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Results for “prognostic stratification”

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PubMed1995

Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group.

BACKGROUND: It has been reported that limited resection (segment or wedge) is equivalent to lobectomy in the management of early stage (T1-2 N0) non-small cell lung cancer. METHODS: A prospective, multiinstitutional randomized trial was instituted comparing limited resection with lobectomy for patients with peripheral T1 N0 non-small cell lung cancer documented at operation. Analysis included locoregional and distant recurrence rates, 5-year survival rates, perioperative morbidity and mortality, and late pulmonary function assessment. RESULTS: There were 276 patients randomized, with 247 patients eligible for analysis. There were no significant differences for all stratification variables, selected prognostic factors, perioperative morbidity, mortality, or late pulmonary function. In patients undergoing limited resection, there was an observed 75% increase in recurrence rates (p = 0.02, one-sided) attributable to an observed tripling of the local recurrence rate (p = 0.008 two-sided), an observed 30% increase in overall death rate (p = 0.08, one-sided), and an observed 50% increase in death with cancer rate (p = 0.09, one-sided) compared to patients undergoing lobectomy (p = 0.10, one-sided was the predefined threshold for statistical significance for this equivalency study). CONCLUSIONS: Compared with lobectomy, limited pulmonary resection does not confer improved perioperative morbidity, mortality, or late postoperative pulmonary function. Because of the higher death rate and locoregional recurrence rate associated with limited resection, lobectomy still must be considered the surgical procedure of choice for patients with peripheral T1 N0 non-small cell lung cancer.

Carcinoma, Non-Small-Cell Lung↗

PubMed2004

Clinical prediction rule for atrial fibrillation after coronary artery bypass grafting.

OBJECTIVES: This study was designed to devise and validate a practical prediction rule for atrial fibrillation/atrial flutter (AF) after coronary artery bypass grafting (CABG) using easily available clinical and standard electrocardiographic (ECG) criteria. BACKGROUND: Reported prediction rules for postoperative AF have suffered from inconsistent results and controversy surrounding the added predictive value of a prolonged P-wave duration. METHODS: In 1,851 consecutive patients undergoing CABG with cardiopulmonary bypass, preoperative clinical characteristics and standard 12-lead ECG data were examined. Patients were continuously monitored for the occurrence of sustained postoperative AF while hospitalized. Multiple logistic regression was used to determine significant predictors of AF and to develop a prediction rule that was evaluated through jackknifing. RESULTS: Atrial fibrillation occurred in 508 of 1,553 patients (33%). Multivariate analysis showed that greater age (odds ratio [OR] 1.1 per year [95% confidence intervals (CI) 1.0 to 1.1], p < 0.0001), prior history of AF (OR 3.7 [95% CI 2.3 to 6.0], p < 0.0001), P-wave duration >110 ms (OR 1.3 [95% CI 1.1 to 1.7], p = 0.02), and postoperative low cardiac output (OR 3.0 [95% CI 1.7 to 5.2], p = 0.0001) were independently associated with AF risk. Using the prediction rule we defined three risk categories for AF: <60 points, 61 of 446 (14%); 60 to 79 points, 330 of 908 (36%); and >or=80 points, 117 of 199 (59%). The area under the receiver-operator characteristic curve for the model was 0.69. CONCLUSIONS: These data show that post-CABG AF can be predicted with moderate accuracy using easily available patient characteristics and may prove useful in prognostic and risk stratification of patients after CABG. The presence of intraatrial conduction delay on ECG contributed least to the prediction model.

Adrenergic beta-Antagonists↗

PubMed2001

Cardiac troponin and beta-type myosin heavy chain concentrations in patients with polymyositis or dermatomyositis.

Cardiac troponin T (cTnT), cardiac troponin I (cTnI), myosin heavy chains (MHC), myoglobin, creatine kinase (CK), and creatine kinase isoenzyme MB (CKMB), were measured in blood samples from 39 polymyositis (PM) or dermatomyositis (DM) patients without clinical evidence for cardiac involvement to evaluate their clinical usefulness in this patient population. MHC, myoglobin, and CKMB were frequently elevated and correlated with each other and with disease severity. Undetectable cTnI in all but one patient indicated that MHC was released from skeletal muscle, thereby providing the first laboratory evidence of frequent slow-twitch muscle fibre-necrosis in patients with PM or DM. CKMB was elevated in 51%, cTnT in 41%, and cTnI in only 2.5% of patients. cTnI did not correlate with other markers or with disease severity scores. The close correlations found between cTnT and skeletal muscle damage markers and the relationship between cTnT with disease severity without clinical evidence for myocardial damage suggest a release of cTnT from skeletal muscle. The relationship of cTnT with disease severity indicates a possible role of the marker for risk stratification. However, the prognostic values of cardiac troponins and other muscle damage markers in PM/DM patients remain to be compared in prospective outcome trials.

Adolescent↗

PubMed2003

Metastatic carcinoma of the prostate: identifying prognostic groups using recursive partitioning.

PURPOSE While in patients with metastatic prostate cancer median survival is approximately 30 months when treated with hormonal therapy, there is substantial interpatient variation. To explain better the outcome in patients with advanced disease we developed a set of prognostic groups within a large-scale clinical trial. MATERIALS AND METHODS Southwest Oncology Group Study 8894 was a randomized prospective clinical trial that compared orchiectomy and flutamide to orchiectomy and placebo. Using the technique of recursive partitioning we analyzed 5-year survival outcomes using a substantial number of patient, treatment and disease related variables to develop a set of prognostic groups with significant differences in survival. RESULTS Of 1,286 eligible patients 1,076 had sufficient data for analysis. The patient data set was split to allow prognostic group development in the first half of patients, followed by validation in the second half of patients accrued to the study. After pruning the regression tree 4 factors had a major impact on outcome, namely appendicular versus axial disease, performance status 0 versus 1 to 3, prostate specific antigen less than 65 versus 65 ng./ml. or greater and Gleason score less than 8 versus 8 or greater. Using these criteria 3 prognostic groups were developed, including a good (hazards ratio 1), intermediate (hazards ratio 1.8) and poor (hazards ratio 2.8) group. Five-year survival estimates in the 3 groups were 42%, 21% and 9%, respectively. Using the validation test set similar 5-year survival estimates for the 3 groups of 46%, 25% and 14%, respectively.CONCLUSIONS These data from a large-scale randomized clinical trial provide a validated set of easily applied prognostic groups. We hope that our results may be validated by other investigators and we would encourage the future reporting of outcomes in patients with advanced prostate cancer using these prognostic groupings. Risk stratification is helpful for designing clinical trials and individual treatment, and it should be incorporated into future reports of outcomes of patients with metastatic disease.

Adenocarcinoma↗

PubMed1997

Planning controlled clinical trials. Prostatic cancer.

OBJECTIVE: To address principles in the design and conduct of clinical trials on prostate cancer (PC) with special reference to localized disease. METHODS: In advance of and during the World Health Organization (WHO) conference on Prostate Cancer in Stockholm in September 1996, 6 members of a working group evaluated and reached consensus on key points for the planning and conduction of controlled clinical trials in PC. The key points discussed were 1) hypothesis formulation, 2) general methodological principles, 3) special problems of PC trials, 4) alternatives to randomization, and 5) trial organization. RESULTS: The hypothesis must be clearly formulated and also clinically relevant enough to justify the expenses (in a broad sense) of a randomized clinical trial. Patient selection, definition of endpoints, and sample size calculations must be carefully considered and correspond to the aims of the study. Stratification on important prognostic factors should be contemplated. Maintaining the accrual rate and ensuring compliance are critical for a quality study. Survival is the main endpoint and intention to treat analysis is the standard methodology. Secondary endpoints (eg, quality of life and costs) are important for the evaluation of many treatment modalities. The use of surrogate endpoints for survival, such as prostate-specific antigen (PSA) elevation, may be misleading. Surrogate endpoints require further validation. Special features, such as long natural history in localized disease and difficulties in assessing objective responses in advanced disease, need consideration in PC trials. The controlled randomized trial is the gold standard methodology. Nonrandomized trials are often hampered by severe methodological problems, such as selection bias and biased ascertainment of endpoints due to the doctor's or patient's preferences. For the organization of a successful trial, a well-constructed study protocol is essential. Good clinical practice as defined within the European Community helps define and solve practical problems. CONCLUSIONS: The past 30 years of poorly designed clinical research on PC has left us without reliable answers in key clinical issues regarding, for example, the efficacy of primary treatment of localized PC. It is a stimulating and important challenge to the urological scientific community to conduct well-organized controlled clinical trials.

Controlled Clinical Trials as Topic↗

PubMed1996

Familial hypertrophic cardiomyopathy: diagnostic and therapeutic implications of recent genetic studies.

Familial hypertrophic cardiomyopathy is the first primary cardiomyopathy to have yielded to the techniques of modern molecular genetics. In the past few years, four genes responsible for this disease have been identified, all of which code for sarcomeric structural proteins. In addition, structure-function analysis and genotype-phenotype correlation studies have shed significant light on the molecular basis of this disease. It is hoped that within the next few years the application of molecular genetic tools will not only facilitate the diagnosis of hypertrophic cardiomyopathy but will also provide prognostic and therapeutic stratification for more definitive therapy.

Cardiomyopathy, Hypertrophic↗

PubMed2000

[Atrial natriuretic peptides: diagnostic and therapeutic potential].

The natriuretic family consists out of three molecules that share significant amino acid sequence homologies and a looped motif. Atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) are similar in their abilities to promote natriuresis and diuresis, to inhibit the renin-angiotensin-aldosteroneaxis and to act as vasodilators. The understanding concerning the actions of the C-type natriuretic peptide is incomplete, but this new family member acts as a vasodilator. Plasma levels of ANP and BNP are elevated in patients with unstable angina, acute myocardial infarction, and with congestive heart failure. BNP may be superior to ANP as a prognosticator for risk stratification after myocardial infarction and is independent of left ventricular ejection fraction. ANP and BNP have little therapeutic potential while experimental work as well as clinical trials suggest that the inhibition of the catabolism of natriuretic peptides in particular in combination with ACE-inhibitors may be clinically beneficial.

Atrial Natriuretic Factor↗

PubMed2004

Gene expression profiling identifies clinically relevant subtypes of prostate cancer.

Prostate cancer, a leading cause of cancer death, displays a broad range of clinical behavior from relatively indolent to aggressive metastatic disease. To explore potential molecular variation underlying this clinical heterogeneity, we profiled gene expression in 62 primary prostate tumors, as well as 41 normal prostate specimens and nine lymph node metastases, using cDNA microarrays containing approximately 26,000 genes. Unsupervised hierarchical clustering readily distinguished tumors from normal samples, and further identified three subclasses of prostate tumors based on distinct patterns of gene expression. High-grade and advanced stage tumors, as well as tumors associated with recurrence, were disproportionately represented among two of the three subtypes, one of which also included most lymph node metastases. To further characterize the clinical relevance of tumor subtypes, we evaluated as surrogate markers two genes differentially expressed among tumor subgroups by using immunohistochemistry on tissue microarrays representing an independent set of 225 prostate tumors. Positive staining for MUC1, a gene highly expressed in the subgroups with "aggressive" clinicopathological features, was associated with an elevated risk of recurrence (P = 0.003), whereas strong staining for AZGP1, a gene highly expressed in the other subgroup, was associated with a decreased risk of recurrence (P = 0.0008). In multivariate analysis, MUC1 and AZGP1 staining were strong predictors of tumor recurrence independent of tumor grade, stage, and preoperative prostate-specific antigen levels. Our results suggest that prostate tumors can be usefully classified according to their gene expression patterns, and these tumor subtypes may provide a basis for improved prognostication and treatment stratification.

Biomarkers, Tumor↗

PubMed1987

Management of the post-myocardial infarction patient. Essential considerations.

Management of patients who survive acute myocardial infarction (MI) demands the physician's awareness of certain essential considerations. Risk stratification, a useful prognostic indicator of mortality, should be done early in convalescence. If present, postinfarction angina or postinfarction syndrome warrants appropriate therapy. Low-level exercise testing should be under-taken within three weeks of acute MI, and left ventricular function should be assessed and arrhythmias delineated before the patient's discharge from the hospital. Findings may indicate the need for coronary bypass surgery or angioplasty, antiarrhythmic drug therapy, or permanent pacing. Digitalis should be used for treating congestive heart failure only if deemed absolutely necessary. If there are no contraindications, all postinfarction patients should receive beta blockers for at least two years after MI. Control of coronary risk factors is essential. Aspirin can be used prophylactically in patients at risk for recurrent MI; routine use of anticoagulants is not indicated.

Angina Pectoris↗

PubMed2004

Isolated bone marrow involvement in diffuse large B cell lymphoma: a report of three cases with review of morphological, immunophenotypic and cytogenetic findings.

Diffuse large B cell lymphoma (DLBL) comprises a heterogenous entity characterized by the presence of large cells, exhibiting a mature B cell phenotype. The high proliferation rate and aggressive disease remain a therapeutic challenge, but the apparent biological diversity permits a risk-stratification model for prognostic grouping through the International Prognostic Index (IPI). Empirical to this approach is the consideration of cytogenetic data, offering an insight into the pathogenetic events which may underlie neoplastic clonal evolution and disease progression. We describe three cases of DLBL presenting with isolated marrow disease, a rare primary finding in this lymphoma. All three cases showed involvement of blood and bone marrow without evidence of splenic or lymph node involvement on imaging studies. Histological and immunophenotypic findings were similar in all three cases, outlining the phenotypic maturity of this disease. Cytogenetic analysis revealed complex karyotypes in the two cases examined. M-FISH (multicolour fluorescent in situ hybridization) performed on bone marrow from case 1 showed several cryptic translocations not evident on G-banding, including a novel translocation between 2p and 9p, and an unbalanced translocation between 14q and 11q. Cytogenetic analysis in case 2 showed abnormalities involving 7q, 9p at the site of the INK4a gene, and the bcl-2 locus, findings confirmed by M-FISH. These cases serve to highlight the biological and cytogenetic heterogenity of DLBL and emphasize the need for complementary investigations in the characterization of this entity.

Adult↗

PubMed2006

Update on risk-stratified management for chronic lymphocytic leukemia.

Major recent advances in understanding the biology of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) have improved clinical evaluation and influenced treatment decisions. CLL can be diagnosed early and accurately, and biological measurements can be used to predict a prognosis at diagnosis. Individual patient care can be risk stratified to optimize benefit and minimize complications of therapy. Purine analogs and monoclonal antibodies have markedly improved the efficacy of initial therapy but are not curative. The treatment of relapsed and refractory CLL is less successful. However, recent developments suggest that allogeneic stem cell transplant could have a larger role in a selected group of these patients. Potential new treatment modalities include targeted molecules that interrupt key components of CLL cell survival pathways, and active and passive immunotherapy. The management of CLL is in a dynamic phase of rapid evolution. Risk stratification using biological prognostic markers can improve current patient care and direct future clinical research.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1994

The role of radiation therapy in the management of gastric cancer.

Gastric cancer continues to be one of the most important gastrointestinal cancers. Despite improved surgery and resection rates of 30%-60% still most of the patients die of loco-regional recurrence or distant metastasis. The role of adjuvant and palliative treatment of gastric cancer has world-wide been assessed in uncontrolled and prospective studies. Many of those were insufficient with respect to the number of patients and inclusion of prognostic factors as stratification criteria. Furthermore, the radiation oncologist would have preferred if these studies had looked at loco-regional tumor control instead of response rates or overall survival. A comprehensive overview of the currently available data for radiation therapy in adjuvant and palliative treatment schedules of gastric cancer is given and the limits of these studies are critically discussed. Until now, there is no clear evidence of improved overall survival from the addition of radiation therapy. However, the data suggest radiation therapy might be an effective measure to reduce loco-regional recurrence rates and similarly increase the recurrence-free survival. For the next future, optimally designed phase III trials with sufficient numbers of patients should be initiated to assess the definite value of radiation therapy for gastric cancer.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1989

A prospective, randomized controlled trial of megestrol acetate among high-risk patients with resected malignant melanoma.

In light of some evidence that hormonal factors may impact on malignant melanoma, we performed a randomized trial of megestrol acetate versus observation among 67 patients with high-risk resected stage I or stage II (nodal) malignant melanoma. Following stratification by relevant prognostic factors, we observed a statistical significance in survival advantage for megestrol acetate that approached 7.6 versus 2.6 years, median survival; two-sided log rank p = 0.06. Disease-free survival was also greater for patients who received this hormonal therapy (3.4 versus 1.1 years, median disease-free survival), but the difference was not statistically significant (two-sided log rank p = 0.20). The most noteworthy side effects were weight gain (median 6-month gain of 8.2 kg) and impotence. Fully recognizing the hazards of limited sample analyses and the need for confirmatory trials, our findings suggest a possible role for megestrol acetate as adjuvant therapy for selected patients with malignant melanoma.

Female↗

PubMed1991

Surgery plus adjuvant chemotherapy for T1-3N0M0 small-cell lung cancer. Rationale for current approach.

Between January 1980 and December 1986, 42 patients with histological confirmed small-cell lung cancer (SCLC) staged pathologically as T1-3N0M0 disease entered a prospective study of surgery plus adjuvant chemotherapy including six courses of i.v. cyclophosphamide (1 g/m2, day 1), epirubicin (60 mg/m2, day 1), and etoposide (120 mg/m2, days 1, 3, and 5), at 3-week intervals. No thoracic or prophylactic cranial irradiation was given. With a 52.5-month median follow-up, estimated 5-year survival was 36% and median survival was 32.7 months (range, 5-100+) for all patients. Seven patients (17%) are currently alive and disease-free at 63 to 100 months. In univariate analysis, baseline characteristics significantly influencing survival and disease-free interval (DFI) were the tumor stage (T1 and T2 versus T3), tumor histology (oat and intermediate versus combined cell type), and type of resection (lobectomy versus pneumonectomy). However, in multivariate analysis, only the tumor stage (T1-2 versus T3) maintained its level of significance. There was a significant correlation (p less than 0.0001) between the pathological tumor size (maximum tumor diameter [(MTD) cm] and survival and DFI; once the MTD (less than versus greater than median value, 3.9 cm) was included in univariate and multivariate analysis, the tumor stage no longer appeared to maintain its level of significance. Treatment was generally well-tolerated and toxicity was acceptable. This study demonstrates the effectiveness of surgery and adjuvant chemotherapy in yielding impressive long-term survival for T1 and T2N0M0 SCLC and provides evidence that the MTD can be used as a powerful and independent prognostic factor for stratification of patients in further trials.

Adult↗

PubMedDate not supplied

Natriuretic peptides and the dialysis patient.

The natriuretic peptide family consists of four structurally similar, but genetically distinct molecules with pronounced cardiovascular and renal actions. They are counterregulatory hormones playing an important role in fluid volume homeostasis. Atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) cause diuresis, natriuresis, and vasodilatation. C-type natriuretic peptide (CNP) has antimitogenic effects and causes vascular smooth muscle relaxation. Dendroaspis natriuretic peptide (DNP) shares many of the actions of ANP and BNP, but its function in humans is not yet fully understood. Natriuretic peptides have been extensively investigated as biochemical markers of the fluid state. Levels are elevated in disease conditions characterized by fluid overload and are closely related to survival in various cardiac disease states. In the dialysis population, BNP correlates significantly with cardiac function, whereas ANP is sensitive to volume changes during dialysis. However, changes in concentration do not predict achievement of euvolemia, and short half-life, combined with complicated assay techniques, make ANP a less than satisfactory tool for assessing hydration. BNP is a superior prognosticator for risk stratification in dialysis patients, and serial estimations will help in the identification of occult cardiac disease.

Biomarkers↗

PubMedDate not supplied

Preradiation chemotherapy with VM-26 and CCNU in patients with glioblastoma multiforme.

AIMS AND BACKGROUND: The objective of the study was to evaluate the efficacy of combined chemoradiation in patients with newly diagnosed glioblastoma multiforme. The main end points were time to progression and overall survival. METHODS: Thirty-one patients with glioblastoma multiforme underwent surgery whenever possible and then received intravenous VM26 (120 mg/m2) and oral CCNU (120 mg/m2) for three cycles followed by radiotherapy (60 Gy). RESULTS: Surgery consisted of a complete resection in 39% of patients, partial resection in 35% and a biopsy in 26%. Sixteen patients had clinical or radiological evidence of progression during or after chemotherapy. Hematologic toxicity was mild. Forty-five percent of patients received the scheduled dose of radiation. The outcome was disappointing, with a median time to progression of 18 weeks and median survival of 37.17 weeks. CONCLUSIONS: The survival of patients with glioblastoma multiforme remains disappointing. Multimodal therapy does not seem to modify the evolution of the tumor. Stratification according to prognostic factors might detect a potential benefit of other therapeutic approaches.

Administration, Oral↗

PubMed2006

Host cytokine genotype is related to adverse prognosis and systemic inflammation in gastro-oesophageal cancer.

BACKGROUND: Systemic inflammation has been linked with reduced survival in cancer, however, the role of the host cytokine genotype versus tumour phenotype in the generation of this response is not clearly established. This study examined the relationship between cytokine polymorphisms (IL-1beta 511, IL-6 174, IL-10 1082, TNFalpha 308 and LTalpha +252) and serum cytokine concentrations, serum CRP concentration and survival duration in patients with gastro-oesophageal malignancy. METHODS: Two hundred and three newly diagnosed patients with gastric or oesophageal cancer had serum CRP and cytokine concentrations determined by ELISA. SNP genotyping was performed by Taqman allelic discrimination genotyping and compared with the genotype observed in 266 healthy volunteers. Clinico-pathological information was collected prospectively and survival duration was recorded. RESULTS: Distribution of the cytokine genotypes was similar between patients and controls. The IL-6 174 CC and IL-10 1082 GG genotypes were associated with elevated serum CRP (P = .03, P = .01, respectively; Mann-Whitney U test) and sTNF-R (P = .015, P = .02) concentrations. These genotypes were also associated with reduced survival duration (P = .01, P = .047; log-rank test). TNFalpha AA genotype was also associated with reduced survival duration on univariate (P = .032) and multivariate analysis (P = .006, multivariate model), but not with inflammatory markers. No other cytokine polymorphisms were associated with systemic inflammatory markers or prognosis. CONCLUSIONS: There is a pro-inflammatory cytokine haplotype (IL-6 CC, IL-10 GG, TNFalpha AA) that is associated with adverse prognosis that may act, at least in part, through an inflammatory mediated mechanism. Determining patients' cytokine haplotype may improve prognostication and allow stratification for intervention studies.

Adolescent↗

PubMed2026

Efferocytosis related KCTD12 is a clinico-immune target in lung adenocarcinoma.

BACKGROUND: Efferocytosis, the clearance of apoptotic cells by phagocytes, contributes to immune homeostasis but may also promote tumor immune tolerance. However, its transcriptional landscape and clinical relevance in lung adenocarcinoma (LUAD) remain incompletely understood. METHODS: We systematically analyzed efferocytosis-associated genes across TCGA and multiple GEO datasets to classify LUAD subtypes and construct a prognostic risk model. The prognostic and immunological relevance of this model was validated in four independent cohorts and further assessed through immune infiltration, genomic, and immunotherapy datasets. Functional and pharmacogenomic analyses were performed to identify potential therapeutic vulnerabilities, and the efferocytosis-associated signature gene KCTD12 was subsequently validated in vitro. RESULTS: Unsupervised clustering identified two efferocytosis-based LUAD subtypes with distinct prognostic and immune-metabolic characteristics. The derived risk model robustly predicted overall survival across validation cohorts. Among the model genes, KCTD12 emerged as an efferocytosis-associated candidate linked to an immune-active tumor microenvironment. Across the analyzed single-cell, spatial transcriptomic, and immunotherapy-treated cohorts, higher KCTD12 expression was associated with enhanced cytotoxic T-cell activity and more favorable treatment outcomes. Functional experiments confirmed that KCTD12 suppresses tumor cell proliferation, reduces colony formation, and enhances OT-1 CD8+ T-cell activation and cytotoxicity. CONCLUSIONS: Our study identifies an efferocytosis-associated transcriptional program linked to immune heterogeneity and prognosis in LUAD. The efferocytosis-related risk signature provides a framework for prognostic and immune stratification, while KCTD12 represents a candidate biomarker associated with immune activation and clinical outcomes in immunotherapy-treated cohorts. Its treatment-specific predictive value requires prospective validation in appropriately controlled studies.

KCTD12↗