Comparison of Clinical Characteristics for Distinguishing COVID-19 From Influenza During the Early Stages in Guangdong, China

Background: To explore the differences in clinical manifestations and infection marker determination for early diagnosis of coronavirus disease-2019 (COVID-19) and influenza (A and B).Methods: A hospital-based retrospective cohort study was designed. Patients with COVID-19 and inpatients with influenza at a sentinel surveillance hospital were recruited. Demographic data, medical history, laboratory findings, and radiographic characteristics were summarized and compared between the two groups. The chi-square test or Fisher's exact test was used for categorical variables, and Kruskal–Wallis H-test was used for continuous variables in each group. Receiver operating characteristic curve (ROC) was used to differentiate the intergroup characteristics. The Cox proportional hazards model was used to analyze the predisposing factors.Results: About 23 patients with COVID-19 and 74 patients with influenza were included in this study. Patients with influenza exhibited more symptoms of cough and sputum production than COVID-19 (p < 0.05). CT showed that consolidation and pleural effusion were more common in influenza than COVID-19 (p < 0.05). Subgroup analysis showed that patients with influenza had high values of infection and coagulation function markers, but low values of blood routine and biochemical test markers than patients with COVID-19 (mild or moderate groups) (p < 0.05). In patients with COVID-19, the ROC analysis showed positive predictions of albumin and hematocrit, but negative predictions of C-reactive protein (CRP), procalcitonin (PCT), lactate dehydrogenase (LDH), hydroxybutyrate dehydrogenase (HBDH), and erythrocyte sedimentation rate. Multivariate analysis revealed that influenza might associate with risk of elevated CRP, PCT, and LDH, whereas COVID-19 might associated with high HBDH.Conclusion: Patients with influenza had more obvious clinical symptoms but less common consolidation lesions and pleural effusion than those with COVID-19. These findings suggested that influenza likely presents with stronger inflammatory reactions than COVID-19, which provides some insights into the pathogenesis of these two contagious respiratory illnesses.

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Abstract 19925: Novel Pre-implant Characteristics Associated With 12 Month Risk of Gastrointestinal Bleeding Among Patients Supported With Continuous Flow Left Ventricular Assist Device Therapy

Circulation ◽

10.1161/circ.132.suppl_3.19925 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Yang Shi ◽

Matthew Rappelt ◽

Rayan Yousefzai ◽

Nasir Sulemanjee ◽

Dianne Zwicke ◽

...

Keyword(s):

Risk Factors ◽

Gastrointestinal Bleeding ◽

Continuous Flow ◽

Proportional Hazards Model ◽

Left Ventricular ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Categorical Variables ◽

Chronic Obstructive ◽

Continuous Variables

Introduction: Continuous-flow Left Ventricular Assisted Device (CF-LVAD) therapy is increasingly utilized for patients with end stage heart failure. Among the most common and unpredictable complications after CF-LVAD is gastrointestinal bleeding (GIB). Hypothesis: We hypothesize that pre-implant characteristics are associated with GIB post-implant of a CF-LVAD. The aim of this analysis is to identify novel pre-implant factors that influence risk of post-implant GIB. Methods: All CF-LVAD implants between January 2006 and December 2014 among patients who survived more than 15 days were included and followed for 12 months. Primary event was GIB and patients were censored at time of re-implant, heart transplant, or death. Student’s t-test was used to compare continuous variables and chi-square test for categorical variables. Cox Proportional Hazards model was used to identify univariate and multivariable models predicting GIB. Results: Among the total 257 patients included, 65 (25.3%) were identified as having a GIB. Baseline differences and their independent univariate hazard ratio (HR) are noted in Table 1. Using stepwise selection and developing a multivariable model, prior GI abnormalities (HR=2.12, p<0.01), prior percutaneous coronary intervention (PCI: HR=2.65, P<0.01) and chronic obstructive pulmonary disease (COPD: HR=1.73, P<0.01) remained statistically significant predictors of GIB (Table 2). Conclusions: We describe novel risk factors (history of GI abnormalities, prior PCI, COPD) as predictors for developing GIB post CF-LVAD implantation. We advocate a closer examination of these risk factors when evaluating patients for CF-LVAD therapy.

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The Success of Surgical and Medical Approach in the Treatment of Cesarean Scar Pregnancy

International Journal of Women s Health and Reproduction Sciences ◽

10.15296/ijwhr.2020.31 ◽

2019 ◽

Vol 8 (2) ◽

pp. 198-202

Author(s):

Sara Masihi ◽

Mahin Najafian ◽

Mojgan Barati ◽

Zohreh Mirfazli

Keyword(s):

Ectopic Pregnancy ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Treatment Approach ◽

Demographic Data ◽

Clinical Manifestations ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Cesarean Scar Pregnancy ◽

Cross Sectional

Objectives: The ectopic pregnancy in the cesarean section (CS) scar (CSP) is one of the potentially dangerous and late complications of CS. The current study aimed to evaluate the therapeutic approaches in managing CS scar ectopic pregnancy. Materials and Methods: This cross-sectional study was carried out on 63 CSP patients. The treatment approach was considered based on the shape and nature of the gestational sac (GS) during ultrasound evolutions. Patients’ demographic data, clinical manifestations, and systemic drug treatment (methotrexate, MTX), as well as the type of surgery, hospitalization times, and treatment-related complications were evaluated, followed by comparing the treatment efficacy in different approaches based on the human chorionic gonadotropin (hCG) resolution time. Results: The mean age of the subjects was 34.2±5.1 years (within the range of 22-44 years) and the median of B-hCG serum levels at diagnosis was 2319 IU. The vaginal bleeding and abdominal pain (27 [42.9%]) were the most common complaints, followed by a delayed menstrual cycle (8 [12.7%]). The majority of patients were subjected to surgical treatment and 29 cases (46%) were treated by medical approaches. The median time to B-hCG resolution was 42 days. The Cox proportional hazards model showed the significant effect of the treatment approach on time to B-hCG resolution (χ2 =37.78, df=4, P<0.0001). Finally, the MTX plus surgery was the most effective treatment approach (OR=10.56, P<0.0001) in managing CSP patients. Conclusions: Our findings in line with previous studies showed the superiority of the surgical approach alone or in combination with medical treatments compared to medical approaches alone.

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Proliferation-dominant high-grade astrocytoma: survival benefit associated with extensive resection of FLAIR abnormality region

Journal of Neurosurgery ◽

10.3171/2018.12.jns182775 ◽

2020 ◽

Vol 132 (4) ◽

pp. 998-1005 ◽

Cited By ~ 4

Author(s):

Haihui Jiang ◽

Yong Cui ◽

Xiang Liu ◽

Xiaohui Ren ◽

Mingxiao Li ◽

...

Keyword(s):

Survival Benefit ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Characteristic Curve ◽

Extent Of Resection ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

High Grade ◽

Extensive Resection ◽

High Grade Astrocytoma

OBJECTIVEThe aim of this study was to investigate the relationship between extent of resection (EOR) and survival in terms of clinical, molecular, and radiological factors in high-grade astrocytoma (HGA).METHODSClinical and radiological data from 585 cases of molecularly defined HGA were reviewed. In each case, the EOR was evaluated twice: once according to contrast-enhanced T1-weighted images (CE-T1WI) and once according to fluid attenuated inversion recovery (FLAIR) images. The ratio of the volume of the region of abnormality in CE-T1WI to that in FLAIR images (VFLAIR/VCE-T1WI) was calculated and a receiver operating characteristic curve was used to determine the optimal cutoff value for that ratio. Univariate and multivariate analyses were performed to identify the prognostic value of each factor.RESULTSBoth the EOR evaluated from CE-T1WI and the EOR evaluated from FLAIR could divide the whole cohort into 4 subgroups with different survival outcomes (p < 0.001). Cases were stratified into 2 subtypes based on VFLAIR/VCE-T1WIwith a cutoff of 10: a proliferation-dominant subtype and a diffusion-dominant subtype. Kaplan-Meier analysis showed a significant survival advantage for the proliferation-dominant subtype (p < 0.0001). The prognostic implication has been further confirmed in the Cox proportional hazards model (HR 1.105, 95% CI 1.078–1.134, p < 0.0001). The survival of patients with proliferation-dominant HGA was significantly prolonged in association with extensive resection of the FLAIR abnormality region beyond contrast-enhancing tumor (p = 0.03), while no survival benefit was observed in association with the extensive resection in the diffusion-dominant subtype (p=0.86).CONCLUSIONSVFLAIR/VCE-T1WIis an important classifier that could divide the HGA into 2 subtypes with distinct invasive features. Patients with proliferation-dominant HGA can benefit from extensive resection of the FLAIR abnormality region, which provides the theoretical basis for a personalized resection strategy.

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Histologic Evaluation Using the Robarts Histopathology Index in Patients With Ulcerative Colitis in Deep Remission and the Association of Histologic Remission With Risk of Relapse

Inflammatory Bowel Diseases ◽

10.1093/ibd/izab340 ◽

2022 ◽

Author(s):

Jin Park ◽

Soo Jin Kang ◽

Hyuk Yoon ◽

Jihye Park ◽

Hyeon Jeong Oh ◽

...

Keyword(s):

Ulcerative Colitis ◽

Proportional Hazards Model ◽

Characteristic Curve ◽

Multivariable Analysis ◽

Fecal Calprotectin ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Clinical Relapse ◽

Endoscopic Remission ◽

Risk Of Relapse

Abstract Background This study prospectively evaluated the risk of relapse according to the status of histologic activity in patients with ulcerative colitis (UC) who achieved deep remission. Methods Patients with UC in clinical remission (partial Mayo score ≤1) and endoscopic remission (ulcerative colitis endoscopic index of severity ≤1) were enrolled. Rectal biopsies were performed in patients, and histologic remission was defined as a Robarts histopathology index of ≤3. Receiver-operating characteristic curve analysis was conducted to determine fecal calprotectin cutoff values for histologic remission. The cumulative risk of relapse was evaluated using the Cox proportional hazards model. Results Among the 187 patients enrolled, 82 (43.9%) achieved histologic remission. The best cutoff value of fecal calprotectin for predicting histologic remission was 80 mg/kg (area under the curve of 0.646, sensitivity of 74%, and specificity of 61%). Among 142 patients who were followed up for >3 months, 56 (39.4%) showed clinical relapse during a median of 42 weeks. The risk of relapse was lower in patients with histologic remission than in those with histologic activity (P = .026). In multivariable analysis, histologic remission (hazard ratio [HR], 0.551; 95% confidence interval [CI], 0.316-0.958; P = .035), elevated C-reactive protein levels (HR, 3.652; 95% CI, 1.400-9.526; P = .008), and history of steroid use (HR, 2.398; 95% CI, 1.196-4.808; P = .014) were significantly associated with clinical relapse. Conclusions In patients with UC who achieved clinical and endoscopic remission, histologic remission was independently associated with a lower risk of clinical relapse.

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17. A Retrospective Cohort Study of Influenza Infected Multiple Myeloma Patients Comparing Clinical Outcomes Between Vaccinated and Unvaccinated

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.219 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S133-S133

Author(s):

Taylor D Wilson ◽

Jacob Leffert ◽

Juan Carlos Rico Crescencio ◽

Mitchell Jenkins ◽

Mary J Burgess

Keyword(s):

Multiple Myeloma ◽

Influenza Vaccine ◽

Influenza A ◽

Morbidity And Mortality ◽

Categorical Variables ◽

Data Repository ◽

Severe Illness ◽

High Dose ◽

Fisher Exact Test ◽

Continuous Variables

Abstract Background The current standard of care for multiple myeloma (MM) patients is to administer the influenza vaccine (InfV) annually. While in immunocompetent patients, the influenza vaccine is associated with significant benefit in morbidity and mortality, the inherent immunodeficiency from MM and its treatments reduce the InfV efficacy but it is thought to have some benefit. The effect on morbidity and mortality in MM patients has not been evaluated. Our study aims to investigate whether InfV vaccination status affects outcomes of MM patients diagnosed with Influenza A or B (FluA, FluB). Methods This was a retrospective study, using Arkansas Clinical Data Repository, which identified all MM patients diagnosed with FluA or FluB during five consecutive flu seasons from September 1st to April 30th, 2015-2020. Those with hospital-acquired influenza were excluded. The outcome data were collected for 30 days following the initial diagnosis. Fisher Exact test was used to compare categorical variables, and Mann Whitney U test to compare continuous variables. Results We identified 194 MM patients diagnosed with FluA or FluB. Sixty-five (34%) were vaccinated and 129 (66%) were not vaccinated. A total of 87 (45%) were admitted to the hospital. Twenty-five (38%) of the vaccinated vs. 62 (48%) of the unvaccinated group were hospitalized (p=0.22), and 4/65 vaccinated vs. 12/129 unvaccinated required ICU treatment (p=0.59). Two patients in the vaccinated and 3 in the non-vaccinated group were intubated (p=1). The mean length of stay (LOS) for the vaccinated and unvaccinated was 10 days and 14 days, respectively, which was not significantly different (p=0.197). Two (3%) patients died within 30 days of diagnosis in the vaccinated group while four (3%) died in the unvaccinated group (p=1). Conclusion The InfV status of MM patients had no effect on outcomes including the need for hospital admission, ICU stay, mechanical ventilation, LOS, and death. Hospitalization was common, but severe illness requiring ICU care and intubation were less common. Six patients died within 30 days of influenza diagnosis. Vaccination strategy, including high-dose and repeat doses, should be examined in MM patients. Disclosures All Authors: No reported disclosures

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A one-year hospital-based prospective COVID-19 open-cohort in the Eastern Mediterranean region: The Khorshid COVID Cohort (KCC) study

PLoS ONE ◽

10.1371/journal.pone.0241537 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241537

Author(s):

Ramin Sami ◽

Forogh Soltaninejad ◽

Babak Amra ◽

Zohre Naderi ◽

Shaghayegh Haghjooy Javanmard ◽

...

Keyword(s):

Oxygen Saturation ◽

Mediterranean Region ◽

Psychotic Disorders ◽

Proportional Hazards Model ◽

Clinical Symptoms ◽

Eastern Mediterranean ◽

Significant Risk ◽

Eastern Mediterranean Region ◽

Cox Proportional Hazards Model ◽

One Year

The COVID-19 is rapidly scattering worldwide, and the number of cases in the Eastern Mediterranean Region is rising. Thus, there is a need for immediate targeted actions. We designed a longitudinal study in a hot outbreak zone to analyze the serial findings between infected patients for detecting temporal changes from February 2020. In a hospital-based open-cohort study, patients are followed from admission until one year from their discharge (the 1st, 4th, 12th weeks, and the first year). The patient recruitment phase finished at the end of August 2020, and the follow-up continues by the end of August 2021. The measurements included demographic, socio-economics, symptoms, health service diagnosis and treatment, contact history, and psychological variables. The signs improvement, death, length of stay in hospital were considered primary, and impaired pulmonary function and psychotic disorders were considered main secondary outcomes. Moreover, clinical symptoms and respiratory functions are being determined in such follow-ups. Among the first 600 COVID-19 cases, 490 patients with complete information (39% female; the average age of 57±15 years) were analyzed. Seven percent of these patients died. The three main leading causes of admission were: fever (77%), dry cough (73%), and fatigue (69%). The most prevalent comorbidities between COVID-19 patients were hypertension (35%), diabetes (28%), and ischemic heart disease (14%). The percentage of primary composite endpoints (PCEP), defined as death, the use of mechanical ventilation, or admission to an intensive care unit was 18%. The Cox Proportional-Hazards Model for PCEP indicated the following significant risk factors: Oxygen saturation < 80% (HR = 6.3; [CI 95%: 2.5,15.5]), lymphopenia (HR = 3.5; [CI 95%: 2.2,5.5]), Oxygen saturation 80%-90% (HR = 2.5; [CI 95%: 1.1,5.8]), and thrombocytopenia (HR = 1.6; [CI 95%: 1.1,2.5]). This long-term prospective Cohort may support healthcare professionals in the management of resources following this pandemic.

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A nomogramic model based on clinical and laboratory parameters at admission for predicting the survival of COVID-19 patients

10.21203/rs.3.rs-34708/v1 ◽

2020 ◽

Author(s):

Xiaojun Ma ◽

Huifang Wang ◽

Junwei Huang ◽

Yan Geng ◽

Shuqi Jiang ◽

...

Keyword(s):

Risk Factors ◽

Bootstrap Method ◽

Characteristic Curve ◽

Laboratory Data ◽

Categorical Variables ◽

P Value ◽

Continuous Variables ◽

Model Based ◽

Independent Risk Factors ◽

D Dimer

Abstract Background and Aim COVID-19 has become a major global threat. The present study aimed to develop a nomogram model to predict the survival of COVID-19 patients based on their clinical and laboratory data at admission. Methods COVID-19 patients who were admitted at Hankou Hospital and Huoshenshan Hospital in Wuhan, China from January 12, 2020 to March 20, 2020, whose outcome during the hospitalization was known, were retrospectively reviewed. The categorical variables were compared using Pearson’s χ2-test or Fisher’s exact test, and continuous variables were analyzed using Student’s t-test or Mann Whitney U-test, as appropriate. Then, variables with a P-value of ≤0.1 were included in the multivariate model, and merely these independent risk factors were used to establish the nomogram model. The discrimination of the nomogram was evaluated using the area under the receiver operating characteristic curve (AUC), and internally verified using the Bootstrap method. Results A total of 262 patients (134 surviving and 128 non-surviving patients) were included in the analysis. Seven variables, which included age (odds ratio [OR]: 0.905, 95% confidence interval [CI]: 0.868-0.944; P<0.001), chronic heart disease (CHD, OR: 0.048, 95% CI: 0.013-0.180; P<0.001), the percentage of lymphocytes (Lym%, OR: 1.116, 95% CI: 1.051-1.184; P<0.001), platelets (OR: 1.008, 95% CI: 1.003-1.012; P=0.001), C-reaction protein (OR: 0.982, 95% CI: 0.973-0.991; P<0.001), lactate dehydrogenase (LDH, OR: 0.993, 95% CI: 0.990-0.997; P<0.001) and D-dimer (OR: 0.734, 95% CI: 0.615-0.875; P=0.001), were identified as the independent risk factors. The nomogram model based on these factors exhibited a good discrimination, with an AUC of 0.948 (95% CI: 0.923-0.973). Conclusion A nomogram based on age, CHD, Lym%, platelets, C-reaction protein, LDH and D-dimer was established to accurately predict the prognosis of COVID-19 patients. This can be used as an alerting tool for clinicians to take early intervention measures, when necessary.

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Comparison of the clinical manifestations between different age groups of patients with overseas imported COVID-19

PLoS ONE ◽

10.1371/journal.pone.0243347 ◽

2020 ◽

Vol 15 (12) ◽

pp. e0243347

Author(s):

Yujuan Han ◽

Zujin Luo ◽

Wenliang Zhai ◽

Yue Zheng ◽

Huan Liu ◽

...

Keyword(s):

Type 2 Diabetes ◽

Clinical Symptoms ◽

Demographic Data ◽

Disease Onset ◽

Age Groups ◽

Clinical Manifestations ◽

Symptom Improvement ◽

Group A ◽

Group B

The current study investigated the clinical manifestations and outcomes of different age groups of patients with overseas imported COVID-19. In total, 53 COVID-19 patients admitted to the designated Beijing Xiaotangshan Hospital between March 16 and April 15 of 2020 were included. Based on the percentage of disease aggravation during hospital stay according to CT, the patients were divided into two groups: ≤40 years (group A; n = 41) and >40 years (group B; n = 12). The demographic data, epidemiological history, disease courses, potential complications, clinical symptoms, lab indices, chest CT outcomes, treatment protocols and turnovers of the two groups were compared. According to clinical typing, compared with group A, group B had a significantly greater proportion of the common type of COVID-19 (P<0.05) and greater comorbidity of type 2 diabetes (P<0.001). The two groups presented significantly different lab indices. Group B showed significantly more frequent CT abnormalities, with greater proportions of multiple lesions and bilateral lung involvement (P<0.05). During hospitalization, group B had a greater proportion of disease aggravation according to CT (P<0.01). Compared with group A, group B received a significantly greater proportion of antiviral therapy and presented a significantly greater occurrence of adverse drug reactions (P<0.05). The two groups did not significantly differ in time from admission to clinical symptom improvement or from disease onset to negative outcomes according to nucleic acid testing, the appearance of IgG or the appearance of IgM. They also did not significantly differ in length of stay. Older imported COVID-19 patients, particularly those with type 2 diabetes, showed a broader pulmonary extent and faster development of the disease, more severe pathogenetic conditions and a greater risk of developing a critically severe type. Increased attention should be given to this population in clinical practice.

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Radiomics Nomogram Analyses for Differentiating Pneumonia and Acute Paraquat Lung Injury

Scientific Reports ◽

10.1038/s41598-019-50886-7 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 6

Author(s):

Wang Yanling ◽

Gao Duo ◽

Geng Zuojun ◽

Shi Zhongqiang ◽

Wu Yankai ◽

...

Keyword(s):

Lung Injury ◽

Predictive Value ◽

Clinical Symptoms ◽

Demographic Data ◽

Characteristic Curve ◽

Public Health Problem ◽

Clinical Information ◽

Therapy Decision ◽

Paraquat Poisoning ◽

Radiomics Signature

Abstract Paraquat poisoning has become a serious public health problem in some Asian countries because of misuse or suicide. We sought to develop and validate a radiomics nomogram incorporating radiomics signature and laboratory bio-markers, for differentiating bacterial pneumonia and acute paraquat lung injury. 180 patients with pneumonia and acute paraquat who underwent CT examinations between December 2014 and October 2017 were retrospectively evaluated for testing and validation. Clinical information including demographic data, clinical symptoms and laboratory test were also recorded. A prediction model was built by using backward logistic regression and presented on a nomogram. The radiomics-based features yielded areas under the receiver operating characteristic curve of 0.870 (95% CI 0.757–0.894), sensitivity of 0.857, specificity of 0.804, positive predictive value of 83.3%, negative predictive value of 0.818 in the primary cohort, while in the validation cohort the model showed similar results (0.865 (95% CI 0.686–0.907), 0.833, 0.792, 81.5%, respectively). The individualized nomogram included radiomics signature, body temperature, nausea and vomiting, and aspartate transaminase. We have developed a radiomics nomogram that combination of the radiomics features and clinical risk factors to differentiate paraquat lung injury and pneumonia for patients with an unclear medical history of exposure to paraquat poisoning, providing appropriate therapy decision support.

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Relationship between biomarkers and everolimus efficacy in the phase III RECORD-1 trial of patients with metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.6_suppl.352 ◽

2013 ◽

Vol 31 (6_suppl) ◽

pp. 352-352

Author(s):

Stephane Oudard ◽

Bernard J. Escudier ◽

John A. Thompson ◽

Viktor Grünwald ◽

Cristina Masini ◽

...

Keyword(s):

Plasma Levels ◽

Time Course ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Day Treatment ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Phase Iii ◽

Continuous Variables ◽

Baseline Levels

352 Background: Compared with placebo, everolimus provided significant improvement in median PFS in the RECORD-1 study of VEGFr-TKI-refractory mRCC. To investigate the role of angiogenesis pathway molecules as potential biomarkers of everolimus efficacy in RECORD-1, plasma levels of sVEGFR-2, VEGF-A, and bFGF were estimated. Methods: In addition to best supportive care, patients received everolimus 10 mg/day (n = 277) or placebo (n = 139). Placebo patients who progressed were offered everolimus. Predose blood samples were collected on day 1 of the first four 28-day treatment cycles. Plasma levels of sVEGFR-2, VEGF-A, and bFGF were assessed by ELISA. Effect of treatment over time on each biomarker was assessed by a mixed effects model. Hazard ratios (HR) for prognostic effects were obtained using log baseline biomarker values as continuous variables in a stratified Cox proportional hazards model. Results: Plasma levels of sVEGFR-2, VEGF-A, and bFGF were available for 45%, 45%, and 39% of everolimus patients and 50%, 50%, and 45% of placebo patients. Patients with biomarker data had baseline characteristics similar to those of the overall population. Mean baseline levels (pg/mL) of sVEGFR-2, VEGF-A, and bFGF were similar for everolimus (8945, 245, and 8, respectively) and placebo (8985, 253, and 13, respectively). Everolimus significantly improved median PFS over placebo irrespective of baseline levels of the analyzed biomarkers (p < 0.001), indicating they are not predictive of everolimus efficacy. Prolonged PFS in the biomarker population was associated with lower VEGF-A baseline level (HR, 1.27; 95% CI, 1.03-1.57; p = 0.028), suggesting VEGF-A may be prognostic for mRCC. Compared with placebo, everolimus significantly reduced bFGF (p = 0.0095) and sVEGFR-2 (p< 0.001) levels over the time course of the study; no effect on VEGF-A levels was observed. Conclusions: Everolimus significantly improved PFS compared with placebo, regardless of baseline biomarker levels. Lower VEGF-A levels may be a potential prognostic factor for longer PFS. Everolimus treatment significantly downregulated plasma levels of bFGF and sVEGFR-2 from baseline. Clinical trial information: NCT00410124.

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