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PubMed2006

Immune complexes containing modified lipoproteins are related to the progression of internal carotid intima-media thickness in patients with type 1 diabetes.

Modified lipoproteins induce autoimmune responses including the synthesis of autoantibodies with pro-inflammatory characteristics. Circulating modified lipoprotein autoantibodies combine with circulating antigens and form immune complexes (IC). We now report the results of a study investigating the role of circulating IC containing modified lipoproteins in the progression of carotid intima-media thickness (IMT) in patients enrolled in the Epidemiology of Diabetes Interventions and Complications (EDIC) Trial, a follow-up study of the Diabetes Control and Complications Trial (DCCT). This cohort includes 1229 patients with type 1 diabetes in whom B-mode ultrasonography of internal and common carotid arteries was performed in 1994-1996 and in 1998-2000. Conventional CHD risk factors, antibodies against modified forms of LDL and modified lipoprotein IC were determined in 1050 of these patients from blood collected in 1996-1998. Cholesterol and apolipoprotein B content of IC (surrogate markers of modified ApoB-rich lipoproteins) were significantly higher in patients who showed progression of the internal carotid IMT than in those showing no progression, regression or mild progression. Multivariate linear and logistic regression modeling using conventional and non-conventional risk factors showed that the cholesterol content of IC was a significant positive predictor of internal carotid IMT progression. In conclusion these data demonstrate that increased levels of modified ApoB-rich IC are associated with increased progression of internal carotid IMT in the DCCT/EDIC cohort of type 1 diabetes.

Adult↗
PubMed2006

Optimizing randomized phase II trials assessing tumor progression.

The traditional development paradigm for phase II trials in oncology has been challenged in recent years by the introduction of cytostatic therapies. These agents slow the growth of tumors rather than cause high rates of shrinkage, this argues for the use of endpoints that measure growth inhibition such as progression free survival. We have previously argued the need for randomized trials in this setting. Here we discuss methodological solutions to enhance the development decision at the end of phase II in the context of progression endpoints employed in randomized trials. There are well recognized issues associated with progression endpoints relating to bias in the timing and interpretation of assessments. In this paper we present design and analysis solutions that will minimize bias by using methods that are either partially or completely time independent. We also discuss other design features to maximize the information yielded in a phase II setting. We advocate the creation of progression endpoints that utilize all available progression data rather than early fixed time-point analyses and show that little is to be gained by assessing progression status any more frequently than would be required in routine clinical practice. Such design and analysis measures will optimize the development decision made at the end of phase II clinical evaluation.

Algorithms↗
PubMed2004

Progression of left ventricular hypertrophy and the angiotensin-converting enzyme gene polymorphism in hypertrophic cardiomyopathy.

BACKGROUND: Hypertrophic cardiomyopathy is an inherited primary disorder of the myocardium characterised by clinical heterogeneity. The severity and rate of progression of hypertrophy is an important factor in prognosis, and is likely to be dependent on factors including age, the disease-causing gene mutation, environmental influences and genetic modifiers. METHODS: To study the influence of age on progression of hypertrophy, 62 patients with hypertrophic cardiomyopathy followed up for a minimum of 2 years were studied to determine the changes in left ventricular hypertrophy based on transthoracic M-mode and 2D echocardiography. DNA studies were performed to determine the role of the angiotensin-converting enzyme (ACE) gene deletion polymorphism in modulating progression of left ventricular hypertrophy. RESULTS: Sixty-two patients were followed-up over a period of 6.0 +/- 3.2 years (range 2-16 years). Patient data were analysed in two age groups: group 1 (patients aged < or = 30 years at first echocardiogram) had an increase in left ventricular septal wall thickness from 23.8 +/- 8.9 to 28.8 +/- 8.7 mm (p < 0.001), while group 2 (patients aged > 30 years) had a smaller but significant increase from 17.8 +/- 4.2 to 19.5 +/- 6.2 mm (p < 0.05). DNA analysis of the ACE gene deletion polymorphism showed those with the deletion/deletion (D/D) genotype had a greater progression of left ventricular hypertrophy compared to those carrying the other ACE genotypes (increase in hypertrophy: 6.2 +/- 3.3 vs. 1.7 +/- 4.2 mm; p < 0.01, D/D vs. I/D genotype; 2.8 +/- 5.8 mm; p = ns, D/D vs. I/I genotype). This association was independent of age, body mass and resting blood pressure. CONCLUSIONS: Progression of left ventricular hypertrophy is most evident in the first 3 decades of life, but is also observed in older age groups. Presence of the ACE gene D/D polymorphism may be an important marker to identify those individuals with hypertrophic cardiomyopathy who are likely to have more progressive disease, and therefore at higher risk of adverse clinical outcomes.

Adult↗
PubMed2005

Perfusion and diffusion MRI of glioblastoma progression in a four-year prospective temozolomide clinical trial.

PURPOSE: This study was performed to determine the impact of perfusion and diffusion magnetic resonance imaging (MRI) sequences on patients during treatment of newly diagnosed glioblastoma. Special emphasis has been given to these imaging technologies as tools to potentially anticipate disease progression, as progression-free survival is frequently used as a surrogate endpoint. METHODS AND MATERIALS: Forty-one patients from a phase II temolozomide clinical trial were included. During follow-up, images were integrated 21 to 28 days after radiochemotherapy and every 2 months thereafter. Assessment of scans included measurement of size of lesion on T1 contrast-enhanced, T2, diffusion, and perfusion images, as well as mass effect. Classical criteria on tumor size variation and clinical parameters were used to set disease progression date. RESULTS: A total of 311 MRI examinations were reviewed. At disease progression (32 patients), a multivariate Cox regression determined 2 significant survival parameters: T1 largest diameter (p < 0.02) and T2 size variation (p < 0.05), whereas perfusion and diffusion were not significant. CONCLUSION: Perfusion and diffusion techniques cannot be used to anticipate tumor progression. Decision making at disease progression is critical, and classical T1 and T2 imaging remain the gold standard. Specifically, a T1 contrast enhancement over 3 cm in largest diameter together with an increased T2 hypersignal is a marker of inferior prognosis.

Analysis of Variance↗
PubMed2005

Fibrosis progression in chronic hepatitis C patients with occult hepatitis B co-infection.

Occult hepatitis B virus (HBV) infection in individuals without hepatitis B surface antigen (HBsAg) can be identified in hepatitis C virus (HCV) infected patients. However, its role in fibrosis progression remains uncertain. This retrospective study compared the fibrosis progression (defined as fibrosis progression by at least one stage) and progression to severe fibrosis (fibrosis stage 3 or 4) in HCV patients with occult HBV infection. Occult HBV infection was diagnosed by the detection of HBV DNA in the serum of 74 consecutive anti-HCV positive patients by PCR. Thirty-one patients (41.9%) had occult HBV infection. All 74 patients had a median of 2 (range 2-3) liver biopsies. The median time between the first and last liver biopsy was 57.7 (range 15.0-132.8) months. Eleven of the 31 patients with occult HBV infection compared with 12 of the 43 patients without occult HBV infection had fibrosis progression (35.5% versus 27.9%, respectively, p=0.608). Six of the 31 patients with occult HBV infection compared with 8 of the 43 patients without occult HBV infection developed severe fibrosis (19.4% versus 18.6%, respectively, p=0.946). In conclusion, chronic HCV patients with occult HBV co-infection does not seem to progress more than patients without occult HBV infection. However, more large-scale studies are needed before a definite conclusion can be obtained.

DNA, Viral↗
PubMed2006

Plasma S100beta and NSE levels and progression in multiple sclerosis.

Plasma levels of the glial cell marker S100beta and the neuronal marker neuron-specific enolase (NSE) are elevated in various conditions of central nervous system damage. In this study we investigated whether plasma levels of S100beta and NSE are related to disease progression in multiple sclerosis (MS). Plasma levels of S100beta and NSE were measured in 25 patients with relapsing remitting MS (RRMS), 23 with secondary progressive MS (SPMS) and 16 with primary progressive MS (PPMS). All MS patients were in a clinically stable phase. Progression and disability were evaluated during a follow-up period of five years. We found that plasma NSE levels were lower in patients with clinically relevant worsening on the Expanded Disability Status Scale (EDSS), defined as 1 point increase from EDSS <6.0 or 0.5 point increase from EDSS> or =6 after five years (p=0.042), and in patients with a progressive disease course (p=0.01). There was a significant negative correlation between plasma NSE levels and both EDSS and Multiple Sclerosis Severity Status (MSSS) scores at baseline and after five years of follow-up (r=-0.33 and -0.38, p=0.027 and 0.003). There were no significant differences between patient groups in plasma S100beta levels. Plasma NSE levels appear inversely related to disease progression in MS.

Adult↗
PubMed2004

Measurement of structural progression in osteoarthritis of the hip: the Barcelona consensus group.

OBJECTIVE: To outline the best available method of measurement for detecting progression of osteoarthritis (OA) of the hip especially in therapeutic trials. METHOD: A Medline search of articles related to progression of hip OA was performed. A group of experts met over a 1.5-day session to review available literature and new research. Specific questions were addressed in order to reach a consensus on measuring progression of OA of the hip. RESULTS: Of the available surrogate measures, a single yearly standing or reclined antero-posterior plain radiograph of the pelvis with feet internally rotated 15-20 degrees, can be evaluated with the use of an atlas for joint space width (JSW, interbone distance). There should be a minimum JSW upon baseline screening that may be 1 or 2 mm. Digitization of films offers a slight reduction in variability of measurements. Progression of OA can be calculated by measurement of the JSW on paired and blinded films. A reduction of > or = 0.5 mm is greater than the 'minimum perceptible difference' as well as the variation of most imaging techniques, and represents a clinically relevant and significant reduction in the JSW. Narrowing of the superomedial or superolateral JSW may tend to progress more rapidly than other changes. In clinical trials, patients who discontinue the study treatment need to be followed after discontinuation, and an imputation strategy which provides unbiased estimates of both the treatment effect and its variance is an appropriate technique for intent-to-treat analysis. CONCLUSION: For the development of new agents intended to prevent, retard, stabilize or reverse the progress of OA of the hip, the radiographic methodology presently available is adequate to detect changes in hip JSW of OA.

Arthroscopy↗
PubMed2006

Arthritis progression after patellofemoral joint replacement.

Progressive symptomatic tibiofemoral osteoarthritis (OA) following patellofemoral joint replacement (PFJR) may necessitate revision to total knee arthroplasty. This study was designed to quantify this problem in a prospective series of 103 consecutive patients who underwent PFJRs undertaken at our institution. At a mean follow-up of 7.1 years (66-102 months), 14 knees (14%) have been revised, 12 of those (12%) because of the development of symptomatic tibiofemoral OA, with a mean time to revision of 55 months (range 14 to 95 months). Available radiographs of the 89 unrevised knees were subject to blinded and randomised assessment by two observers. Postoperative AP knee radiographs were scored to assess for tibiofemoral OA progression, with definite progression seen in a median of 7% of medial compartments but 0% of lateral compartments, over a mean period of 51 months. Sulcus angles on preoperative 30 degrees skyline radiographs were measured to assess for trochlear dysplasia. Seventeen percent of the knees without preoperative trochlear dysplasia have been revised for progression of tibiofemoral OA, compared to none of the knees with preoperative trochlear dysplasia. Furthermore, in the unrevised knees, statistically significantly more radiographic progression of tibiofemoral OA was seen in those without preoperative trochlear dysplasia (p = 0.01). Our results suggest that progressive tibiofemoral OA following PFJR is an important cause of failure, but it is seen significantly less frequently when the patellofemoral arthritis is secondary to dysplasia of the femoral trochlea, suggesting that these patients are the ideal candidates for PFJR.

Aged↗
PubMed2026

An Integrative Proteomic Approach to Reveal Altered Signaling Modules During Alzheimer's Disease Progression in PS19 Tauopathy Mice.

Alzheimer's disease (AD) is a slowly progressive neurodegenerative disease that is characterized by cognitive, functional, and behavioral impairments. These changes occur owing to the progressive accumulation of extracellular amyloid-beta plaques and intracellular neurofibrillary tangles of hyperphosphorylated tau protein. AD is associated with the dysfunction of several essential neurotransmitter systems, such as dopamine, and impaired neurotransmission. Despite the association of neurotransmitter changes within the brain and AD pathology, in-depth profiling studies on neurotransmitters and their related proteomic changes are limited. This study was conducted to profile and integrate the proteomes and neurotransmitters in seven brain regions of PS19 (Tau P301S) mice according to AD progression between 4 and 7 months. Proteomic analysis revealed significantly altered canonical pathways in various brain regions, including metabolic abnormalities. In the neurotransmitter profile, we found significant alterations in the levels of six neurotransmitters-dopamine, serotonin, homovanillic acid, norepinephrine, 3-methoxytyramine, and 3,4-dihydroxyphenylacetic acid-during AD progression. Using an integrative approach between proteome and neurotransmitter profiles, we found that AD progression-dependent dopamine- and serotonin-related signaling modules are closely related to neurotransmitter changes, especially in the hippocampus and cerebellum. This integrative approach could provide new signaling modules to help understand AD progression and thereby enable improved treatment and clinical outcomes.

Animals↗
PubMed2005

A hypothesis matrix for studying biomechanical factors associated with the initiation and progression of posttraumatic osteoarthritis.

In this paper the current theories on how osteoarthritis (OA) may be initiated and progressed is described. This is done in relation to the biomechanical events that would predispose the joint to the degenerative process, as well as further progression of the process within an 'OA' cycle. The relationship between the types of loading to the type of joint damage that occurs is discussed. Subsequently the influence on the rate at which OA progresses from the trauma, is presented within a hypotheses matrix. For the type of tissue damage, four phases are distinguished, phase I: superficial cells or matrix only, phase II: deeper chondral region, phase III: the tidemark or calcified region, and phase IV: subchondral bone region. The biomechanical event (A) is stipulated as having a possibility of six outcomes. (A3) is the direct damage to the calcified cartilage near the tidemark that leads most rapidly into the cycle for OA to develop and progress. Another three outcomes (A1, A2 and A4) involve damage to regions other than the calcified cartilage near the tidemark. These three outcomes involve the cells or matrix, chondral or subchondral regions. It is hypothesised that damage involved in one of these three outcomes results in all likelihood to a new level of joint deficiency or vulnerability. This new predisposition could lead to A3 type outcome and directly into the OA progression cycle or result in more A1, A2 or A4 type outcomes which remains out of the OA cycle. The biomechanical events are therefore used to predict the risk of mechanically driven OA and the rapidity in which it progresses in relation to joint loading.

Biomechanical Phenomena↗
PubMed2006

Relationship between acetabular labrum evaluation by using radial magnetic resonance imaging and progressive joint space narrowing in mild hip dysplasia.

OBJECTIVE: The aim of this study was to investigate the relationship between abnormal acetabular labrum depicted by radial magnetic resonance and progressive joint space narrowing (JSN) of hip dysplasia. METHODS: Subjects were 23 joints [21 patients; mean age: 35.1 years (16-53 years)] that had acetabular dysplasia with lateral center-edge angle of Wiberg (CE angle) greater than 5 degrees and smaller than 25 degrees (mean, 16.4 degrees ), which did not show any arthrotic changes on plain radiograms and were followed up for 3 years or longer. Radial images of acetabular labrum were classified into three stages. RESULTS: Progression of JSN was not significantly related to CE angle but to progression of MRI stage (P=.006). In multivariate analysis, one rank progression of MRI stage was significantly associated with progression of JSN (adjusted OR=11.41, 95% CI: 1.51-86.24, P=.018). CONCLUSION: Our findings showed that in patients whose acetabular dysplasia has 5-25 degrees CE angle, MRI staging based on radial MRI is a better factor for prediction of progression of JSN than CE angle.

Acetabulum↗
PubMed2004

Relating neocortical pathology to disability progression in multiple sclerosis using MRI.

Cortical grey matter (cGM) develops a substantial burden of pathology in multiple sclerosis (MS). Previous cross-sectional studies have suggested a relationship between measures of cortical atrophy and disability. Our objective was to develop a method for automatically measuring the apparent cGM thickness as well as the integrity of the interface between cGM and subcortical white matter (GM/WM) both globally and regionally on T(1)-weighted MRI, and use this method in a longitudinal investigation of how these measures differed between patients with stable MS and patients with progressing disability. Measurements were made over the whole brain and for anatomically specified cortical regions, both cross-sectionally at baseline and longitudinally on two MRI scans performed on average 1 year apart. We found a higher average rate of apparent loss of cGM thickness across the whole brain in the group that progressed over the interscan interval compared to the group that remained stable (progressing = -3.13 +/- 2.88%/year, stable = 0.06 +/- 2.31%/year, P = 0.002). This difference was detected with regional measures in parietal and precentral cortex. In contrast, change in the GM/WM interface integrity did not show detectable regional differences, although the group of MS patients whose disability progressed showed a significant decrease in GM/WM interface integrity compared to the stable group (P = 0.003). Regional measures of apparent loss of cGM thickness enhance sensitivity to cortical pathological changes. A measure of integrity offers a new index of disease-associated cortical changes at the GM/WM interface. The results suggest that progression of disability in MS is associated with the progression of MRI-detectable cortical pathology.

Adult↗
PubMed2004

Statistical evaluation of the diagnostic accuracy of methods used to determine the progression of visual field defects in glaucoma.

OBJECTIVE: To evaluate trend-type analyses to judge the progression of visual field damage (VFD) of glaucoma in terms of ratios of making judgments of progression and specificity, and to report a new method. DESIGN: Retrospective analysis of visual field (VF) results of actual glaucoma cases and those simulated by computer, and receiver operating characteristic curve analysis of performance of methods to judge the progression of VFD. PARTICIPANTS: One hundred five eyes of 105 open-angle glaucoma (OAG) patients with progressing VFD and 355 eyes of 355 clinically stable OAG patients for VF simulation from 4 university-based referral practices. METHODS: Methods using regression analysis of total deviation (TD), mean deviation (MD), mean TD of a sectored VF, and original scoring used in the Advanced Glaucoma Intervention Study (AGIS) were compared. A VF test was repeated twice in a short period on the 355 stable OAG eyes, and test-retest fluctuation, including variance at each test point and covariance between 2 test points, was calculated to simulate stable glaucomatous VF series by computer. The sensitivity of each method was calculated with 105 progressing VF series, and specificity was calculated with 10,000 simulated stable glaucomatous VF series. MAIN OUTCOME MEASURES: Sensitivity (ratios of making judgments of progression), specificity, and diagnostic power. RESULTS: The methods using the TD slope on one test location showed a sensitivity of 0.848 to 1.000, with a specificity of 0.105 to 0.721, and on 2 adjacent test locations showed a sensitivity of 0.848, with a specificity of 0.722. A significant negative MD slope with P<0.05 showed a sensitivity of 0.524, with a specificity of 0.945. The method using a sectored VF showed a sensitivity of 0.695, with a high specificity of 0.946. The AGIS method showed a sensitivity of 0.305 to 0.467, with a very high specificity of 0.999 to 1.000. The method using previously reported mathematically sectored VFs showed a sensitivity of 0.790, with a specificity of 0.900, and higher diagnostic power (1.69) than the others in this study population. CONCLUSIONS: Most of the methods using the TD slope were characterized by high sensitivity, the AGIS method had a very high specificity, and those using VF sectors had reasonable sensitivity and specificity.

Adolescent↗
PubMed2006

Centrum use and progression of age-related cataract in the Age-Related Eye Disease Study: a propensity score approach. AREDS report No. 21.

PURPOSE: To evaluate the effect of the multivitamin Centrum on the development and progression of age-related lens opacities. DESIGN: Clinic-based prospective cohort study. PARTICIPANTS: Four thousand five hundred ninety individuals with at least one natural lens and photographic follow-up (median, 6.3 years) were assessed for development or progression of lens opacities. MAIN OUTCOME MEASURES: Progression of "any" lens opacity or type-specific opacity was ascertained from lens photographs taken at baseline and at annual visits beginning at year 2. METHODS: The Age-Related Eye Disease Study (AREDS) showed no statistically significant effect of a high-dose antioxidant formulation on progression of lens opacities. Centrum also was provided to approximately two thirds of the study participants. Because Centrum use was elective, a logistic regression model of baseline characteristics was used to generate a propensity score for Centrum use. Repeated-measures logistic regression, adjusted for propensity score and other covariates, was used to evaluate associations of Centrum use and lens opacity. RESULTS: Centrum use, adjusted for propensity score and other covariates, was associated with a reduction in "any" lens opacity progression (odds ratio [OR] = 0.84, 95% confidence interval [CI] = 0.72-0.98, P = 0.025). Results for individual lens opacity types suggested that Centrum use was protective for nuclear opacity events (OR = 0.75, 95% CI = 0.61-0.91, P = 0.004). CONCLUSION: Observational data from the AREDS and other studies suggest that use of a multivitamin may delay the progression of lens opacities. A National Eye Institute-sponsored clinical trial scheduled for completion in 2007 will provide additional data on Centrum use and cataract development.

Aged↗
PubMed2004

Immediate (overnight) switching from carbamazepine to oxcarbazepine monotherapy is equivalent to a progressive switch.

This study compared immediate (overnight) and progressive switching to oxcarbazepine monotherapy in patients with partial seizures unsatisfactorily treated with carbamazepine monotherapy. Patients were randomised to either an overnight (n = 140) or a progressive switch (n = 146) from carbamazepine to oxcarbazepine monotherapy at a dose ratio of 1:1.5. The difference between the two switch groups in the mean monthly seizure frequency supported the equivalence of overnight and progressive switching (difference of 0.02 excluding outliers; 95% confidence interval (CI) -0.74, 0.78). Following the switch from carbamazepine to oxcarbazepine, there was a reduction in median monthly seizure frequency in both the overnight group (from 1.5 to 0; P = 0.0005) and the progressive group (from 1.0 to 0.4; P = 0.003). The proportion of seizure-free patients increased from 38 to 51% (P = 0.002) and 39 to 49% (P = -0.01) in the overnight and progressive groups, respectively. In addition, the proportion of patients experiencing no clinically significant adverse events did not differ between the two switch methods (difference of 2.5; 95% CI -4.1, 9.0). For patients who are unsatisfactorily treated with carbamazepine monotherapy, overnight switch to oxcarbazepine monotherapy is as effective and well tolerated as a progressive switch, therefore allowing simple and flexible individualised treatment. Switching to oxcarbazepine monotherapy appears to be beneficial for patients who are unsatisfactorily treated with carbamazepine monotherapy, independently of the switch method used.

Adolescent↗
PubMed2005

Socioeconomic differences in the progression of carotid atherosclerosis in middle-aged men and women with subclinical atherosclerosis in Sweden.

While the persistence of socioeconomic differences in cardiovascular disease (CVD) has been recognized for many years, less is known about whether socioeconomic factors are of importance to CVD before symptoms of the disease appear. In this study the associations among educational level, occupational status and progression of atherosclerosis were investigated in 1016 Swedish middle-aged men and women with signs of subclinical atherosclerosis, i.e., carotid plaque (defined as focal intima-media thickness (IMT) > 1.2 mm). IMT in the common carotid artery (CCA) and in the carotid bifurcation area, as well as carotid plaque score, was determined by B-mode ultrasound. Results showed only weak associations between educational level, occupational status and age-, sex- and baseline IMT-adjusted progression of IMT in the CCA. However, in the age, sex- and baseline IMT-adjusted analyses, those in unskilled manual occupations showed a significantly higher yearly progression of carotid IMT in the bifurcation area compared to those in high- or medium-level non-manual occupations. Those with primary education tended to show a higher yearly progression of carotid IMT in the bifurcation area compared to those with completed secondary education. After adjustment for risk factors, the magnitude of these associations were somewhat attenuated. Similar patterns of associations were seen for the change of carotid plaque score. We conclude that low socioeconomic status (SES) is associated with progression of atherosclerosis in a middle-aged population with signs of subclinical atherosclerosis. Even though socioeconomic differences in cardiovascular risk factor levels could explain part of the found differences in progression rate in women, the mechanisms involved remain to be further established.

Aged↗
PubMed2004

Targeting FSH in androgen-independent prostate cancer: abarelix for prostate cancer progressing after orchiectomy.

OBJECTIVES: To determine the efficacy of the gonadotropin-releasing hormone antagonist abarelix in patients with androgen-independent prostate cancer progressing after orchiectomy and to measure its effect on serum follicle-stimulating hormone (FSH). METHODS: Sixteen patients with prostate cancer progressing after orchiectomy received abarelix-depot 100 mg by intramuscular injection on days 1, 15, and 29 and then every 28 days for up to 24 weeks (52 weeks in patients who met the criteria for a prostate-specific antigen [PSA] response after 24 weeks). PSA response was the primary endpoint and was defined as a 50% reduction confirmed 4 weeks later. The time to progression and effect of therapy on serum FSH were secondary endpoints. RESULTS: No patient met the criteria for a PSA response. Five patients (31%, 95% confidence interval 11% to 58%) experienced confirmed reductions in the PSA level ranging from 9.3% to 31.8%. At the end of the six cycles of therapy, 6 patients remained stable without PSA progression or other signs of disease progression. The median time to progression was 12 weeks (95% confidence interval 6 to 18). The mean serum FSH concentration declined after 4 weeks of study treatment by nearly 90% from a baseline of 45.1 IU/L (95% confidence interval 34.0 to 56.2) and remained suppressed throughout the observation period. Treatment was well tolerated, with one grade 3 allergic reaction. CONCLUSIONS: Treatment with abarelix in patients with androgen-independent prostate cancer after orchiectomy results in marked reduction in circulating FSH. None of the patients met the PSA response criteria; nonetheless, minor reductions in serum PSA were observed in 5 of 16 patients.

Adenocarcinoma↗
PubMed2004

Intravesical bacille Calmette-Guérin versus mitomycin C in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression.

OBJECTIVES: To compare the therapeutic efficacy of intravesical bacille Calmette-Guérin (BCG) with mitomycin C (MMC) on progression of Stage Ta and T1 bladder carcinoma. METHODS: Combined published and unpublished data from comparative studies on BCG versus MMC in superficial bladder carcinoma were analyzed, considering possible confounding factors. Odds ratios (ORs) and 95% confidence intervals (CIs) were used as the primary effect size estimate. Tumor progression was defined as progression to a higher tumor stage or the development of metastatic disease. RESULTS: In nine eligible clinical trials, 1277 patients were treated with BCG and 1133 with MMC. Within the overall median follow-up of 26 months, 7.67% of the patients in the BCG group and 9.44% of the patients in the MMC group developed tumor progression. In all nine individual studies and in the combined results, no statistically significant difference in the ORs for progression between the BCG and MMC-treated groups was found (combined OR = 0.77; 95% CI 0.57 to 1.03; P = 0.081). In the subgroup with BCG maintenance, the combined result of the five individual studies showed a statistically significant superiority of BCG over MMC (OR = 0.66; 95% CI 0.47 to 0.94; P = 0.02). In the four studies without BCG maintenance, the combined result indicated no statistically significant difference between the two treatments (OR = 1.16; 95% CI 0.65 to 2.07; P = 0.612). Potential confounders, such as tumor risk status, duration of follow-up, BCG strain, BCG and MMC treatment regimen, and year of publication did not significantly influence these results. CONCLUSIONS: The results demonstrated statistically significant superiority for BCG compared with MMC for the prevention of tumor progression only if BCG maintenance therapy was provided.

Adjuvants, Immunologic↗