scholarly journals Safety and preliminary efficacy of the Gam-COVID-Vac vaccine and outcomes of SARS-CoV-2 infection in Russian patients with genitourinary malignancies

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Ilya Tsimafeyeu ◽  
Maria Volkova ◽  
Galina Alekseeva ◽  
Maria Berkut ◽  
Alexander Nosov ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Rt Pcr ◽  
Injection Site Reactions ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Common Grade ◽  
Anonymized Data ◽  
Grade 3 ◽  
Pcr Test

Abstract Background To our knowledge, there is no clinical data pertaining to COVID-19 outcomes and safety of COVID-19 vaccination in Russian patients with genitourinary (GU) malignancies. Aim of our analysis was to describe the characteristics of the COVID-19 infection course as well as preliminary safety and efficacy of Gam-COVID-Vac vaccine in patients with active GU malignancies. Methods Patients were retrospectively identified at nine cancer centers in different regions. Patients were included if COVID-19 was diagnosed by a polymerase chain reaction. Data from additional patients with GU cancers who had no positive SARS-CoV-2 RT-PCR test before vaccination and who received two doses of Gam-COVID-Vac (Sputnik V) between 11 February and 31 August 2021 were collected for safety assessment. Anonymized data were collected through an online registry covering demographics, treatments, and outcomes. Results The Gam-COVID-Vac vaccine was well tolerated; no grade 3–5 toxicities were reported in 112 vaccinated metastatic GU cancer patients. The most common grade 1 adverse events (81%) were injection site reactions (76%), flu-like illness (68%), and asthenia (49%). Five patients experienced grade 2 chills (4.5%) and 3 patients had grade 2 fever (2.7%). With median follow-up of 6.2 months, two COVID-19 cases were confirmed by RT-PCR test in the vaccine group (of 112 participants; 1.8%). Eighty-eight patients with COVID-19 disease were included in the analysis. The average age as of the study enrollment was 66 (range 39–81) and the majority of patients were male with renal cell carcinoma (RCC). Thirty-six patients (41%) had evidence of metastatic disease, of these 22 patients were receiving systemic therapy. More than half of patients required hospitalization. Fifty-four patients (61%) experienced complications. Sixteen patients who developed COVID-19 pneumonia required mechanical ventilator support. Sixteen patients (18%) died in a median of 23.5 days after the date of COVID-19 diagnosis was established. The 3-month survival rate was 82%. Clinical and/or radiographic progression of cancer during COVID-19 infection or the subsequent 3 months was observed in 10 patients (11.4%). Conclusion Patients with GU malignancies are at increased risk of mortality from COVID-19 infection when compared to the general population. Vaccination could be safe in GU cancer patients. Trial registration: retrospectively registered.

scholarly journals Diagnostic, Clinical and Post-SARS-CoV-2 Scenarios in Cancer Patients with SARS-CoV-2: Retrospective Analysis in Three German Cancer Centers

Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2917
Author(s):  
Evgenii Shumilov ◽  
Petra Hoffknecht ◽  
Raphael Koch ◽  
Rudolf Peceny ◽  
Steffen Voigt ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
Cancer Patients ◽  
Progressive Disease ◽  
Significant Risk ◽  
Rt Pcr ◽  
Cancer Centers ◽  
Remission Status ◽  
Increased Risk ◽  
Anti Cancer

Oncologists face challenges in the management of SARS-CoV-2 infections and post-SARS-CoV-2 cancer treatment. We analyzed diagnostic, clinical and post-SARS-CoV-2 scenarios in patients from three German cancer centers with RT-PCR confirmed SARS-CoV-2 infection. Sixty-three patients with SARS-CoV-2 and hematologic or solid neoplasms were included. Thirty patients were initially asymptomatic, 10 of whom developed COVID-19 symptoms subsequently. Altogether 20 (32%) patients were asymptomatic, 18 (29%) had mild, 12 (19%) severe and 13 (20%) critical courses. Lymphocytopenia increased risk of severe/critical COVID-19 three-fold (p = 0.015). Asymptomatic course was not associated with age, remission status, therapies or co-morbidities. Secondary bacterial infection accompanied more than one third of critical COVID-19 cases. Treatment was delayed post-SARS-CoV-2 in 46 patients, 9 of whom developed progressive disease (PD). Cancer therapy was modified in 8 SARS-CoV-2 survivors because of deteriorating performance or PD. At the last follow-up, 17 patients had died from COVID-19 (n = 8) or PD (n = 9) giving an estimated 73% four-month overall survival rate. SARS-CoV-2 infection has a heterogenous course in cancer patients. Lymphocytopenia carries a significant risk of severe/critical COVID-19. SARS-CoV-2 disruption of therapy is as serious as SARS-CoV-2 infection itself. Careful surveillance will allow early restart of the anti-cancer treatment.

scholarly journals COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3573
Author(s):  
Alfred Chung Pui So ◽  
Harriet McGrath ◽  
Jonathan Ting ◽  
Krishnie Srikandarajah ◽  
Styliani Germanou ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Safety Data ◽  
Vaccine Safety ◽  
Phase Iii ◽  
Solid Malignancy ◽  
Common Grade ◽  
Phase Iii Trials ◽  
Oncology Care ◽  
Grade 3 ◽  
Oncology Centre

Emergency approval of vaccines against COVID-19 provides an opportunity for us to return to pre-pandemic oncology care. However, safety data in cancer patients is lacking due to their exclusion from most phase III trials. We included all patients aged less than 65 years who received a COVID-19 vaccine from 8 December 2020 to 28 February 2021 at our London tertiary oncology centre. Solicited and unsolicited vaccine-related adverse events (VRAEs) were collected using telephone or face-to-face consultation. Within the study period, 373 patients received their first dose of vaccine: Pfizer/BioNTech (75.1%), Oxford/AstraZeneca (23.6%), Moderna (0.3%), and unknown (1.1%). Median follow-up was 25 days (5–85). Median age was 56 years (19–65). Of the patients, 94.9% had a solid malignancy and 76.7% were stage 3–4. The most common cancers were breast (34.0%), lung (13.4%), colorectal (10.2%), and gynaecological (10.2%). Of the patients, 88.5% were receiving anti-cancer treatment (36.2% parenteral chemotherapy and 15.3% immunotherapy), 76.1% developed any grade VRAE of which 2.1% were grade 3. No grade 4/5 or anaphylaxis were observed. The most common VRAEs within 7 days post-vaccination were sore arm (61.7%), fatigue (18.2%), and headaches (12.1%). Most common grade 3 VRAE was fatigue (1.1%). Our results demonstrate that COVID-19 vaccines in oncology patients have mild reactogenicity.

scholarly journals Supper Timing and Cardiovascular Mortality: The Japan Collaborative Cohort Study

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3389
Author(s):  
Jingyun Tang ◽  
Jia-Yi Dong ◽  
Ehab S. Eshak ◽  
Renzhe Cui ◽  
Kokoro Shirai ◽  
...  
Keyword(s):  
Hemorrhagic Stroke ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Stroke Mortality ◽  
Hazard Ratios ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Study Participants

Evidence on the role of supper timing in the development of cardiovascular disease (CVD) is limited. In this study, we examined the associations between supper timing and risks of mortality from stroke, coronary heart disease (CHD), and total CVD. A total of 28,625 males and 43,213 females, aged 40 to 79 years, free from CVD and cancers at baseline were involved in this study. Participants were divided into three groups: the early supper group (before 8:00 p.m.), the irregular supper group (time irregular), and the late supper group (after 8:00 p.m.). Cox proportional hazards regression models were used to calculate hazard ratios (HRs) for stroke, CHD, and total CVD according to the supper time groups. During the 19-year follow-up, we identified 4706 deaths from total CVD. Compared with the early supper group, the multivariable HR of hemorrhagic stroke mortality for the irregular supper group was 1.44 (95% confidence interval [CI]: 1.05–1.97). There was no significant association between supper timing and the risk of mortality from other types of stroke, CHD, and CVD. We found that adopting an irregular supper timing compared with having dinner before 8:00 p.m. was associated with an increased risk of hemorrhagic stroke mortality.

Abstract 16961: Time-dependent Markers of Chronic Obstructive Pulmonary Disease Severity and Change are Associated With Increased Risk of Mortality in the General Heart Failure Population: A National Study of 50,114 Patients From the United Kingdom

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Claire A Rushton ◽  
Lucy Riley ◽  
Duwarakan K Satchithananda ◽  
Peter W Jones ◽  
Umesh T Kadam
Keyword(s):  
Heart Failure ◽  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Chronic Obstructive ◽  
Forced Expiration ◽  
Obstructive Pulmonary Disease ◽  
Gold Stage ◽  
Risk Of Mortality ◽  
Increased Risk

Purpose: Heart failure (HF) carries poor prognosis which changes over time. Chronic obstructive pulmonary disease (COPD) is common in HF and increases risk of mortality but how COPD severity and change influences HF prognosis is unknown. We hypothesised that in the HF general population, comorbidity stratification by increasing severity and longitudinal change would be associated with increased mortality. Methods: We used a case-control study nested within the UK Clinical Practice Research Datalink database (12-year time-period to 2014), of newly diagnosed HF patients aged over 40 years. Using risk set sampling, four controls were matched to cases on calendar and follow-up time. Routinely collected clinical measures of severity and change for COPD were (i) forced expiration volume in 1 second (FEV 1 ) stages, defined by Global Initiatives for Chronic Obstructive Lung Disease (GOLD) guidelines and (ii) prescribed medications in two time-windows covering 1-year prior to the match date. Conditional logistic regression was used to estimate risk ratios (RR) for all-cause mortality adjusted for known confounders. Results: Of the 50,114 HF sample, 5,848 (11.7%) had COPD and of these 62% died during follow-up compared to 52% of patients without COPD. COPD comorbidity risk associated with mortality stratified by GOLD stages was as follows: stage 1; adjusted RR 1.73 (95% CI 1.50-1.99) to stage 4; 3.14 (2.65, 3.73). Estimates for COPD FEV 1 change compared to no COPD were: GOLD stage same or better; 2.15 (1.97, 2.34) and GOLD stage worse; 2.70 (2.30, 3.17). The mortality estimates for medications severity were: inhalers only 1.13 (1.07,1.19), oral steroids; 1.83 (1.69,1.97) and oxygen; 2.94 (2.47, 3.51). The estimates for medications change were: no new steroids or oxygen; 1.22, (1.16, 1.28), new steroids but not oxygen; 1.84, (1.67,1.28) and new on oxygen; 3.41, (2.71,4.29). Conclusions: COPD is an important and common comorbidity in HF. Our results show that worse COPD severity and recent change based on routinely collected clinical data was associated with increased mortality and provides key prognostic information for clinical assessment in practice.

Abstract 2099: Pretransplant Toxoplasma Gondii Seropositivity Amongst Heart Transplant Recipients Is Associated With An Increased Risk Of All-cause And Cardiac Mortality

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Satish Arora ◽  
Pål Jenum ◽  
Pål Aukrust ◽  
Halvor Rollag ◽  
Arne Andreassen ◽  
...  
Keyword(s):  
Toxoplasma Gondii ◽  
Heart Transplant ◽  
Acute Cellular Rejection ◽  
Serum Samples ◽  
Regulatory Changes ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Cellular Rejection

Chronic Toxoplasma gondii (T. gondii ) infection is known to trigger potentially adverse immuno-regulatory changes, but the long-term implication for heart transplant (HTx) recipients has not been assessed previously. Hence, we evaluated the risk of mortality, development of cardiac allograft vasculopathy (CAV) and acute cellular rejection amongst T. gondii seropositive HTx recipients and the four donor/recipient seropairing groups. Methods: Frozen pre-HTx serum samples of 288 recipients and 246 donors were evaluated for T. gondii serostatus using Platelia IgG immunoassay method. All patients had also undergone prospective serostatus evaluation using alternative assays and results determined by the two methods were compared. Follow-up data regarding mortality, CAV development and acute cellular rejection was available for all patients. Results: Overall, 211 (73%) recipients were seronegative and 77 (27%) were seropositive. In total, 82 recipients died, 76 developed CAV and 82 had significant cellular rejection. Recipient seropositivity was associated with a significantly higher risk of all-cause mortality (hazard ratio [HR], 1.9; 95% CI, 1.1–3.4; p= 0.02) and CAV mortality (HR=4.4; 95% CI, 1.3–15.6, p=0.02), but was not associated with earlier CAV development or higher rejection score. Donor/recipient seropairing status was not a risk factor for any endpoint. Conclusions: T. gondii seropositivity amongst HTx recipients is associated with a significantly increased risk of long-term total, and in particular CAV-related, mortality. This may be mediated via immunoregulatory changes triggered by chronic T. gondii infection and needs to be explored further.

Impact of dose-capping chemotherapy in concurrent chemoradiotherapy in rectal cancer patients

2020 ◽  
pp. 107815522096219
Author(s):  
Ran Yang ◽  
Moftah Younis ◽  
Kurian Joseph ◽  
Sunita Ghosh ◽  
Tirath Nijjar ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Cancer Patients ◽  
Binary Logistic Regression ◽  
Disease Recurrence ◽  
Kaplan Meier ◽  
Significant Toxicity ◽  
Increased Risk ◽  
Risk Of Disease ◽  
Chemotherapy Dose

Introduction The study evaluated the effect of chemotherapy dose-capping on disease recurrence, toxicity and survival of rectal cancer patients treated with chemoradiotherapy (CRT). Methods 601 consecutive rectal cancer patients treated with concurrent CRT were retrospectively analysed. Dose-capped patients were defined as having a body surface area (BSA) ≥2.0 m2 and who received <95% full weight-based chemotherapy dose. Binary logistic regression was used to study the factors associated with the outcome variables (capped vs. uncapped). Kaplan-Meier estimation evaluated significant predictors of survival. Results The median follow-up time was 7.54 years. The rate of disease recurrence was significantly higher in dose-capped patients (35%) compared to those without dose-capping (24%, P = 0.016). The adjusted odds ratio for dose-capped patients experiencing recurrence was 1.64 compared to uncapped patients (95% CI, 1.10–2.43). Overall, dose-capped patients were less likely to experience significant toxicity requiring dose reduction and/or treatment break when compared to uncapped patients (15% and 28% respectively, P = 0.008).There was significant differences in PFS between capped and uncapped group (77% vs. 85%; P = 0.017). The 5-year OS in the capped group was 75.0%, and 80% in the uncapped group ( P = 0.149). Conclusions Rectal cancer patients treated with dose-capped CRT were at increased risk of disease recurrence. Patients dosed by actual BSA did experience excessive toxicity compared to dose-capped group. We recommend that chemotherapy dose-capping based on BSA should not be practiced in rectal cancer patients undergoing CRT.

Magnitude of bacteraemia is a predictor of mortality during 1 year of follow-up

2008 ◽  
Vol 137 (1) ◽  
pp. 94-101 ◽  
Author(s):  
K. O. GRADEL ◽  
M. SØGAARD ◽  
C. DETHLEFSEN ◽  
H. NIELSEN ◽  
H. C. SCHØNHEYDER
Keyword(s):  
Surgical Patients ◽  
Adjusted Risk ◽  
High Magnitude ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Cox's Regression ◽  
First Time ◽  
Long Term Mortality

SUMMARYWe evaluated magnitude of bacteraemia as a predictor of mortality, comprising all adult patients with a first-time mono-microbial bacteraemia. The number of positive bottles [1 (reference), 2, or 3] in the first positive blood culture (BC) was an index of magnitude of bacteraemia. We used Cox's regression analysis to determine age and comorbidity adjusted risk of mortality at days 0–7, 8–30, and 31–365. Of 6406 patients, 31·1% had BC index 1 (BCI 1), 18·3% BCI 2, and 50·6% BCI 3. BCI 3 patients had increased risk of mortality for days 0–7 (1·30, 95% CI 1·10–1·55) and days 8–30 (1·37, 95% CI 1·12–1·68), but not thereafter. However, in surgical patients mortality increased only beyond day 7 (8–30 days: 2·04, 95% CI 1·25–3·33; 31–365 days: 1·27, 95% CI 0·98–1·65). Thus, high magnitude of bacteraemia predicted mortality during the first month with a shift towards long-term mortality in surgical patients.

Randomized phase II trial of irofulven (IROF)/prednisone (P), IROF/capecitabine (C)/P or mitoxantrone (M)/P in docetaxel-pretreated hormone refractory prostate cancer (HRPC) patients (pts)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14513-14513 ◽  
Author(s):  
L. Hart ◽  
T. Ciuleanu ◽  
J. Hainsworth ◽  
S. Oudard ◽  
E. R. Berger ◽  
...  
Keyword(s):  
Site Distribution ◽  
Randomized Phase Ii ◽  
Common Grade ◽  
Psa Response ◽  
Secondary Endpoints ◽  
M 12 ◽  
Hormone Refractory ◽  
Grade 3 ◽  
Semisynthetic Derivative

14513 Background: IROF, a semisynthetic derivative of the natural product illudin S, is a novel DNA binding agent. IROF alone or in combination has shown activity in phase I-II trials in HRPC, notably with IROF/C (Cvitkovic et al, ASCO 2004). Methods: Pts with histologically-proven metastatic HRPC who progressed (RECIST or PSA) during prior docetaxel or within 3 months of discontinuing treatment, with adequate hematologic and organ functions and KPS ≥70% were stratified by pain and randomized to one of three treatments: Arm A: IROF (0.45 mg/kg, day 1 and 8 q3weeks [w]) and P (10 mg po daily); Arm B: IROF (0.4 mg/kg day 1 and 15), C(2000 mg/m2 day 1–15 q4w) and P; or Arm C: M (12 mg/m2 q3w) and P. Primary endpoint was TTP (RECIST, PSA or clinical progression); secondary endpoints included PSA response (≥50% decrease for ≥4 w), pain response, and toxicity; 135 pts are planned in a 2:2:1 ratio. The study was powered to detect a difference in TTP of 1.5 vs 3 months. Results: As of Dec 2005, 78 pts were randomized and treated with ≥ 5 months follow-up (A/B/C: 31/31/16). Median age (A/B/C) 69/70/61, KPS ≥80% 24/28/9, median baseline PSA ng/mL 90/147/235, disease related pain at baseline 61%/58%/63%; other characteristics, including metastatic site distribution, were similar between arms. Safety: 65 pts were evaluated for safety. Median cycles/Pt (A, B, C) 3/2/2; grade 3/4 toxicities (% pts A, B, C): asthenia (4%, 16%, 0%), vomiting (0%, 12%, 0%) and diarrhea (4%, 8%, 0%). The most common grade 3/4 laboratory abnormalities were neutropenia (10%, 6%, 31%) and thrombocytopenia (15%, 12%, 0%). Conclusion: IROF in combination with P and, in particular, C/P shows improved activity and acceptable tolerance compared to M/P in docetaxel-resistant HRPC. Patient accrual is complete as of Jan 2006, and final results will be presented. [Table: see text] [Table: see text]

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