The association between immune-related adverse events and efficacy outcomes with consolidation pembrolizumab after chemoradiation in patients with stage III NSCLC: an analysis from HCRN LUN 14-179.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9032-9032
Author(s):  
Nikhil Shukla ◽  
Sandra K. Althouse ◽  
Ahad Ali Sadiq ◽  
Shadia Ibrahim Jalal ◽  
Salma K. Jabbour ◽  
...  
Keyword(s):  
Adverse Events ◽  
Stage Iv ◽  
Wilcoxon Test ◽  
Stage Iii ◽  
Categorical Variables ◽  
Rank Test ◽  
Continuous Variables ◽  
Current Standard ◽  
Group A ◽  
Stage Iii Nsclc

9032 Background: Consolidation checkpoint inhibitor therapy (CPI) for up to 1 year following chemoradiation (CRT) is a current standard of care for pts with inoperable stage III NSCLC. However, some pts are not able to complete 1 year of CPI due to immune-related adverse events (irAES). In multiple retrospective studies, pts with stage IV NSCLC treated with CPI who experience irAEs generally receive fewer cycles of CPI without a significant detrimental effect on efficacy. The association between irAEs and outcomes with consolidation CPI after CRT has never been reported. Here we report the association between irAEs and efficacy outcomes from the HCRN LUN 14-179, a single-arm phase II trial of consolidation pembrolizumab following concurrent CRT in pts with unresectable stage III NSCLC. Methods: After completion of CRT eligible pts with stage III NSCLC without PD received pembrolizumab 200 mg IV q 3 wks for up to 1 yr. Demographics, disease characteristics, and number of cycles of pembrolizumab received were reported in pts who had any grade irAEs (except pneumonitis which included grade >2 only) [Group A] and those without irAEs (except grade 1 pneumonitis) [Group B]. Chi-square test (or Fisher's Exact test) were used for comparisons for categorical variables and Wilcoxon test for continuous variables. The Kaplan-Meier method was used to analyze time to metastatic disease (TMDD), PFS, and OS. A log-rank test was used to compare groups. Results: 92 eligible pts for efficacy analysis were enrolled from March 2015 to November 2016. 4 yr OS estimate for all pts is 46.2%. Any grade irAEs (except grade I pneumonitis) (n = 37 pts) included pneumonitis (18.5%), colitis (3.3%), increased creatinine (5.4%), elevated transaminases (3.3%), hyperthyroidism (7.6%), hypothyroidism (13.0%). Grade ≥ 2 irAEs (n = 32 pts) included pneumonitis (18.5%), hypothyroidism (10.8%), and colitis (3.3%). Group A/B: male (21/38), female (16/17), current or former smoker (35/52), stage IIIA (20/35), stage IIIB (17/20), non-squamous (21/30), squamous (16/25). Median number of pembrolizumab cycles received in Group A/B pts were 9 vs 15 (p = 0.0942) respectively. 4 yr efficacy endpoints in Groups A/B were TMDD 35.3% vs 41.3% (p = 0.83), PFS 27.8% vs 28.7% (p = 0.97), OS 43.5% vs 47.9% (p = 0.99), respectively. Conclusions: Despite receiving fewer cycles of consolidation pembrolizumab, pts who experienced any grade irAEs (excluding grade 1 pneumonitis) did not have significantly reduced efficacy outcomes. Clinical trial information: NCT02343952.

Survival disparity and racial differences in the use of neoadjuvant chemotherapy (NAC) compared with primary debulking surgery (PDS) in women with ovarian cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17099-e17099
Author(s):  
Eirwen M Miller ◽  
Joan Tymon-Rosario ◽  
Xianhong Xie ◽  
Harriet Olivia Smith ◽  
Gary L. Goldberg ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Racial Differences ◽  
Survival Data ◽  
Racial Disparity ◽  
Stage Iv ◽  
Stage Iii ◽  
Disease Stage ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Black Patients

e17099 Background: Studies demonstrate racial disparity in ovarian cancer survival though survival differences seem to be mitigated when patients receive similar care. We sought to identify whether racial disparity exists in the use of NAC or PDS for women with ovarian cancer. Methods: After IRB approval, all patients with epithelial ovarian cancer who received primary treatment at our institution from 2005-2016 were identified from our tumor registry. Charts were retrospectively reviewed for clinicopathologic and survival data. Categorical variables were compared with chi-squared and continuous variables with the student t-test. Kaplan-Meier was used to compare survival probabilities. Results: 302 evaluable patients were identified. 240 (79%) patients underwent PDS and 62 (21%) received NAC. Older patients, black patients, and those with stage III/IV disease were more likely to receive NAC. In a multivariate analysis controlling for stage and age, black race remained associated with NAC [OR 3.25 (95% CI 1.41-7.47), p < 0.01]. In a subgroup of advanced disease, stage III patients (n = 138) were more likely than stage IV patients (n = 52) to undergo PDS (78% v 44%, p < 0.01) and black patients were more likely than others to present with stage IV disease (39% v 22%, p = 0.01). NAC was utilized more frequently (48% v 24%, p < 0.01) in black patients compared with all other races. In the advanced stage subgroup analysis, patients that underwent PDS had a longer PFS than those that received NAC [HR 2.21 (95% CI 1.26-3.89), p = 0.01]. Conclusions: Racial disparity exists in the selection of PDS compared with NAC for patients with ovarian cancer and this disparity persists when controlling for stage and age. The choice of NAC or PDS may result in survival disparity. Further investigation is needed to examine other reasons, such as medical co-morbidities and disease distribution, for racial disparity in management. [Table: see text]

Trends in demographics and survival for patients (pts) with advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7114-7114
Author(s):  
K. Kubota ◽  
H. Masuhara ◽  
K. Hosoya ◽  
K. Yoh ◽  
S. Niho ◽  
...  
Keyword(s):  
Kinase Inhibitors ◽  
Statistical Significance ◽  
Performance Status ◽  
Stage Iv ◽  
Stage Iii ◽  
Smoking History ◽  
Rank Test ◽  
Cancer Center ◽  
Group A ◽  
Group B

7114 Background: In clinical trials, concurrent chemoradiotherapy improves survival of pts with inoperable stage III NSCLC compared with sequential chemoradiotherapy or radiotherapy alone, and platinum doublets with third-generation chemotherapy prolong survival of pts with stage IV NSCLC. Epidermal growth factor receptor antagonist is active as second-line chemotherapy. Few outcomes research regarding demographics and survival trends in advanced NSCLC has been conducted. Methods: The National Cancer Center Hospital East Database was searched for all pts with inoperable stage III and IV NSCLC. Data was recorded for histology, age, sex, smoking history, tumor location, stage, performance status (PS), and treatment modality. Pts were divided into two groups; group A: newly registered pts from July 1992 to December 1997, group B: from January 1998 to June 2004. Survival curves were evaluated using the Kaplan-Meier methods, and statistical significance was estimated by the log-rank test. Results: 2,135 pts (771 pts group A vs. 1364 pts group B) were identified. Pts demographics of each group (% group A/B) were as follows; male; 74/77, non-smoker; 19/19, PS 0–1; 79/85, squamous cell histology; 26/24, stage III; 45/44. Median age was 63 years old in group A and 64 in group B. Median survival (MS), 1-year survival rate (1ys), 2ys and 3ys were 8 months (M), 33%, 12% and 7% in group A, 10M, 42%, 23% and 14% in group B, respectively (P < .0001). In pts with stage III, MS, 1ys, 2ys, 3ys were 12M, 46%, 20%, 12% in group A and 15M, 56%, 34%, 20% in group B (P < .0001). In non-smoker, MS, 1 ys, 2 ys were 11 M, 46%, 19% in group A and 15 M, 56%, 30% in group B (P < .0001). In females, MS, 1 ys, 2 ys were 10 M, 39%, 16% in group A and 15 M, 55%, 31% in group B (P < .0001). Conclusion: Although there were no apparent differences in demographics between the two groups, survival was significantly improved chronologically. The improvement was prominent in stage III, non-smokers and females suggesting the benefit of chemoradiotherapy and tyrosine kinase inhibitors. [Table: see text]

The role of apoptosis in colorectal carcinogenesis and its prognostic value.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e22131-e22131
Author(s):  
Julia Alcaide ◽  
Rafael Funez ◽  
Antonio Rueda ◽  
Elisabeth Pérez-Ruiz ◽  
Teresa Pereda ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Proportional Hazards ◽  
Disease Free Survival ◽  
Stage Iv ◽  
Colorectal Carcinogenesis ◽  
Categorical Variables ◽  
Rank Test ◽  
Continuous Variables ◽  
Normal Epithelium

e22131 Background: Most colorectal cancers (CRCs) progress through a multistep process from normal tissue to adenoma to carcinoma. The role of apoptosis during this tumourigenesis sequence has not yet been completely clarified. The aim of our study was to determine the influence of apoptotic variations on the carcinogenesis and prognosis of CRC. Methods: A TUNEL assay was performed on the formalin-fixed, paraffin-embedded tissues from 103 CRCs resected at the Costa del Sol Hospital (after excluding patients previously treated with chemotherapy or radiation therapy), 26 adenomas and 20 samples of normal epithelia. Clinical data were obtained from the tumour registry and hospital charts. The study was approved by Research Ethics Committee. We used the median (m) of apoptotic percentage (1%, range: 0-6%) as a threshold value for survival (sv) studies. Analysis of association between apoptosis and prognostic factors used the X2test for categorical variables and the analysis of variance test for continuous variables (natural log transformed if necessary). We estimated sv using the Kaplan-Meier method, and sv curves were compared with the log rank test. Cox’s proportional hazards sv analysis was used to determine the relative risk (RR) through multivariate analyses. Results: Median follow-up was 50 months (mo). Apoptotic index (AI) was higher in CRCs (1.09 ± 0.13) than in adenomas (0.38 ± 0.23, p=0.059) and significantly greater than in normal epithelium (0.06 ± 0.04, p=0.001). AI was greater in stage IV than in other stages (p=0.017). Higher AI was associated with lower disease-free survival (DFS) and overall survival (OS) than lower AI (Table). In multivariate analysis, AI (RR=2.18, 95% CI 1.08-4.37) and TNM stage (RR=2.41, 95% CI 1.20-4.85) were independent prognostic factors for OS. Conclusions: Our study demonstrates an increase in apoptosis during colorectal carcinogenesis and a correlation between apoptotic rates and survival. Higher AIs are associated with more aggressive tumours and a poorer prognosis in CRC. [Table: see text]

A phase II trial of consolidation nivolumab or nivolumab plus ipilimumab following concurrent chemoradiation in unresectable stage III NSCLC: BTCRC LUN16-081.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. TPS179-TPS179 ◽  
Author(s):  
Greg Andrew Durm ◽  
Susan M. Perkins ◽  
Nasser H. Hanna
Keyword(s):  
Phase Ii ◽  
Stage Iv ◽  
Standard Of Care ◽  
Concurrent Chemoradiation ◽  
Stage Iii ◽  
Current Standard ◽  
Unresectable Stage ◽  
Secondary Endpoints ◽  
Stage Iii Nsclc ◽  
Nsclc Patients

TPS179 Background: Unresectable stage III NSCLC demonstrates poor 5-yr OS outcomes. The current standard of care for fit patients in this setting is concurrent chemoradiation. Previous studies evaluating the addition of induction or consolidation chemotherapy, EGFR-targeted agents, ant-angiogenic agents, and higher doses of radiation have failed to definitively improve OS over chemoradiation alone. Recently, a trial of consolidation PD-L1 inhibition demonstrated improved PFS over chemoradiation alone, and a second trial of consolidation PD-1 inhibition is awaiting data maturation. This may herald a change to the standard of care in this setting. The addition of CTLA-4 inhibition to anti-PD-1 monoclonal antibodies has shown improved OS in melanoma and has demonstrated encouraging early phase data in stage IV NSCLC. Therefore, we initiated a trial evaluating the addition of a CTLA-4 inhibitor to PD-1 inhibition for consolidation treatment of unresectable stage III NSCLC. Methods: This is a multi-center, randomized, phase II study of nivolumab or the combination of nivolumab and ipilimumab as consolidation therapy following concurrent chemoradiation in unresectable stage III NSCLC. Patients will receive concurrent chemoradiation with one of three standard chemotherapy backbones (Cis-Etop, Cis-Pem, or Carbo-Pac), and repeat imaging will be done 4-8 weeks following completion of therapy. Patients without progressive disease will be randomized 1:1 to receive either niv 480mg IV every 4 weeks or the combination of niv 3mg/kg IV every 2 weeks and ipi 1mg/kg IV every 6 weeks for up to 6 months. The trial will enroll a total of 108 patients with 54 in each arm. The two arms are non-comparator arms and will be compared with historical controls. The primary endpoint is the improvement of PFS at 18 months, and key secondary endpoints include OS and the toxicity of consolidation niv and niv/ipi. Exploratory endpoints will look at the correlation between multiple clinical, radiographic, and laboratory parameters and outcomes, as well as the association of these parameters with the development of pneumonitis. This trial opened to accrual in September 2017. Clinical trial information: NCT03285321.

scholarly journals Epilepsy as a Comorbidity in Polymyositis and Dermatomyositis—A Cross-Sectional Study

2021 ◽  
Vol 18 (8) ◽  
pp. 3983
Author(s):  
Ella Nissan ◽  
Abdulla Watad ◽  
Arnon D. Cohen ◽  
Kassem Sharif ◽  
Johnatan Nissan ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Cross Sectional Study ◽  
Cox Proportional Hazards ◽  
Categorical Variables ◽  
Rank Test ◽  
Control Group ◽  
Multivariable Logistic Regression Analysis ◽  
Positive Trend ◽  
Continuous Variables ◽  
Cross Sectional

Polymyositis (PM) and dermatomyositis (DM) are autoimmune-mediated multisystemic myopathies, characterized mainly by proximal muscle weakness. A connection between epilepsy and PM/DM has not been reported previously. Our study aim is to evaluate this association. A case–control study was conducted, enrolling a total of 12,278 patients with 2085 cases (17.0%) and 10,193 subjects in the control group (83.0%). Student’s t-test was used to evaluate continuous variables, while the chi-square test was applied for the distribution of categorical variables. Log-rank test, Kaplan–Meier curves and multivariate Cox proportional hazards method were performed for the analysis regarding survival. Of the studied 2085 cases, 1475 subjects (70.7%) were diagnosed with DM, and 610 patients (29.3%) with PM. Participants enrolled as cases had a significantly higher rate of epilepsy (n = 48 [2.3%]) as compared to controls (n = 141 [1.4%], p < 0.0005). Using multivariable logistic regression analysis, PM was found only to be significantly associated with epilepsy (OR 2.2 [95%CI 1.36 to 3.55], p = 0.0014), whereas a non-significant positive trend was noted in DM (OR 1.51 [95%CI 0.99 to 2.30], p = 0.0547). Our data suggest that PM is associated with a higher rate of epilepsy compared to controls. Physicians should be aware of this comorbidity in patients with immune-mediated myopathies.

scholarly journals The predictive value of absolute lymphocyte counts on tumor progression and pseudoprogression in patients with glioblastoma

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jing Xi ◽  
Bilal Hassan ◽  
Ruth G. N. Katumba ◽  
Karam Khaddour ◽  
Akshay Govindan ◽  
...  
Keyword(s):  
Tumor Progression ◽  
Predictive Value ◽  
Absolute Lymphocyte Count ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Current Standard ◽  
Surgical Biopsy ◽  
Cell Counts ◽  
Significant Difference ◽  
True Progression

Abstract Background Differentiating true glioblastoma multiforme (GBM) from pseudoprogression (PsP) remains a challenge with current standard magnetic resonance imaging (MRI). The objective of this study was to explore whether patients’ absolute lymphocyte count (ALC) levels can be utilized to predict true tumor progression and PsP. Methods Patients were considered eligible for the study if they had 1) GBM diagnosis, 2) a series of blood cell counts and clinical follow-ups, and 3) tumor progression documented by both MRI and pathology. Data analysis results include descriptive statistics, median (IQR) for continuous variables and count (%) for categorical variables, p values from Wilcoxon rank sum test or Fisher’s exact test for comparison, respectively, and Kaplan-Meier analysis for overall survival (OS). OS was defined as the time from patients’ second surgery to their time of death or last follow up if patients were still alive. Results 78 patients were included in this study. The median age was 56 years. Median ALC dropped 34.5% from baseline 1400 cells/mm3 to 917 cells/mm3 after completion of radiation therapy (RT) and temozolomide (TMZ). All study patients had undergone surgical biopsy upon MRI-documented progression. 37 had true tumor progression (47.44%) and 41 had pseudoprogression (52.56%). ALC before RT/TMZ, post RT/TMZ and at the time of MRI-documented progression did not show significant difference between patients with true progression and PsP. Although not statistically significant, this study found that patients with true progression had worse OS compared to those with PsP (Hazard Ratio [HR] 1.44, 95% CI 0.86–2.43, P = 0.178). This study also found that patients with high ALC (dichotomized by median) post-radiation had longer OS. Conclusion Our results indicate that ALC level in GBM patients before or after treatment does not have predictive value for true disease progression or pseudoprogression. Patients with true progression had worse OS compared to those who had pseudoprogression. A larger sample size that includes CD4 cell counts may be needed to evaluate the PsP predictive value of peripheral blood biomarkers.

scholarly journals Leptospira spp. seroprevalence in humans involved in a cross-sectional study in Garissa and Tana River Counties, Kenya

2020 ◽  
Author(s):  
Arithi Mutembei ◽  
Festus K. Mutai ◽  
Damaris Mwololo ◽  
John Muriuki ◽  
Mark Obonyo ◽  
...  
Keyword(s):  
Case Fatality ◽  
Cross Sectional Study ◽  
Wilcoxon Test ◽  
Categorical Variables ◽  
P Value ◽  
Continuous Variables ◽  
Sectional Study ◽  
Test Statistic ◽  
Cross Sectional ◽  
Tana River

AbstractIntroductionLeptospirosis is a neglected bacterial zoonotic infection caused by spirochetes of Leptospira genus. Humans get infected through direct or indirect contact with urine of infected animals or environment. It accounts for more than 300,000 severe cases annually worldwide with case fatality rates of over 30%. Costs of diagnosis and treatment for human and animals, disruption of international trade of animals and products, reduced productivity and reproductivity in animals constitute economic importance. In Kenya, leptospirosis burden is significant but under-diagnosis and under-reporting affects the awareness of the disease. This study aimed to determine and compare the sero-prevalence and factors associated with Leptospira spp. in the two counties.MethodsWe conducted a cross-sectional study that involved apparently healthy people of at least 5 years of age in randomly selected households in Garissa and Tana River Counties. Blood samples were collected and tested for Leptospira spp antibodies using IgM ELISA. Standardized structured questionnaires were administered to collect socio-demographic and exposure information. We calculated frequencies and proportions for categorical variables and odds ratios (OR) and 95% confidence interval (CI) to evaluate association between sero-positivity and exposure factors. We used Wilcoxon test to evaluate statistical difference in sero-positivity for continuous variables and calculated test statistic (H) and p-value.ResultsA total of 952 subjects were recruited into the study – these included 482 persons from Garissa and 470 from Tana River. The overall sero-prevalence was 26% [(244/952); (CI: 23% to 29%)]. Garissa County had significantly higher Leptospira spp. seroprevalence (31%, n = 147; CI: 27% to 35%) compared to Tana River County (21 %, n = 97; CI: 17% to 25%). Being a female (OR=1.6, CI: 1.2-2.2) and engaging in pastoralism (OR=2.7, CI: 1.8-3.9) were significantly associated with higher odds of Leptospira spp. seropositivity compared to being a male or working in irrigated areas. The mean altitude of residence of sero-positive patients was 73m ± 21 SD (standard deviation) above sea level and that for sero-negative was 80m ± 22 SD (H=35, p-value = 0.00).ConclusionThis study determined the seroprevalence and risk factors for Leptospira spp. exposure in Garissa and Tana River Counties, Kenya. Females in pastoral communities experience high burden of the disease. Enhanced surveillance in humans and animals and further research is required to understand the complex and multifactorial drivers of leptospirosis transmission in the two Counties.

Eight Cycles of BEACOPP Escalated Compared with 4 Cycles of BEACOPP Escalated Followed by 4 Cycles of BEACOPP Baseline with Our without Radiotherapy in Patients in Advanced Stage Hodgkin Lymphoma (HL): Final Analysis of the Randomised HD12 Trial of the German Hodgkin Study Group (GHSG).

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1558-1558 ◽  
Author(s):  
Volker Diehl ◽  
Heinz Haverkamp ◽  
Rolf Peter Mueller ◽  
Hans Theodor Eich ◽  
Hans Konrad Mueller-Hermelink ◽  
...  
Keyword(s):  
Residual Disease ◽  
Stage Iv ◽  
Final Analysis ◽  
Stage Iii ◽  
Rank Test ◽  
Advanced Stage ◽  
Data Set ◽  
Who Grade ◽  
Free Survival ◽  
Significant Difference

Abstract Purpose: The GHSG HD9 trial had established BEACOPP escalated (BE) as new standard of care for advanced-stage HL patients by showing significant superiority in terms of failure-free survival (FFTF) and overall survival (OS) over COPP/ABVD and BEACOPP baseline (BB) (each 8 cycles). The successor study, HD12, evaluated a possible reduction in toxicity by comparing 8 cycles of BE with 4 cycles BE followed by 4 cycles BB. The second question in this trial related to the need of additional radiotherapy (RT) to initial bulk and residual disease. Patients and methods: HL patients in stage IIB with large mediastinal mass and/or E-lesions or stage III/IV were randomised according to a 2×2-factorial design between: 8BE + RT, 8BE no RT, 4BE+4BB + RT, 4BE+4BB no RT. Reviewing CT-images before and after chemotherapy treatment, fields for RT were centrally planned by a multidisciplinary diagnostic panel blinded for the randomisation arm. Primary endpoint of the trial was FFTF. Between 9/1999 and 1/2003, a total of 1,670 patients aged 16–65 were randomized. For this final analysis at a median follow up of 78 months, 99 patients were excluded (42 HL not confirmed, 20 revision of stage, 20 no study treatment or documentation, 17 others) resulting in 1,571 eligible patients. Results: Patient characteristics in the 4 groups were comparable with 49% of patients in stage III, 35% in stage IV, 68% reporting B-symptoms and 28% having a large mediastinal tumor. An IPS of 3 or greater was reported for 38% of patients, predominant histology was nodular sclerosis with 57% of cases. Treatment-related toxicity of WHO grade III/IV was observed in 97% of patients. Most prominent differences between pooled chemotherapy arms were anemia (65% 8BE vs 51% 4BE+4BB) and thrombopenia (65% vs 51%). Treatment outcome: complete remission 92.4%; early progression 2.2%; progression/relapse 7.8% (6.6% and 8.5%). A total of 156 (9.9%) deaths (72 vs 84) have been observed (22 vs 32 acute or salvage treatment toxicity; 15 vs 24 HL; 22 vs 13 secondary neoplasia). Most treatment related deaths occurred in the &gt;60 years age group, the first 4 cycles and the IPS&gt; 3 RF groups. Secondary neoplasias were observed in 77 patients (4.9%): AML/MDS 1.5% vs 1.4%, NHL 1.4% vs 0.6% and solid tumors/others 2.5% vs 2.3%. At 5 years, OS was 91%, FFTF 85.5% and progression free survival (PFS) 86.2% (Kaplan- Meier estimates). Estimates for the difference at 5 years are 1.8% for OS, 2.3% for FFTF and 2.7% for PFS favoring BE. However, there was no statistical difference between 8x BE and 4BE+4BB in all outcome parameters (p&gt;0.19, log rank test). There is also no significant difference between the RT or no-RT arms in this study with the caveat that a number of high-risk patients receiving RT based on the blinded panel decision. Conclusion: The adoption of 4BE+4BB as a new standard in the future GHSG studies will depend on a refined analysis of the total data set and will be presented.

Prognosis and comorbidities in stage III and IV endometrial cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16553-e16553
Author(s):  
K. Wright ◽  
E. Munro ◽  
M. del Carmen ◽  
A. K. Goodman
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
Stage Iv ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Rank Test ◽  
Laboratory Values ◽  
Significant Difference ◽  
Baseline Creatinine

e16553 Background: While endometrial cancer may be associated with many comorbid conditions, none have been characterized as changing overall prognosis. The aim of this study was to identify medical conditions or laboratory values, that may serve as prognostic factors in stage III and IV endometrial cancer. Methods: A retrospective chart review identified 112 women with stage III or IV endometrial cancer between years 1993–1998. Information about medical comorbidities and presenting lab values were collected using electronic medical records. Progression free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier survival method and the log rank test. Results: The average age was 64.9 yrs. 79 women (70.5%) had stage III disease and 33 women (29.5%) had stage IV disease. For those with a baseline creatinine <1.2 (n = 91), the PFS and OS were not significantly different from those with a baseline creatinine ≥1.2 (n = 17; p = 0.554 and p = 0.487, respectively). There was a non-significant trend toward worse PFS for the 41 patients with hypertension (HTN) compared to the 62 without (48.0 and 61.2 months, p = 0.191). The overall survival was significantly worse for those with HTN (38.7 months vs. 56.0 months p = 0.046). For those with known coronary artery disease, no significant difference in PFS or OS was found (p = 0.792 and p = 0.312 respectively). Those with diabetes (n = 15) did not have a significantly different PFS compared to those who did not (n = 88; p = 0.728). The OS was worse at 20.1 months for those with diabetes compared to 54.3 months for those without (p = 0.001). Baseline albumin had a significant effect on both PFS and OS. Those with an albumin <3.5 (n = 54) had a PFS of 46.2 months compared to 94.0 months for those with an albumin ≥3.5 (n = 23; p = 0.007), and the OS for those with low albumin was 44.8 months compared to 83.4 months for those with the higher albumin (p = 0.005). Conclusions: These results suggest that past medical history and some baseline laboratory values may be important in considering prognosis. In particular, patients with a history of HTN or diabetes have a worse overall survival. Those with a baseline albumin of <3.5 have a worse PFS and OS. No significant financial relationships to disclose.

Significance and reliability of pathologic marker Ki-67 in patients with neuroendocrine cancers.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 264-264 ◽  
Author(s):  
S. Singh ◽  
Y. Feinberg ◽  
C. Rowsell ◽  
C. Law
Keyword(s):  
Treatment Options ◽  
Kappa Statistic ◽  
Categorical Variables ◽  
Rank Test ◽  
Ki 67 ◽  
Exact Test ◽  
Expert Pathologist ◽  
Group A ◽  
Group B ◽  
Neuroendocrine Cancers

264 Background: Molecular markers, especially Ki-67, in neuroendocrine cancers (NETs) have become increasingly important. Debate exists as to the optimal role of ki-67 in the treatment of this uncommon cancer. This study was designed to examine the significance of ki-67 as a clinical predictor and its reliability in the treatment of NETs. Methods: A retrospectively assembled integrated database with prospectively collected data of patients undergoing multidisciplinary management for NETs between 2000 to 2009 was analysed. Clinical and outcomes data were collected. Ki-67 was then categorized to Group A (≤2%), B (3-15%) and C (>15%). We compared the original Ki-67 value to the reviewed value. We then used a kappa statistic to calculate the inter-rater agreement between the original and reviewed determination of Ki-67. Fisher's exact test was used to compare categorical variables. Survival was evaluated using the log-rank test. All analyses were carried out using SAS 9.1.3. Results: A total of 184 patients were seen at our clinic. Ki-67 correlated with metastases at presentation (36, 52, 63% for Groups A, B, C respectively, p<0.05), while influencing treatment with chemotherapy even in the absence of metastases (14, 29, 57% for Groups A, B, C respectively, p< 0.002). Ki-67 predicted overall survival (p=0.0005) in favor of Group A. 99 patients had an original Ki-67 reported from the referring center and then a review by an expert pathologist at the multidisciplinary clinic. In Group A, there was 94.4% agreement, with 3.7% of cases upgraded at review to Group B and 1.9% of cases upgraded to Group C. In Group B, there was 94.3% agreement, with 5.7% of cases downgraded to Group A, and 0% upgraded. In Group C, there was 90% agreement, with 10% of cases downgraded to Group B and none to Group A (kappa = 0.89). Conclusions: Our previous report had demonstrated that Ki-67 influenced decisions regarding treatment options. In our updated population of NETs patients, Ki-67 continued to predict biology, influence treatment, and predict survival. In addition we demonstrated high reproducibility of Ki-67. It appears that with modern techniques Ki-67 can be highly reproducible and reliable tool in improving outcomes in this patient population. No significant financial relationships to disclose.

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