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PubMed1986

Esophageal prothesis for neoplastic stenosis. A prognostic study of 77 cases.

Esophageal prothesis (EP) is a palliative treatment for inoperable neoplastic stenosis. Ninety-one patients were candidates for EP placement between 1978 and 1983. EP placement was successful in 77 patients. Of these: 85% had primary esophageal cancer; 15% had bronchial or mediastinal carcinoma; 83% had stenosis in the middle third. Dysphagia was the main symptom in 84%, and tracheoesophageal fistulae in 16%. The observed median survival was 3.2 months +/- 1.9 (2 standard deviations [SD]), and the survival rate at 1 year was 7%. With the single-factor analysis method, not one of 12 factors presented any significance (age, sex, general status, anterior treatment, lesion site, endoscopic feature, stenosis diameter, histologic features, metastasis, tracheal involvement, symptoms, and type of prothesis). Two factors had a P value approaching significance: there were slightly longer survival rates in patients with a stenosis diameter less than 7 mm (P less than 0.07), and with stenosis located in the lower third and cardia (P less than 0.07). By multivariate analysis (Cox model), prognostic significance was found in only one factor: the location in the lower third and cardia (P = 0.002, relative risk = 3). The quality of life after EP placement was briefly improved: 80% of 73 evaluable patients had improvement in dysphagia for a mean duration of 3.7 months +/- 2 (2 SD), especially patients with a good general status (0 and 1; P less than 0.01); and 45% of patients had improvement of their general status for a mean duration of 4.1 months +/- 2 (2 SD). Minor complications related to EP placement were observed in 40% of patients (pain, obstruction, and mobilization), and severe complications were observed in 20% (perforation, 11 cases; fistulae, 5 cases, with death in 3 cases; hemorrhages, 4 cases). In conclusion, EP is a good palliative treatment, although complications are frequent, and evaluation of patient comfort is required to compare this procedure with other available techniques.

Actuarial Analysis↗

PubMed2006

Treatment and prognostic factors in patients with hepatocellular carcinoma.

INTRODUCTION: Hepatocellular carcinoma is a leading cause of death from cancer worldwide. Survival of patients depends on tumor extension and liver function, but yet there is no consensual prognostic model. AIMS: To evaluate the influence on survival of pretreatment parameters (clinico-laboratorial, liver function, tumor extension, Okuda and Cancer of the Liver Italian program (CLIP) staging) and treatment modalities. METHODS: We retrospectively analyzed 207 patients, diagnosed between 1993 and 2003. The initial treatment was: surgery--six patients; radiofrequency ablation--21; percutaneous ethanol injection--29; transarterial chemoembolization--49; tamoxifen--49; supportive care alone--53. Factors determining survival were assessed by Kaplan-Meier method and Cox regression models. RESULTS: Median survival was 24 months. In univariate analysis, Child-Pugh classification and Model for end-stage liver disease (MELD) score, portal vein thrombosis (PVT), tumor size, number of lesions, Okuda and CLIP scores were all associated with prognosis (P < 0.001). Alpha-fetoprotein levels were not predictive of survival. Independent predictors of survival were ascites, bilirubin, PVT and therapeutic modalities (P < 0.001). In early stage hepatocellular carcinoma (HCC), survival was similar for both percutaneous ablation modalities, either radiofrequency or ethanol injection (P = NS). In advanced HCC, survival was better in patients receiving tamoxifen than supportive care alone (P < 0.001). CONCLUSION: This study reinforces the importance of baseline liver function (Child-Pugh classification and MELD score) in the survival of patients with HCC, although staging systems allowed the stratification of patients in different prognostic groups. Ascites, bilirubin and PVT were independent pretreatment predictors of survival. All treatments influenced the patient's outcome, whether in early or advanced stages.

Adult↗

PubMed2002

Clinical grading in chronic graft-versus-host disease: is it time for change?

Many hematologic disorders, leukemias and lymphomas in particular, can be cured with allogeneic hematopoietic stem cell transplantation (allo-SCT). However, chronic graft-versus-host disease (cGVHD) appears to remain as a major determinant of long term outcome and quality of life following allo-SCT. The gradual increase in the incidence of cGVHD over the past decade has recently gained another momentum along with the use of blood as a source of stem cells. Donor lymphocyte infusion (DLI) is also associated with a progressive form of cGVHD, mostly refractory to treatment. Prediction of the outcome of patients with newly diagnosed chronic GVHD may be important in identifying those who are likely to benefit from reduced treatment and patients who are unlikely to have a sustained response to standard treatment. In addition, a reliable predictive model could allow us to design better clinical trials and facilitate the communication among the centers. Although it is highly reproducible, the current system of grading in cGVHD is of limited utility since it does not stratify patients for outcome. It divides patients into those needing treatment (extensive cGVHD) and those who do not (limited cGVHD). Therefore, a new clinical grading system is needed to classify all patients based on their prognosis so like patients with similar features can be grouped for study and clinical management purposes. Using multivariate analysis, we recently identified three independent risk factors affecting the survival without recurrent malignancy. These factors are extensive skin involvement (>50% BSA), thrombocytopenia, and progressive-type onset of cGVHD. We are in the process of validating this prognostic model in three other cohorts from different institutions. We expect that the new grading system, based on this model, may allow us to identify the diversity of outcome within "extensive stage" cGVHD.

Algorithms↗

PubMed2025

Notch pathway defines an aggressive and immune-suppressive phenotype associated with checkpoint inhibitor resistance in pan-gastrointestinal adenocarcinomas.

The Notch pathway regulates the homeostasis and tumorigenesis of gastrointestinal epithelium. Given its roles in cancer stem cell capacity and cancer immunity, we hypothesized that Notch activation can predict poor prognosis and resistance to immune checkpoint inhibitors (ICIs) in gastrointestinal adenocarcinoma (GIAC). The mRNA expression and genomic alterations of Notch pathway were characterized in esophagus (ESAD), stomach (STAD), colon (COAD), or rectum (READ) adenocarcinomas from The Cancer Genome Atlas (TCGA) dataset. The prognostic model (mRNA-score) was constructed using the TCGA dataset (the training set) and was validated in 3 independent sets (GSE19417 [ESAD], GSE84437 [STAD], and GSE40967 [COAD]). The associations of the mRNA-score with drug sensitivity, immune cell infiltration, and immunotherapy efficacy were, respectively, analyzed using the Genomics of Drug Sensitivity in Cancer (GDSC) database, the TCGA dataset, and multiple clinical cohorts including GSE165252, PRJEB25780, IMvigor210, and CheckMate-009/010/025. Notch pathway genes exhibited conserved genomic/transcriptomic features across four GIAC subtypes. Three pan-GIAC clusters were determined by unsupervised clustering, and the cluster with higher expression of the Notch pathway genes had shorter overall survival (OS), immunosuppressive microenvironment, and higher scores of the signatures concerning angiogenesis, cell cycle, PI3K-AKT-mTOR, TGF-β, glycolysis, etc. A prognostic algorithm (mRNA-score) was constructed, which was correlated with poor OS in the training set (TCGA, P < 0.001) and three validation sets (GSE19417, P = 0.025; GSE84437, P = 0.001, GSE40967, P = 0.007). A high mRNA-score was linked with more "resting"/ "anti-inflammatory" rather than "activated"/ "pro-inflammatory" tumor-infiltrating immune cells and ICI resistance in GIACs (GSE165252, P = 0.047; PRJEB25780, P = 0.047) and other solid tumors such as urothelial carcinoma and clear cell renal cell carcinoma. Our findings demonstrate the utility of the Notch pathway in predicting prognosis and ICI resistance. Further studies are warranted to explore the efficacy of Notch inhibitors as immunotherapeutic adjuvants to overcome ICI resistance.

Humans↗

PubMed1980

Reduction of operative morbidity and mortality by combined preoperative and postoperative nutritional support.

A previously developed and validated predictive nutritional assessment model (Prognostic Nutritional Index) was applied to a heterogenous surgical population. Without knowledge of the then undeveloped PNI, adequate preoperative nutritional repletion (TPN) was provided on clinical indications alone to 50 of 145 patients with the remaining 95 patients receiving no preoperative total parenteral nutrition. Analysis of the two groups found no baseline differences in nutritional status, type and severity of disease and/or operative therapy, and other potentially important variables. In the high-risk stratified group as defined by admission nutritional assessment and calculated PNI (greater than or equal to 50%), adequate preoperative TPN reduced postoperative complications 2.5-fold (p < 0.01), postoperative major sepsis six-fold (p < 0.005) and mortality five-fold (p < 0.01). Clinical "eyeball" evaluation of nutritional status cannot identify high-risk individuals. This nutritional assessment predictive model (PNI) identifies the subset of operative candidates in whom adequate preoperative nutritional support significantly reduces operative morbidity and/or mortality.

Bacterial Infections↗

PubMed1995

BCL6 gene rearrangement and other cytogenetic abnormalities in diffuse large cell lymphoma.

Evidence for rearrangement of the BCL6 gene at 3q27 has been documented in 20-30% diffuse lymphomas with a large cell component (DLLC), and was found to be of prognostic significance at the time of diagnosis. To incorporate these observations into current cytogenetic and clinical prognostic models, 76 cases of DLLC with known BCL6 status were analyzed. Cytogenetic indicators of progression, including trisomy 7, trisomy 12, del(6)(q21q25), and structural alterations of 17p were less frequent in BCL6 rearranged DLLC compared to BCL6 germline tumors. Despite a 93% overall survival at median follow-up of 30 months, a trend for continued relapse resulted in a projected freedom from progression for the BCL6 rearranged cohort of 66% at 4 years, compared to 39% for the BCL6 germline cohort. Six cases among the BCL6 rearranged group lacked additional cytogenetic indicators of progression and remained free of disease at follow-up in excess of 7 years, whereas BCL6 rearranged cases with increasing numbers of cytogenetic aberrations showed decreased intervals free from progression of disease. These results suggest that BCL6 rearrangement should be combined with other known clinical and cytogenetic indicators in prognostic analyses of patients with DLLC.

Chromosome Aberrations↗

PubMed2004

Predictors of wound complications after laryngectomy: A study of over 2000 patients.

OBJECTIVES: To identify risk factors for and the rate of wound complications after laryngectomy in a large, prospectively collected national dataset, and to generate a predictive model. Study design We used the National Surgical Quality Improvement Program (NSQIP) registry created by the Department of Veterans Affairs (VA) to identify patients undergoing total laryngectomy from 1989 to 1999 (n = 2063). We linked these data to inpatient and outpatient VA administrative records to capture data for prior radiation. Over 20 preoperative and intraoperative risk factors were analyzed using bivariate techniques. Those significant at the P < 0.01 level were analyzed with logistic regression and conjunctive consolidation to identify independent predictors of wound complications. RESULTS: The overall wound complication rate was 10.0%. In adjusted analyses, prolonged operative time (>10 hours, odds ratio = 2.10, 95% confidence interval: 1.32-3.36), exposure to prior radiation therapy (OR =1.63, 1.07-2.46), presence of diabetes (OR =1.78, 1.04-3.04), preoperative hypoalbuminemia (OR =1.90, 1.32-2.74), anemia (OR =1.59, 1.07-2.36), and thrombocytosis (OR =1.48, 1.04-2.10) were independently associated with postoperative wound complications. A prognostic model using three variables-prior radiation therapy, diabetes, and hypoalbuminemia-provided excellent risk stratification into three tiers (6.3%, 13.7%, 21.7%). CONCLUSIONS: Preoperative radiation, prolonged operative time, low albumin, and diabetes were independently associated with postoperative wound infections. These results will help to identify patients at risk for wound complications, thus allowing for heightened surveillance and preventive measures where possible.

Diabetes Complications↗

PubMed2006

Evaluation of model for end-stage liver disease for prediction of mortality in decompensated chronic hepatitis B.

OBJECTIVES: We aimed to study the predictive ability of model for end-stage liver disease (MELD) for short-term mortality in chronic hepatitis B. METHODS: All patients admitted from 1996 to 2003 because of chronic hepatitis B and its related complications were identified by electronic search of the hospital database. MELD and Child-Turcotte-Pugh (CTP) scores on initial admissions were calculated. Cox proportional hazard model was used to determine the factors associated with mortality. The area under receiver operator characteristics curve (AUC) was used to determine the predictive abilities of the two models for 3-month and 1-yr mortalities. RESULTS: A total of 2,073 patients was admitted because of liver-related problems and 506 patients had chronic hepatitis B-related complications. Two hundred fifty-six (51%) patients died and 16 (3%) patients underwent liver transplantation. In multivariate analysis, MELD and CTP scores were independent predictors of 3-month and 1-yr mortality. Other independent predictors of mortality included older age, hepatocellular carcinoma (HCC), lamivudine treatment, and lower serum sodium. At both 3 months and 1 yr, the AUC of the MELD score (0.65 and 0.63, respectively) was significantly lower than that of the CTP score (0.75 and 0.77, respectively) (p < 0.0001). The differences remained significant when only liver cirrhosis patients without HCC at presentation were analyzed, but the AUC of the two scores became comparable when patients on lamivudine were excluded. CONCLUSIONS: The MELD score is a valid prognostic model in decompensated chronic hepatitis B. Lamivudine treatment may affect the performance of MELD score. Other variables including those in CTP score may improve its predictive ability.

Adult↗

PubMed2002

Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies.

BACKGROUND: Insufficient data are available from single cohort studies to allow estimation of the prognosis of HIV-1 infected, treatment-naive patients who start highly active antiretroviral therapy (HAART). The ART Cohort Collaboration, which includes 13 cohort studies from Europe and North America, was established to fill this knowledge gap. METHODS: We analysed data on 12,574 adult patients starting HAART with a combination of at least three drugs. Data were analysed by intention-to-continue-treatment, ignoring treatment changes and interruptions. We considered progression to a combined endpoint of a new AIDS-defining disease or death, and to death alone. The prognostic model that generalised best was a Weibull model, stratified by baseline CD4 cell count and transmission group. FINDINGS During 24,310 person-years of follow up, 1094 patients developed AIDS or died and 344 patients died. Baseline CD4 cell count was strongly associated with the probability of progression to AIDS or death: compared with patients starting HAART with less than 50 CD4 cells/microL, adjusted hazard ratios were 0.74 (95% CI 0.62-0.89) for 50-99 cells/microL, 0.52 (0.44-0.63) for 100-199 cells/microL, 0.24 (0.20-0.30) for 200-349 cells/microL, and 0.18 (0.14-0.22) for 350 or more CD4 cells/microL. Baseline HIV-1 viral load was associated with a higher probability of progression only if 100,000 copies/microL or above. Other independent predictors of poorer outcome were advanced age, infection through injection-drug use, and a previous diagnosis of AIDS. The probability of progression to AIDS or death at 3 years ranged from 3.4% (2.8-4.1) in patients in the lowest-risk stratum for each prognostic variable, to 50% (43-58) in patients in the highest-risk strata. INTERPRETATION: The CD4 cell count at initiation was the dominant prognostic factor in patients starting HAART. Our findings have important implications for clinical management and should be taken into account in future treatment guidelines.

Adolescent↗

PubMed1999

Rising PSA after local therapy failure: immediate vs deferred treatment.

Patients whose only sign of recurrence after local therapy for prostate cancer is a rising prostate-specific antigen level (PSA-only recurrence) have become more common. We have developed two models to predict PSA-only recurrence after radical prostatectomy, one using traditional factors (race, sigmoidal transformation of PSA, postoperative Gleason sum, and organ confinement) and a second using traditional clinical and pathologic variables combined with molecular biomarker levels. Treatment options for patients with PSA-only recurrence include observation, radiation therapy for patients who have undergone surgery, salvage surgery or cryotherapy for patients who have received radiotherapy, and traditional or nontraditional hormonal therapy. Radiation for PSA-only recurrence is likely to benefit men who have no adverse pathology, a low PSA level at recurrence, and PSA recurrence after the first year. Salvage radical prostatectomy and cryotherapy pose a relatively high risk of incontinence and other morbidity and should be reserved for carefully selected patients with a high likelihood of organ-confined disease. Hormonal therapy is probably the single most beneficial treatment for PSA-only recurrence. Nontraditional low-dose oral hormonal therapy and intermittent hormonal therapy are gaining in popularity, although their long-term efficacy is unknown. More clinical trials are needed to fine-tune prognostic models and to determine the best treatments, alone or in combination, for PSA-only recurrence.

Biomarkers, Tumor↗

PubMed2003

[The relationship between insulin-dependent diabetes mellitus and acute infections in children].

The morbidity of insulin-dependent diabetes mellitus (IDDM) in children develops not evenly. Epidemiological leaps are periodically registered. This character of dynamics suggests the existence of environmental factors having the influence on the IDDM morbidity. One of these environmental factors is viral infection. We have set ourselves as an object to analyze the relationship between the primary morbidity of IDDM and some infectious diseases in children, to build up the prognostic models for the dynamics of IDDM morbidity and to evaluate their quality. Statistic analysis of the relationship between the primary morbidity of chicken pox, scarlet fever, measles, mumps, viral hepatitis, acute intestinal infectious diseases (AIID), acute upper respiratory infections (AURI) and insulin-dependent diabetes mellitus in children of Grodno region covering the period from 1980 to 2001 years has been performed. It has been established, that morbidity rate of IDDM reliably positively correlated with morbidity of AURJ and AIID (accordingly r=0.62; and p=0.02 and r=0.46; p=0.04) and negatively with the scarlet fever and mumps morbidity (accordingly r=-0.55; p=0.008 and r=-0.53; p=0.01). But cluster analysis has shown, that really only indices of AURI and AIID morbidity were connected and formed one cluster. Morbidity rate of IDDM in children in the current year is most closely connected with AURI and AIID frequency in the previous year, but frequency of the above-mentioned infections registered in the same year influences less on diabetes morbidity, not mentioning the infections of 2-years standing which practically have no influence. If the increase in AURI morbidity accounts for 10% as compared to the previous year one may prognosticate with high reliability an increase of primary morbidity of IDDM by 7.7% on the average during the same year, and by 8.3% in the following year. For AIID these indices account for 3.5% and 4.4% correspondingly. In the increase of the morbidity rate of AIID the morbidity rate of IDDM reduces.

Acute Disease↗

PubMed2006

Proposal of a modified Child-Turcotte-Pugh scoring system and comparison with the model for end-stage liver disease for outcome prediction in patients with cirrhosis.

The model for end-stage liver disease (MELD) has a better predictive accuracy for survival than the Child-Turcotte-Pugh (CTP) system and has been the primary reference for organ allocation in liver transplantation. The CTP system, with a score range of 5-15, has a ceiling effect that may compromise its predictive power. In this study, we proposed a refined CTP scoring method and investigated its predictive ability. An additional point was given to patients with serum albumin < 2.3 g/dL, bilirubin > 8 mg/dL or prothrombin time prolongation > 11 seconds. The modified CTP system, containing class D, was compared to the MELD and original CTP system in 436 patients. There was a significant correlation between the MELD and modified CTP score (rho = 0.59, P< 0.001). Using mortality as the endpoint, the area under receiver operating characteristic curve for modified CTP system was 0.895 compared with 0.872 for MELD (P = 0.450) and 0.809 for original CTP system (P < 0.001) at 3 months; the area was 0.890, 0.837 and 0.756, respectively (P = 0.051 and < 0.001, respectively) at 6 months. The risk ratio per unit increase for the modified CTP score was 2.7 and 3.08 at 3 and 6 months respectively (P < 0.001). In conclusion, the modified CTP system can be proposed as an alternative prognostic model for cirrhotic patients. By extending the score range according to the influence of the laboratory-derived variables, the modified CTP system has a better performance than the original system and is as efficient as the MELD for outcome prediction.

Adult↗

PubMed2002

Predictors of long-term outcome following high-dose chemotherapy in high-risk primary breast cancer.

We report on a predictive model of long-term outcome in 114 high-risk breast cancer patients treated with high-dose chemotherapy between 1989 and 1994. Paraffin-blocks from 90 of the 114 primaries were assessed for the presence of five risk factors: grade, mitotic index, protein expression of p53, HER2/neu, and oestrogen/progesterone receptor status; we could analyse the effect of risk factors in 84 of these 90 tumours. Seven-year relapse-free and overall survival was 58% (95% confidence interval 44-74%) and 82% (95% confidence interval 71-94%) vs 33% (95% confidence interval 21-52%) and 41% (95% confidence interval 28-60%) for patients whose primary tumours displayed > or =3 risk factors vs patients with < or =2 risk factors. For the entire group of 168 high-risk breast cancer patients, inflammatory stage IIIB disease and involved post-mastectomy margins were associated with decreased relapse-free survival and overall survival; patients treated with non-doxorubicin containing standard adjuvant therapy experienced worse overall survival (RR, 2.08; 95% confidence interval 1.04 to 4.16; P=0.04), while adjuvant tamoxifen improved overall survival (RR, 0.65; 95% confidence interval 0.41-1.01; P=0.054). Future trial designs and patient selection for studies specific for high-risk breast cancer patients should include appropriate prognostic models. Validation of such models could come from recently completed randomised, prospective trials.

Adult↗

PubMed2003

Patterns of clinical presentation, treatment, and outcome in patients with Waldenstrom's macroglobulinemia: a two-institution study.

Waldenstrom's macroglobulinemia (WM) is in the World Health Organization (WHO) classification considered to be a clinical syndrome rather than a specific pathologic diagnosis. The clinical manifestations associated with WM relate to direct tumor infiltration, hyperviscosity, and deposition of IgM in various tissues. The indications for and choice of treatment vary considerably and no generally accepted prognostic models exist. The clinical features, treatment, and prognosis of 72 patients with WM seen at one British (n = 36) and one Swedish (n = 36) academic center were therefore compared. Significantly more patients presented with a low albumin concentration (< v > 40 g/L, P <.001), anemia (hemoglobin < v > 120 g/L; P <.001), thrombocytopenia (< v > 150 x 10(9)/L; P <.05), hepatomegaly (P <.001), splenomegaly (P <.01), and lymphadenopathy (P <.01), at St Bartholomew's Hospital (SBH) in comparison to the Karolinska Hospital (KH). Fifty-six percent of SBH patients received chemotherapy immediately following diagnosis as compared to 14% at KH. The median overall survival of all patients was 6.3 years; 4.2 years and 11.0 years at SBH and KH, respectively (P <.001). In univariate analysis, anemia (hemoglobin < 120 g/L) and albumin < 35 g/L (but not <40 g/L) at diagnosis predicted a worse overall survival. The presence of hepatomegaly and/or splenomegaly and/or lymphadenopathy was significantly associated with anemia (P <.001) and hypoalbuminaemia (P <.001). The mean Morel score (including age, albumin, and cytopenias) of patients treated at SBH (2.6) was significantly higher than that of KH patients (1.6; P <.001). These findings illustrate the clinical heterogeneity of WM, most probably explained by differences in referral patterns, and in addition, indicate the need for establishing standard criteria for diagnosis, response to treatment, and prognostic features.

Adult↗

PubMed2006

MELD and prediction of post-liver transplantation survival.

The model for end-stage liver disease (MELD) was developed to predict short-term mortality in patients with cirrhosis. It has since become the standard tool to prioritize patients for liver transplantation. We assessed the value of pretransplant MELD in the prediction of posttransplant survival. We identified adult patients who underwent liver transplantation at our institution during 1991-2002. Among 2,009 recipients, 1,472 met the inclusion criteria. Based on pretransplant MELD scores, recipients were stratified as low risk (< or = 15), medium risk (16-25), and high risk (>25). The primary endpoints were patient and graft survival. Mean posttransplant follow-up was 5.5 years. One-, 5- and 10-year patient survival was 83%, 72%, and 58%, respectively, and graft survival was 76%, 65%, and 53%, respectively. In univariable analysis, patient and donor age, patient sex, MELD score, disease etiology, and retransplantation were associated with posttransplantation patient and graft survival. In multivariable analysis adjusted for year of transplantation, patient age >65 years, donor age >50 years, male sex, and retransplantation and pretransplant MELD scores >25 were associated with poor patient and graft survival. The impact of MELD score >25 was maximal during the first year posttransplant. In conclusion, older patient and donor age, male sex of recipient, retransplantation, and high pretransplant MELD score are associated with poor posttransplant outcome. Pretransplant MELD scores correlate inversely with posttransplant survival. However, better prognostic models are needed that would provide an overall assessment of transplant benefit relative to the severity of hepatic dysfunction.

Adult↗

PubMed1999

Cell cycle flow cytometric analysis in the diagnosis and management of colorectal carcinoma.

OBJECTIVE: To establish prognostic models and protocols for individualized management in colorectal carcinoma patients based on both clinical and DNA flow cytometric parameters. STUDY DESIGN: Prospective study of 88 colon carcinoma patients with a minimum follow-up of 12 months, operated on with the intent to cure and not treated with radiotherapy or chemotherapy. All the cases were subjected to a clinical evaluation: age, sex, tumor localization and size, histologic grade, tumor stage, disease-free interval, survival and flow cytometric study (ploidy, DNA index and S-phase fraction [SPF]). RESULTS: From the total of 88 neoplasms studied, 56 (63.6%) were from males and 32 (36.4%) from females; 30 (34%) were located in the right side of the colon, 7 (8%) in the transverse colon and 51 (58%) in the left side of the colon. Eleven (12.5%) were stage I, 52 (59.1%) stage II and 25 (28%) stage III. Forty-two (47.7%) were diploid and 46 (52.3%) aneuploid. The S-phase mean was 14.6% (12% for diploids and 16.9% for aneuploids). During the follow-up period, 26.1% of diploid tumors recurred, whereas aneuploid tumors recurred in 36.9% (P < .05). SPF from diploid and aneuploid tumors was analyzed separately. CONCLUSION: Regarding relapse-free interval, the behavior of diploid tumors with a high SPF was similar to that of aneuploid ones. Two kinetic profiles were established, favorable (diploid tumors with low S phase) and unfavorable (diploid with high S phase and all aneuploid tumors), that had significant prognostic value for progression and survival and that allowed identification of patients at high risk of recurrence. We formulated a prognostic index according to SPF and tumor stage that has discriminatory capacity for biologic behavior in colorectal tumors.

Adenocarcinoma↗

PubMed1997

Medroxyprogesterone acetate addition or substitution for tamoxifen in advanced tamoxifen-resistant breast cancer: a phase III randomized trial. Australian-New Zealand Breast Cancer Trials Group.

PURPOSE: To determine whether a strategy of adding medroxyprogesterone acetate (MPA) to tamoxifen (TAM) is superior to the substitution of MPA for TAM among women with advanced breast cancer and disease progressing on TAM. To assess the patterns or response and subsequent progression in sites and tissues according to prior involvement and treatment. PATIENTS AND METHODS: Two-hundred-fifteen postmenopausal women with advanced breast cancer progressing on TAM after receiving TAM for at least six months were randomized: 109 to add MPA 500 mg/day orally (TAM + MPA), and 106 to stop TAM and to substitute MPA. RESULTS: There were no significant differences between the groups with respect to complete plus partial response rates: TAM + MPA 10%, MPA 9%, median time to progression TAM + MPA 3.0 months, MPA 4.5 months, or median overall survival, TAM + MPA 17.2 months, MPA 18.4 months. In a multivariate model, prognostic factors significant for a shorter time to disease progression were worse for performance status, involvement of more than one tissue, prior radiotherapy, and shorter time from recurrence after primary therapy to randomization. Adjusting for these factors, treatment with TAM + MPA was associated with a higher relative risk for disease progression, with a hazards ratio of 1.31, but this was not significant (95% confidence interval, 0.98 to 1.74; P = .067). However, in an exploratory analysis, the time to disease progression, among patients with progesterone receptor positive (PR+) tumors, was 6.3 months with MPA versus 2.9 months with TAM + MPA, with a hazards ratio of 1.92 (95% confidence interval, 1.12 to 3.32; P = .02). There was a significant interaction, P = .04, between PR status and treatment, indicating an advantage to treatment substitution for those who have PR+ tumors. Tumor response occurred in 14% of assessed metastatic sites. Subsequent progression occurred in a new tissue alone in 13% of patients, in both new and previously involved (old) tissues in 76%, and in old tissues only in 11%. In 23% of patients, progression occurred only at a new site, in 50% at both old and new sites, and in 27% only at old sites. No significant differences in the patterns of response or progression were seen in the different treatment groups. CONCLUSION: Among women with breast cancer whose disease is progressing after at least six months of treatment with TAM, there is no advantage to maintaining TAM when MPA is to be given. An overall effect of treatment on the pattern of failure at old sites or at new sites or tissues cannot be discerned.

Aged↗

PubMed2007

Prognostic values of proliferative markers ki-67 and repp86 in breast cancer.

BACKGROUND: Breast cancer is the leading cause of carcinoma death in women. Proper treatment depends on the consideration of molecular biology status of tumor cells, which may determine the patient's treatment and prognosis. To determine the prognostic models for this disease, we evaluated the role of cell proliferation-related antigens including ki-67 (a nuclear antigen, expressed in G1, G2, and M phases of cell cycle) and repp86 (an 86-kDa nuclear protein expressed in S, G2, and M phases of cell cycle) for detection of biologic behavior of breast cancer. METHODS: We studied 60 women with grade I and II lymph node-negative and 27 with grade III lymph node-positive breast cancers. The mean follow-up periods for these two groups were 60 and 72 months, respectively. Tumor cell proliferation was measured by immunohistochemical methods with monoclonal antibodies directed against the nuclear antigens ki-67 and repp86. RESULTS: The ki-67, repp86 labeling indices (percentage of antibody-stained tumor cell nuclei) were not statistically different between the cases and controls of lymph node-negative patients (ki-67 with P = 0.33; repp86 with P = 0.40). The odds ratio (the mean chance of ki-67 labeling index > 10%, repp86 labeling index >10%) in patients with recurrence was 4 (CI = 0.2 - 76.5) for ki-67 and 3.6 (CI = 0.4 - 32.5) for repp86. Both indices were statistically different in lymph node-positive cases and controls (P < 0.0001). The odds ratio in patients with recurrence was 87 (CI = 4 - 18.71) for ki-67 and 71.5 (CI = 5.7 - 899.2) for repp86. CONCLUSION: The present study confirms the importance of cell proliferation as a determinant of biologic behavior of breast cancer. Measurement of ki-67 and repp86 labeling indices may be very helpful for physicians to detect high-risk patients and to adopt appropriate procedure such as adjuvant therapy.

Adult↗