Clinical Prognostic Factors In Patients Research Articles

Genomic and Clinical Prognostic Factors in Patients With Advanced Urothelial Carcinoma Receiving Immune Checkpoint Inhibitors.

Recently data suggest that telomerase reverse transcripatase (TERT) promoter mutations portend superior outcomes with immune checkpoint inhibitor (ICI) therapy in mUC. In our retrospective analysis from 2 tertiary cancer centers, we assessed the predictive role of TERT mutations along with other parameters. Patient registries were queried for patients treated with ICI for mUC with available genomic and clinical data. Select clinical and laboratory parameters, in addition to primary tumor site, histology, treatment modality, and setting were recorded. Tumor mutational burden (TMB), and mutational status of TERT, CDKN2A, CDKN2B, TMB, TP53, RB1, KMT2D, ARID1A, ERBB2, KDM6A, PIK3CA, FGFR3, and ATM were noted. Univariate analysis of significance concerning overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) was conducted. In total, 113 patients were found to meet inclusion criteria. In our study, ORR was 55%, median PFS was 5.1 months (0.2-71.8), and median OS was 13.4 months (0.2-84.8). On univariate analysis, female sex, NLR>5, and ATM mutation were associated with inferior PFS and OS, whereas upper tract primary disease and ECOG score ≥ 2 were associated with worse OS. On multivariate analysis, NLR >5 was associated with worse PFS and OS whereas upper tract primary disease, albumin <3.4 g/dL, hemoglobin <10 g/dL and ATM mutation were significantly associated with worse OS on multivariate analysis. No significant differences were seen in ORR, PFS, or OS regarding TERT promoter mutations. TERT promoter mutations were not significantly associated with any difference in outcome in patients treated with ICI.

Construction of an individualized clinical prognostic index based on ubiquitination-associated lncRNA in clear cell renal cell carcinoma patients

BackgroundccRCC is considered as the main subtype of RCC, which accounted for sixth deadliest cancer worldwide. Recently, ubiquitination has been reported to be closely involved in the progression of tumore. The purpose of this study was to identify the ubiquitination-associated genes and co-expressed lncRNAs on the prognosis of clear cell renal cell carcinoma (ccRCC) patients.Methods and patientsWe downloaded 530 cases and the corresponding transcriptome profiling from The Cancer Genome Atlas (TCGA) database. We distinguished mRNA and lncRNA expression data from the transcriptome profiling and then extracted the expression of mRNAs that regulate protein ubiquitination. We obtained lncRNAs associated with protein ubiquitination regulation from the lncRNA data by gene co-expression analysis. Cox regression analysis of survival time, survival status, and lncRNA expression level was carried out, and a prognostic index (PI) was constructed.ResultsThe PI was established based on 8 prognostic lncRNAs that regulate protein ubiquitination and distinguish the high-risk group patients from all patients. Multivariate analysis indicated that this PI was an individualized clinical prognostic factor for patients with ccRCC. Regarding clinical characteristics, a ubiquitination-associated clinical-prognostic index (UCPI), containing 8 ubiquitination-related lncRNAs and age, was established and tested with AUC of 0.80.ConclusionWe established a UCPI containing 8 lncRNAs related to protein ubiquitination. This UCPI may become an appropriate model to predict the prognosis in ccRCC patients and guide clinicians to adjust the follow-up regimen.

Proposal and Validation of a Novel Scoring System for Hepatocellular Carcinomas Beyond Curability Borders.

Optimal scoring system for clinical prognostic factors in patients with unresectable hepatocellular carcinoma (HCC) is currently uncertain. We aimed to develop and externally validate an easy to use tool, particularly for this population, and named it the “unresectable hepatocellular carcinoma prognostic index” (UHPI). We evaluated the data of patients with treatment‐naive unresectable HCC who were diagnosed in the training center from 2010 to 2019 (n = 209). A simple prognostic model was developed by assigning points for each covariate in proportion to the beta coefficients in the Cox multivariable model. Predictive performance and distinction ability of the UHPI were further evaluated in an independent European validation cohort (n = 147) and compared with 11 other available models. A simple scoring system was derived, assigning 0.5/1/2 scores for six independent covariates including, the Child‐Pugh score, Eastern Cooperative Oncology Group performance status, maximum tumor size, vascular invasion or extrahepatic metastasis, lymph node involvement, and alpha‐fetoprotein. The UHPI score, ranging from 0 to 6, showed superior performance in prognosis prediction and outperformed 11 other staging or prognostic models, giving the highest homogeneity (c‐index, 6‐month and 1‐year area under the receiver operator characteristic curves), lowest Akaike information criterion, and –2 log‐likelihood ratio values. The UHPI score allocated well the risk of patients with unresectable HCC for mortality within the first year, using two cut‐off values (low‐risk, <0.5; intermediate‐risk, 0.5‐2; high‐risk, >2). Conclusion: The UHPI score can predict prognosis better than other systems in subjects with unresectable HCC and can be used in clinical practice or trials to estimate the 6‐month and 1‐year survival probabilities for this group.

The clinical prognostic factors of patients with stage IB lung adenocarcinoma.

BackgroundLung adenocarcinoma (ADC) at stage IB has its own prognostic characteristics. This study aimed to investigate the clinical factors that may affect the prognosis of patients with stage IB ADC.MethodsThe data of ADC cases were selected from the Surveillance, Epidemiology, and End Results (SEER) database (2010–2016) and patients in Zhongshan Hospital, Fudan University (Department of Thoracic Surgery, 2015–2016). Kaplan-Meier method was used to obtain the overall survival (OS). Factors that significantly related to the prognosis were evaluated by univariate and multivariate analysis (UVA, MVA) using the Cox model. A nomogram was developed and validated to predict the 3-year OSs of those patients.Results7,605 patients with stage IB ADC were included ultimately and were divided into two groups, a training cohort (n=5,324) and a test cohort (n=2,281). Besides, there was a validation cohort (n=272) for the verification of the nomogram model. Those with significantly older age, male, the white race, lower grades of tumor differentiation, larger tumor size (31–40 mm) without pleural layer (PL) invasion as well as receiving sublobectomy suffered from poorer survival (P<0.001), which were identified as independent factors for stage IB ADC (P<0.001), and according to which, a nomogram model was created.ConclusionsAge, sex, race, histological grade, surgery to the primary site, and tumor size combined with PL invasion were independent risk factors for stage IB ADC, based on which a nomogram was constructed to predict the prognosis.

Clinical Prognostic Factors for Patients With Esophageal Cancer Treated With Definitive Chemoradiotherapy.

BackgroundTreatment with definitive chemoradiotherapy (CRT) is the best option for patients with locally advanced esophageal tumors considered unresectable or for patients without clinical conditions to undergo surgical treatment. Technological advances in radiotherapy in the last decades have made treatment more accurate with less toxicity, and the association with more effective systemic treatment has been gradually improving survival rates.AimEvaluate clinical prognostic factors for progression-free survival (PFS) and overall survival (OS) in patients with esophageal cancer treated with definitive radiotherapy (RT) and chemotherapy (ChT).Material and methodsThe clinical records of 60 patients treated from April 2011 until December 2019 with esophageal cancer considered unresectable and/or without clinical conditions for surgery, treated with definitive CRT, were analyzed. All patients had upper digestive endoscopy (UDE) with positive biopsy, neck, chest, and abdominal CT scan, and 18F-fluorodeoxyglucose positron-emission tomography (PET-CT). Patients were followed with physical examination and CTs every three months in the first and second years and every six months from the third year of follow-up. UDE was made every three to six months after the end of the treatment or in suspicion of tumor recurrence. PET-CT was also performed in the follow-up when clinically necessary. Local and regional failure (LRF) was defined as abnormalities in the image tests within the planning target volume (PTV) and/or positive biopsy on UDE. Any other failure was defined as a distant failure (DF). PFS was defined in the record of the first tumor recurrence site and OS in the death record from the date of the start of treatment.ResultsThe median age of the patients was 66 years (range: 33 to 83 years) and 46 patients (76.7%) were male. Squamous cell carcinoma (SCC) was the most frequent histological type (85%). Most patients had tumors located in the mid-thoracic esophagus (53.3%) and stage III or IV (59.9%). All patients were treated using 3D (76.7%) or intensity-modulated radiotherapy (IMRT; 23.3%). The median total dose was 50.4Gy (41.4-50.4). All patients received platinum-based ChT concomitant with RT. The most common regimen used was carboplatin and paclitaxel, with a median of five cycles. With a median follow-up of 19 months, the median PFS and OS were 10 and 20 months, respectively. LRF and DF as the first site of failure were observed in 22 (36.6%) and 26 (43.3%) patients, respectively. In the univariate analysis, tumor length lower than 2.6 cm, gross tumor volume (GTV) volume lower than 28 cm3, clinical tumor stages T1 and T2, clinical node stage N0, clinical prognostic stage groups I and II, and complete response to treatment, were statistically significant factors for better PFS and OS. In the multivariate analysis, the presence of clinical nodal stage N0 was related to better PFS (p=0.02).ConclusionNode clinical status was the most important clinical factor for PFS. Despite all the technical progress observed in radiotherapy, treatments concomitant with platinum-based chemotherapy are associated with high levels of LRF and DF. New strategies in systemic therapy and radiotherapy are necessary for improving outcomes.

Clinical Prognostic Factors in Patients With Metastatic Adrenocortical Carcinoma Treated With Second Line Gemcitabine Plus Capecitabine Chemotherapy.

Gemcitabine plus Capecitabine (Gem/Cape) is a frequently adopted second line chemotherapy for metastatic adrenocortical carcinoma (ACC), but only a minority of patients is destined to obtain a clinical benefit. The identification of baseline predictive factors of efficacy is relevant. We retrospectively analyzed clinical data from 50 consecutive patients with metastatic progressing ACC treated between 2011 and 2019. Patients received intravenous Gemcitabine and oral Capecitabine on a metronomic schedule. Previous mitotane therapy was maintained. Clinical benefit (partial response + stable disease) at 4 months was 30%, median progression-free survival (PFS) and disease-specific survival (DSS) from Gem/Cape start were 3 and 8 months, respectively. Among clinical variables evaluated before the start of Gem/Cape, presence of ECOG performance status ≥1 [HR 6.93 95% confidence interval (CI) 0.03–0.54, p.004] and neutrophil-to-lymphocyte ratio (NLR) ≥5 [HR 3.88, 95% (CI) 0.81–0.90, p.003] were independent indicators of poor PFS at multivariate analysis. Conversely, surgery of primary tumor, the presence of lung or lymph-node metastases, blood mitotane level, anemia, and the Advanced Lung cancer Inflammation index (ALI) failed to be independently associated. This study confirms that the Gem/Cape schedule is modestly active in heavily pretreated ACC patients (28% received at least two previous chemotherapy lines). NLR and performance status (PS) are easily available clinical parameters that are helpful to identify patients not likely to derive significant advantage from Gem/Cape chemotherapy.

Body Composition Changes in Hepatocellular Carcinoma: Prediction of Survival to Transcatheter Arterial Chemoembolization in Combination With Clinical Prognostic Factors

Treatment-related toxicities and decreased levels of patient performance during cancer therapy might contribute to body composition changes (BCC) and thereby impact outcomes. This study investigated the association between BCC during transcatheter arterial chemoembolization (TACE) and outcome in patients with hepatocellular carcinoma (HCC), and developed a nomogram for predicting survival in combination with clinical prognostic factors (CPF). Pretreatment and posttreatment computed tomography (CT) images of 75 patients with HCC who were treated between 2015 and 2018 were analyzed. The bone mineral density (BMD), cross-sectional area of paraspinal muscles (CSAmuscle), subcutaneous fat area (SFA), and visceral fat area (VFA) were measured from two sets of CT images. Count the changes in body composition during treatment and sort out the CPF of patients. Using cox regression models, CSAmuscle change, SFA change, VFA change, child-push class, and portal vein thrombosis were independent prognostic factors for overall survival (OS) (HR=5.932, 2.384, 3.140, 1.744, 1.794, respectively. P < 0.05). Receiver operating characteristic curves (ROCs) showed the prediction model combination of BCC and CPF exhibited the highest predictive performance (AUC=0.937). Independent prognostic factors were all contained into the prognostic nomogram, the concordance index (C-index) of prognostic nomogram was 0.787 (95% CI, 0.675−0.887). Decision curve analysis (DCA) demonstrated that the prognostic nomogram was clinically useful. Nomogram-based risk classification systems were also constructed to facilitate risk stratification in HCC for optimization of clinical management. In conclusion, we identified CSAmuscle change, SFA change, VFA change, Child-Pugh class, and portal vein thrombosis were independent prognostic factors for HCC. The prognostic nomogram with a combination of BCC and CPF that can be applied in the individualized prediction of survival in patients with HCC after TACE.

Impact of smoking amount on clinicopathological features and survival in non-small cell lung cancer

BackgroundScreening for early detection of lung cancer has been performed in high-risk individuals with smoking history. However, researches on the distribution, clinical characteristics, and prognosis of these high-risk individuals in an actual cohort are lacking. Thus, the objective of this study was to retrospectively review characteristics and prognosis of patients with smoking history in an actual lung cancer cohort.MethodsThe present study used the lung cancer cohort of the Catholic Medical Centers at the Catholic University of Korea from 2014 to 2017. Patients with non-small cell lung cancer were enrolled. They were categorized into high and low-risk groups based on their smoking history using the national lung screening trial guideline. Distribution, clinical characteristics, and survival data of each group were estimated.ResultsOf 439 patients, 223 (50.8%) patients were in the high-risk group. Patients in the high-risk group had unfavorable clinical characteristics and tumor biologic features. Overall survival of the high-risk group was significantly shorter than that of the low-risk group with both early (I, II) and advanced stages (III, IV). In multivariate analysis, heavy smoking remained one of the most important poor clinical prognostic factors in patients with lung cancer. It showed a dose-dependent relationship with patients’ survival.ConclusionsHigh-risk individuals had poor clinical outcomes. Patients’ prognosis seemed to be deteriorated as smoking amount increased. Therefore, active screening and clinical attention are needed for high-risk individuals.

Clinical phenotypes based on clinical prognostic factors in patients with secondary hip osteoarthritis: preliminary findings from a prospective cohort study.

Recently, several clinical prognostic factors for hip osteoarthritis (OA) progression such as spinal malalignment, reduced spinal mobility, and excessive daily cumulative hip loading have been identified. This study aimed to identify clinical phenotypes based on clinical prognostic factors in patients with secondary hip OA using data from prospective cohort studies and to define the clinical features of each phenotype. Fifty patients participated. Two-step cluster analysis was performed to identify the phenotypes using the following potential prognostic factors for hip OA progression: spinal inclination in standing, thoracolumbar spine mobility, daily cumulative hip moment, and minimum joint space width (JSW) at baseline. Comprehensive basic and clinical features (age, body mass index, hip pain, Harris hip score, JSW, radiographic hip morphology, hip impairments, spinal alignment and mobility, and gait-related variables) and ratio of progressors in 12months were compared among the phenotypes using bootstrap method (unadjusted and adjusted for age). Three phenotypes were identified and each phenotype was characterized as follows (P < 0.05): phenotype 1 (30%)-relatively young age and higher daily cumulative hip loading; phenotype 2 (42.0%)-relatively older age, reduced JSW, and less spinal mobility; and phenotype 3 (28.0%)-changed thoracic spine alignment and less spinal (especially in the thoracic spine) mobility. The ratio of progressors among the phenotypes was not statistically significantly different. These characteristics remained after adjustment for age. Three phenotypes with similar progression risk were identified. This finding will help in designing treatment tailored to each phenotype for hip OA progression prevention.Key Points• Three phenotypes with similar progression risk were identified based on clinical prognostic factors.• Phenotype 1 was characterized by young age and higher daily cumulative hip loading.• Phenotype 2 was relatively old age and had reduced JSW and less spinal mobility.• Phenotype 3 had changed thoracic spine alignment and less thoracic spine mobility.

Clinical prognostic factors in patients with resected pancreatic head cancer

Backround: Surgical resection is the best option for patients with pancreatic ductal adenocarcinoma (PDAC) stage I and II. At the time of diagnosis many of apparently resectable tumors are in more advanced stages, and pancreatic cancer must be considered as systematic disease. Determination of pre-operative prognostic factors for 6 months postoperative mortality may improve patients’ selection for surgical resection. Methods: Retrospective review of the Pancreatic Cancer database was performed and patients who underwent radical surgery for adenocarcinoma of the pancreatic head between 2005 and 2015 were included. Khorana score (KS) and inflammatory burden markers- neutrophil-lymphocyte ratio (NLR), lymphocyte- monocyte ratio (LMR), thrombocyte-lymphocyte ratio (PLR) were calculated. The retrieved data was analyzed using SPSS 21.0 A p value <0.05 was concidered significant. The retrospective study was reviewed and approved by Ethics committee. Results: 187 patients were included in the study. Median survival was 13 months, and the 6-month mortality rate 23.4%. Forty-seven patients were classified as high risk according to KS (≥3), with no statistical significance of these patients dying during 6 months following surgery (p=0.158). The postoperative survival was better in LMR>3 group (28±5.1 vs 16.3±2.6 months) and in PLR<150 group (29.1±4.3 vs 25.5±3.9 months), however, no statistically significant difference was found. Patients in NLR<5 group had statistically significant higher rate of survival after pancreatic resection (86.7% vs 13.3%, p=0.05) in a period of six months. We found that NLR>5 (HR: 1.833; 95% Cl: 0.890-3.774, p=0.1) and LMR<3 (HR: 1.316; 95% Cl: 0.535-3.240, p=0.5) might predict early death, however without statistical significance. Conclusions: Marker of inflammatory burden NLR<5 appeared to be useful prognosing increased 6 months survival and longer overall postoperative survival following surgery for PDAC. However, possibly due to insufficient number of patients, we were unable to prove statistical significance in other inflammatory markers and KS.

Presence of copy number aberration and clinical prognostic factors in patients with acute myeloid leukemia: an analysis of effect modification.

Acute myeloid leukemia (AML) is characterized by multiple acquired genetic events, chromosomal abnormalities such as copy number aberrations (CNAs), disease progression, and low survival rates. We assessed the utility of a multiplex ligation-dependent probe amplification (MLPA) assay in AML as well as correlations of CNAs with various biological and clinical features of patients with AML, including somatic mutations in the FLT3, NPM1, and DNMT3A genes and survival. The study included 283 patients with AML. The MLPA was used for investigation of CNAs. The status of somatic mutations was analyzed in all cases. The presence of CNAs was associated with the adverse (high) risk category according to the European LeukemiaNet (ELN) classification (PFDR <0.0001). The significant predictors of mortality were age of 65 years or older (hazard ratio [HR], 2.30; 95% CI, 1.71-3.09), ELN high‑risk category (HR, 1.71; 95% CI, 1.15-2.56), and the Eastern Cooperative Oncologic Group Scale (ECOG) performance status grade of 3 or higher (HR, 2.43; 95% CI, 1.80-3.30), but not the presence of CNA. An interaction between CNAs and the ECOG performance status was shown (HRinteraction, 2.24; 95% CI, 1.09-4.57, P = 0.02). The presence of CNAs was positively correlated with the risk of death in patients with an ECOG grade of 3 or higher (HR, 2.02; 95% CI, 1.30-3.12), while for patients with the performance status of 2 or lower, the presence of CNAs was a protective factor against the risk of death. The presence of CNAs may modify the effect of the ECOG performance status on survival. Independent predictors of mortality in patients with AML include age, ELN adverse risk category, and the ECOG grade of at least 3.

Clinical prognostic factors in patients with recurrent or metastatic carcinoma of the head and neck treated with immune checkpoints therapies.

e17530 Background: Immunotherapy (IT) provides advantages in a small proportion of recurrent / metastatic head and neck squamous cell carcinoma (RM HNSCC) patients (pts). Predictive biomarkers are still an unmet need. We aimed to determine if known prognostic clinical factors in RM HNSCC as well as new variables hold prognostic value in the IT era. Methods: We conducted a retrospective analysis of a cohort of 106 RM HNSCC pts enrolled into IT trials at National Cancer Institute of Milan-Italy between Oct 2014 - Jul 2018. Using Log Rank test and Cox proportional hazard model we computed univariate and multivariate analysis (UVA; MVA) of demographics, clinical and biological data to assess their prognostic value for progression free survival (PFS) and overall survival (OS). Results: Ninety-three pts (M 75; F: 18) were included in the final analysis with a median follow up of 20.8 months. The majority (96%) were treated in platinum-refractory setting. Approximately half of pts received anti-PD-1 or anti-PDL-1 monotherapy while the remaining 52% received them in combination with other IT agents. Median OS and PFS were 6.5 (CI 95%: 4.6-10.4) and 2.1 months (CI 95%: 1.8-2.2), respectively. Statistically significant factors at UVA for PFS were smoking history - both pos vs neg and &lt; vs ≥ 30 PY, disease subsite, weight loss &gt; 5%, Karnosfky performance status (PSK), occurrence of any and G3-G4 drug related (DR) toxicities, neutrophil to lymphocytes ratio (NLR). Without stratification for disease subsite, MVA showed independent predictive value of prolonged PFS for positive smoking history (HR 0.5, p 0.02) and any DR toxicities (HR 0.43, p &lt; 0.01). Several factors reached significance for OS in UVA (smoking history and PY, weight loss &gt; 5%, ECOG PS, PSK, occurrence of any toxicities, CRP, baseline C-reactive protein, antibiotic use, steroid use in the 30 days before IT). Of these, PSK (HR 0.95, p 0.01) and any DR toxicities (HR 0.3, p &lt; 0.01) resulted to be predictive in the MVA. Conclusions: Clinical parameters, especially pretreatment PSK, smoking history and occurrence of any DR toxicities, appear to be strong predictors of outcome in RM HNSCC pts treated with IT. These results should be validated in an independent cohort.

1094P - Clinical prognostic factors in patients (pts) with recurrent and/or metastatic (RM) head and neck carcinoma (HNC) treated with cetuximab plus chemotherapy

1094P - Clinical prognostic factors in patients (pts) with recurrent and/or metastatic (RM) head and neck carcinoma (HNC) treated with cetuximab plus chemotherapy

Analysis of Prognostic Factors for 96 Patients with Acute Lymphoblastic Leukemia

To investigate the clinical characteristics and clinical prognostic factors of patients with acute lymphoblastic leukemia (ALL). Ninety-six ALL patients in our hospital from June 2012 to August 2014 were selected and their clinical data were collected. The related clinical data of patients were recorded, and the relation between clinical characteristics and therapeutic efficacy was analyzed. The COX analysis was used to reveal the risk factors affecting the patient's OS and DFS time. Among 96 ALL patients, 65 patients achieved complete remission (CR) after treatment. The age, immunophenotype, central nervous system leukemia (CNSL) and peripheral blood WBC count correlated with complete remission (P<0.05). The age, WBC count, platelet level, immune typing and consolidation therapy were the prognostic factors (P<0.05), the 2 year OS rate was influenced by age, WBC count, CD34 and consolidation therapy (P<0.05), the 2 year DFS rate was influenced by age, CD34 and consolidation therapy (P<0.05). Age, WBC counts, CD34 and consolidated treatment after remission are prognostic factors for ALL patients, which has guiding significance for clinical treatment of ALL.

Exploratory Analysis of Clinical Prognostic Factors in Patients with Advanced Cancer Using Computational Text Mining of Routine Digitised Oncology Correspondence

Exploratory Analysis of Clinical Prognostic Factors in Patients with Advanced Cancer Using Computational Text Mining of Routine Digitised Oncology Correspondence

Prognostic Factors for Survival in Patients with Advanced Intrahepatic Cholangiocarcinoma Treated with Gemcitabine plus Cisplatin as First-Line Treatment

Objectives: Intrahepatic cholangiocarcinoma (ICC) is a rare type of liver cancer. No clinically useful prognostic factors have been reported for patients with advanced ICC. In the present study, we aimed to evaluate the clinical prognostic factors of patients with advanced ICC receiving gemcitabine plus cisplatin combination therapy (GC) as standard first-line chemotherapy. Methods: A retrospective analysis was performed of the data of patients with ICC treated at our institution from March 2011 to January 2016. We used the Cox regression model and estimated the hazard ratios of potential prognostic factors for survival. Results: Of 216 patients with biliary tract cancer receiving GC as first-line chemotherapy, we extracted data for 77 patients who were diagnosed with ICC and received GC as first-line chemotherapy. The median overall survival was 13.8 months (95% CI, 8.9-18.6). In multivariate analysis, pretreatment serum lactate dehydrogenase (hazard ratio [HR]: 2.53, p = 0.005), C-reactive protein (HR: 3.06, p = 0.001), and carcinoembryonic antigen (HR: 2.39, p = 0.03) levels were significantly associated with overall survival. Conclusions: Readily available clinical laboratory values reliably predicted the prognosis of ICC patients receiving GC therapy. If validated in other studies, these results may provide a useful tool for individual patient-risk evaluation and the design and interpretation of future trials.

Baseline risk stratification or duration of prior therapy predicts prognosis in patients with metastatic renal cell carcinoma treated with axitinib.

To elucidate the clinical prognostic factors in patients with metastatic renal cell carcinoma (mRCC) treated with axitinib. A total of 58 patients were retrospectively analyzed. All patients received axitinib treatment for mRCC at Keio University hospital in Japan. Baseline clinical factors and on treatment adverse events were assessed to predict survival. The median progression free survival (PFS) for axitinib treatment was 10.9 months (95% CI 5.8-13.5), and the median overall survival (OS) from the start of axitinib treatment was 39.8 months (95% CI 25.9-NR), respectively. The PFS (P < 0.0001) and OS (P = 0.0022) were significantly correlated with the International mRCC Database Consortium (IMDC) classification, respectively. The PFS and OS were significantly longer in patients who received longer prior treatment (P = 0.0424 and 0.0067, respectively). On-treatment hypertension, hand foot syndrome and hypothyroidism were associated with longer PFS (P = 0.0002, 0.0055 and 0.0290, respectively). On-treatment hypertension, diarrhea, and hand foot syndrome were associated with longer OS (P = 0.0004, 0.0036 and 0.0115, respectively). Baseline and on treatment factors are identified as prognostic markers in mRCC patients treated with axitinib. Our findings might be helpful for clinicians to select the best treatment to individual patients.

Circulating tumor DNA (ctDNA) and correlations with clinical prognostic factors in patients with metastatic castration-resistant prostate cancer (mCRPC).

186 Background: Sequencing of ctDNA is a minimally invasive method to study somatic DNA alterations. Quantitation and characterization of ctDNA may correlate with tumor burden and poor risk clinical features, but this is unproven in mCRPC. Methods: We performed deep targeted sequencing of 73 mCRPC-related genes in plasma ctDNA from 136 treatment naïve mCRPC patients. Fraction of ctDNA was determined by quantifying somatic mutant allele frequency and the deviation from heterozygosity for germline single nucleotide polymorphisms at regions of somatic copy number alterations. Baseline clinical factors were correlated with ctDNA fraction and genomic aberrations. Results: ctDNA could be quantified in 86/136 (63%) patients. Increasing fraction correlated with elevated ALP (chi2, p &lt; 0.001), LDH (p &lt; 0.001) and presence of liver metastasis (p = 0.01). Patients with any one of these factors were more likely to have a ctDNA fraction ≥ 40% (67% vs 36% of patients with neither factor, p = 0.001) and less likely to have unquantifiable ctDNA (26% vs 49%, p = 0.006). A decreased ctDNA fraction was associated with metastases only to lymph nodes (p = 0.012). Among the most frequently aberrant genes were Androgen Receptor (AR), p53, RB1, and PTEN, present in 38%, 30%, 23% and 22% of patients, respectively. Aberrations were associated with poor prognosis factors, including: AR and p53 alterations, which both correlated with presence of liver metastasis (p = 0.020 and p = 0.004 respectively), elevated LDH (p = 0.001, p &lt; 0.001), and presence of ≥ 10 bone metastasis (p = 0.018, p = 0.017); PTEN deletion which correlated with elevated ALP (p &lt; 0.001), elevated LDH (p = 0.001), ≥ 10 bone metastasis (p = 0.009) and time to CPRC of &lt; 12 months (p = 0.021); and RB1 correlated with ≥ 10 bone metastasis (p = 0.009). Conclusions: We found an association between poor prognostic factors and increasing ctDNA fraction in patients with mCRPC. Genomic aberrations, particularly alteration in AR, p53 and PTEN, correlated with poor prognostic factors. These data show that clinical factors may help predict ctDNA yield in patients with mCRPC, and also provide insight into the role of deleterious genetic alterations.

Longitudinal study of clinical prognostic factors in patients with early rheumatoid arthritis: the PREDICT study.

To assess the association between baseline clinical prognostic factors and subsequent Disease Activity Score of 28 joints (DAS28) remission in early rheumatoid arthritis (RA). Data were collected using point of care clinical software from participating rheumatology centres. Patients aged 18 years or over whose date of clinical onset of RA was within the previous 12-24 months, who had at least 6 months of follow-up data and a DAS28-ESR (erythrocyte sedimentation rate) score recorded between 12 and 24 months from first being seen for RA were included. Data collected included baseline demographics, mode of disease onset, pattern of joint involvement at onset, smoking status, DAS28, rheumatoid factor (RF), anti-citrullinated peptide antibodies (ACPA), time from symptom onset to presentation and disease activity at baseline. Univariate and multivariate logistic regression of DAS28-ESR remission between 12 and 24 months after first assessment were performed. Data from 1017 patients were analyzed: 70% female; mean age 60 years (SD: 14.7); 70% RF-positive, 58% ACPA-positive. The strongest age and sex adjusted baseline predictors of DAS28-ESR remission at 12-24 months were remission at baseline (odds ratio [OR]: 4.49, 95% CI: 2.17-9.29, P < 0.001), being male (OR: 2.42, 95% CI: 1.46-4.01, P < 0.001), abstaining from alcohol (P < 0.001) and being lower weight (OR: 0.98, 95% CI: 0.97-1.00, P = 0.015). There was no statistically significant association between joint onset patterns, mode of onset, RF, ACPA or smoking status. In this observational study, patients with early RA at risk of not achieving remission include those with high disease activity at baseline, women, those who drink alcohol and those with higher body weight.

Clinical prognostic factors in patients with idiopathic peripheral facial nerve paralysis (Bell’s palsy)

Objective. The aim of this study was to analyse the clinical prognostic factors that are associated with treatment outcomes in patients with idiopathic peripheral facial nerve paralysis (PFNP). Methods. The study was performed retrospectively with 80 patients in a tertiary medical center. All of the patients were treated and followed for idiopathic PFNP (Bell’s palsy). The patient charts were reviewed for patient demographics and characteristics. The comorbidities (hypertension, diabetes mellitus), the side, grade and duration of palsy, and the acoustic stapedius reflex were analysed. Results. Forty-three male and 37 female patients were diagnosed with idiopathic PFNP. Sixty-seven of patients had complete, 13 patients had partial recovery. Of the partial recoveries, 12 patients had Grade 2 and one patient Grade 3 PFNP at the end of primary treatment. Patients tended to have incomplete recovery if they have a diagnosis of diabetes mellitus, but the difference between groups was not statistically significant ( p =0.326). A positive stapedius reflex was associated with complete recovery ( p =0.023). Patients had much more risk of incomplete recovery if age is more than 40 years ( p =0.006). Conclusion. A detailed history and complete physical examination are very important in peripheral facial palsy. Co-morbid diseases and demographic features such as high blood pressure, diabetes mellitus and advanced age might influence the treatment outcomes.