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PubMed2006

Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial.

We evaluated the contribution of an epirubicin-based adjuvant chemotherapy on disease-free survival (DFS) in poor prognosis, node-negative breast cancer (BC) patients. Poor prognostic factors were defined as: pathologic tumor size >or= 4 cm, estrogen-receptor negative, and progesterone-receptor negative. Scarff-Bloom Richardson grade 2 tumors must have two of these factors, and only one in case of grade 3. Between 1988 and 1994, 328 patients were randomized to receive either no systemic treatment (control, n = 161), or fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2), cyclophosphamide 500 mg/m(2), 6 cycles every 21 days (FEC50, n = 167), without any hormonal treatment. The median follow up was 114 months. The 10-year DFS rates were 64 and 71%, respectively (p = 0.23). In the Cox regression model, independent prognostic factors of relapse were the number of nodes examined < 10 (p = 0.002), BCS (p = 0.01), and premenopausal status (p = 0.04). In this model, the relative risk of relapse was 1.46 (CI95 %: 1.05-1.87) in favor of FEC50. In patients who underwent BCS, 21 % developed a local relapse (24 versus 18 %, respectively). The 10-year local DFS was 70.5 and 79.3 %, respectively (p = 0.27). The 10-year overall survival was not different (74.1 versus 70.7 %, p = 0.82). After 10 years of follow-up, the FEC50 regimen reduced the risk of relapse in poor-prognosis node-negative BC patients. The incidence of local relapse was high, and probably related to inclusion criteria. Epirubicin was probably underdosed in such patients, and ongoing studies using 100 mg/m(2) of epirubicin will give us the answer in a near future.

Adult↗

PubMed1992

[Long-term observation after percutaneous transluminal angioplasty in the pelvic and leg areas].

In this study 163 patients had long term follow ups after PTA; the value of a test which had previously hardly been used, the "Cox proportional hazards model", for prognostic purposes is stressed. In this test account is taken of the severity of the stenosis before PTA, the extent of re-stenosis following PTA and the distance of the occlusion from the aorta and these are related to the likelihood of success. The use of the Cox proportional hazards model with an accurate description of the clinical material and the use of the Kaplan-Meier method is recommended in order to obtain comparable figures for the results obtained in various centres. In this study patency after six months was 77%, after a year 67%, after three years 46% and after five years 37%.

Angioplasty, Balloon↗

PubMed1991

[Chronic lymphatic leukemia. II. Analysis of prognostic factors and development of survival predicting models. Study of 187 patients].

The univariate analysis of prognostic factors showed the value of clinical variables (age, symptoms, lymph node enlargement, splenomegaly, hepatomegaly, clinical stage), haematological variables (haemoglobin, platelet count, leucocyte count, lymphocyte count, bone marrow involvement and biopsy pattern, cleaved lymphocytes, prolymphocytes, LDT) and biochemical variables (BUN, creatinine, calcium, phosphorus, uric acid and albumin). The multivariate analysis chose the combination of Rai's stage, age, cervical lymph node involvement, phosphorus and BUN. Two predictive models capable of separating appropriately low, intermediate and high risk groups were developed and validated. The results were compared with others in the literature. The interest of predictive models arising from multivariate analysis is stressed.

Adult↗

PubMed2000

Recurrent squamous cell carcinoma of the vulva: clinicopathologic determinants identifying low risk patients.

BACKGROUND: The identification of prognostic factors in the recurrence of vulvar squamous cell carcinoma is crucial for less invasive treatments. METHODS: The authors studied 101 patients treated for primary invasive squamous cell carcinoma of the vulva. Selected pathologic variables were observed in a standardized manner during treatment, and their association with disease free survival was investigated using the Cox model. Independent prognostic factors were selected by a stepwise procedure. The absolute survival of patient groups determined on the basis of such factors was computed by the product limit method. RESULTS: The median follow-up was 3.1 years (range, 56 days to 15.5 years). Recurrences developed in 33 patients. The independent recurrence predictors were as follows: International Federation of Gynecology and Obstetrics (FIGO) Stage IVA (vs. IB, II, or III) (risk ratio [RR]adjusted for other independent factors, 7.39), tumor multifocality (RR, 4.10), lymphovascular space involvement (LVSI) (RR, 2.96), the presence of associated vulvar intraepithelial neoplasia (VIN) Grade 2 or 3 (RR, 3.34), and the involvement of resection margins (RR, 4.88). By ignoring the FIGO stage and lymph node status, the independent predictors were then as follows: greatest tumor dimension < 2.5 cm, 2.5-4 cm (RR, 2.86), or > 4 cm (RR, 5.98); tumor multifocality (RR, 3.36); LVSI (RR, 4.19); the presence of VIN 2 or 3 (RR, 3.06); and the involvement of surgical margins (RR, 2.78). No recurrences were observed in 119 at-risk years among patients with unifocal tumors < 2.5 cm in greatest dimension, free surgical margins, no LVSI, and no associated VIN 2 or 3. CONCLUSIONS: The presence of associated VIN 2 or 3 was revealed to be a previously unidentified independent prognostic factor for recurrence. Subjects at low risk of recurrence could be identified even without consideration of lymph node status.

Carcinoma, Squamous Cell↗

PubMedDate not supplied

[Diagnosis of localized cancer of the prostate].

The study was made to improve preoperative diagnosis of the stage of prostatic cancer (PC) to raise efficacy of subsequent treatment. A total of 152 patients entered the study who had undergone in 1997-2002 a radical prostatectomy for local PC. Basing on pathomorphological findings, the patients were divided into two groups: with localized CP (68 patients) and spread CP (84 patients). The comparison of clinical and pathomorphological diagnosis in the same patients demonstrated that there is a correlation between them, therefore it is possible to predict pathomorphological diagnosis at the stage of clinical diagnosis. The formula of establishment of a pathomorphological stage of the disease has been developed and its efficacy was tested in 30 control patients. The mathematical model of complex evaluation of the symptoms allows in 81% of cases to correctly determine the spread of CP while examination of separate symptoms provides a correct diagnosis in less than half the cases. The model can prognosticate radicality of the future operative intervention and duration of recurrence-free course and, consequently, to reduce the rate of intra- and postoperative complications and design further treatment policy.

Humans↗

PubMed2001

[Transcatheter arterial chemoembolization for postoperative residual tumor of hepatocellular carcinoma].

OBJECTIVE: To understand and analyze the survival and prognostic factors of postoperative residual tumor of hepatocellular carcinoma treated by transcatheter arterial chemoembolization. METHODS: Transcatheter arterial chemoembolization was performed in 74 patients who were identified as having residual lesions by ultrasonography, hepatic arterial angiography or enhanced computed tomography about two months after resection of hepatocellular carcinoma. Kaplan-Meier method was used for survival and Cox regression model for prognostic factors. RESULTS: The 1-, 2- and 3-year survival rates were 78.0%, 57.6%, 37.0%, with a median survival of 33 months. Univariate analysis indicated that a primary tumor over > 5 cm in diameter, vascular involvement by the primary tumor and TNM extent of the residual lesion were important factors indicating a bad prognosis, where as the combination of other treatment methods such as percutaneous ethanol injection (PEI), and/or radiotherapy indicated a better prognosis. However, multivariate analysis showed that vascular involvement by the primary tumor and the other combined local treatments were independent factors of prognosis. CONCLUSION: Transcatheter arterial chemoembolization is effective in treating the postoperative residual tumor of hepatocellular carcinoma. Further improvement is observed if combined with other local therapies such as percutaneous ethanol injection or radiotherapy.

Adolescent↗

PubMed1986

Tissue glycolytic enzymes in primary breast cancer patients receiving adjuvant chemotherapy.

Primary breast cancers from 85 patients undergoing post-surgical adjuvant chemotherapy were analyzed for five glycolytic enzymes: lactate dehydrogenase (LDH); phosphohexose isomerase (PHI); glucose-6-phosphate dehydrogenase (G-6PD); pyruvate-kinase (PK); and 6-phospho-gluconate dehydrogenase (6-PGD). The purpose of this study was to determine whether biochemical parameters could offer a prognostic index to determine outcome of therapy. The patients were followed up to a maximum of 54 months; during this period 30 of them developed recurrent or metastatic disease. The enzyme activities were expressed by the three following reference parameters: units/g proteins, units/g tissue weight and units/mg DNA. Two methods of analysis were compared: firstly, univariate analysis using life tables; and secondly, multivariate analysis using the Cox's model, where enzyme levels were tested for each mode of expression in addition to node status, histological features, receptor and menopausal status. Life table analyses appear limited when subsets of patients were studied because the sample size tends to become too small to warrant firm conclusions. Using the Cox's model, a prognostic index 1 was proposed, including the number of involved nodes and the product of logarithms of G-6PD and 6-PGD expressed as units/mg DNA. Compared to the number of involved nodes, this index gives a slightly better discrimination of the patients at 2 yr after mastectomy.

Adult↗

PubMed2006

The prognostic value of depressive symptoms, fear-avoidance, and self-efficacy for duration of lost-time benefits in workers with musculoskeletal disorders.

BACKGROUND: The psychological factors of depressive symptoms, fear-avoidance, and self-efficacy are deemed to be important in the work disability process. However, the prognostic value of these factors for time on benefit is not well understood. AIMS: To analyse the prognostic value of psychological factors for the number of days on total compensation benefit over a 12 month period. METHODS: In a longitudinal study of 187 workers receiving total compensation benefits due to musculoskeletal disorders, the prognostic value of psychological factors measured 4-5 weeks post-injury for duration on total compensation benefit over 12 months was analysed. Cox proportional hazard regression analyses were conducted. Special emphasis was given to variable selection and to the analysis of confounding effects of potential prognostic variables. RESULTS: The final model indicated that increased depressive symptoms and poorer physical health significantly increase the number of days on total benefit. Confounders included in the final model were pain and fear of income loss. In the final model the impact of fear-avoidance ceased to be significant when work related variables were included in the fully adjusted model. This illustrates that interrelationships between variables must be taken into account when building multivariate prognostic models. The addition of work related variables to the model did not result in any major changes in the adjusted model, which suggests that when measured 4-5 weeks post-injury, psychological and physical health factors are strong predictors of time on benefits, while work conditions are less important. CONCLUSION: Results suggest that the presence of depressive symptoms and poor physical health in workers on benefit due to musculoskeletal disorders increases the number of days on total compensation benefits significantly, when controlling for confounding variables.

Adult↗

PubMed1993

Serologic determinants of survival in patients with head and neck cancer: validating a clinical prediction model.

Quantitative measurements of serum C1q-binding macromolecules (C1qBM) and immunoglobulin A (IgA) were done on 162 patients using previously described methodology. The measurements were compared to a previously described head and neck cancer population. Using the Cox Proportional Hazards model, the prognostic implications regarding high C1qBM and subsequent death with disease (P = .02), and regional recurrence (P = .0094) were validated, but not our previous IgA-related prognostic implications. When both study populations were combined, C1qBM was predictive of survival in those patients treated with induction chemotherapy (P = .0001). C1qBM was not a significant predictor of survival in patients treated with surgery plus postoperative radiation therapy in either this second "test" population or in the original "training" population. The findings demonstrate the confounding influence of treatment modalities and the importance of model validation.

Age Factors↗

PubMed1996

Microvessel density is a prognostic indicator for patients with astroglial brain tumors.

BACKGROUND: Microvessel density in tumors, a measure of angiogenesis, has been shown to be a prognostic indicator that correlates with an increased risk of metastasis in various epithelial cancers and with overall and relapse free survival in patients with breast cancer. Astrocytic brain tumors, particularly malignant astrocytomas, are recognized to be highly vascular tumors with potent angiogenic activity. However, the prognostic significance of microvessel density in these tumors is not known. METHODS: Sections from formalin fixed paraffin embedded tumor tissue from 93 unselected adult patients with supratentorial astrocytic brain tumors were immunostained for factor VIII-related antigen in order to highlight microvessel endothelial cells. Microvessels were counted at 200x and 400x magnification. Microvessel density was graded as 1+ to 4+ on 1 low power field, without knowledge of clinical outcome. Microvessel count and microvessel grade were correlated with postoperative survival using the Cox proportional hazards regression model. The prognostic significance of microvessel count and grade were also compared with established prognostic indicators, including patient age, Karnofsky performance status, and tumor histology using multivariate analyses. RESULTS: Both microvessel grade and microvessel count correlated significantly with postoperative survival by univariate analysis in both previously untreated and treated patients. Patients with tumors containing a microvessel Grade of 3+ or 4+ had significantly shorter survival time than patients with a microvessel Grade of 1+ or 2+ (P = 0.0022). Likewise, patients with microvessel counts of 70 or greater had significantly shorter survival than those with microvessel counts of fewer than 70 (P = 0.041). Patient age, Karnofsky performance status, tumor histology, and extent of resection were also correlated with survival by univariate analysis. Microvessel count was further shown to be an independent prognostic indicator by multivariate analyses. There were correlations between microvessel density and patient age and between microvessel density and astrocytic tumor grade. CONCLUSIONS: These findings support the importance of microvessel density as a prognostic indicator of postoperative survival of patients with astroglial brain tumors. Regional tumor heterogeneity may limit the use of these techniques for routine pathologic examination.

Adult↗

PubMed2003

Prognostic factors for survival after neoadjuvant chemotherapy in operable breast cancer. the role of clinical response.

The aim of this retrospective study was to assess predictive factors for clinical response to preoperative chemotherapy and prognostic factors for survival. From 1981 to 1992, 936 patients with T2-T3, N0-N1 breast cancer who received 2-6 months (median 4) of preoperative chemotherapy were selected from the Institute Curie database. Preoperative treatment was followed by surgery and/or radiotherapy. Median follow-up was 8.5 years (range 7-211 months). The objective response rate before surgery and/or radiotherapy was 58.3%. In stepwise multivariate analysis (Cox model), favourable prognostic factors for survival were the absence of pathological axillary lymph node involvement (Relative Risk (RR) 1.54; P=0.0004), low histological tumour grade (RR=1.54; P=0.0017), clinical response to preoperative chemotherapy (RR=1.45, P=0.0013), positive progesterone receptor (PR) status (RR=1.56; P=0.0001), smaller tumour size (RR=1.37; P=0.005) and lack of clinical lymph node involvement (RR=1.42; P=0.007). The association of clinical tumour response with survival is independent of the baseline characteristics of the tumour. Clinical response could be used as a surrogate marker for evaluation of the efficacy of neoadjuvant chemotherapy before assessment of the pathological response.

Adult↗

PubMed1990

Significance of C1q-binding macromolecules within the head and neck cancer patient.

Elevated levels of macromolecules, within the peripheral blood of head and neck cancer patients, capable of binding the first component of complement (C1qBM) in vitro have prognostic implication. Namely, elevated levels of C1qBM have been associated with nonresponse to induction chemotherapy. In this investigation, a series of in vitro studies regarding the biological properties of C1qBM were combined with a longitudinal analysis of 112 previously untreated head and neck cancer patients. Our purpose was to shed light on the biological significance of this circulating macromolecule, a substance composed, in part, of IgG and IgM. A potential confounding influence of C1qBM with induction chemotherapy, which could contribute to observed prognostic findings, was negated by two in vitro observations: the macromolecule failed both to bind the chemotherapeutic agents cisplatin, bleomycin, and 5-fluorouracil and to impede the cytotoxic effect of these same drugs on a cultured human head and neck cancer cell line. The clinical relevance of C1qBM was reinforced by the observation that elevated levels predicted a high probability of death with disease (P = 0.005 by Cox's proportional hazards model). The prognostic implication was independent of the use of induction chemotherapy, i.e., patients with high C1qBM levels treated with multimodality therapy not composed of anticancer drugs did equally poorly. Thus, the prognostic significance of C1qBM in patients undergoing induction chemotherapy appears independent of drug effect and appears reflective of tumors that are more rapidly progressive and potentially less responsive to therapeutic intervention, including combinations of surgery, radiation, and/or chemotherapy.

Antigen-Antibody Complex↗

PubMedDate not supplied

Compensated cirrhosis: natural history and prognostic factors.

To investigate the natural history of compensated cirrhosis, 293 consecutive patients without previous major complications (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) were studied in terms of morbidity (probability of developing decompensated cirrhosis during follow-up) and survival. Patients were diagnosed by liver histology between 1968 and 1980. Median follow-up was 63 months. Decompensation of cirrhosis was considered when a patient first developed one of the major complications of the disease. Ten years after diagnosis, the probability of developing decompensated cirrhosis and the survival probability rate were 58 and 47%, respectively. A multivariate survival analysis (Cox's regression model) using clinical, biochemical and histological data obtained at diagnosis disclosed seven factors that predicted prognosis: serum bilirubin; serum gamma-globulin concentration; hepatic stigmata; prothrombin time; sex; age, and alkaline phosphatase. According to the contribution of each one of these factors to the final model, a prognostic index was constructed that allows calculation of the estimated survival probability. The predicting value of this index was validated by a split sample testing technique.

Adult↗

PubMed1994

[A multivariate prospective study of prognostic factors in non-small-cell lung carcinoma (NSCLC): the results at 5 years].

We present the results of a 5-year prospective study of 153 patients with a diagnosis of bronchogenic carcinoma (BC) who underwent curative surgery. Clinical and anatomical variables were analyzed by multiple regression analysis for prediction of death. Among the anatomical variables, the most significant were the following: stages of anatomical spread (p < or = 0.00000), ganglionic state (p < or = 0.00000), type for surgery (curative or non-curative) (p < or = 0.00000) and state of tumor (p = 0.00012). Significant clinical variables were clinical stage by Feinstein's classification (p = 0.00037), functional capacity (ECOG scale) (p = 0.01196) and tumor size measured conventionally (p = 0.01196). These variables were entered into a multivariate model for prognostic prediction in order to determine the patient's relative risk over time. The best combination of anatomical variables was obtained by associating the stages of spread and ganglionic state (chi 2 = 34.24; p = < 0.00000); the best combination of clinical variables was clinical stage and tumor size (chi 2 = 17.37; p = 0.00023). Thus, although the anatomical variables are more important than clinical ones, the latter have independent prognostic value, are easy to obtain and are available before surgery. They therefore represent an alternative to prognosis based on anatomical spread.

Adult↗

PubMedDate not supplied

Prognostic determinants and a new view of staging for patients with nasopharyngeal carcinoma.

There is no agreement on the single best staging system for patients with nasopharyngeal carcinoma. We have evaluated prospectively several staging systems and have assessed the predictive value of many variables on survival and found that the most important are extensive tumor within the nasopharynx or regional extension, nodes in the lower portion of the neck, and cranial nerve involvement. Other variables that have not been used in traditional extent of disease staging systems but that have an adverse bearing on survival have been studied by multiple regression techniques in the Cox proportional hazards model. Two prognostic scores, which can be used for classifying patients into survival groups, ranging from excellent survival (low score) to poor survival (high score), have also been presented. With these schemes, patients who are at high risk for recurrence after conventional therapy can be reliably selected.

Carcinoma↗

PubMed2004

Outcome and prognostic factors in advanced Hodgkin's disease treated with high-dose chemotherapy and autologous stem cell transplantation: a study of 341 patients.

BACKGROUND: The reported probability of survival of patients with Hodgkin's disease (HD) following high-dose chemotherapy with autologous stem cell transplantation (HDC/ASCT) is 35-65% at 5 years. The Polish Lymphoma Research Group investigated retrospectively prognostic factors for overall survival (OS) and event-free survival (EFS), and the risk of secondary malignancies in a large series of patients who underwent HDC/ASCT. PATIENTS AND METHODS: The data of 341 consecutive patients treated in 10 centers from 1990 to 2002 were collected and analyzed. RESULTS: The actuarial 5-year OS and EFS were 64% [95% confidence interval (CI) 57% to 71%] and 45% (95% CI 39% to 51%), respectively. In the multivariate model, unfavorable prognostic factors for EFS were less than partial response at the time of ASCT [relative risk (RR), 2.92 (95% CI 1.68-5.08); P<0.001] and three or more previous chemotherapy lines (RR, 2.16; 95% CI 1.42-3.30; P<0.001). These two factors were also associated with unfavorable OS (RR, 3.32; 95% CI 1.90-5.79; P<0.001 and RR, 2.34, 95% CI 1.51-3.64; P<0.001). Five-year cumulative risk of secondary malignancy was 8.4% (95% CI 2% to 13%) and the only identified risk factor was splenectomy (P=0.02). CONCLUSIONS: HDC/ASCT should be considered early in the course of disease for patients with a response after standard therapy.

Adolescent↗

PubMed2000

The last six months of life for patients with congestive heart failure.

OBJECTIVE: To characterize the experiences of patients with congestive heart failure (CHF) during their last 6 months of life. DESIGN: A retrospective analysis of data from a prospective cohort study. SETTING: Five geographically diverse tertiary care academic medical centers. PARTICIPANTS: A total of 1404 patients enrolled in the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) with a diagnosis of an acute exacerbation of CHF, of whom 539 patients died within 1 year of their index hospitalization. METHODS: Data from interviews with patients or their surrogates were collected and chart abstractions performed at several time points in SUPPORT. To describe progression to death, we constructed four observational windows backward in time, beginning with patients' dates of death and ending with their date of entry into the SUPPORT project or 6 months before death, whichever came first. For each outcome, patients contributed information to all windows for which they had data collected. We describe frequency distributions for each outcome over time and report tests for trend. OUTCOME MEASURES: Outcomes examined over time included: percentage of days spent in a hospital; model-based prognostic estimates of 6-month survival; functional status; occurrence of severe physical and emotional symptoms, including pain, depression and anxiety; patients' preferences for care; and the financial impact of patients' illnesses on their families. RESULTS: As death approached, patients' prognoses became poorer and illnesses more severe. Median Acute Physiology Scores for hospitalized patients rose from 33 in the interval 6 months to 3 months before death, to 44 within 3 days of death. However, the median model-based estimate of 6-month survival was 54% even within 3 days of death. Number of functional impairments, median depression scores and percent of patients reporting severe pain or dyspnea increased as death approached, with 41% of patient surrogates reporting that the patient was in severe pain and 63% reporting that the patient was severely short of breath during the 3 days before death. Perceived quality of life did not change appreciably, with 29 to 58 % of patients reporting good to excellent quality of life in all intervals before death. As death approached, patients were more likely to prefer Do Not Resuscitate (DNR) status, with the percent of patients preferring DNR rising from 33% at 6 months to 3 months before death to 47% at 1 month to 3 days before death (P < .05). The frequency with which DNR orders were written for hospitalized patients also increased as death approached. The patients' illnesses had marked financial impact on their families, with 23 % of patients' families reporting the loss of most or all of family savings at the time of the patient's death. CONCLUSIONS: As death approaches during the last 6 months of life in CHF, illness becomes more severe, disability and the experience of certain symptoms more frequent, and patient preference not to be resuscitated more common. However, there is no significant decrement in quality of life as death approaches. Reflecting the unpredictable course of CHF during the last month of life, many patients have good median model-based 6-month prognoses and enjoy good to excellent quality of life.

APACHE↗

PubMed1992

Aminopyrine breath test in the prognostic evaluation of patients with cirrhosis.

This prospective study assessed the role of aminopyrine breath test in the prognosis of patients with cirrhosis, and evaluated whether the test provided useful information not included in the Pugh score. During a period of 36 months, 125 patients with biopsy proven liver cirrhosis were included, and followed for up to 48 months (median 17 months). During follow up 43 patients died (20 of liver failure). Survival was univariately related to aminopyrine breath test (p less than 0.02), Pugh score (p less than 0.01), presence of ascites (p less than 0.01), and sex (p less than 0.05). Using Cox's regression analysis, Pugh score, aminopyrine breath test, and sex, were independent significant predictors of survival. From the Cox's model a prognostic index was computed. According to a receiver operating characteristic curve analysis, the prognostic index predicting death showed an improvement in area under the curve when compared with a prognostic index calculated excluding aminopyrine breath test, but the improvement did not reach statistical significance (p = 0.12). A similar prognostic index was calculated to predict death from liver failure. Cox's regression analysis selected aminopyrine breath test, Pugh score, and aetiology as the best set of predictor covariates. According to a receiver operating characteristic curve analysis, a prognostic index cut off value of 2.6 had a 94% sensitivity and a 88% specificity. The prognostic index significantly improved prognostic accuracy when compared with a prognostic index calculated from Pugh score and aetiology, but excluding aminopyrine breath test (p = 0.05). These data disclose that the aminopyrine breath test offers additional prognostic information to the Pugh score, and the prognosis of patients with cirrhosis.

Adult↗