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PubMed1998

A new prognostic system for hepatocellular carcinoma: a retrospective study of 435 patients: the Cancer of the Liver Italian Program (CLIP) investigators.

The clinical outcome of cirrhotic patients with hepatocellular carcinoma (HCC) depends both on the residual liver function and tumor characteristics. However, the relative prognostic weight of these variables is not well defined. The aims of this study were to verify the value of known prognostic factors and to devise a prognostic index more sensitive than the commonly used Okuda stage. A retrospective analysis of the cases of HCC diagnosed at 16 Italian institutions from 1990 to 1992 was performed. Overall survival was the only end point used in the analysis. The Cox model, stratified by locoregional treatment, was used for multivariate analyses. The final model was derived from 10 randomly chosen training samples, and the prognostic validity of the Cancer of the Liver Italian Program (CLIP) score was assessed on the corresponding testing samples. Four hundred thirty-five cases of HCC were collected. As of January 1997, 313 patients (72%) were deceased. Overall median survival was 20 months. At multivariate analysis, independent predictive factors of survival were Child-Pugh stage, tumor morphology, alpha-fetoprotein (AFP), and portal vein thrombosis. A simple scoring system (CLIP score) was thus produced, assigning linear scores (0/1/2) to the covariates. Compared with Okuda stage, the CLIP score, structured as a six-category tool, has a greater discriminant ability, revealing a class of patients with an impressively more favorable prognosis and another class with a relatively shorter life expectancy. The CLIP score is a new prognostic system that accounts for both liver function and tumor characteristics. It is easy to calculate and appears to give more precise information than the Okuda stage.

Adult↗

PubMed2003

Prognostic value of bcl-6, CD10 and CD38 immunoreactivity in stage I-II gastric lymphomas: identification of a subset of CD10+ large B-cell lymphomas with a favorable outcome.

bcl-6, CD10 and CD38 are useful markers for identifying 2 molecularly and prognostically distinct profiles of diffuse large B-cell lymphomas (LCLs), defined as germinal-center B-like and activated B-like. We investigated the prognostic role of bcl-6, CD10 and CD38 immunoreactivity in 102 gastrectomized patients with primary gastric lymphomas (PGLs). There were 41 low-grade marginal zone lymphomas of MALT-type (LGML) and 61 diffuse large B-cell lymphomas with (DLCLMLs; n = 31) or without (DLCLs; n = 30) an LGML component. bcl-6, CD10 and CD38 were significantly more commonly expressed in DLCL or DLCML as compared with LGML (50% vs. 48% vs. 17%, p = 0.0002 for bcl-6; 27% vs. 26% vs. 0%, p = 0.0004 for CD10; 45% vs. 48% vs. 13%, p = 0.0005 for CD38, respectively). CD10 immunoreactivity was independently associated with a better survival in diffuse LCL patients (5-year overall survival: 88% +/- 8% vs. 66% +/- 7%; p = 0.04); bcl-6 or CD38 immunoreactivities did not disclose any prognostic implication. Age, presence of LGML component, lactic dehydrogenase serum levels and use of chemotherapy were additional independent prognostic factors. We conclude that CD10 immunoreactivity assessment could be a clear, easy-to-interpret and reliable prognostic factor in PGL. Accordingly, patients with CD10(+) gastric large B-cell lymphomas may be at reduced risk and eligible for clinical trials evaluating more conservative therapeutic options.

ADP-ribosyl Cyclase↗

PubMed2006

Hypoxia inducible factor-1alpha is a prognostic marker in premenopausal patients with intermediate to highly differentiated breast cancer but not a predictive marker for tamoxifen response.

Hypoxia is common in many solid tumours, including breast cancer. Hypoxia triggers the expression of hypoxia inducible factor-1alpha (HIF-1alpha), and HIF-1alpha has been associated with an impaired prognosis in breast cancer and down-regulation of the oestrogen receptor (ER), potentially affecting the treatment efficiency of antioestrogens. The role of HIF-1alpha regarding prognostic and treatment predictive information in breast cancer has not been established and we therefore analyzed HIF-1alpha using immunohistochemistry in a cohort of 377 premenopausal stage II breast cancers arranged in a tissue microarray. The patients were included in a randomized trial with either 2 years of tamoxifen or no adjuvant treatment. The tamoxifen treatment effect could be studied in subgroups of breast cancer and pure prognostic information could be scrutinized for untreated control patients. HIF-1alpha was scored as positive in 24% of the tumours and correlated positively to tumour size, Nottingham histological grade (NHG), Ki-67, Her2 and cyclin E expression and negatively to lymph node status, cyclin D1, ER and PR (progesterone receptor) expression. Surprisingly, there was no difference in tamoxifen response for patients with high or low HIF-1alpha expressing tumours. In lymph node-positive patients as well as NHG 1/2 tumours, high HIF-1alpha protein expression was significantly associated with an impaired recurrence-free survival (p=0.014, 0.018). When analyzing the subgroup of NHG 1/2 tumours, a high HIF-1alpha expression was the only independent significant prognostic marker in multivariate analysis, including standard prognostic markers, suggesting that HIF-1alpha might be a useful prognostic marker in this subgroup of breast cancer, with a rather good but diverse prognosis.

Adult↗

PubMed1987

Pretreatment prognostic factors and scoring system in 407 small-cell lung cancer patients.

In 407 patients with small-cell lung cancer (SCLC), 61 pretreatment variables were evaluated in a Cox multiple regression analysis to assess their prognostic value. All patients received short-term intensive regimens (cyclophosphamide, etoposide and methotrexate or ifosfamide and etoposide, both followed by thoracic irradiation if complete response was noted). Lactate dehydrogenase (p = 0.001), tumour stage (p = 0.0001), serum sodium (p = 0.0009), pretreatment Karnofsky performance score (p = 0.0121), alkaline phosphatase (p = 0.0186) and serum bicarbonate (p = 0.0321) were the important prognostic factors. Once these variables were taken into account no other variable provided additional prognostic information. A simple scoring system ("Manchester Score") using these variables was established and shows little loss of information compared to the Cox analysis. The score distinguishes 3 prognostic groups, the best of which contains all long-term survivors, whereas the bad prognostic group contains no patient surviving longer than one year. The scoring system may help to design new treatment strategies and may also facilitate the comparison of different studies.

Carcinoma, Small Cell↗

PubMed1990

Prognostic significance of DNA-ploidy in a series of 690 primary breast cancer patients.

Flow cytometric DNA-ploidy measurements were performed on paraffin-embedded and fresh tumor specimens from 690 patients with Stage I-III breast cancer. The conventional classification of DNA-ploidy (diploid versus aneuploid) was compared with a division of tumor ploidy into 5 classes based on DNA index (DI) range. The DI-classification showed a better correlation with tumor size and TNM stage than the conventional classification. Aneuploidy was associated with an impaired survival and distant relapse-free survival (p = 0.02) but the DI-classification improved the discrimination between different prognostic groups of patients. In general, this indicated a more aggressive phenotype for tumors evolved via polyploidization. Hyper-tetraploidy (DI greater than 2.10) indicated a very poor prognosis in pre-menopausal patients. No prognostic effect of aneuploidy and DI-class was found in node-negative and TI patients. Cox multivariate regression analysis showed that aneuploidy was an additional prognostic factor to nodal status (I less than or equal to N less than or equal to 3, N greater than 3 vs. N = 0) and tumor size (T2-4 vs. TI) for overall and distant relapse-free survival. Subdivision according to DI-class did not improve the prognostic power of DNA-ploidy due to stronger correlations with established prognostic factors.

Aged↗

PubMed1992

DNA flow cytometry, nuclear morphometry, mitotic indices and steroid receptors as independent prognostic factors in female breast cancer.

Clinical features, 8 histological variables, 7 nuclear morphometric variables, 2 mitotic indices, oestrogen-receptor (ER) and progesterone-receptor content (PR), DNA ploidy and S-phase fraction (SPF) were entered in a Cox's model to assess their independent predictive value in 216 breast-cancer patients followed up for over 9 years. In the whole series, histological type (p = 0.007), volume-corrected mitotic index (M/V index) (p = 0.01), axillary-lymph-node (pN) status (p = 0.024) and the year of treatment (p = 0.045) predicted independently the recurrence-free survival (RFS). In a sub-analysis including SPF (n = 148), the year of treatment (p = 0.003), tumour diameter (p = 0.004), SPF (p = 0.022) and nuclear pleomorphism (p = 0.056) independently predicted the RFS. In a Cox's analysis of the whole series, tumour diameter (p less than 0.001), pN status (p = 0.001), PR status (p = 0.002) and the year of treatment (p = 0.021) were independent predictors of survival. In a separate analysis including also SPF (n = 148), tumour diameter (p less than 0.001), SPF (p = 0.003), pN status (p = 0.008) and the year of treatment (p = 0.015) proved to be independent prognostic factors. The results show that tumour diameter, pN status, M/V-index, histological type, SPF and PR status comprise a sufficient combination of prognostic factors in female breast cancer. In pN patients, age and SDPE may be of additional prognostic significance. The prognostic scores combining the independent prognostic variables reflecting both the proliferative rate and metastatic potential of the tumours are accurate predictors of the RFS and overall survival.

Adult↗

PubMed1994

Cell kinetics in human breast cancer: comparison between the prognostic value of the cytofluorimetric S-phase fraction and that of the antibodies to Ki-67 and PCNA antigens detected by immunocytochemistry.

The determination of cell proliferation is one of the more widely used tools for assessing prognosis. However, additional research in this field is warranted because today there are several methodological procedures available for monitoring cell kinetics and it has still not been established which is the most reliable marker of proliferation and which possesses the greatest prognostic value. We performed this study in a series of primary invasive breast cancers to compare the prognostic value of S-phase fraction (SPF) by flow cytometry, the most widely used method for detecting proliferation at present, with that of antibodies to Ki-67 and PC-10 to proliferating-cell nuclear antigen (PCNA) detected by immunocytochemical methods. A significant linear relationship was observed only between SPF and Ki-67. In univariate analysis SPF and Ki-67 values, nodal status, histological grading and peritumoral lymphatic-vessel invasion were significant predictors of relapse-free survival (RFS). As far as overall survival (OS) is concerned, only SPF, Ki-67 and nodal status were significantly associated with the risk of death. PCNA had no prognostic value for either RFS or OS. In multivariate analysis only SPF and nodal status retained a significant and independent prognostic value. Neither the cell-kinetics parameters assessed by immunocytochemistry (i.e. Ki-67 and PCNA) nor histological grading were independent prognosticators. In conclusion, our results provide evidence that the determination of SPF by flow cytometry was the strongest cell-kinetics marker used to assess prognosis in this series of breast cancers. However, different and novel markers of cell kinetics need to be compared in larger series in order to identify the best one.

Breast Neoplasms↗

PubMed1995

Different risk groups in node-negative breast cancer: prognostic value of cytophotometrically assessed DNA, morphometry and texture.

Feulgen-stained imprints and fine-needle aspirates from 528 lymph-node-negative breast cancers were investigated by means of an image analysis system. Several DNA, morphometric and textural parameters were evaluated for each patient. The prognostic value of the parameters was investigated by multivariate Cox regression analysis. As prognostic criteria, a distant recurrence-free survival of 5 years and an overall survival of 8 years were considered. In multivariate analyses the anisokaryosis (standard deviation of nuclear radius, Rad-SD) was the strongest parameter in predicting the clinical course of node-negative patients. This was followed by a textural parameter (run-length, NR2 M) and the tumor size (pT). The DNA histogram type could also add prognostic information concerning distant recurrence-free survival, but not overall survival. In both approaches a multivariate prognostic factor was calculated for each of the node-negative patients by a linear combination of the selected variables. Using this factor, patients could be split into 5 subgroups with significantly different risks of distant metastases. Thus, a low-risk subgroup, with a 5-year distant recurrence rate of only 3%, and a subgroup with a considerably higher risk and a distant recurrence rate of 35%, could be distinguished. In survival analysis the low-risk group of node-negative patients showed an 8-year death rate of only 3%, whereas in the high-risk group 30% of the patients had died at 8 years. Thus DNA, morphometric and textural parameters can provide powerful prognostic information in node-negative breast carcinomas. The multivariate combination of the relevant variables may allow a better selection of those node-negative patients with a proven good prognosis, and of those who are at risk of distant recurrence and therefore may benefit from adjuvant treatment.

Adult↗

PubMed2002

Serum HCG beta, CA 72-4 and CEA are independent prognostic factors in colorectal cancer.

In colorectal cancer, stage is considered to be the strongest prognostic factor, but also serum tumour markers have been reported to be of prognostic value. The aim of our study was to investigate the prognostic value of serum carcinoembryonic antigen (CEA), CA 19-9, CA 242, CA 72-4 and free beta subunit of human chorionic gonadotropin (hCG beta) in colorectal cancer. Preoperative serum samples were obtained from 204 colorectal cancer patients, including 31 patients with Dukes' A, 70 with Dukes' B, 49 with Dukes' C and 54 with Dukes' D cancer. The serum levels of CEA, CA 19-9, CA 242 and CA 72-4 were measured with commercial kits with cut-off values of 5 microg/L for CEA, 37 kU/L for CA 19-9, 20 kU/L for CA 242 and 6 kU/L for CA 72-4. The serum hCG beta was quantitated by an immunofluorometric assay (IFMA) with 2 pmol/L as a cut-off value. Survival analyses were performed with Kaplan-Meier life tables, log-rank test and Cox proportional hazards model. The sensitivity was 44% for CEA, 26% for CA 19-9, 36% for CA 242, 27% for CA 72-4 and 16% for hCG beta. The overall 5-year survival was 55%, and in Dukes' A, B, C and D cancers the survival was 89%, 77%, 52% and 3%, respectively. Elevated serum values of all markers correlated with worse survival (p < 0.001). In Cox multivariate analysis, the strongest prognostic factor was Dukes' stage (p < 0.001), followed by tumour location (p = 0.002) and preoperative serum markers hCG beta (p = 0.002), CA 72-4 (p = 0.003) and CEA (p = 0.005). In conclusion, elevated CEA, CA 19-9, CA 242, CA 72-4 and hCG beta relate to poor outcome in colorectal cancer. In multivariate analysis, independent prognostic significance was observed with hCG beta, CA 72-4 and CEA.

Adult↗

PubMed2006

A scoring system based on the expression of six surface molecules allows the identification of three prognostic risk groups in B-cell chronic lymphocytic leukemia.

We have previously identified 12 surface antigens whose differential expression represented the signature of B-cell chronic lymphocytic leukemia (B-CLL) subsets with different prognosis. In the present study, expression data for these antigens, as determined in 137 B-CLL cases, all with survivals, were utilized to devise a comprehensive immunophenotypic scoring system of prognostic relevance for B-CLL patients. In particular, univariate z score was employed to identify the markers with greater prognostic impact, while maximally selected log-rank statistics were chosen to define the optimal cut-off points capable to split patients into two groups with different survivals. A weighted immunophenotypic scoring system was developed by integrating results from these analyses. Six antigens were selected: three positive prognosticators (CD62L, CD54, CD49c) and three negative prognosticators (CD49d, CD38, CD79b), with cut-off values ranging from 30% to 50% of positive cells. By weighing the expression of each marker according to its statistical power, a complete scoring system, with point values comprised between 0 (complete absence of phenotypic conditions associated with good prognosis) and 9 (all the phenotypic conditions associated with good prognosis fulfilled), allowed to split the whole set of B-CLL patients, into three distinctive prognostic groups (P = 4.78 x 10(-11)) with high- (score 0-3), intermediate- (score 4-6), and low- (score 7-9) risk of death. The three risk groups showed different distribution of cases as for Rai's stages, IgVH mutations, and ZAP-70 expression. The proposed immunophenotypic scoring system may be an additional useful tool in routine diagnostic/prognostic procedures for B-CLL.

ADP-ribosyl Cyclase 1↗

PubMed2003

Prospective evaluation of prognostic factors in patients with colorectal cancer undergoing curative resection.

BACKGROUND AND OBJECTIVES: Streak type, defined by the presence of white streaks at the advancing margin of tumor invasion; focal dedifferentiation, seen as undifferentiated cancer cells with an infiltrative pattern at the invasive front; and perineural invasion have been demonstrated to be prognostic factors in patients with colorectal cancer. We performed a prospective study to examine the usefulness of these features as prognostic factors. METHODS: We reviewed a total of 391 patients who underwent curative surgery for colorectal cancer between May 1997 and June 1999. Of these, 50 patients with multiple cancers were excluded, and a total of 341 patients were finally entered into the study. RESULTS: Of the prognostic factors investigated, depth of invasion, lymph node status, lymphatic invasion, venous invasion, growth type, streak type, focal dedifferentiation, and perineural invasion were significant prognostic factors in univariate analysis. In multivariate analysis, lymph node status, depth of invasion, and perineural invasion were significant prognostic factors. The survival of patients with perineural invasion was significantly poorer than that of patients without perineural invasion in both stage II and III cancer. CONCLUSIONS: Perineural invasion status can be used to facilitate the selection of colorectal cancer patients for adjuvant chemotherapy and should be described in routine pathology reports.

Colorectal Neoplasms↗

PubMed2005

The prognostic significance of p53, p27 kip1, p21 waf1, HER-2/neu, and Ki67 proteins expression in gastric cancer: a clinicopathological and immunohistochemical study of 121 Arab patients.

BACKGROUND: The variability of prognosis within a pathological stage of gastric cancer (GC) at presentation, underscores the need for specific biological markers to identify subgroups of patients with aggressive course for intensive treatment. To our knowledge, this is the first study from an Arab population reporting on the relationship of p53, p27 kip1, p21 waf1, HER-2/neu, and Ki67 expression, and clinicopathological features and their prognostic significance. METHODS: Formalin-fixed paraffin-embedded tumors were studied by immunohistochemistry, using monoclonal antibodies to p53, p27 kip1, p21 waf1, HER-2/neu, and Ki67. The results were correlated with clinicopathological features and survival. RESULTS: M:F = 80:41; median age = 60 years; stage III and IV = 71%; and median follow-up = 34.4 months. Positive expression rates of p53, p27 kip1, p21 waf1, Ki67, and HER-2/neu were 54%, 40%, 8.3%, 70%, and 12% respectively. p53 expression correlated with age <60 years (P = 0.03), tumor size >5 cm (P = 0.01), p27 kip1 and Ki67 expression (P = 0.0001), and HER-2/neu (P = 0.04). p21 waf1 correlated inversely with T-stage (P = 0.008) and Her-2/neu expression correlated with histological grade (P = 0.04) and T-stage (P = 0.008). Univariate analysis showed that p53 overexpression (P = 0.01), fungating and infiltrative macroscopic appearance (P = 0.02), size >5 cm (P = 0.0001), lymph node metastasis (P = 0.0001), p T3 and T4 disease (P = 0.01), and overall stage III and IV (P = 0.0001) disease were adverse prognostic factors. Patients with tumor profiles p53 (-)/p27 (+) had better survival than those with p53 (+)/p27 kip1 (-)(P = 0.02). On multivariate analysis by Cox regression model, the expression of p53 (P = 0.03) and lymph node involvement (P = 0.01) were significant adverse prognostic factors for overall survival. CONCLUSIONS: The expression of p53 in Arab patients with GC correlates with aggressive tumor characteristics and is an independent prognostic factor. The combined analysis of p53 and p27 kip1 is of added prognostic value.

Adult↗

PubMed2005

Systematic review and validation of prognostic models in liver transplantation.

A model that can accurately predict post-liver transplant mortality would be useful for clinical decision making, would help to provide patients with prognostic information, and would facilitate fair comparisons of surgical performance between transplant units. A systematic review of the literature was carried out to assess the quality of the studies that developed and validated prognostic models for mortality after liver transplantation and to validate existing models in a large data set of patients transplanted in the United Kingdom (UK) and Ireland between March 1994 and September 2003. Five prognostic model papers were identified. The quality of the development and validation of all prognostic models was suboptimal according to an explicit assessment tool of the internal, external, and statistical validity, model evaluation, and practicality. The discriminatory ability of the identified models in the UK and Ireland data set was poor (area under the receiver operating characteristic curve always smaller than 0.7 for adult populations). Due to the poor quality of the reporting, the methodology used for the development of the model could not always be determined. In conclusion, these findings demonstrate that currently available prognostic models of mortality after liver transplantation can have only a limited role in clinical practice, audit, and research.

Humans↗

PubMed1986

Analysis of prognostic factors in acute lymphoblastic leukemia.

Children with ALL who have a high probability of excellent response, long-term survival, and cure when treated with widely available standard therapy can be identified at the time of diagnosis. Others can be identified who are at high risk of failure to respond, early relapse, and death. The importance of such prognostic characteristics is so great that they should be considered in the selection of appropriate treatment for each patient. Prognostic factors also must be considered in the design and analysis of clinical trials. All prognostic factors are not equally significant and many of them are closely associated. It is possible to rank them in importance and usefulness by appropriate statistical methods. As additional prognostic factors are identified, and as more effective and more specific therapies are developed, the relative importance of prognostic factors will change.

Adolescent↗

PubMed2002

Telomerase as a prognostic marker in breast cancer: high-throughput tissue microarray analysis of hTERT and hTR.

Telomerase activity (TA) has been shown to correlate with poor clinical outcome in various tumour entities, indicating that tumours expressing this enzyme may be more aggressive and that TA may be a useful prognostic marker. For breast cancer, however, TA is a controversial prognostic marker; whereas some studies suggest an association between TA and disease outcome, others do not find this association. This study used tissue microarrays (breast carcinoma prognosis arrays) containing 611 samples (each 0.6 mm in diameter) from the tumour centre of paraffin-embedded breast carcinomas to analyse the catalytic subunit of telomerase, human telomerase reverse-transcriptase (hTERT), and the internal RNA component (hTR), which are the core components of the telomerase holoenzyme complex. hTERT protein expression was obtained by immunohistochemistry (human anti-telomerase antibody Ab-2, Calbiochem), and hTR RNA was measured by radioactive in situ hybridization. hTERT and hTR expression were determined semi-quantitatively and graded (scores 1-4). Clinical data, such as histological subtype, pT stage, tumour diameter, pN stage, BRE grade, tumour-specific survival (in months), patient's age and others, were available for statistical analysis. A statistically significant correlation was found between tumour-specific survival (overall survival) and hTERT expression (p < 0.0001) or hTR expression (p = 0.00110). Tumours with higher scores (scores 3, 4) for hTR and/or hTERT were associated with a worse prognosis. In multivariate analysis, hTERT expression was an independent prognostic factor. Previous studies, focusing on analysis of TA in smaller numbers of fresh-frozen breast carcinomas by the TRAP assay, gave controversial results with respect to TA as a prognostic marker. Using tissue microarrays from 611 breast carcinomas, this study has demonstrated that increased expression levels of the telomerase core components, hTERT and hTR, are associated with lower overall survival. These findings suggest that TA should be included in future validation studies as a prognostic marker in breast cancer.

Adult↗

PubMed2005

Prognostic factors for relapsed childhood acute lymphoblastic leukemia: impact of allogeneic stem cell transplantation--a report from the Kyushu-Yamaguchi Children's Cancer Study Group.

BACKGROUND: The treatment results of childhood acute lymphoblastic leukemia (ALL) with a first relapse were retrospectively analyzed to determine prognostic factors. In particular, an attempt was made to clarify whether stem cell transplantation (SCT) had any advantages over chemotherapy. PROCEDURES: Of the 407 children with ALL diagnosed between 1984 and 1996, 117 suffered from a relapse before December 1999. The patients were treated differently according to the protocols of each institution. The potential prognostic factors examined were: the time of initial diagnosis, gender, immunophenotype of leukemic blasts and the NCI-risk classification at initial diagnosis, the site of relapse, the time of relapse (early: within 18 months after diagnosis, intermediate: other than either early or late relapse, late: later than 6 months after the discontinuation of front-line chemotherapy), and the treatment after relapse (chemotherapy alone and SCT). RESULTS: A second complete remission (CR2) was achieved in 90 patients (77%) and thirty of them maintained CR2, thus resulting in an event-free survival rate (EFS) of 25.1% and an overall survival rate of 26.1%. The significant prognostic factors identified by a multivariate analysis included the time of relapse (EFS: early 16.2%, intermediate 23.9%, late 35.1%, P = 0.012) and the treatment after relapse (EFS: SCT 30.3%, chemotherapy 22.0%, P = 0.049). When patients with an isolated bone marrow relapse and continuous CR2 for more than 3 months were analyzed, the treatment in CR2 was the only independent prognostic factor (EFS: SCT 60.2%, chemotherapy 25.7%, P = 0.005). CONCLUSIONS: In children with ALL and a first relapse, the time of relapse and the treatment after relapse were found to be independent prognostic factors. Allogeneic SCT in CR2 showed significantly better results than chemotherapy in patients with an isolated bone marrow relapse.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2004

Development and validation of a prognostic model for survival time data: application to prognosis of HIV positive patients treated with antiretroviral therapy.

The process of developing and validating a prognostic model for survival time data has been much discussed in the literature. Assessment of the performance of candidate prognostic models on data other than that used to fit the models is essential for choosing a model that will generalize well to independent data. However, there remain difficulties in current methods of measuring the accuracy of predictions of prognostic models for censored survival time data. In this paper, flexible parametric models based on the Weibull, loglogistic and lognormal distributions with spline smoothing of the baseline log cumulative hazard function are used to fit a set of candidate prognostic models across k data sets. The model that generalizes best to new data is chosen using a cross-validation scheme which fits the model on k-1 data sets and tests the predictive accuracy on the omitted data set. The procedure is repeated, omitting each data set in turn. The quality of the predictions is measured using three different methods: two commonly proposed validation methods, Harrell's concordance statistic and the Brier statistic, and a novel method using deviance differences. The results show that the deviance statistic is able to discriminate between quite similar models and can be used to choose a prognostic model that generalizes well to new data. The methods are illustrated by using a model developed to predict progression to a new AIDS event or death in HIV-1 positive patients starting antiretroviral therapy.

Anti-HIV Agents↗

PubMedDate not supplied

Therapeutic implications of prognostic factors in differentiated carcinoma of the thyroid gland.

Differentiated thyroid carcinoma is a relatively indolent disease. Despite the usually favorable prognosis, differentiated thyroid cancer is fatal in some patients. In the past, treatment strategies were often based upon incomplete knowledge or inaccurate assumptions regarding the significance of the presenting characteristics of the tumor and patient. More recently, several large retrospective reviews have analyzed various presenting factors and have identified those that have prognostic significance and those that do not. Significant prognostic factors are age, primary tumor size, histology, grade, local tumor extension, and M stage. N stage appears to be a significant factor in older patients but not in younger patients. Gender, focality, and a history of prior irradiation are not significant prognostic factors. Using this knowledge, patients can be grouped into low, intermediate, and high risk groups. Prognostic factor and risk group analysis has facilitated the development of more rational treatment algorithms. Low risk patients can usually be treated with lobectomy and suppression therapy. For high risk patients, total thyroidectomy and adjuvant radioiodine is advocated. Treatment for patients in the intermediate risk group should be individualized. Prognostic factor and risk group analysis makes a selective approach to differentiated thyroid cancer possible. Such an approach can spare many patients the morbidity and expense of unnecessarily aggressive treatment without compromising outcome.

Adult↗