Secondary Malignancies after Treatment of Aggressive Non-Hodgkin Lymphoma: A GISL Cohort Study on 1259 Patients.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 522-522
Author(s):  
Stefano Sacchi ◽  
Luigi Marcheselli ◽  
Alessia Bari ◽  
Raffaella Marcheselli ◽  
Samantha Pozzi ◽  
...  
Keyword(s):  
Cox Regression ◽  
Aggressive Lymphoma ◽  
Second Malignancy ◽  
Secondary Malignancies ◽  
Second Cancer ◽  
Score System ◽  
Cox Regression Analysis ◽  
Non Hodgkin Lymphoma ◽  
Kaplan Meier

Abstract BACKGROUND Secondary malignancies have been associated with Non Hodgkin Lymphoma (NHL) treatment. Nevertheless few analyses have addressed this issue focusing on aggressive lymphoma. Aims of this study were to determine the incidence and the risk factors for developing secondary cancer during long term follow up of patients treated for aggressive lymphoma. METHODS For the purpose of this study we identified in the GISL database, 1259 naïve patients with histologically confirmed diagnosis of aggressive NHL. Observed cancer were classified by site. The incidence numbers of second neoplasia was compared to the incidence of malignancies in the Italian population. The standardized incidence ratio was calculated from the ratio between observed and expected number of cancers. Absolute excess risk was calculated by subtracting the expected from the observed cases and dividing by the person-years at risk. The Time Free 2nd Tumour (TF2T) was measured from the end of the first treatment to last follow-up or date of diagnosis. Cumulative incidences were estimated either with a Kaplan-Meier estimate or by Gooley’s method. Effects of potential risk factors on second cancer rates were examined in a Cox proportional-hazard model. RESULTS The cohort consisted of 1259 patients enrolled in GISL trials in the period 1988–2003, accounting for 6180 person-year at risk of second tumor. Median age at diagnosis was 58 years. All patients were treated with chemotherapy either alone or in combination with radiotherapy. During follow up, 44 patients (3.5%) developed a second cancer. Twelve out of 44 patients developed hematological malignancies and 32 solid tumors, including 7 lung cancer, 6 colorectal cancer, 4 prostate cancer and 15 other type of cancers. The median time for developing second tumors was 42 months. The risk of secondary malignancy overall was not increased. The analysis of risk by cohort of age at diagnosis of second cancer showed an excess of risk for the cohort age 20–39 and 40–59 years. Cumulative incidence of second malignancy, estimated by Kaplan Meier and by Gooley’s method at 5, 10 and 15 years was 3.2%, 6.9% and 13.8%, and 2.7%, 5.2% and 9.6%, respectively. By univariate analysis we observed a significant negative impact on TF2T for age at first treatment and only marginally significant for elevated LDH level. Further, we performed a Cox regression analysis with gender, age at 1st treatment and LDH >UNL that showed the prognostic ability of these variables in predicting the risk of second tumour. We divided the log(HR) predicted from multivariate analysis, at the 33° and the 66° percentiles to obtain a score system. We observed three groups with significant difference (p< .0001) in the risk of developing second cancers. CONCLUSIONS Our results showed that the risk of second malignancy overall was not increased in patients treated for aggressive lymphoma. Cancer risk was age-related, as demonstrated by the excess of risk observed in the cohort age 20–39 and 40–59 years. Further, utilizing age, male gender and LDH in a Cox regression analysis, we demonstrated the prognostic value of these variables and we produced a score system able to identify groups with different risk of developing second malignancies.

scholarly journals P-Cresyl Sulfate Is a Valuable Predictor of Clinical Outcomes in Pre-ESRD Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Cheng-Jui Lin ◽  
Chi-Feng Pan ◽  
Chih-Kuang Chuang ◽  
Fang-Ju Sun ◽  
Duen-Jen Wang ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cardiovascular Event ◽  
Cox Regression ◽  
Medical Center ◽  
Serum Biochemistry ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Valuable Marker ◽  
Valuable Predictor

Background/Aims. Previous studies have reported p-cresyl sulfate (PCS) was related to endothelial dysfunction and adverse clinical effect. We investigate the adverse effects of PCS on clinical outcomes in a chronic kidney disease (CKD) cohort study.Methods. 72 predialysis patients were enrolled from a single medical center. Serum biochemistry data and PCS were measured. The clinical outcomes including cardiovascular event, all-cause mortality, and dialysis event were recorded during a 3-year follow-up.Results. After adjusting other independent variables, multivariate Cox regression analysis showed age (HR: 1.12,P=0.01), cardiovascular disease history (HR: 6.28,P=0.02), and PCS (HR: 1.12,P=0.02) were independently associated with cardiovascular event; age (HR: 0.91,P<0.01), serum albumin (HR: 0.03,P<0.01), and PCS level (HR: 1.17,P<0.01) reached significant correlation with dialysis event. Kaplan-Meier analysis revealed that patients with higher serum p-cresyl sulfate (>6 mg/L) were significantly associated with cardiovascular and dialysis event (log rankP=0.03, log rankP<0.01, resp.).Conclusion. Our study shows serum PCS could be a valuable marker in predicting cardiovascular event and renal function progression in CKD patients without dialysis.

scholarly journals Matrix metalloproteinase 12 is an independent prognostic factor predicting postoperative relapse of conventional renal cell carcinoma - a short report

2021 ◽  
Author(s):  
Bence Beres ◽  
Maria Yusenko ◽  
Lehel Peterfi ◽  
Gyula Kovacs ◽  
Daniel Banyai
Keyword(s):  
Renal Cell ◽  
Cox Regression ◽  
Tissue Array ◽  
Short Report ◽  
Free Survival ◽  
Cox Regression Analysis ◽  
Conventional Renal Cell Carcinoma ◽  
Kaplan Meier ◽  
Matrix Metalloproteinase 12

Abstract Purpose Approximately 15% of clinically localised conventional renal cell carcinomas (cRCC) develop metastases within 5 years of follow-up. Sarcomatous cRCC is a highly malignant cancer of the kidney. The aim of our study was to identify biomarkers for estimating the postoperative progression of cRCCs. Methods Global microarray-based gene expression analysis of RCCs with and without sarcomatous changes revealed that a high MMP12 expression was associated with a sarcomatous histology. Additionally, we analysed MMP12 expression using a multi-tissue array comprising 736 cRCC patients without metastasis at the time of surgery. The median follow-up time was 66 ± 29 months. Results Immunohistochemistry revealed MMP12 expression in 187 of 736 cRCCs with good follow-up data. Subsequent Kaplan–Meier analysis revealed that patients with MMP12 positive tumours exhibited a significantly shorter tumour-free survival (p < 0.001). In multivariate Cox regression analysis a weak to strong MMP12 expression indicated a 2.4–2.8 times higher risk of postoperative tumour relapse (p < 0.001; p < 0.003, respectively). Conclusions MMP12 may serve as a biomarker to estimate postoperative cRCC relapse and as a possible target for penfluridol therapy.

scholarly journals Mortality in Patients with Diabetic Foot Ulcers: Causes, Risk Factors, and Their Association with Evolution and Severity of Ulcer

2020 ◽  
Vol 9 (9) ◽  
pp. 3009
Author(s):  
José Antonio Rubio ◽  
Sara Jiménez ◽  
José Luis Lázaro-Martínez
Keyword(s):  
Diabetic Foot ◽  
Cox Regression ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
History Of

Background: This study reviews the mortality of patients with diabetic foot ulcers (DFU) from the first consultation with a Multidisciplinary Diabetic Foot Team (MDFT) and analyzes the main cause of death, as well as the relevant clinical factors associated with survival. Methods: Data of 338 consecutive patients referred to the MDFT center for a new DFU during the 2008–2014 period were analyzed. Follow-up: until death or until 30 April 2020, for up to 12.2 years. Results: Clinical characteristics: median age was 71 years, 92.9% had type 2 diabetes, and about 50% had micro-macrovascular complications. Ulcer characteristics: Wagner grade 1–2 (82.3%), ischemic (49.2%), and infected ulcers (56.2%). During follow-up, 201 patients died (59.5%), 110 (54.7%) due to cardiovascular disease. Kaplan—Meier curves estimated a reduction in survival of 60% with a 95% confidence interval (95% CI), (54.7–65.3) at 5 years. Cox regression analysis adjusted to a multivariate model showed the following associations with mortality, with hazard ratios (HRs) (95% CI): age, 1.07 (1.05–1.08); HbA1c value < 7% (53 mmol/mol), 1.43 (1.02–2.0); active smoking, 1.59 (1.02–2.47); ischemic heart or cerebrovascular disease, 1.55 (1.15–2.11); chronic kidney disease, 1.86 (1.37–2.53); and ulcer severity (SINBAD system) 1.12 (1.02–1.26). Conclusion: Patients with a history of DFU have high mortality. Two less known predictors of mortality were identified: HbA1c value < 7% (53 mmol/mol) and ulcer severity.

Assessment of Losartan 50 mg on Survival of Post-Dialysis Euvolemic Hypertensive Patients: Findings from HELD Trial

2019 ◽  
Vol 48 (3) ◽  
pp. 233-242
Author(s):  
Raja Ahsan Aftab ◽  
Amer Hayat Khan ◽  
Azreen Syazril Adnan ◽  
Syed Azhar Syed Sulaiman ◽  
Tahir Mehmood Khan
Keyword(s):  
Cox Regression ◽  
Dialysis Session ◽  
Hypertensive Patients ◽  
Cox Regression Analysis ◽  
Probability Of Survival ◽  
End Point ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Single Blind

Aims and objective: To estimate the effect of losartan 50 mg on survival of post-dialysis euvolemic hypertensive patients. Methodology: A single center, prospective, single-blind randomized trial was conducted to estimate the survival of post-dialysis euvolemic hypertensive patients when treated with lorsartan 50 mg every other day. Post-dialysis euvolemic assessment was done by a body composition monitor. Covariate Adaptive Randomization was used for allocation of participants to the standard or intervention arm, and the follow-up duration was twelve months. The primary end point was achieving targeted blood pressure (BP) of <140/90 mm Hg and maintaining for 4 weeks, whereas secondary end point was all cause of mortality. Pre-, intra-, and post-dialysis session BP measurements were recorded, and survival trends were analyzed using Kaplan-Meier analysis. Results: Of the total 229 patients, 96 (41.9%) were identified as post-dialysis euvolemic hypertensive. Final samples of 88 (40.1%) patients were randomized into standard (n = 44) and intervention arms (n = 44), and 36 (81.8%) patients in each arm completed a follow-up of 12 months. A total of eight patients passed away during the 12-month follow-up period (6 deaths among standard arm and 2 in intervention arm). However, the probability of survival between both arms was not significant (p = 0.13). Cox regression analysis revealed that chances of survival were higher among the patients in the intervention (OR 3.17) arm than the standard arm (OR 0.31); however, the survival was found not statistically significant. Conclusion: There was no statistical significant difference in 1 year survival of post-dialysis euvolemic hypertensive patients when treated with losartan 50 mg.

scholarly journals Evaluation of pulse wave velocity for predicting major advanced cardiovascular events in patients with chronic myocardial infarction

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
Z Meiszterics ◽  
T Simor ◽  
R J Van Der Geest ◽  
N Farkas ◽  
B Gaszner
Keyword(s):  
Myocardial Infarction ◽  
Regression Analysis ◽  
Cardiovascular Events ◽  
Pulse Wave ◽  
Cox Regression ◽  
Event Free Survival ◽  
Free Survival ◽  
Cox Regression Analysis ◽  
Kaplan Meier

Abstract Introduction Increased aortic pulse wave velocity (PWV) as a strong predictor of major advanced cardiovascular events (MACE) has a prognostic relevance in patients after myocardial infarction (MI). Several non-invasive methods have been proposed for the assessment of arterial stiffness, but the PWV values show significant differences according to the applied techniques. Cardiac magnetic resonance imaging (CMR) provides an accurate method to measure PWV and infarct size in patients after MI. Purpose Calculated PWV values of CMR based phase-contrast (PC) and invasively validated oscillometric methods were compared in this prospective observational study. We aimed to evaluate the cut-off PWV values for each method, while MACE predicted and validated the prognostic value of high PWV in post-infarcted patients in a 6-year follow-up. Methods 3D aortic angiography and PC velocity imaging was performed using a Siemens Avanto 1,5 T CMR device. Oscillometric based Arteriograph (AG) was used to assess PWV using direct body surface distance measurements. The comparison between the two techniques was tested. Patients received follow-up for MACE comprising all-cause death, non-fatal MI, ischemic stroke, hospitalization for heart failure and coronary revascularization. Event-free survival was analysed using Kaplan-Meier plots and log-rank tests. Univariable and multivariable Cox regression analysis was performed to identify outcome predictors. Results 75 patients (56 male, 19 female, average age: 56±13 years) referred for CMR were investigated, of whom 50 had coronary artery disease (CAD) including 35 patients with previous MI developing ischaemic late gadolinium enhancement (LGE) pattern. AG and CMR derived PWV values were significantly correlated (rho: 0,343, p&lt;0,05), however absolute PWV values were significantly higher for AG (median (IQR): 10,4 (9,2–11,9) vs. 6,44 (5,64–7,5); p&lt;0,001). Bland Altman analysis showed an acceptable agreement with a mean difference of 3,7 m/s between the two measures. In patients with CAD significantly (p&lt;0,01) higher PWV values were measured by AG and CMR, respectively. During the median follow-up of 6 years, totally 69 MACE events occurred. Optimized PWV cut-off values for MACE prediction were calculated (CMR: 6,47 m/s; AG: 9,625 m/s) by receiver operating characteristic analysis. Kaplan-Meier analysis in both methods showed a significantly lower event-free survival in case of high PWV (p&lt;0,01, respectively). Cox regression analysis revealed PWV for both methods as a predictor of MACE (PWV CMR hazard ratio (HR): 2,6 (confidence interval (CI) 1,3–5,1), PWV AG HR: 3,1 (CI: 1,3–7,1), p&lt;0,005, respectively). Conclusions Our study showed good agreement between the AG and CMR methods for PWV calculation. Both techniques are feasible for MACE prediction in postinfarcted patients. However, different AG and CMR PWV cut-off values were calculated to improve risk stratification. FUNDunding Acknowledgement Type of funding sources: None. Agreement between the two methods Kaplan-Meier event curves for MACE

scholarly journals Long-term survival of cemented versus uncemented total hip arthroplasty in the treatment of acute femoral neck fracture: A retrospective observational study with a mean 10-year follow-up

2020 ◽  
Author(s):  
Xiulan Han ◽  
Weiguang Yu ◽  
Jinluan Lin ◽  
Mingdong Zhao ◽  
Guowei Han ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Cox Regression ◽  
Cox Regression Analysis ◽  
Total Hip ◽  
Kaplan Meier ◽  
Uncemented Total Hip Arthroplasty

Abstract Background Despite the increased use of uncemented total hip arthroplasty (UTHA), there is little evidence of its superiority over cemented total hip arthroplasty (CTHA). The purpose of this retrospective study was to compare the long-term survivorship and Harris Hip Scores (HHSs) of CTHA versus UTHA in the treatment of acute femoral neck fractures (FNFs). Methods Data involving 224 hips (CTHA, n= 112; UTHA, n=112) that underwent primary surgery in our medical institutions during 2005-2017 were analysed retrospectively. The primary endpoint was the risk of all-cause revision. The difference in the risk of all-cause revision between groups was assessed by Kaplan-Meier survival analysis with a log-rank test and Cox regression analysis. Results The mean follow-up from surgery was 10 years (range, 3 - 13 years). Kaplan-Meier estimated that the 10-year implant survival was 98.1% (CI: 96.1–98.5) in the CTHA group and 96.2% (CI: 95.2–97.3) in the UTHA group (p = 0.030). The adjusted Cox regression analysis demonstrated a lower risk of revision in CTHA than in UTHA (hazard ratio [HR] = 1.4, 95% confidence interval [CI] = 1.1-2.6, p = 0.000). At the final follow-up, significant differences were detected in HHS (85.10[±12.21] for CTHA vs. 79.11[±13.19] for UTHA). Conclusion This retrospective analysis demonstrates that CTHA has superior survival to UTHA, with a significantly reduced revision risk and higher functional outcome scores. Further follow-up is necessary to verify whether the CTHA advantage persists over time.

scholarly journals Survival analysis of renal patients underwent transplantation in Kyrgyz Republic and various countries by 10 years follow-up

2019 ◽  
Vol 3 (Issue 4) ◽  
pp. 243
Author(s):  
Zhanybek Gaibyldaev ◽  
Zhamalbek Ashimov ◽  
Damirbek Abibillaev ◽  
Fuat Kocyigit
Keyword(s):  
Survival Analysis ◽  
Heart Surgery ◽  
Cox Regression ◽  
Statistical Significance ◽  
Survival Function ◽  
Strong Impact ◽  
Kyrgyz Republic ◽  
Cox Regression Analysis ◽  
Kaplan Meier

In our study we conducted survival analysis of 204 patients visited Scientific-Research Institute of Heart Surgery and Organs transplantation and who underwent renal transplantation in Kyrgyzstan and other Eurasian countries between 2005 and 2016 years (age range: 9-71 years, mean: 38.21 (12.74) years, median: 34.0 (0.89) years; gender: 142 male (69.6%)). During follow-up period, mortality event was observed in 16 (7.84%) patients. Survival function probabilities of patients and rational risk factors of survival functions were evaluated by Kaplan-Meier and Cox regression analyses, respectively. According to Kaplan-Meier results survival probabilities calculated for 1st year: 0.96 (0.014), for 3rd year: 0.94 (0.018), for 5th year: 0.86 (0.04), for 7th year: 0.75 (0.10). Among age groups 28-39 age ranges prevailed by 11 patients. Nevertheless, that difference did not show statistical significance: p˃0.322. The intensity of transplantation also analyzed according to years, which revealed increasing in numbers of operations by time. For instance, when in 2006 only two cases were registered in our center, but numbers of transplanted patients reached up to 48 in 2015. The association of mortality states and years of transplantation found significantly by Kaplan-Meier test (Breslow p˂0.001). The survival analysis was compared according to countries and revealed significant results (Breslow p˂0.05). From other factors influencing mortality, sex did not show strong impact on survival by Kaplan-Meier analysis, but significant association was found by Cox regression analysis.

scholarly journals Malnutrition Affects Cholesterol Paradox in Coronary Artery Disease: a 41,229 Chinese Cohort Study

2021 ◽  
Author(s):  
Bo Wang ◽  
Jin Liu ◽  
Shiqun Chen ◽  
Ming Ying ◽  
Guanzhong Chen ◽  
...  
Keyword(s):  
Cox Regression ◽  
Cox Model ◽  
Cox Regression Analysis ◽  
Coronary Syndrome ◽  
Kaplan Meier ◽  
All Cause Mortality ◽  
Chinese Cohort ◽  
Artery Disease

Abstract Background: Several studies found that baseline low LDL-C concentration was associated with poor prognosis in patients with acute coronary syndrome (ACS), which was called “cholesterol paradox”. Low LDL-C concentration may reflect underlying malnutrition, which was strongly associated with increased mortality. We objected to investigate the cholesterol paradox in patients with CAD and the effects of malnutrition.Method: A total of 41,229 CAD patients admitted to Guangdong Provincial People's Hospital in China were included in this study from January 2007 to December 2018, and divided into two groups (LDL-C < 1.8 mmol/L, n=4,863; LDL-C ≥ 1.8 mmol/L, n = 36,366). We used Kaplan-Meier method and Cox regression analyses to assess the association between LDL-C levels and long-term all-cause mortality and the effect of malnutrition. Result: In this real-world cohort (mean age 62.94 years; 74.94% male), there were 5257 incidents of all-cause death during a median follow-up of 5.20 years [Inter-quartile range (IQR): 3.05-7.78 years]. Kaplan–Meier analysis showed that low LDL-C levels were associated with worse prognosis. After adjusting for baseline confounders (e.g., age, sex and comorbidities, etc.), multivariate Cox regression analysis revealed that low LDL-C level (<1.8mmol/L) was not significantly associated with all-cause mortality (adjusted HR, 1.04; 95% CI, 0.96-1.24). After adjustment of nutritional status, risk of all-cause mortality of patients with low LDL-C level decreased (adjusted HR, 0.90; 95% CI, 0.83-0.98). In the final multivariate Cox model, low LDL-C level was related to better prognosis (adjusted HR, 0.91; 95% CI, 0.84-0.99).Conclusion: Our results demonstrate that the cholesterol paradox persisted in CAD patients, but disappeared after accounting for the effects of malnutrition.

scholarly journals P1787 Pharmacologic stress test: still an important prognostic factor? a follow-up study

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
V Ferreira ◽  
L Moura Branco ◽  
A Galrinho ◽  
P Rio ◽  
S Aguiar Rosa ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Cox Regression ◽  
Stress Test ◽  
Bypass Graft ◽  
Dobutamine Stress ◽  
Left Ventricular ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
All Cause Mortality

Abstract Introduction Dobutamine stress echocardiography (DSE) is an established exam for evaluation of extent and severity of coronary artery disease. Purpose To analyse the results and complications of DSE and identify prognostic predictors in patients (P) who underwent DSE for myocardial ischemia detection. Methods 220P who underwent consecutive DSE from 2013 to 2017. P with significant valvular disease were excluded. Clinical data, echocardiographic parameters and data from follow up (FU) regarding all-cause mortality and MACEs were analysed. Mean age 64.8 ± 12.0 years(Y), 143 men (65%). Results 88P (40%) had positive, 102 had negative and 30 had inconclusive DSE; complications rate of 15%. Prevalence of hypertension, diabetes mellitus (DM), dyslipidemia, prior MI, percutaneous coronary interventionc (PCI), coronary arterial bypass graft (CABG) and HF was 82.7%, 42.3%, 67.7%, 35.9%, 31.8%, 10.9% and 9.5%, respectively. Mean left ventricular endsystolic (LVSD) and enddiastolic dimensions were 33.7 ± 8.9 and 52.8 ± 7.1 mm. Mean resting wall motion score index (rWMSI) and peak (pWMSI) were 1.16 ± 0.28 and 1.24 ± 0.34. Mean resting GLS (rGLS) and peak GLS (pGLS) were -16.3 ± 4.3 and -16.6 ± 4.3. Mean no. of ischemic segments was 1.7 ± 2.4 and 16.8% had ischemia &gt;3 segments. There was ischemia in left anterior descending (LAD) coronary in 53P and in circumflex and right coronary territories in 18 and 68P. 22.6% had more than one ischemic territory. 43P (49.4%) underwent intervention, 38 with PCI and 5 with CABG. During a mean FU of 38.8 ± 16.8 months, 47 MACEs were observed, including 32 deaths (14.5%). Positive DSE (p = 0.012), no. of ischemic segments (p = 0.019), ischemia in the LAD (p = 0.003), rGLS (p = 0.038) and pGLS (p = 0.038) were related to the occurrence of MACEs. In Cox regression analysis, age (p = 0.005), DM (p = 0.005), HF (p = 0.006), prior CABG (p = 0.015), LVSD (p = 0.026), rWMSI (p = 0.029), pWMSI (p = 0.013) and pGLS (p = 0.038) were associated with increased all-cause mortality. Kaplan–Meier survival analysis showed that survival was significantly worse for ischemia &gt; 3 segments (log rank 0.005), ischemia of more than one territory (log rank 0.025) and pWMSI &gt;1.5 (log rank &lt; 0.0005). With multivariate Cox regression analysis, age &gt;65Y (HR 4.22, p = 0.004), DM (HR 2.49,p = 0.038) and pWMSI &gt; 1.5 (HR 9.73,p = 0.007) were independently associated with all-cause mortality. Conclusion In patients who underwent DSE there were some baseline and DSE-related independent predictors of long-term prognosis: age, DM and peak WMSI. Abstract P1787 Figure. Kaplan–Meier curves

Three-year survival outcomes in a prospective cohort evaluating a prognostic 31-gene expression profile (31-GEP) test for cutaneous melanoma (CM).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9519-9519 ◽  
Author(s):  
Eddy C. Hsueh ◽  
James R. DeBloom ◽  
Robert W. Cook ◽  
Kelly McMasters
Keyword(s):  
High Risk ◽  
Cox Regression ◽  
Clinical Care ◽  
Positive Sentinel Lymph Node ◽  
Clinical Registry ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Class 1 ◽  
Data Censoring

9519 Background: A 31-GEP test is a validated prognostic tool for predicting the risk of metastasis in CM, classifying patients (pts) as Class 1 (low risk) or Class 2 (high risk). Here we report updated survival analysis from two clinical registry studies (NCT02355574/NCT02355587) designed to prospectively evaluate outcomes in patients for whom the GEP test was part of their clinical care. Methods: Eleven US dermatologic and surgical centers participated using IRB-approved protocols. Participants were CM pts ≥16 years old who had successful 31-GEP test results. Recurrence-free (RFS), distant metastasis-free (DMFS) and overall survival (OS) were assessed using Kaplan-Meier and Cox regression analysis. Results: At data censoring, 340 pts were accrued who had completed at least one follow-up visit. Median age was 58 years (range 18-87), 53.5% were male, median Breslow thickness was 1.2mm (range 0.2-12mm), 18.2% (62/340) were ulcerated, and 11.2% (38/340) had a positive sentinel lymph node (SLN). Median follow-up was 3.2 years for pts without an event. Six percent (16/265) of Class 1 pts had a recurrence compared to 33% (25/75) of Class 2 pts (p < 0.001). Three-year RFS was 96%, 91%, 80%, and 62% for Class 1A, 1B, 2A, and 2B, respectively (p < 0.001). Three-year DMFS was 97%, 93%, 84%, and 80% for Class 1A, 1B, 2A, and 2B, respectively (p < 0.001). Three-year OS was 98%, 90%, 96%, and 74% for Class 1A, 1B, 2A, and 2B, respectively (p < 0.001). Class 2 was an independent predictor of RFS and OS in multivariate analysis (respective HRs: 2.28 and 3.70, p < 0.05). Conclusions: Consistent with results from previous studies, this analysis demonstrates that the GEP test complements conventional staging and improves the ability to identify high-risk CM pts. These results support use of the test for guiding decisions related to follow-up, surveillance, and treatment in CM pts. Clinical trial information: NCT02355574/NCT02355587.

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