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Results for “prognostic stratification”

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PubMed1998

High prognostic significance of Mdm2/p53 co-overexpression in soft tissue sarcomas of the extremities.

Soft tissue sarcomas are a heterogeneous group of neoplasms with various histological subtypes. Up to now, no individual causal molecular markers for prognosis and therapeutic success have been identified. A tumorigenic connection between the oncogene product Mdm2 and tumor suppressor p53 is generally accepted, but their possible clinical relevance has not yet been investigated sufficiently in soft tissue sarcoma. In 86 primary soft tissue sarcoma of the extremities (RO-resected, T1/2 N0 M0), Mdm2 and p53 overexpression were investigated by immunohistochemistry. The results were adjusted to clinico-pathological characteristics and evaluated for their prognostic relevance by multivariate analysis. In Cox's multivariate analysis with stratification of Mdm2 to p53 results, we determined four groups which had different prognostic values for relapse-free and overall survival (Mdm2-/p53- < Mdm2-/p53+ < Mdm2+/p53- < Mdm2+/p53+). The most striking finding was a relative risk (rr) for overall survival of 18.77 (P=0.006) for patients with Mdm2/p53 co-overexpression (n=40). It is noticeably higher than the additive risk from both factors. Coincident Mdm2/p53 overexpression is an independent molecular marker with the highest prognostic relevance described for soft tissue sarcoma. Thus, a high risk sarcoma group has been defined which we believe requires alternative therapeutic approaches.

Adult↗

PubMed1985

Factors affecting survival in patients presenting with synchronous hepatic metastases from colorectal cancer: a clinical and computer analysis.

A review of 90 patients presenting in Leeds over the period 1976-80 with synchronous hepatic metastases from colorectal cancer has been undertaken. The median survival for the group was 10.3 months (range 1-48 months). A multivariate analysis identified factors in the history and examination of the patient, results of biochemical and haematological investigations and characteristics of both the primary and secondary tumour, which influenced survival. Recognition of these factors allowed both a clinical scoring index and computer survival model to be constructed. When applied to the group as a whole both were reasonably accurate at predicting survival (62 per cent for the survival model and 66 per cent for the scoring index). However, the computer model correctly identified 80 per cent of the 'long-term' survivors (greater than 12 months from the time of diagnosis). It is concluded that many trials of therapy for hepatic metastases from colorectal cancer have failed to consider the natural history of the disease and the identification of prognostic indices should allow for adequate stratification within the treatment arms of any future study.

Adult↗

PubMed2003

Clinical significance of cellular drug resistance in childhood leukemia.

Cellular drug resistance is an important determinant of the response to chemotherapy, and its precise measurement may have clinical relevance. Potential applications are: prognostic factor for risk-group stratification, tailored chemotherapy for subgroups or individual patients with a specific cellular drug resistance profile, determination of cross-resistance patterns, study of drug interactions, study of resistance modulation or circumvention, selection of patients for phase II studies and screening for the cytotoxicity of novel compounds. The colorimetric 4-day MTT assay is a frequently used method. However, a distinction between malignant and non-malignant cells cannot be made, which should be taken into account. In the case of a relatively high percentage of contaminating non-malignant cells, the differential staining cytotoxicity (DiSC) assay can be used. The MTT assay's technical success percentage is about 80% for fresh ALL and AML samples. For methotrexate (MTX) a different assay must be used, such as the thymidylate synthase inhibition assay (TSIA). The MTT assay measures the number of living cells that survived drug exposure. Therefore, the effect of many if not most drugs to induce leukemia cell death by apoptosis is also included. This review mainly summarizes the data on cellular drug resistance in childhood leukemia, as obtained by the MTT assay and TSIA, in our laboratory in Amsterdam. These data clearly demonstrate the significant relation between in vitro cellular drug resistance and clinical and cell biological features and short- and long-term clinical outcome in childhood leukemia. In conclusion, cellular drug resistance testing provides clinically relevant information that can be available within 1 week and can be performed successfully in the vast majority of leukemia samples. The data are more and more being used and being considered for use in clinical trials in leukemia.

Antineoplastic Agents↗

PubMed2002

A new prognostic scoring system for meningococcal septic shock in children. Comparison with three other scoring systems.

OBJECTIVE: To develop a quick and sensitive method for identification of children with presumed meningococcal septic shock at risk of death at admission to the pediatric intensive care unit (PICU) and to compare its performance with three other prognostic systems: Glasgow Meningococcal Septicaemia Prognostic Score (GMSPS), Malley score and the Paediatric Index of Mortality (PIM). DESIGN: Multicenter retrospective cohort study. SETTING: PICUs of 14 tertiary hospitals. PATIENTS: The developmental sample included 192 children consecutively admitted to the PICUs with presumed or confirmed meningococcal septic shock from 1983 to 1995. The validation sample included 158 children consecutively admitted from 1996 to 1998. INTERVENTIONS: Clinical and laboratory data gathered during the first 2 h after admission were used to develop the new score and to compute the other scoring systems. Logistic regression was applied to identify the independent predictors of death. MEASUREMENTS AND RESULTS: Overall mortality was 31.5%. The new score included seven variables: cyanosis (2 points), Glasgow coma scale less than 8 (2 points), refractory hypotension (2 points), oliguria (1 point), leukocytes less than 4000/mm(3) (1 point), partial thromboplastin time more than 150% of control value (1 point) and base deficit more than 10 mmol/l (1 point). The new score provided the best discriminative capability, as measured by the area under the ROC curve (SEM) in the validation sample =0.88 (0.03), PIM =0.82 (0.04), Malley I =0.80 (0.04), GMSPS =0.79 (0.04) and Malley II =0.76 (0.04). CONCLUSIONS: A new prognostic score is proposed for therapeutic stratification of children with presumed meningococcal septic shock.

Adolescent↗

PubMed1990

Random assignment in clinical trials: issues in planning (Infant Health and Development Program).

Various options available for the randomization of subjects into groups in a clinical trial are discussed, emphasizing the issues of logistics given less focus in more mathematical treatments. We discuss advantages and disadvantages of total randomization, of Zelen-type randomization procedures, of Efron-type procedures vs more classical blocking procedures to control the balance between groups, and of Simon-Pocock-type procedures vs more classical stratification for controlling possible biases in prognostic factors. Finally, we discuss issues related to choice and implementation of randomization procedures. The discussion is illustrated with the processes of decision-making in a national collaborative randomized clinical trial, the Infant Health and Development Program.

Bias↗

PubMed2005

Usefulness of biomarkers for predicting long-term mortality in patients with diabetes mellitus and non-ST-elevation acute coronary syndromes (a GUSTO IV substudy).

The present study evaluated whether biomarkers of ischemia, inflammation, myocardial damage, and dysfunction are equally useful in patients who have diabetes mellitus (DM) for prediction of cardiac events in non-ST-elevation acute coronary syndrome (ACS). DM was present in 1,677 of 7,800 patients (21.5%) who had non-ST-elevation ACS and were included in the Fourth Global Utilization of Strategies To Open Occluded Arteries (GUSTO IV) trial. Creatinine, N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), troponin T, C-reactive protein, and interleukin-6 were analyzed in serum samples that were obtained at a median of 9.5 hours from symptom onset. One-year mortality rates were 13.5% among patients who had DM (n = 227) and 6.9% among those who did not (n = 418, p < 0.001). The median level of NT-pro-BNP was 2 times as high in patients who had DM, whereas troponin T levels did not differ by DM status. Mortality increased with ascending quartiles of NT-pro-BNP, with 1-year mortality rates of 3.9% (n = 11) in the bottom quartile and 29% (n = 103) in the top quartile. In multivariable analyses, factors that were predictive of 1-year mortality in patients who did not have DM were also significant for those who did. Presence of ST depression > 0.5 mm had the highest odds ratio of 2.3 (95% confidence interval 1.2 to 4.6). NT-pro-BNP levels > 669 ng/L (odds ratio 2.0, 95% confidence interval 1.1 to 3.6) and interleukin-6 levels > 10 ng/L (odds ratio 1.9, 95% confidence interval 1.2 to 3.0) were significant biomarker predictors. In conclusion, DM confers a high long-term mortality in non-ST-elevation ACS. Despite a larger proportion of ST depression and increased levels of NT-pro-BNP and interleukin-6 at admission, these factors provide independent prognostic information that may improve risk stratification and guidance of treatment.

Aged↗

PubMed2006

Tissue plasminogen activator on admission is an important predictor of 30-day mortality in patients with acute myocardial infarction undergoing primary angioplasty.

Tissue plasminogen activator (tPA) is emerging as an important risk factor for coronary heart disease, but the association between tPA concentration and mortality in acute myocardial infarction (AMI) remains uncertain. We studied the relationship between tPA antigen level on admission and 30-day mortality in 226 consecutive patients with AMI undergoing primary angioplasty. Death within 30 days occurred in 13 patients (5.7%). The concentration of tPA was significantly higher among the 13 patients who died than among the 213 who survived (26.5+/-16.3 versus 12.5+/-8.5 ng/mL, p<0.001). Compared with those in the lowest quartile (<9 ng/mL), patients in the highest quartile (>16 ng/mL) had a relative risk of subsequent death of 13.1 (p=0.014). In a Cox regression model, a tPA concentration >19 ng/mL was independently associated with mortality (HR 12.1, 95% CI, 1.9-76.7, p=0.001). This cutoff value had a 76.9% sensitivity and an 85.9% specificity for predicting 30-day mortality. tPA concentration was also higher in patients with severe heart failure (20.9+/-14.2 ng/mL versus 11.7+/-7.5 ng/mL, p=0.001) or ventricular tachyarrhythmia (24.3+/-13.9 ng/mL versus 12.2+/-8.4 ng/mL, p=0.001). In conclusions, elevated tPA antigen at initial presentation in patients with AMI was associated with higher short-term risk of death, suggesting that tPA may be a useful prognostic biomarker for the early risk stratification of these patients.

Aged↗

PubMed2000

Improved outcome of APACHE II score-defined escalating systemic inflammatory response syndrome in patients post cardiac surgery in 1996 compared to 1988-1990: the ESSICS-study pilot project.

OBJECTIVE: Cardiac surgery using extracorporeal circulation leads to the release of cytokines and subsequently to a systemic inflammatory response syndrome, which is thought to be a negative prognostic factor for patients' outcome. A stratification for the risk of an escalating systemic inflammatory response syndrome had been achieved in a monocenter study carried out in 1988-1990, using APACHE II scoring on the morning of the 1st postoperative day. We now re-evaluated this concept prospectively in three independent centers. METHODS: The APACHE II based risk stratification was put to test in three independent heart surgery centers in the period from June to December 1996. Nine hundred and forty-five patients after elective cardiac surgery (excluding heart transplantation) with the assistance of the cardiopulmonary bypass were prospectively monitored. RESULTS: We found an increase in mortality with higher APACHE II score values determined on the 1st postoperative day. The mortality rose to nearly 50% with an APACHE II score of > or = 28. Patients at high risk for the development of a systemic inflammatory response syndrome (APACHE II score > or = 24) significantly differed from patients at lower risk (APACHE II score < 19) in the duration of mechanical ventilation and extracorporeal circulation, age and New York Heart Association (NYHA) classification (P < 0.05). CONCLUSION: The APACHE II score determined on the morning of the 1st postoperative day helps identifying the subgroup of patients with escalating systemic inflammatory response syndrome. Comparison with the data obtained in the years 1988-1990, suggests a better prognosis in the current trial for patients at high risk with a similar degree of escalating systemic inflammatory response syndrome.

APACHE↗

PubMed1995

Immunohistochemically detectable bcl-2 expression in colorectal carcinoma: correlation with tumour stage and patient survival.

The bcl-2 gene encodes for a mitochondrial membrane proto-oncoprotein, the expression of which is known to suppress programmed cell death (apoptosis). In the present study the prognostic value of bcl-2 proto-oncoprotein was immunohistochemically investigated in a series of 104 colorectal carcinomas. The bcl-2 staining patterns were semiquantitatively assessed and correlated with the pTNM stage, Dukes' classification, lymphocytic infiltration (Jass classification) and tumour grade as well as parameters not associated with prognosis (gender, age, tumour site, histological tumour type). Statistical analysis was carried out using the Kaplan-Meier method, the log-rank test, hazard ratios and their confidence intervals. Fifty-five out of 104 cases completely lacked immunohistochemical bcl-2 expression. Fewer than 5% of bcl-2-positive cells were found in 25, 5-50% in 17 and more than 50% in five cases. The extent of bcl-2 expression by tumour cells decreased significantly with respect to increasing tumour size (P < 0.05), decreasing lymphocytic infiltration (P < 0.05) and chance of poor clinical outcome (P < 0.05), but not with worsening of Dukes stages. In multivariate analysis (Cox regression model) bcl-2 expression remained as an independent prognostic parameter with Dukes' classification as stratification factor (P < 0.001). Although the biological functions of bcl-2 protein are not yet well understood, our results provide further evidence that bcl-2 oncoprotein appears to be associated with favourable clinical outcome. Thus immunohistochemical bcl-2 phenotyping of colorectal carcinoma may contribute in future to the clinical management of these patients.

Adult↗

PubMed2002

Clinical staging for sleep-disordered breathing.

OBJECTIVE: The purpose of this study was to identify prognostic indicators that would lead to stratification of patients likely to have successful surgery for sleep-disordered breathing (SDB) versus those destined to fail. STUDY DESIGN: We retrospectively reviewed 134 patients to correlate palate position and tonsil size to the success of the UPPP as based on postoperative polysomnography results. Similar to our previously published data on the Friedman Score as a predictor of the presence and severity of SDB, the palate position was determined on physical examination of the oral cavity and was graded for each patient. This grade combined with tonsil size was used to stage the patients. Stage I was defined as having palate position 1 or 2 combined with tonsil size 3 or 4. Stage II was defined as having palate position 3 or 4 and tonsil size 3 or 4. Stage III patients had palate position 3 or 4 and tonsil size 0, 1, or 2. Any patient with body mass index of greater than 40 was placed in the stage III group. The results of uvulopalatopharyngoplasty (UPPP) were then graded as success or failure and success rates were compared by stage. SETTING: Academically affiliated tertiary care referral center. RESULTS: Stage I patients who underwent UPPP had a success rate of 80.6%, stage II patients had a success rate of 37.9%, and stage III patients had a success rate of 8.1%. CONCLUSION: A clinical staging system for SDB based on palate position, tonsil size, and body mass index is presented. It appears to be a valuable predictor of the success of UPPP. Additional studies and wider use of the staging system will ultimately define its role in the treatment of SDB.

Adult↗

PubMed1992

Cardiac imaging after acute myocardial infarction. Identification of patients at continued risk.

Diagnostic imaging performed early in the course of acute myocardial infarction provides anatomic and functional information that is useful in assessing patients at risk for future cardiac events and premature death. Early identification of left ventricular dysfunction or complications of myocardial infarction allows appropriate and timely management of high-risk patients and early transfer of stable patients from the intensive care environment. Noninvasive predischarge functional imaging to unmask patients with jeopardized myocardium identifies high-risk patients who may need invasive studies and surgical or interventional treatment. Postdischarge risk stratification with diagnostic imaging provides vital prognostic information in high- and low-risk patients, allowing for appropriate allocation of medical resources.

Echocardiography↗

PubMed2005

Vascular surgery patients: perioperative and long-term risk according to the ACC/AHA guidelines, the additive role of post-operative troponin elevation.

AIMS: The objectives of this study are to evaluate the prognostic role of pre-operative stratification in patients undergoing elective major vascular surgery, the timing of adverse outcomes, and the predictive role of troponin (cTn). METHODS AND RESULTS: Consecutive vascular surgery candidates (n=391) were prospectively stratified and treated according to the ACC/AHA guidelines. The patients were categorized into three groups: (1) with coronary revascularization in the past 5 years, (2) with intermediate clinical risk predictors, and (3) with minor or no clinical risk predictors. cTnI was measured post-operatively. By 18 months, 18.7% of subjects had experienced death or acute myocardial infarction (MI) (by the ACC/ESC criteria). The hazard ratio (HR) was 5.21 (95% CI=2.60-10.43; P<0.0001) in group 1 and 2.58 (95% CI=1.27-4.38; P=0.004) in group 2 when compared with group 3. Most events occurred within 30 days. Elevations of cTnI were associated with adverse outcomes even after multivariable adjustment at long-term (adjusted overall HR=4.73, 95% CI=2.92-7.65; P<0.0001) and at 30 days (adjusted HR=5.52, 95% CI=3.23-9.42; P<0.0001). CONCLUSION: After pre-operative stratification, patients undergoing elective major vascular surgery remain at high risk of MI and death. Events occur mainly early after surgery. cTnI elevations are frequent and independently associated with increased risk. These findings suggest the need for a major re-evaluation of our approach to these patients.

Adrenergic beta-Antagonists↗

PubMed2004

Predictors of response to treatment of acute bipolar manic episodes with divalproex sodium or placebo in 2 randomized, controlled, parallel-group trials.

Identification and control of factors that are associated with placebo and drug response in acute mania may influence the design and analysis of future trials in this condition. We analyzed pooled data from 2 multicenter, placebo-controlled, randomized trials of divalproex sodium for the treatment of acute manic episodes, using linear and logistic regression to search for common and treatment-specific predictors of response. In both treatment groups, patients with greater numbers of prior hospitalizations, more severe baseline symptoms, or younger age at onset of illness were found to be significantly less likely to respond. The effect sizes associated with these factors were of comparable magnitude to the effect size associated with divalproex treatment. Stratification on the basis of these prognostic factors may improve the power of future trials for the treatment of acute mania and may help explain patient response to treatment.

Adult↗

PubMed1996

Prospective study of the role of cardiac troponin T in patients admitted with unstable angina.

OBJECTIVE: To examine the prognostic significance and role in risk stratification of the biochemical marker troponin T in patients admitted with unstable angina. DESIGN: Single centre, blinded, prospective study of patients admitted with chest pain. SETTING: Coronary care unit of a district general hospital. SUBJECTS: 460 patients admitted with chest pain and followed up for a median of three years. 183 patients had a final diagnosis of unstable angina. MAIN OUTCOME MEASURES: Cardiac death, need for coronary revascularisation, or readmission with non-fatal myocardial infarction as first events. RESULTS: 62 (34%) unstable angina patients were troponin T positive. This group had significantly increased incidence rates of subsequent cardiac death (12 cases (19%) v 14 (12%)), coronary revascularisation (22 (35%) v 26 (21%)), death or revascularisation (33 (53%) v 40 (33%)), and death or non-fatal myocardial infarction (18 (29%) v 21 (17%)) compared with the troponin T negative group. In multiple logistic regression troponin T status was a highly significant predictor for the end points coronary revascularisation and cardiac death or revascularisation as first events. CONCLUSION: Troponin T in the serum of patients with unstable angina identifies a subgroup at higher risk of subsequent cardiac events and its measurement aids in risk factor stratification. The increased risk extends to two years after admission. Prospective randomised trials are required to identify optimum therapeutic strategies for this subgroup.

Angina, Unstable↗

PubMed1998

Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer. Final analysis of EORTC GU Group Trial 30843. European Organization for Research and Treatment of Cancer (EROTC) Genito-Urinary Tract Cancer Cooperative Group.

This is the final analysis of EORTC GU Group Trial 30843 in which the treatment of advanced, metastatic prostate cancer with a combination of the LHRH agonist buserelin (nasal spray) and cyproterone acetate (Androcur), either continuously of only during the first 2 weeks, was compared with orchidectomy. There was no significant difference between the three arms as far as response rate, time to progression (subjective and objective) and duration of survival are concerned. Retrospective stratification according to the most important prognostic factors did not change the conclusions. Possible reasons for the difference with trial 30853, which used the same entry criteria but compared goserelin and flutamide with orchidectomy, are discussed. Reasons for using cyproterone acetate in combination treatment are the prevention of flare of the disease after LHRH agonists only and the prevention/reduction of toxicity in the form of hot flushes.

Acid Phosphatase↗

PubMedDate not supplied

Risk stratification prior to vascular surgery: does the location of a dipyridamole thallium scintigram defect provide prognostic information?

BACKGROUND: While the value of myocardial scintigraphy using dipyridamole thallium is accepted for risk assessment prior to vascular surgery, it is unknown whether the location of the thallium abnormalities provides prognostic information. METHODS: Records from 435 consecutive patients scheduled for vascular surgery were reviewed and patients with dipyridamole thallium abnormalities involving the anterior distribution (ANTERIOR n = 62), or inferior or inferolateral distribution (INFERIOR n = 105) were assessed for cardiac complications of surgery (death, myocardial infarction, unstable angina or ischemic congestive heart failure). RESULTS: Patients with a normal dipyridamole thallium scintigraphy had few surgical cardiac complications: 2/86 (2%). Patients with an ANTERIOR dipyridamole thallium defect had a 12% incidence of surgical cardiac complications (7/57) without any cardiac deaths, while patients with an INFERIOR dipyridamole thallium defect had a similar incidence of surgical cardiac complications, 18% (18/100; p = 0.65 vs. ANTERIOR) including 4 cardiac deaths. CONCLUSIONS: Significant inferior or inferolateral dipyridamole thallium scintigraphy abnormalities are not associated with a lower risk of cardiac complications following vascular surgery than anterior abnormalities. Rather, any clearly abnormal dipyridamole thallium study is a marker for increased risk of perioperative events and may warrant further evaluation and treatment.

Aged↗

PubMed2004

Perspectives and limitations of gene expression profiling in rheumatology: new molecular strategies.

The deciphering of the sequence of the human genome has raised the expectation of unravelling the specific role of each gene in physiology and pathology. High-throughput technologies for gene expression profiling provide the first practical basis for applying this information. In rheumatology, with its many diseases of unknown pathogenesis and puzzling inflammatory aspects, these advances appear to promise a significant advance towards the identification of leading mechanisms of pathology. Expression patterns reflect the complexity of the molecular processes and are expected to provide the molecular basis for specific diagnosis, therapeutic stratification, long-term monitoring and prognostic evaluation. Identification of the molecular networks will help in the discovery of appropriate drug targets, and permit focusing on the most effective and least toxic compounds. Current limitations in screening technologies, experimental strategies and bioinformatic interpretation will shortly be overcome by the rapid development in this field. However, gene expression profiling, by its nature, will not provide biochemical information on functional activities of proteins and might only in part reflect underlying genetic dysfunction. Genomic and proteomic technologies will therefore be complementary in their scientific and clinical application.

Animals↗

PubMed2002

Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma.

PURPOSE: To define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma (RCC) treated with interferon-alfa as initial systemic therapy. The data can be applied to design and interpretation of clinical trials of new agents and treatment programs against this refractory malignancy. PATIENTS AND METHODS: Four hundred sixty-three patients with advanced RCC administered interferon-alpha as first-line systemic therapy on six prospective clinical trials were the subjects of this retrospective analysis. Three risk categories for predicting survival were identified on the basis of five pretreatment clinical features by a stratified Cox proportional hazards model. RESULTS: The median overall survival time was 13 months. The median time to progression was 4.7 months. Five variables were used as risk factors for short survival: low Karnofsky performance status, high lactate dehydrogenase, low serum hemoglobin, high corrected serum calcium, and time from initial RCC diagnosis to start of interferon-alpha therapy of less than one year. Each patient was assigned to one of three risk groups: those with zero risk factors (favorable risk), those with one or two (intermediate risk), and those with three or more (poor risk). The median time to death of patients deemed favorable risk was 30 months. Median survival time in the intermediate-risk group was 14 months. In contrast, the poor-risk group had a median survival time of 5 months. CONCLUSION: Progression-free and overall survival with interferon-alpha treatment can be compared with new therapies in phase II and III clinical investigations. The prognostic model is suitable for risk stratification of phase III trials using interferon-alpha as the comparative treatment arm.

Adult↗