro, Clovis, GSK, MSD;Financial Interests, Personal, Other, Travel or accommodation expenses: Roche, AstraZeneca, Tesaro. G. Scambia: Financial Interests, Personal, Invited Speaker, Speaker: Johnson & Johnson, AstraZeneca&MSD, Olympus Europa, Baxter Healthcare, Intuitive Surgical Inc., GlaxoSmithKline;Financial Interests, Personal, Expert Testimony, Trainer: Covidien AG (Medtronic company);Financial Interests, Institutional, Invited Speaker, 'IsoMSLN' in Ovarian Cancer and Malignant Pleural Mesothelioma: Kiromic;Financial Interests, Institutional, Invited Speaker, Roll-over study for patients who have completed a previous cancer study with olaparib and who the investigator believes can benefit from continued treatment - ROSY-O: AstraZeneca;Financial Interests, Institutional, Invited Speaker, CATCH-R: Roll-over study to provide continuous access to clinical therapy with rucaparib.: Clovis Oncology;Financial Interests, Institutional, Invited Speaker, Phase 3, multicenter, placebo-controlled clinical study comparing chemo-immunotherapy (paclitaxel-carboplatin-oregovomab) versus chemotherapy (paclitaxel-carboplatin-placebo) in patients with advanced epithelial ovarian, tubal cancer of fallopian or peritoneal (FLORA-5): Oncoquest Pharmaceuticals Inc.;Financial Interests, Institutional, Invited Speaker, Phase 2b randomized, open-label,active comparator, parallel-group, multicenter study designed to evaluate the efficacy and safety of three different doses of the P2X3 receptor antagonist (BAY 1817080) versus placebo and Elagolix 150 mg in women with symptomatic endometriosis: Bayer AG;Financial Interests, Institutional, Invited Speaker, Usability of ITE transducers for sending electric fields for tumor treatment (TTFields): Novocure Ltd.;Financial Interests, Institutional, Invited Speaker Phase III, multicentre, open-label extension trial to evaluate long-term safety and efficacy in patients with advanced cancers currently undergoing treatment or in follow-up in a pembrolizumab trial.: Merck. E.M. Guerra Alia: Financial Interests, Institutional, Invited Speaker: PharmaMar, Pfizer;Financial Interests, Personal, Invited Speaker: Pfizer. C. Lefeuvre-Plesse: Financial Interests, Personal, Advisory Role: Pfizer, AstraZeneca, Roche, and Daiichi-Sanko;Financial Interests, Personal, Other, Travel/accommodation/medical congress expenses: Roche, Novartis, Pfizer, and Pierre Fabre. A. Belau: Financial Interests, Personal, Other, Honoraria: Roche, AstraZeneca, Clovis, MSD, Daiichi Sankyo Company, Lilly, Seagen;Financial Interests, Personal, Advisory Role: Pfizer, Roche, AstraZeneca, MSD, Lilly, Daiichi Sankyo Company, Seagen;Financial Interests, Personal, Other, Travel or accommodation expenses: Roche, AstraZeneca, Daiichi Sankyo Company. A. lortholary: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD and Tesaro;Financial Interests, Personal, Speaker's Bureau: Clovis Oncology, and Roche;Financial Interests, Personal, Other, Participation in a medical congress: Novartis, Pfizer, MSD, Lilly and Roche. E. Pujade-Lauraine: Financial Interests, Personal, Other, Lecture fees: AstraZeneca, Tesaro, Roche, Clovis Oncology, Incyte, Pfizer;Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Tesaro, and Roche;Financial Interests, Personal, Other, Travel/accommodation: AstraZeneca, Tesaro, and Roche;Financial Interests, Personal, Full or part-time Employment: ARCAGY Research. P. Harter: Financial Interests, Personal, Advisory Board, Value includes honoraria for lectures: AstraZeneca;Financial Interests, Personal, Advisory Board, includes honoraria for lectu es: GSK, Roche, MSD;Financial Interests, Personal, Invited Speaker: Amgen, Stryker, Zailab;Financial Interests, Personal, Advisory Board: Clovis, Immunogen;Financial Interests, Personal, Other, IDMC member: Sotio;Financial Interests, Institutional, Invited Speaker: AstraZeneca, Roche, GSK, Genmab, Immunogen;Financial Interests, Institutional, Funding: Seagen, Clovis. All other authors have declared no conflicts of interest. Copyright © 2022

16.
Annals of Oncology ; 33(Supplement 9):S1467, 2022.
Article in English | EMBASE | ID: covidwho-2129908

ABSTRACT

Background: Atezo + Bev has been approved as first-line treatment in pts with uHCC based on a global phase 3 study (IMbrave 150). However, there is a lack of real-world data worldwide. Thus, we conducted the ELIXIR study to evaluate the safety and efficacy of Atezo + Bev prospectively in 500 real-world Japanese pts. Here, we report the first pre-planned safety assessment in 105 initially registered pts out of 500 pts. Method(s): In this prospective, multicenter, observational study, 500 systemic treatment-naive pts with uHCC and Child-Pugh A received Atezo 1200 mg IV q3w + Bev 15 mg/kg IV q3w. The primary endpoint was adverse events of special interest (AESI). Efficacy outcomes including progression-free survival (PFS) and objective response rate (ORR) were assessed in this analysis. Result(s): A total of 500 pts were enrolled between Apr 2021 and Feb 2022. One hundred and five initially registered pts finished enrollment by Aug 2021 and the median follow-up time was 6.4 mo. A total of 49 AESIs and 35 AESIs Grade >=3 were observed in these pts (Table). Median PFS was 6.0 mo (95% CI, 5.1, 6.7) per RECIST 1.1 and 6.5 mo (95% CI, 5.2, 8.0) per modified RECIST (mRECIST). ORR was 23.8% (95% CI, 16.0, 33.1) per RECIST 1.1 and 34.3% (95% CI, 25.3, 44.2) per mRECIST. [Formula presented]. Conclusion(s): In this analysis, additional safety signals were not observed in Japanese pts. Efficacy data could be underestimated at this time. The ELIXIR study showed that Atezo + Bev is a promising first-line treatment for Japanese pts with uHCC in the real world. Clinical trial identification: UMIN000043463. Editorial acknowledgement: Medical writing assistance for this was provided by Tetsuji Asao, PhD, of SunFlare Co., Ltd. Legal entity responsible for the study: Chugai Pharmaceutical Co., Ltd. Funding(s): Chugai Pharmaceutical Co., Ltd. Disclosure: M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, Ono, Takeda, GlaxoSmithKline;Financial Interests, Personal, Invited Speaker: AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Eli Lilly Japan, Eisai, NIHON SERVIER, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Abbott Japan, Fujifilm Toyama Chemical, Incyte Biosciences Japan, ASLAN, Chugai, NIHON SERVIER, Takeda;Financial Interests, Institutional, Invited Speaker: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, Merck Serono, MSD, Ono, Yakult, Novartis, Takeda, J-Pharma, Pfizer, Chiome Bioscience, NIHON SERVIER, Delta-Fly Pharma, Syneos Health, Merus.N.V. N. Kato: Financial Interests, Personal, Invited Speaker: Gilead Sciences Inc., AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., Olympus Corporation, Eisai Co., Ltd., Aska Pharmaceutical Co., Ltd., Tsumura & Co., Mochida Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., Covidien Japan Inc., Eli Lilly Japan K.K., Nobelpharma Co., Ltd., Kowa Company, Ltd., Incyte Biosciences Japan GK, Yakult Honsha Co.,Ltd., Olympus Marketing, Inc., Taisho Pharmaceutical Co.,Ltd., Janssen Pharmaceutical K.K.;Financial Interests, Institutional, Research Grant: AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Sumitomo Dainippon Pharma Co., Ltd., Shionogi & Co., Ltd., Eisai Co., Ltd., Tsumura & Co., Nippon Kayaku Co., Ltd., JIMRO Co., Ltd., Kowa Company, Ltd. T. Kagawa: Financial Interests, Personal, Invited Speaker: AbbVie, Eisai, Chugai, Sumitomo Pharma, Gilead, EA Pharma, Asuka, Takeda, Miyarisan, Otsuka, Eli Lilly, Kowa, Bayer;Financial Interests, Personal, Funding: AbbVie, Chugai, Sumitomo Pharma, Diichi Sankyo, Tanabe Mitsubishi, Takeda, MSD, Eisai, Shionogi, EA Pharma, Otsuka, Kyowa Kirin, Sanofi, Teijin, Eli Lilly. T. Yamashita: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Lilly, Bayer;inancial Interests, Institutional, Invited Speaker: Bristol Myers Squibb, MSD, Ono. M. Moriguchi: Financial Interests, Personal, Invited Speaker: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd.;Financial Interests, Personal, Advisory Board: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd.;Financial Interests, Institutional, Funding: MSD K.K. Eisai Co., Ltd., Bristol Myers Squibb K.K., Bayer Yakuhin, Ltd. H. Iijima: Financial Interests, Institutional, Funding: Canon Medical systems, GE healthcare. K. Ohkawa: Financial Interests, Personal, Invited Speaker: Gilead, Eisai, Century Medical, Takeda;Financial Interests, Personal, Research Grant: Towa, Sumitomo Chemical. R. Sugimoto: Financial Interests, Personal, Invited Speaker, Speaker and moderator fees: Eisai Co, Eli Lilly Japan K.K., Ono Pharmaceutical Co., Ltd.;Financial Interests, Personal, Invited Speaker, Speaker fees: Gilead Sciences, Chugai Pharmaceutical Co., Ltd.;Financial Interests, Personal, Invited Speaker, Speaker fees: Bayer Yakuhin Ltd, Nobelpharma Co., Ltd., Takeda Pharmaceutical Company Limited. T. Takehara: Financial Interests, Personal, Invited Speaker: Chugai;Financial Interests, Institutional, Research Grant: Chugai. M. Kudo: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Eli Lilly, Bayer, Takeda, MSD;Financial Interests, Institutional, Research Grant: Otsuka, Sumitomo Dainippon Pharma, EA Pharma, Taiho, Eisai, AbbVie, Gilead Sciences, Takeda, GE Healthcare, Chugai. K. Yamamoto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, CMIC holdings, Johokiko, Triceps, Kanagawa Medical Practitioners Association;Financial Interests, Personal, Other, Statistical analysis: Otsuka Pharmaceutical;Financial Interests, Personal, Other, Statistical consultation: J-Pharma, Craif, Kanagawa Prefectural Hospital Organization;Financial Interests, Institutional, Other, unlimited grant: Taiho Pharmaceutical;Financial Interests, Institutional, Other, Unlimited grant: Boehringer Ingelheim, Ono Pharmaceutical, Takeda Pharmaceutical, Bayer Yakuhin, Daiichi-Sankyo, Astellas, Kyowa Kirin, Data Vehicle Inc., EP Croit. All other authors have declared no conflicts of interest. Copyright © 2022

17.
Annals of Oncology ; 33(Supplement 9):S1459-S1460, 2022.
Article in English | EMBASE | ID: covidwho-2129907

ABSTRACT

Background: In an interim analysis of Asian pts with uHCC in the observational REFINE study of regorafenib (NCT03289273), treatment-emergent adverse events (TEAEs) were consistent with those reported in the global, phase 3 RESORCE trial. Here, we present the final analysis of Asian pts with uHCC in REFINE. Method(s): REFINE is an international, prospective, multicenter study that enrolled pts with uHCC for whom a decision to treat with regorafenib was made by the treating physician prior to enrollment, according to the local health authority approved label. The primary objective is safety, including the incidences of TEAEs and dose modifications due to TEAEs (NCI-CTCAE v4.03). Secondary endpoints include overall survival, progression-free survival, and treatment duration. Result(s): Of the 1005 evaluable pts, 557 (55%) were from Asia (Korea [31%], Japan [26%], Taiwan [24%], China [18%], Thailand [1%]) and 82% were male. At baseline, median age was 65 years (range 21-94) and the most common HCC etiology in Asian pts was hepatitis B (60%) and in non-Asian pts was alcohol use (36%;Table). More Asian pts (71%) had received prior transarterial chemoembolization vs non-Asian pts (42%). The initial daily regorafenib dose was 160/120/80/40 mg in 51%/12%/35%/3% of Asian pts and 42%/9%/45%/4% of non-Asian pts. The median treatment duration was 3.7 months (range 0-34.4) in Asian pts and 3.6 months (range 0-38.9) in non-Asian pts. The most common TEAEs in Asian pts were hand-foot skin reaction (40%), diarrhea (27%), and decreased appetite (17%). TEAEs led to dose modification in 44% of Asian pts. [Formula presented]. Conclusion(s): These final data from REFINE confirm the safety and effectiveness of regorafenib in Asian pts with uHCC from a broad population in real-world practice. Final analyses from REFINE are ongoing and will be presented at the conference. Clinical trial identification: NCT03289273. Editorial acknowledgement: Editorial assistance in the preparation of this manuscript was provided by Matthew Reynolds of OPEN Health Communications (London, UK), with financial support from Bayer. Legal entity responsible for the study: Bayer. Funding(s): Bayer. Disclosure: Y.J. Kim: Financial Interests, Personal, Advisory Role: Bayer, Bristol Myers Squibb, Samil, PharmaKing, Celltrion, Bukwang;Financial Interests, Personal, Invited Speaker: Roche, AbbVie, Eisai, Ipsen, Boston Scientific, Bristol Myers Squibb, BTG, Bayer, MSD, Gilead Sciences, Novo Nordisk, Green Cross Cell, Boehringer Ingelheim, AstraZeneca;Financial Interests, Personal, Funding: BTG, Bayer, Boston Scientific, AstraZeneca, Gilead Sciences, Samjin, BL&H. M. Kurosaki: Financial Interests, Personal, Speaker's Bureau: Gilead Sciences, AbbVie, Eisai, Chugai, Lilly, Takeda. H.Y. Lim: Financial Interests, Personal, Advisory Role: Bayer, Eisai, Roche, Ipsen. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, Nihon Servier, Novartis, Ono, Takeda, GlaxoSmithKline;Financial Interests, Personal, Invited Speaker: AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Eli Lilly Japan, Eisai, Nihon Servier, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Abbott Japan, Fujifilm Toyama Chemical, Incyte Biosciences Japan, ASLAN, Chugai, Nihon Servier, Takeda;Financial Interests, Institutional, Invited Speaker: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, Merck Serono, MSD, Ono, Yakult, Novartis, Takeda, J-Pharma, Pfizer, Chiome Bioscience, Nihon Servier, Delta-Fly Pharma, Syneos Health, Merus.N.V. M. Kudo: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Eli Liiy, Bayer, Takeda, MSD;Financial Interests, Institutional, Research Grant: Otsuka, Sumitomo Dainippon Pharma, EA Pharma, Taiho, Eisai, AbbVie, Gilead Sciences, Takeda, GE Healthcare, Chugai. Y. Huang: Financial Interests, Personal, Advisory Role: Eisai, Bayer, BMS, Ono, Gilead, Lilly, AbbVie, Roche;Financial Interests, Personal, Invited Speaker: Eisai, Bayer, BMS, Ono, Gilead, Lilly, AbbVie, Roche;Financial Inte ests, Personal, Speaker's Bureau: Eisai, Bayer, BMS, Ono, Gilead, Lilly, AbbVie, Roche;Financial Interests, Institutional, Funding: Gilead. N. Kato: Financial Interests, Personal, Invited Speaker: Gilead Sciences Inc., AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., Olympus Corporation, Eisai Co., Ltd., Aska Pharmaceutical Co., Ltd., Tsumura & Co., Mochida Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., Covidien Japan Inc., Eli Lilly Japan K.K., Nobelpharma Co., Ltd., Kowa Company, Ltd., Incyte Biosciences Japan GK, Yakult Honsha Co.,Ltd., Olympus Marketing, Inc., Taisho Pharmaceutical Co.,Ltd., Janssen Pharmaceutical K.K.;Financial Interests, Institutional, Research Grant: AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Sumitomo Dainippon Pharma Co., Ltd., Shionogi & Co., Ltd., Eisai Co., Ltd., Tsumura & Co., Nippon Kayaku Co., Ltd., JIMRO Co., Ltd., Kowa Company, Ltd. C. Hsu: Financial Interests, Personal, Speaker's Bureau: Bristol Myers Squibb, Ono Pharmaceutical, Merck Sharp & Dohme, Roche, Eisai;Financial Interests, Institutional, Funding: Ono Pharmaceutical, AstraZeneca, MSD, Merck Serono, Taiho Pharmaceutical, Bristol Myers Squibb, BeiGene, NuCana BioMed, Johnson & Johnson, Roche/Genentech, BeiGene;Financial Interests, Personal, Advisory Role: Ono Pharmaceutical, MSD, Bristol Myers Squibb, Merck Serono, Roche/Genentech. B. Chewaskulyong: Financial Interests, Personal, Advisory Role: Pfizer, STADA;Financial Interests, Personal, Invited Speaker: AstraZeneca, Pfizer, DKSH, Janssen, BMS, MSD, Roche, TAIHO;Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Pfizer, DKSH, Janssen, BMS, MSD, Roche, TAIHO;Financial Interests, Institutional, Funding: Bayer. J. Khan: Financial Interests, Institutional, Full or part-time Employment: Bayer. K. Ozgurdal: Financial Interests, Institutional, Full or part-time Employment: Bayer;Financial Interests, Personal, Stocks/Shares: Bayer. All other authors have declared no conflicts of interest. Copyright © 2022

18.
Research and Practice in Thrombosis and Haemostasis Conference ; 6(Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2128258

ABSTRACT

Background: There is an association between Coronavirus Disease 2019 (COVID-19) and coagulation abnormalities. Platelet monitoring is important for COVID-19 because abnormalities can occur in terms of quantity and quality. Impaired function of platelets can occur at the activation or aggregation stages. An increase in CD62P is associated with a 1.7-fold increased risk of venous thrombosis. In the event of thrombosis, platelet activation causes interactions between fibrinogen and GP IIb/IIIa molecules which will form intracellular bonds between platelets, causing platelet aggregation. This suggests the role of CD62P as a major marker of platelet activation and may mediate cancer cell adhesion, inflammation, and thrombosis Aims: This study aims to determine the description of platelet function as reflected in CD62P platelet expression in COVID-19 patients Methods: This study is a prospective study that take place from November 2020 to September 2021 at RSUP Dr. Sardjito, Yogyakarta, Indonesia. The subjects involved were adult patients aged over 18 years, men and women with confirmed COVID-19 through PCR swab results. Patients with leukemia, history of coagulation disease, and immunodeficiency were excluded from this study. Flowcytometry analysis using FACS Canto was used to measure CD62P expression on platelets. Antibody used was anti human monoclonal CD41 PE and CD62P FITC antibody. The CD62P examination was carried out on the first day of treatment. Patients were grouped according to the severity of COVID-19 as severe and non-severe. Mann Whitney test was used to compare CD62P platelet expression percentage between groups. Result(s): The CD62P platelet expression on day 1 of the deceased subjects were higher compared to the survived subjects (46.77% vs 43.38%;p = 0.04). On day 1, the severe subjects have a higher mean CD62P platelet expression compared to non-severe subjects (47.88 % vs 39.75%). Conclusion(s): CD62P platelet expression in deceased COVID-19 subjects is higher compared to survived subjects. (Figure Presented).

19.
Journal of the American Society of Nephrology ; 33:35-36, 2022.
Article in English | EMBASE | ID: covidwho-2125946

ABSTRACT

Background: COVID-19 continues to spread worldwide with considerable morbidity and mortality. CKD is among the most prevalent diseases related to COVID-19 mortality. AKI is a common COVID-19 complication. Distinct pandemic waves were observed as a function of specific COVID-19 variants, public health policies and vaccination status. Studies reported changing patient characteristics and outcomes by different waves. However, changes in the effect of clinical risk factors as a function of each wave have not been well studied. Here, we examine the temporal effects of pre-existing CKD (also KDIGO A and G stages) on COVID-19 outcomes by waves. Method(s): We used estimated effective reproduction numbers with US data to define distinct waves. We designed a COVID-19 algorithm based on WHO guidelines, N3C COVID-19 V2.2 and local data characteristics as having >=1 positive SARSCov- 2 RT-PCR or antibody test, or >=3 diagnosis or problem codes if no relevant tests. Comorbidities and outcomes were captured electronically using published algorithms. We used logistic regression and survival analysis to identify predictors of COVID-19 outcomes for each wave. Result(s): Five national waves were identified and mapped to 4 distinct NYC waves observed at Columbia University Medical Center (CUMC). We identified 64246 COVID-19 cases at CUMC, 8% were severe, 18% were hospitalized. The risk of severe COVID-19 was associated with pre-existing CKD, heart disease, diabetes and hypertension in most waves;and lung disease, obesity and cancer in at least one wave. AKI occurred in 49% of severe cases and 35% of hospitalized ones. The risk of AKI was associated with heart failure, obesity, diabetes and cancer in most waves;and CKD, CAD, hypertension and stroke in one or two waves. The risk of AKI was not associated with pre-existing lung disease. A and G stages independently predicted severe COVID-19 and COVID-19 related AKI across all waves. Pre-existing albuminuria significantly predicted COVID-19 mortality independent of G-stage, diabetes, obesity, hypertension, cancer or cardiovascular disease throughout the entire pandemic. Conclusion(s): Pre-existing kidney disease was among the strongest and most consistent clinical predictors of poor COVID-19 outcomes regardless of the pandemic wave. Even in the pandemic late phase, patients with decreased kidney function or albuminuria were at a higher risk of severe COVID-19, AKI and death.

20.
Tumori ; 108(4 Supplement):135-136, 2022.
Article in English | EMBASE | ID: covidwho-2114868

ABSTRACT

Background: Studies evaluating COVID-19 in cancer patients beyond the effects of the infection itself are generally from single institutions, voluntary surveillance registries, or surveys. To extend the limited evidence available, we analyzed both the incidence and one-year mortality of breast cancer (BC) female patients at a population level in Lombardy, the first Italian region affected by the pandemic and the most populous one. Method(s): The regional COVID-19 database, including all SARS-CoV2 cases based on a positive swab result, was integrated with the Regional Health Information System, collecting data from 10 million habitants on primary medical care;hospitalization;pharmaceuticals;and survival status. From the database, we extracted data of newly-diagnosed not previously treated BC patients, including patient characteristics and comorbidities (respiratory insufficiency, diabetes, chronic kidney disease, cerebral vasculopathy, hypertension and cardiovascular disease), BC stage, and treatment. Result(s): The study population consisted of 12912 newlydiagnosed/ not previously treated BC patients, 7349 in 2019 and 5563 in 2020. There were two drops of newly diagnosed cases, one in the first wave (March-May 2020;-37.2%), the other in the second wave (October-December 2020;-15.8%). No major differences were found between characteristics of cases occurring in 2019 and 2020;with the exception of a reduced use of both chemotherapy (86.2% vs 53.4%) and radiotherapy (65.7% vs 42.1%) in 2020. One-year overall survival was 97.6% in 2020 vs 98.3% in 2019, Hazard Ratio [HR] (95% Confidence Interval [95%CI]): 1.51 (1.18-1.93);p=0.0010 at univariate analysis;HR 0.91 (0.71-1.17), p= 0.47, after adjusting for age, stage, BC treatment and comorbidities at multivariable analysis. COVID-19 occurred in 250 of 5563 (4.5%) newly-diagnosed BC cases in 2020. Notably, the time-dependent COVID-19 effect was significantly associated with mortality (multivariable Cox analysis HR 2.25 (1.35-3.74);p=0.0018) even after adjusting for age, stage, treatment and comorbidities. Conclusion(s): Breast cancer incidence and survival were both reduced in 2020, and COVID-19 was an independent predictor of death in BC patients. While follow-up is ongoing to assess long sequelae of COVID-19, these results encourage prevention of infection regardless of BC stage;and at the same time warn against suboptimal treatment and overlooking new diagnoses to ensure a favourable prognostic outcome.

SELECTION OF CITATIONS
SEARCH DETAIL