Prognostic Factors in CBFB-MYH11 Positive AML: Trisomy 21, AGE, and t(16;16) Are Associated with Inferior Outcome.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 486-486 ◽  
Author(s):  
Martin Weisser ◽  
Susanne Schnittger ◽  
Wolfgang Kern ◽  
Wolfgang Hiddemann ◽  
Torsten Haferllach ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Trisomy 21 ◽  
Cox Regression ◽  
De Novo ◽  
Fusion Transcript ◽  
Rank Test ◽  
Cox Regression Analysis ◽  
Log Rank Test ◽  
De Novo Aml ◽  
Worse Prognosis

Abstract The fusion transcript CBFB-MYH11 is the molecular correlate of inv(16)/t(16;16) and strictly associated with FAB subtype M4eo. This subgroup is associated with a favorable prognosis in AML. However, approximately 30% of the patients relapse. Our intention was to examine prognostic factors for the outcome within this subgroup. Therefore 153 CBFB-MYH11 positive AML patients were analyzed. The median age was 52 years (range 18–83), 80 patients were female, 73 were male. In 22 cases AML was therapy-related, in 131 cases a de novo AML was diagnosed. Inv(16) was detected in 138 and t(16;16) in 12 cases. In 3 cases neither inv(16) nor t(16;16) were detectable despite PCR and FISH positivity for CBFB-MYH11 suggesting cryptic rearrangements. The most frequent additional cytogenetic abnormalities were +8 (n=19), +9 (n=3), +21 (n=7), +22 (n=23). Cox regression analysis revealed that advanced age (OS: p=0.026; EFS: p=0.029) and increased CBFB-MYH11/ABL ratio at diagnosis (OS: 0.016, EFS: p=0.064) were associated with a worse prognosis. Using log rank test additional factors influencing survival were detected. These included: t(16;16) vs inv(16) (OS: n=8, censored 4, median 362 days vs n=118, censored 92, median not reached, p=0.018; EFS: n=8, censored 4, median 232 days vs n=118, censored 70, median 918 days, p=0.048) and trisomy 21 vs no additional aberrations (OS: n=6, censored 3, median 435 days vs n=74, censored 59, median not reached, p=0.024; EFS: n=6, censored 2, median 293 d vs n=74, censored 44, median 764 days, p=0.0047). Therapy related AML was associated with worse EFS than de novo AML (n=16, censored 6, median 371 days vs n=112, censored 70, median 1179 days, p=0.0167) and there was a trend towards worse OS (p=0.157 n=16, censored 10, median 764 days vs n=112, censored 88, median not reached). A multivariate analysis including t(16;16), age, CBFB-MYH11/ABL ratio, therapy related AML and +21 as covariates revealed t(16;16) and age as independent factor for OS (p=0.014 and p=0.015, respectively) and age, t(16;16), and +21 as independent factors for EFS (p=0.047, p=0.013, and p=0.016, respectively). There was no evidence that the additional aberrations +22 or +8 had an influence on survival. Taken together our data suggest that t(16;16) as compared to inv(16), trisomy 21 and age are associated with worse prognosis in patients with CBFB-MYH11 positive AML.

Prognostic factors for survival in patients with metastatic malign melanoma treated with ipilimumab: Turkish Oncology Group study

2018 ◽  
Vol 25 (7) ◽  
pp. 1658-1664 ◽  
Author(s):  
Yuksel Urun ◽  
H Arzu Yasar ◽  
Hande Turna ◽  
Ece Esin ◽  
A Murat Sedef ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Prognostic Factors ◽  
Cox Regression ◽  
Survival Rates ◽  
Lactic Dehydrogenase ◽  
Rank Test ◽  
Cox Regression Analysis ◽  
Log Rank Test ◽  
Metastatic Sites ◽  
Ecog Ps

Purpose Studies in the last decade show survival improvement with checkpoint blocker therapy in patients with metastatic malign melanoma. Our purpose was to define the efficacy of ipilimumab according to the patient's baseline characteristics including absolute lymphocytes count. Methods We collected the data of 97 patients with advanced malign melanoma treated with ipilimumab (3 mg/kg, q3w) retrospectively. Log-rank test was used to analyze the univariate effects of patient's characteristics (age, gender, metastatic sites, ECOG PS, type of melanoma, lactic dehydrogenase levels, anemia, lymphocytes (L), neutrophils (N), N/L ratio), c-kit and BRAF status. Survival analyses were estimated with Kaplan–Meier method. Cox regression analysis was used to assess the possible factors identified with log-rank test. Results The median age was 58, and 58% were male and 90% of patients had at least one prior systemic therapy. The median survival was 9.7 months for all patients; and the 12- and 24-month survival rates were 43% and 19%, respectively. Absolute lymphocytes count, lactic dehydrogenase level, bone metastasis, the number of metastatic sites, and RECIST response were significantly related to survival. After Cox regression analysis, RECIST response (complete or partial response), absolute lymphocytes count (more than 1500/mm3) and the number of metastatic sites (less than three sites) remained as significant independent prognostic factors for longer survival. Conclusion Ipilimumab improved survival of patients with metastatic malign melanoma. However, patients with fewer metastatic sites and higher absolute lymphocytes count have a significantly better benefit. To determine if these markers could be used to direct patient therapy, further validation analysis is needed.

scholarly journals Predictive impact of PVL assessments on clinical outcomes in patients undergoing TAVR

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Matsushita ◽  
B Marchandot ◽  
M Kibler ◽  
C Sato ◽  
J Heger ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cox Regression ◽  
Adenosine Diphosphate ◽  
Rank Test ◽  
Multicenter Studies ◽  
Cox Regression Analysis ◽  
Paravalvular Leakage ◽  
Transcatheter Aortic Valve ◽  
Log Rank Test ◽  
Cerebrovascular Events

Abstract Introduction Paravalvular leakage (PVL) following transcatheter aortic valve replacement (TAVR) is associated with greater mortality. In clinical practice, determining PVL severity after TAVR remains challenging and often requires multiparametric assessment. Purpose This study sought to evaluate the respective value of various modalities of PVL assessments, including transthoracic echocardiography (TTE), cine-angiography, aortic regurgitation index (ARI), and closure time with adenosine diphosphate (CT-ADP), in the prediction of adverse clinical outcomes. Methods We included 1044 patients from our prospective TAVR registry between February 2010 and May 2019. Major adverse cardiac and cerebrovascular events (MACCE) was defined as a composite of all-cause death, myocardial infarction, stroke, and heart failure hospitalization within 1-year. Established cutoff values of ARI (<25) and CT-ADP (>180 sec) were used to assess the presence of PVL after TAVR. Results Moderate to severe PVL occurred in 14.2% and 5.2% of patients as measured by TTE and angiography. The rate of patients with ARI <25 and CT-ADP >180 sec were 36.5% and 24.9%, respectively. Among the four modalities, PVL evaluated by angiography predicted poorer clinical outcomes (Log rank test; p=0.001), whereas TTE, ARI <25, and CT-ADP >180 sec were not associated with 1-year MACCE. By multivariate Cox regression analysis, moderate to severe PVL by angiography was an independent predictor of 1-year MACCE (hazard ratio: 1.96; 95% confidence interval: 1.22–3.00; p=0.007). Conclusions Paravalvular leakage measured by angiography was evidenced as the most meaningful modality in the prediction of adverse clinical outcomes. Future multicenter studies are warranted to ensure these findings in the current TAVR era. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Tumor Volume Reduction Rate to Induction Chemotherapy Is a Prognostic Factor for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Retrospective Cohort Study

2021 ◽  
Author(s):  
Chi-hsien Huang ◽  
Ting-Chun Lin ◽  
Ming-Yu Lien ◽  
Fu-Ming Cheng ◽  
Kai-Chiun Li ◽  
...  
Keyword(s):  
Tumor Volume ◽  
Cox Regression ◽  
Reduction Rate ◽  
Volume Reduction ◽  
Cancer Site ◽  
Rank Test ◽  
Primary Cancer ◽  
Cox Regression Analysis ◽  
Log Rank Test ◽  
Tumor Volume Reduction

Abstract BackgroundAim of this study was to evaluate the prognostic of tumor volume reduction rate (TVRR) status post induction chemotherapy (IC) in LA-HNSCC.MethodsPatients with newly diagnosed LA-HNSCC from year 2007 to 2016 at a single center were included in this retrospective study. All patients had received IC as TPF (taxotere, platinum, fluorouracil) followed by daily definitive intensity-modulated radiotherapy (IMRT) for 70 Gy in 35 fractions concurrent with or without cisplatin-based chemotherapy. Tumor volume reduction rate of the primary tumor (TVRR-T) and lymph node (TVRR-N) was measured and calculated by contrast-enhanced CT images at diagnosis, and one month after final IC cycle, and analyzed though a univariate and multivariate Cox regression model.ResultsNinety patients of the primary cancer sites at hypopharynx (31/90, 34.4%), oropharynx (29/90, 32.2%), oral cavity (19/90, 21.1%) and larynx (11/90, 12.2%) were included in this study, with a median follow-up time interval of 3.9 years. In univariate Cox regression analysis, the TVRR-T as the only variable showed a significant difference for disease-free survival (DFS) (hazard ratio [HR] 0.77, 95% confidence interval (CI) 0.63 to 0.96; P = 0.02), aside from cancer site, RECIST, age and IC dose. In multivariate Cox regression analysis, The TVRR-T was also an independently significant prognostic factor for DFS (HR 0.77, 95% CI 0.62 to 0.97; P = 0.02). At a cutoff value using TVRR-T of 50% in Kaplan-Meier survival analysis, the DFS was significant higher with TVRR-T ≥ 50% group (log-rank test, p = 0.024), and also a trend of improved OS. (log-rank test, p = 0.069).ConclusionsTVRR-T was related to improved DFS and trend of improved OS. Other factors including patient’s age at diagnosis, the primary cancer site, and RECIST, were not significantly related to DFS.

miR-181 Expression is Associated With The Prognosis in Lung Cancer.

2020 ◽  
Author(s):  
Yue Zhao ◽  
Xiangjun Kong ◽  
Hongbing Wang
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Prognostic Value ◽  
Cox Regression ◽  
Suppressor Gene ◽  
Rank Test ◽  
High Morbidity ◽  
Cox Regression Analysis ◽  
Log Rank Test ◽  
Cancer Tissues

Abstract Background: Lung cancer is one of the most common cancers, with high morbidity and mortality. MiRNAs are proved to play important roles in various human cancers. In our study, we aimed to explore the prognostic value of miR-181 in lung cancerMethods: Quantitative real-time polymerase chain reaction (QRT-PCR) was used to detect the expression level of miR-181 in lung cancer tissues and the paired non-cancerous tissues. The relationship between miR-181 expression and clinicopathologic parameters were analyzed by chi-square test. Kaplan-Meier method with log rank test was applied for overall survival analysis. Furthermore, the Cox regression analyses were performed to evaluate the prognostic value of miR-181 in lung cancer.Results: Down-regulated miR-181 expression was observed in lung cancer tissues (P<0.001), moreover, its expression was significantly correlated with TNM stage (P=0.015) and metastasis (P=0.000). In addition, lung cancer patients with lower miR-181 expression level had poorer overall survival than those with higher expression (log rank test, P=0.011). Cox regression analysis suggested that miR-181 was an independent prognostic factor for lung cancer (HR=1.961, 95%CI=1.135-3.388, P=0.016).Conclusion: MiR-181 may be a tumor suppressor gene in lung cancer, which can predict outcomes for the patients.

BCIRG 001 molecular analysis: Identification of prognostic factors in patients (pts) receiving adjuvant therapy for node- positive (N+) breast cancer (BC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 525-525
Author(s):  
C. M. Dumontet ◽  
J. C. Reed ◽  
M. Krajewska ◽  
I. Treilleux ◽  
J. R. Mackey ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Adjuvant Therapy ◽  
Tau Protein ◽  
Cox Regression ◽  
Disease Free Survival ◽  
Rank Test ◽  
Lymph Node Status ◽  
Training Set ◽  
Primary Tumors ◽  
Cox Regression Analysis

525 Background: BCIRG 001 (1,491 pts) demonstrated significant superiority of docetaxel/doxorubicin/cyclophosphamide (TAC) over fluorouracil/doxorubicin/cyclophosphamide (FAC) given as adjuvant therapy for N+ operable BC in terms of disease-free survival (DFS) and overall survival (OS) (Martin et al, N Eng J Med, 2005). This ancillary study was aimed to identify tumor-associated factors related to DFS and OS. Methods: Formalin-fixed primary tumors from pts in BCIRG 001 were analysed by immunohistochemistry. Protocol- specified assessment of histological grade (GR), tumor size (TS), estrogen (ER) and progesterone receptors (PR), lymph node status (LN), HER2, MUC1, Mib, p53, Bcl-2, Bax, Bcl-X, Bag-1, tubulin β isotypes II, III and IV, tau protein and detyrosinated a tubulin was performed. Parameters were scored as the percentage of positive cells and analysed as lower or greater than median values. The samples were randomly split into training (2/3) and validation (1/3) sets. Associations between selected parameters and DFS or OS were tested through univariate analyses using the Kaplan Meier method (log-rank test) on the training set. A backward stepwise Cox regression analysis was performed to identify the final model of prognostic factors on the training set. Multivariate analyses were applied to the validation set. Results: 1,350 samples were split into a training (n=906) and a validation (n=444) set. In univariate GR, TS, LN, ER and PR, Mib, tau protein and HER2 were correlated with DFS in both sets. In multivariate ER, PR, TS, LN, Mib (all p<0.01) and tau (p=0.043) were significantly associated with DFS in the training set. In univariate GR, TS, LN, ER and PR, Mib, MUC1, Bcl-2, tubulin III and IV and tau were correlated with OS in both sets, with a trend for p53. In multivariate ER, TS, LN, Mib, p53 (all p<0.01) and PR (p=0.028) were independently correlated with OS in the training set. Conclusions: These data suggest that tau and p53 are independent markers of DFS and OS, respectively, while Mib is correlated with both DFS and OS in pts receiving these forms of adjuvant chemotherapy for N+ BC. Complementary analyses will be presented. No significant financial relationships to disclose.

Cetuximab (CTX) in first-line treatment of elderly patients with metastatic colorectal cancer (mCRC), KRAS wild type: French multicentre prospective community-based registry and results.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 760-760
Author(s):  
Laurent Mineur ◽  
Eric François ◽  
Jean Marc Phelip ◽  
Rosine Guimbaud ◽  
Carine Plassot ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Prognostic Factor ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Rank Test ◽  
Wild Type ◽  
Community Based ◽  
Cox Models ◽  
Cox Regression Analysis ◽  
Effective Age

760 Background: Pts included in clinical trials represent the unusual population in mCRC. This study aims to provide oncologist with a better understanding of the potential benefit of CT with CTX in older patients with mCRC KRAS wild type and evaluate prognostic variables on the PFS including the age. Methods: Premium cancer study is a French multicentre prospective community-based registry. 493 pts enrolled and 487 included between September 2009 to March 2012 from 94 French centers and physicians. Pts had to provide written informed consent and protocol submitted to regulatory authorities. Predefined efficacy endpoints was PFS. CTX was administrated at 250 mg/m2 weekly (n=100; 20.3%) or 500 mg/m2 every 2 weeks (n=380;77,2%), other n=13; 2.5%) CT regimen choice was at physician’s discretion.. The main analysis is PFS as well as analysis of prognostic factors of this PFS (29 items including age (< 65 years n=229; 65-74 years n= 165.; ≥75years n=93). Univariate analysis was performed for each covariate, PFS was estimated by Kaplan-Meier curves and compared by log-rank test. univariable Cox regression analysis was used to assess the association between each variable and outcome. Multivariable stepwise Cox models were then fitted for final variable selection of prognostic factors on PFS. Results: Univariate significant prognostic factors for PFS are OMS (0-1 vs 2-3), Tobacco, Site of tumor (right vs other), Number of metastatic organ (1 vs 2-3), Resecability of metastatic disease defined before CT (definitively non resectable metastases vs possible resectable), Surgery of mCRC, folliculitis or xerosis or paronychia grade 0-1 vs 2-4. Age was unidentified as a prognostic factor in univariate analysis. Four factors were independently associated with a better PFS: xerosis [hazard ratio (HR0,651); 95% confidence interval (CI) 0,494-0,857], (WHO PS) 0–1 (HR0,519 ; 95% CI 0,371–0,726) and folliculitis (HR 0,711; 95% CI0,558–0,956) metastases surgery 0,287(CI 0,205-0,403). Conclusions: CTX in combination with standard CT is effective, age is not identified as a prognostic factor for the PFS. Both groups of pts based on age benefit from CTX.

scholarly journals Clinical Characteristics and Prognostic Factors of Small Intestine Angiosarcoma: a Retrospective Clinical Analysis of 66 Cases

2017 ◽  
Vol 44 (2) ◽  
pp. 817-827 ◽  
Author(s):  
Rong Li ◽  
Ze-ying Ouyang ◽  
Jun-bo Xiao ◽  
Jian He ◽  
Yan-wu Zhou ◽  
...  
Keyword(s):  
Small Intestine ◽  
Prognostic Factors ◽  
Adjuvant Therapy ◽  
Cox Regression ◽  
Clinical Symptoms ◽  
Rank Test ◽  
Gi Bleeding ◽  
Log Rank Test ◽  
Clinical Records ◽  
Year 2000

Background/Aims: Primary angiosarcoma of the small intestine is a rare neoplasia, and there are limited data from systematic analyses. The aim of this study is to describe the clinical and pathological characteristics in addition to the prognostic factors for this rare neoplasia. Methods: We retrospectively collected the clinical records and prognostic information of 66 patients with small intestine angiosarcoma reported between 1970 and 2017. We used the Chi-square test, the log-rank test, and Cox regression analyses to evaluate the data. Results: There were 66 patients diagnosed with small intestine angiosarcoma. The onset age ranged from 24–92 years old. There were 24 patients diagnosed before the year 2000, and 42 patients were diagnosed after 2000. The data indicated that 49 cases were diagnosed as primary disease, and the remaining 15 cases were secondary disease. The main clinical symptoms were nonspecific and included gastrointestinal (GI) bleeding and abdominal pain. Additionally, we found multi-center foci were one of the characteristics of this disease. Radiation-induced small intestine angiosarcoma (RSIA) is a special type of disease with a similar prognosis. This type was more frequent in females and decreased after the year 2000. We also found that GI bleeding was less common in RSIA cases. The log-rank test results revealed that old-age, poor differentiation, and GI bleeding were associated with worse prognosis. Surgical treatment showed a trend toward a prolonged survival time. However, the result was not statistically significant. Our results show treatment with adjuvant therapy improved prognosis. The multivariate Cox analysis demonstrated adjuvant therapy was an independent indicator of a favorable outcome in small intestine angiosarcoma patients. Conclusion: Pay attention to the unexplained gastrointestinal bleeding could lead to a faster diagnosis and control of small intestine angiosarcoma. Furthermore, treatments including adjuvant therapy can effectively improve the prognosis.

scholarly journals Clinical significance of dysregulation of miR-381 in pediatric acute myeloid leukemia

2020 ◽  
Vol 25 (1) ◽  
Author(s):  
Piqiang Zhang ◽  
Deyun Sun ◽  
Xuemei Sun ◽  
Hongjuan Li
Keyword(s):  
Bone Marrow ◽  
Clinical Significance ◽  
Myeloid Leukemia ◽  
Prognostic Value ◽  
Cox Regression ◽  
Rank Test ◽  
Pediatric Acute Myeloid Leukemia ◽  
Cox Regression Analysis ◽  
Log Rank Test ◽  
Pediatric Aml

Abstract Background microRNA-381 is dysregulated in a variety of cancers. However, its clinical significance in pediatric acute myeloid leukemia (AML) is still unclear. The purpose of this study was to detect the expression level of miR-381 in pediatric AML patients and to explore its potential clinical significance. Methods The levels of miR-381 in bone marrow and serum of 102 pediatric AML patients were measured by quantitative real-time polymorperase chain reaction (qRT-PCR). The diagnostic value of serum miR-381 in pediatric AML patients was evaluated by the receiver operating characteristic (ROC) curve. A Chi square test was used to analyze the relationship between serum miR-381 and the clinical characteristics of patients. Cox regression analysis and Kaplan–Meier evaluated the prognostic value of serum miR-381 in patients. Finally, the proliferation of the cells was analyzed by the CCK-8 assay. Results Compared with healthy controls, the levels of miR-381 in serum and bone marrow of pediatric AML patients were significantly decreased (P < 0.001). ROC curve showed that miR-381 could distinguish pediatric AML cases from normal controls. At the same time, the downregulation of miR-381 was associated with M7 in the French–American–British (FAB) classifications and unfavorable cytogenetic risks (P < 0.05). Low serum miR-381 levels were associated with poor overall survival of pediatric AML (log-rank test, P = 0.011) and poor relapse-free survival (log-rank test, P = 0.004). Cox regression analysis confirmed that reduced serum miR-381 was an independent predictor of poor prognosis in AML (HR = 3.794, 95% CI 1.3633–10.559, P = 0.011). In addition, low expression of miR-381 significantly reduced the proliferation of cells (P < 0.05). Conclusion All experimental results confirm that miR-381 has reduced bone marrow and serum expression in pediatric AML, and low levels of serum miR-381 have certain diagnostic and prognostic value in pediatric AML and may be a potential therapeutic target for AML.

scholarly journals Prognostic Factors in Elderly Patients with High-grade Gliomas: A Retrospective Analysis of 24 Cases

2018 ◽  
Vol 09 (03) ◽  
pp. 312-316 ◽  
Author(s):  
Meenu Gupta ◽  
Saurabh Bansal ◽  
Deep Shankar Pruthi ◽  
Manju Saini ◽  
Nadia Shirazi ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Elderly Patients ◽  
Retrospective Analysis ◽  
Cox Regression ◽  
Rank Test ◽  
Karnofsky Performance Scale ◽  
High Grade ◽  
Concomitant Chemotherapy ◽  
Cox Regression Analysis ◽  
High Grade Gliomas

ABSTRACT Background and Objectives: Due to the aging of the population, diagnosis of high-grade gliomas (HGGs) in the elderly is becoming more common. The purpose of this study was to report our experience in 24 elderly patients with HGGs and evaluate the value of different prognostic factors. Design and Setting: Retrospective analysis of 24 elderly patients of ≥60 years with newly diagnosed HGGs, who were treated at our department between January 2009 and December 2012, was done. Patients and Methods: Age, gender, Karnofsky performance scale (KPS) score, extent of surgery, and use of temozolomide were evaluated using univariate and multivariate analyses. Survival was determined using the Kaplan–Meier method, and differences were compared using the log-rank test. Cox regression analysis was conducted to identify the independent prognostic factors. Results: The median overall survival of the patient cohort was 10 months. The 1- and 2-year survival rates were 45.8% and 16.6%, respectively. The analysis revealed that KPS score and use of concomitant chemotherapy were significant prognostic factors. Conclusion: The results of our analyses demonstrate that KPS score and use of concomitant chemotherapy yield encouraging outcomes in elderly patients with HGGs, validating the results published in research papers.

Prognostic impact of LDH and HCG levels in marker-positive seminomas.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 392-392 ◽  
Author(s):  
Christoph Alexander Seidel ◽  
Gedske Daugaard ◽  
Tim Nestler ◽  
Alexey Tryakin ◽  
Christian Daniel Fankhauser ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Cox Regression ◽  
Serum Levels ◽  
Rank Test ◽  
Prognostic Impact ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Cox Regression Analysis ◽  
Oncological Outcomes ◽  
Log Rank Test

392 Background: The prognostic impact of LDH and HCG serum levels in marker positive metastatic seminoma patients is uncertain. This analysis evaluated the association between LDH and HCG levels with oncological outcomes in this patient population. Methods: Seminoma patients with elevated HCG levels were retrospectively analyzed. After stratification according to tumor marker levels pre- and post-orchiectomy, outcomes of subgroups were compared using log-rank test and cox-regression analysis. Study endpoints were cancer specific- (CSS) and recurrence-free survival (RFS). Results: In total, 429 HCG-positive metastatic seminoma patients (stage II n=291; stage III n=138) diagnosed between 1981 and 2018 were included. LDH + HCG levels ranged from 124 U/l to 8833 U/l (median: 619; IQR: 955) + 2 IU/l to 283,782 IU/l (median: 20; IQR: 63) pre- and from 107 U/l to 8650 U/l (median: 324; IQR: 481) + 0 IU/l to 36700 IU/l post-orchiectomy (median: 30; IQR: 121), respectively. Five-year CSS and RFS rates were 90% and 79%, respectively. Patients with LDH levels pre-orchiectomy <1.5 UNL (n=142) had a 5-year CSS (RFS) rate of 97% (88%), compared to 86% (81%) for ≥1.5 to 3 UNL (n=40), 83% (77%) for >3 to 5 UNL (n=44) and 83% (72%) for >5 UNL (n=44) (CSS p <0.001; RFS p=0.142). Concerning LDH levels post-orchiectomy this stratification was not significant but patients with LDH levels ≥3 UNL (n=77) displayed an impaired prognosis associated with a 5-year CSS (RFS) rate of 85% (79%) compared to 94% (82%) for levels <3 UNL (n=186) (CSS p=0.025; RFS p=0.447). Patients with HCG levels ≥2000 IU/l (n=17) pre- but not post-orchiectomy had a 5-year CSS (RFS) rate of 73% (60%) compared to 94% (79%) for patients with HCG levels <2000 IU/l (n=855) (CSS p=0.09; RFS p=0.04). In cox-regression analysis LDH ≥1.5 UNL (p=0.037; HR 3.32, CI95%1.08-10.26) and HCG levels ≥2000 IU/l (p=0.044; HR 3.69, 95%CI1.04-13.13) pre-orchiectomy were confirmed as prognostic factors for CSS. Conclusions: LDH levels inversely correlate with survival outcomes, suggesting ≥1.5 UNL pre- and ≥3 UNL post-orchiectomy as potential cut-off values for further risk assessment. Patients with extensive HCG elevations may represent an unfavorable subgroup concerning RFS and CSS, but only few patients were affected.

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