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Biomedical subjects

A A Bartolucci

Publications and source records attributed to A A Bartolucci.

At least 19 recordsLinked to original sources
PubMed2001

Relationship of urinary myelin basic protein-like material with cranial magnetic resonance imaging in advanced multiple sclerosis.

BACKGROUND: A significant correlation exists between disability and the volume of black holes (BHL VOL), defined as hypointense lesions on T1-weighted cranial magnetic resonance imaging. A consistent correlation has also been reported between urinary myelin basic protein-like material (MBPLM) and the transition toward secondary progression (SP) from relapsing-remitting (RR) multiple sclerosis (MS). OBJECTIVE: To improve the management of MS through a noninvasive and cost-effective test for monitoring disease activity or disease status. DESIGN AND METHODS: From 662 patients with MS (86 with RR MS, 259 with SP MS without continued attacks, and 317 with SP MS with continued attacks), 24-hour urine samples were obtained at enrollment in the phase 3 Linomide (roquinimex) drug study. The urine specimens were analyzed for MBPLM and correlated with clinical features and findings on cranial magnetic resonance imaging. RESULTS: Significant but weak correlations existed between urinary MBPLM and BHL VOL in all patients with MS (r = 0.114, P =.003; n = 662), patients with SP MS without attacks (r = 0.185, P =.003; n = 259), and all patients with SP MS (r = 0.122, P =.003; n = 576). No significant correlations were detected in the RR MS group or any of the disease groups or subgroups whose Expanded Disability Status Scale score was 5.0 or lower. In subgroup analysis, the most significant correlation was detected between urinary MBPLM after adjustment for creatinine and BHL VOL in patients with SP MS with an Expanded Disability Status Scale score of 5.5 or higher but without continued relapses (r = 0.417, P<.001; n = 138). CONCLUSIONS: In patients with advanced SP MS, urinary MBPLM may possibly serve as an indicator of failed remission and axonal damage. Urinary MBPLM correlates with disease status in MS, especially the transition of RR MS to SP MS with advancing disability.

Adjuvants, Immunologic↗
PubMed2001

Systemic lupus erythematosus in three ethnic groups. IX. Differences in damage accrual.

OBJECTIVE: To determine the factors predictive of damage in a multiethnic (Hispanic, African American, and Caucasian) LUMINA (lupus in minority populations, nature versus nurture) cohort of patients with systemic lupus erythematosus (SLE) with disease duration of < or =5 years at enrollment (T0). METHODS: Variables (socioeconomic/demographic, clinical, immunologic, immunogenetic, behavioral, and psychological) were measured at T0 and annually thereafter. Disease damage was measured with the Systemic Lupus International Collaborating Clinics Damage Index (SDI), and disease activity was measured with the Systemic Lupus Activity Measure. The relationship between the different variables and the SDI at the last visit (TL) was examined (mean followup from diagnosis to TL 61 months; adjusted for disease duration). Poisson regression was used to identify the independent association between the different variables and SDI scores at TL. RESULTS: Seventy-two Hispanics, 104 African Americans, and 82 Caucasians were included. One-half of patients had not accrued any damage. Caucasians had the lowest SDI scores at T0, and Hispanics had the highest scores at TL. Renal damage occurred more frequently among Hispanics and African Americans, while integument damage was more frequent among African Americans. Neuropsychiatric (20%), renal (16%), and ocular (15%) damage occurred most frequently among all patients. Independent predictors of SDI at TL were age, corticosteroid use (maximum dose at T0), number of American College of Rheumatology (ACR) criteria met, disease activity, and abnormal illness-related behaviors. Other variables were less consistently associated with damage accrual (poverty in African Americans, lack of HLA-DRB1*0301 in Hispanics, presence of HLA-DQB1*0201 and acute onset of SLE in Caucasians). CONCLUSION: Damage in SLE occurs from the outset in some, but not all, patients; Hispanics accrue damage more rapidly. Disease factors (corticosteroid use, number of ACR criteria met, disease activity, and acute-onset type) are important, but age and abnormal illness-related behaviors also contribute to overall damage in SLE.

Adult↗
PubMed2001

A longitudinal study of resting energy expenditure relative to body composition during puberty in African American and white children.

BACKGROUND: Body composition and resting energy expenditure (REE) have not been examined longitudinally during puberty. OBJECTIVE: The purpose of this longitudinal study was to examine the influence of pubertal maturation on REE relative to body composition in African American and white children. DESIGN: The study included 92 white and 64 African American children (mean age at baseline: 8.3 and 7.9 y, respectively) from Birmingham, AL. The children had 2-5 annual measurements of fat mass (FM), lean mass (LM), and REE. The Tanner stages of the children ranged from 1 to 5. Mixed-model repeated-measures analyses were used to test the change in REE relative to body composition with increasing Tanner stage among ethnic and sex groups. RESULTS: LM increased from Tanner stage 1 to subsequent stages. FM relative to LM decreased from Tanner stage 1 to stages 3, 4, and 5 but not from stage 1 to stage 2. The African American children had relatively higher limb LM and lower trunk LM than did the white children. REE declined with Tanner stage after adjustment for ethnicity, sex, FM, and LM. This decline was significant from Tanner stage 1 to stages 3, 4, and 5 but not to Tanner stage 2. After adjustment for age, Tanner stage, FM, and LM or LM distribution, REE was significantly higher in white than in African American children (by approximately 250 kJ/d). CONCLUSION: In a large sample of children at various Tanner stages, we found an ethnic difference in REE after adjustment for age, Tanner stage, FM, and LM that was not explained by the difference in LM distribution.

Basal Metabolism↗
PubMed2001

An instrument to measure healing in pressure ulcers: development and validation of the pressure ulcer scale for healing (PUSH).

BACKGROUND: Currently, there is no instrument that provides an accurate and simple method of monitoring pressure ulcer healing in clinical practice. This article reports the two studies that were conducted to assess the validity of the Pressure Ulcer Scale for Healing (PUSH) as a tool to monitor healing of stage II-IV pressure ulcers. METHODS: Subjects in both studies (N = 103 and N = 269) were elderly (mean Study 1, 75 years, mean Study 2, 80 years), and the majority were women (Study 1, 51%, Study 2, 70%). Study data were extracted from patients' permanent records. RESULTS: Principal components analysis confirmed that the PUSH tool accounted for 58% to 74% of the wound healing variance over a 10-week period in Study 1 and 40% to 57% of the wound healing variance over a 12-week period in Study 2. In addition, multiple regression analysis, used to measure the sensitivity of the model to total healing, showed PUSH accounted for 39% of the variance in 6 weeks and 31% of the variance over 12 weeks (p <.001; Studies 1 and 2, respectively). CONCLUSIONS: Data from these two studies confirmed that the PUSH tool, with the components of length times width, exudate amount, and tissue type, is a valid and sensitive measure of pressure ulcer healing. It is a practical approach that provides clinically valid data regarding pressure ulcer healing. Further testing is needed to confirm these findings.

Aged↗
PubMed2001

Social problem-solving telephone partnerships with family caregivers of persons with stroke.

As individuals with significant functional deficits are discharged earlier from the hospital, health care professionals are challenged to develop cost-effective intervention programmes that will assist family members to manage caregiving problems in the home. The literature suggests that social problem-solving can positively influence the physical and psychological well-being of individuals. This paper describes a social problem-solving training procedure provided primarily by telephone to assist family caregivers to manage caregiving issues in the home.

Aged↗
PubMed2001

Analysis of the posterior fossa in children with the Chiari 0 malformation.

OBJECTIVE: We previously reported the resolution of syringohydromyelia without cerebellar tonsillar ectopia in five patients after posterior fossa decompression of the so-called Chiari 0 malformation. A sixth patient is described. In this study, the anatomy of the posterior fossa is analyzed using radiological imaging, enabling features of the posterior fossa in this uncommon subgroup of children to be characterized. METHODS: Multiple measurements were made on magnetic resonance imaging studies in six children with Chiari 0 malformation to determine the position of the brainstem relative to the foramen magnum. Fifty children with normal magnetic resonance imaging studies of the brain were used as controls. RESULTS: All children with a Chiari 0 malformation were found to have the following positive results: obices that were located more than 2 standard deviations below normal, an increase in the anteroposterior midsagittal distance of the spinomedullary junction at the level of the foramen magnum, an increase in the angle between the floor of the fourth ventricle and clivus, and an increase in the anteroposterior midsagittal distance of the foramen magnum. CONCLUSION: The findings of this study suggest that the contents of the posterior fossa are indeed compromised and/or distorted in patients with syringohydromyelia but no tonsillar ectopia. In this group, the brainstem was caudally displaced more than 3 standard deviations below normal.

Adolescent↗
PubMed2000

Is there immune dysregulation in symptomatic Gulf War veterans?

Many Gulf War veterans complain of a variety of symptoms including skin rashes and joint pain which may have a common immunological basis. Other Gulf War veterans have post-traumatic stress disorder (PTSD), an anxiety disorder associated with chronic stress. Whether or not chronic stress may affect the capacity to resist disease has not been fully delineated, but recent work suggests that a dysregulated balance of cytokines produced by T helper cells of the immune system may play a role in stress-related illnesses. It is known that a balanced immune response (cell-mediated and humoral immunity) is an important defense mechanism. Although the mechanism(s) by which a change in immune system balance occurs is not clear, it may be secondary to stress-induced changes in hormones such as cortisol and catecholamines, both of which have been implicated in altering levels of cellular or humoral immunity. For these reasons, we are investigating the function of both the cellular and humoral arms of the immune system as well as the cytokine patterns associated with these different functions in symptomatic Gulf War veterans and control groups consisting of asymptomatic Gulf War veterans and symptomatic non-Gulf War veterans.

Adult↗
PubMed2000

Sociodemographic, physical, and psychosocial characteristics of depressed and non-depressed family caregivers of stroke survivors.

A variety of sociodemographic, physical, and psychosocial variables are linked to depressive behaviour in family caregivers. This study was conducted to determine the best predictors of caregiver depression at onset of the caregiver role among persons providing care to a stroke survivor. The relative contributions of stroke survivor and caregiver sociodemographic characteristics, as well as caregiver general health, physical functioning, social support, life satisfaction, preparedness, and reaction in the prediction of depression status, were examined. A correlational study of 52 primary family caregivers of individuals who had a cerebrovascular accident was conducted. General health and physical functioning scales from the SF-36, and measures of caregiver social support, life satisfaction, preparedness, and reaction were used. Caregiver depression was best predicted by lower life satisfaction, lower physical functioning, and a lack of tangible social support.

Activities of Daily Living↗
PubMed2000

The position of the conus medullaris in children with a Chiari I malformation.

The purpose of this study is to determine whether there is a relationship between the conus level and patients with a Chiari I malformation. This retrospective MRI study evaluated conus levels and degrees of tonsillar ectopia in 26 children ages 5-16 years with a Chiari I malformation. Our results show that there seems to be no relationship between the conus level and the amount of tonsillar ectopia that a child with a Chiari I malformation might have. In fact, there seemed to be an inverse relationship between these two entities. Interestingly, we have also found that of all coni located at the L2-L3 disc space or below, these patients had a syrinx associated with their Chiari I malformation and that all malformations without a syrinx had a 'normally' positioned conus medullaris.

Adolescent↗
PubMed2000

Radiographic assessment of disease progression in rheumatoid arthritis patients treated with methotrexate or minocycline.

Radiographic studies of methotrexate (MTX) treated and minocycline treated patients with rheumatoid arthritis (RA) are reviewed. A formal metaanalysis of publications of RA treated with MTX was undertaken at the time when MTX was used for patients with established RA. Thus the conclusions of that metaanalysis may not be applicable to patients treated with MTX earlier in the course of their disease. On the other hand, there are no sufficient data to conduct a formal metaanalysis of patients with RA treated with minocycline.

Anti-Bacterial Agents↗
PubMed1999

Urinary myelin basic protein-like material in patients with multiple sclerosis during interferon beta-1b treatment.

OBJECTIVES: To determine levels of urinary myelin basic protein-like material (MBPLM) in patients with multiple sclerosis (MS) openly treated with interferon beta-1b and to correlate these with clinical changes. BACKGROUND: Levels of urinary MBPLM correlate with the presence of the progressive phase of MS and with the disease burden detected on T2-weighted, cranial magnetic resonance imaging. Measurement of urinary MBPLM level may be a feasible test for monitoring or predicting response to therapeutic measures. DESIGN AND METHODS: In a prospective study at one site, 166 patients with MS (131 with relapsing-remitting [RR] and 35 with secondary progressive [SP] disease) were treated for a minimum of 1 year and up to 3 years with interferon beta-1b and underwent assessment for neurologic disability (Expanded Disability Status Scale and Scripps Neurological Rating Scale) and change in disease subtype. Urine samples were obtained at 1219 of 1378 clinic visits, and urinary MBPLM level was determined and related to creatinine level to adjust for renal function. RESULTS: Statistical analysis using the general linear models procedure confirmed previous findings that the level of urinary MBPLM related to urinary creatinine level (MBPLM/creatinine) was higher (P<.001) in patients with SP than RR MS. Of the 131 patients with RR MS, SP disease developed in 13 during the observation period. Compared with those in the RR group, the RR to SP group had a higher level (P<.001) of urinary MBPLM and did not differ from the SP group. CONCLUSIONS: The level of urinary MBPLM is higher in SP MS than RR MS but not in RR MS that converts to SP MS. Level of urinary MBPLM may permit the examination of treatment tested to prevent RR disease from becoming progressive.

Adjuvants, Immunologic↗
PubMed1999

Do hormonal indices of maturation explain energy expenditure differences in African American and Caucasian prepubertal children?

OBJECTIVE: To examine the relationships between hormonal indices of maturation and total, resting and physical activity-related energy expenditure (TEE, REE and AEE) in African American and Caucasian prepubertal children. DESIGN: Cross-sectional study. SUBJECTS: Sixty-four African American and 48 Caucasian prepubertal children. MEASUREMENTS: TEE (by doubly labeled water), REE (by indirect calorimetry), fat mass and fat-free mass (by dual-energy X-ray absorptiometry), fasting serum dehydroepiandrosterone-sulfate (DHEAS), androstenedione, and estrone-sulfate (by radioimmunoassay). RESULTS: Serum concentrations of hormones correlated significantly with REE and TEE (r values range from 0.33 to 0.76, P<0.001). Only androstenedione correlated significantly with AEE (r = 0.23, P<0.05). However, these correlations were no longer significant after adjusting energy expenditure components for fat-free mass. In multiple regression models, ethnicity was not a significant determinant of any energy expenditure component after adjusting for body composition and hormone concentrations. CONCLUSION: Hormonal indices of maturation do not influence energy expenditure in this group of African American and Caucasian prepubertal children.

Analysis of Variance↗
PubMed1999

Systemic lupus erythematosus in three ethnic groups: III. A comparison of characteristics early in the natural history of the LUMINA cohort. LUpus in MInority populations: NAture vs. Nurture.

AIM: To determine and contrast the socioeconomic-demographic and clinical features of patients with recent onset (< or =5 y) systemic lupus erythematosus (SLE) from three ethnic groups, Hispanic, African-American and Caucasian (H, AA, C). SUBJECTS AND METHODS: SLE cases (American College of Rheumatology criteria) (incident (n = 56), prevalent (n = 173)), were enrolled in a longitudinal study at The University of Alabama at Birmingham, The University of Texas-Houston Health Science Center and The University of Texas Medical Branch at Galveston. Socioeconomic-demographic, clinical, immunological, behavioral and psychological data were obtained using validated instruments and standard laboratory techniques, and compared. RESULTS: 70 H, 88 AA and 71 C SLE patients constitute this cohort. H and AA patients were younger and of lower socioeconomic-demographic status. They also had evidence of more frequent organ system involvement (renal, cardiovascular), more auto-antibodies, more active disease (after adjusting for discrepant socioeconomic-demographic features), lower levels of social support and more abnormal illness-related behaviors (more in H than in AA). H also were more likely to have an abrupt disease onset; C were more likely to be on antimalarials but less likely to be on corticosteroids. H, AA, and C used health care resources comparably. They had similar levels of pain and physical and mental functioning after adjusting for age, disease duration, income, education, social support, illness-related behaviors, and Systemic Lupus Activity Measure or SLAM scores. CONCLUSIONS: H and AA patients have more active SLE, at an earlier age of onset, and a less favorable socioeconomic-demographic structure (worse among the H than AA) which predispose them to a less favorable natural history.

Adolescent↗
PubMed1998

Ten-year disease free survival after transperineal sonography-guided iodine-125 brachytherapy with or without 45-gray external beam irradiation in the treatment of patients with clinically localized, low to high Gleason grade prostate carcinoma.

BACKGROUND: The authors report observed 10-year brachytherapy results in the treatment of 152 consecutive patients with clinically organ-confined prostate carcinoma. METHODS: One hundred and fifty-two consecutive patients with T1-T3, low to high Gleason grade, prostate carcinoma were treated between January 1987 and June 1988 at Northwest Hospital in Seattle, Washington. Their median age was 70 years (range, 53-92 years). Of these 152 patients, 98 (64%) received an iodine-125 implant alone (Group 1), and the remaining 54 patients (36%), who were judged to have a higher risk of extraprostatic extension, also were treated with 45 gray (Gy) of external beam irradiation to the pelvis (Group 2). No patient underwent lymph node sampling, and none received androgen ablation therapy. Multivariate regression and the Mann-Whitney rank sum test were used for statistical analysis. Preoperative patient data with associated success or failure outcomes at 10 years after treatment were used for training and validating a back-propagation neural network prediction program. RESULTS: The average preoperative prostate specific antigen (PSA) value, clinical stage, and Gleason grade were 11.0 ng/mL, T2, and 5, respectively. The median posttreatment follow-up was 119 months (range, 3-134 months). Overall survival 10 years after treatment was 65%. At last follow-up only 3 of the 152 patients (2%) had died of prostate carcinoma. Ninety-seven patients (64%) remained clinically and biochemically free of disease at 10 years of follow-up and had an average PSA value of 0.18 ng/mL (range, 0.01-0.5 ng/mL). In these patients a period of 42 months was required to reach the average PSA (0.5 ng/mL). The median to last PSA follow-up was 95 months (range, 3-134 months). Postoperative needle biopsies were negative in 56% of patients, positive in 15% of patients, and not available in 29% of patients. Only 6% of patients developed bone metastasis. At 10 years there was no statistically significant difference in treatment outcome between patients who received iodine-125 alone, and those who received iodine-125 with 45-Gy external beam irradiation (P = 0.08). Nevertheless, in these two groups preoperative PSA, stage, and Gleason grade were significantly different (P < 0.01). In the artificial neural network analysis, pretreatment serum PSA was the most accurate predictor of disease-free survival. CONCLUSIONS: Percutaneous prostate brachytherapy is a valid and efficient option for treating patients with clinically organ-confined, low to high Gleason grade, prostate carcinoma. Observed 10-year follow-up documents serum PSA levels superior to those reported in several published external beam irradiation series, and comparable to those published in a number of published radical prostatectomy series.

Aged↗
PubMed1998

Systemic lupus erythematosus in three ethnic groups: II. Features predictive of disease activity early in its course. LUMINA Study Group. Lupus in minority populations, nature versus nurture.

OBJECTIVE: To determine the factors associated with disease activity in patients with recent-onset (< or =5 years) systemic lupus erythematosus (SLE) who were of Hispanic, African-American, or Caucasian ethnicity. METHODS: Incident and prevalent cases of SLE, as defined by the American College of Rheumatology criteria for SLE, among the 3 ethnic groups were identified in Alabama (The University of Alabama at Birmingham) and Texas (The University of Texas-Houston Health Science Center and The University of Texas Medical Branch at Galveston). Variables from the sociodemographic, clinical, immunologic, immunogenetic, behavioral, and psychological domains were obtained using validated instruments. Disease activity was ascertained with the Systemic Lupus Activity Measure (SLAM). Stepwise domain regressions with SLAM score as the dependent variable were performed. Final ethnic-specific and overall regression models were obtained by entering variables that were retained in the domain regressions. RESULTS: SLAM scores at study entry were higher in the African Americans (mean +/- SD 12.6 +/- 6.9) and Hispanics (11.0 +/- 6.2) than in the Caucasians (8.5 +/- 3.7) (P < or = 0.001). The final overall regression model (R2 = 28%) for higher SLAM score included the following variables: African-American ethnicity, lack of private health insurance, abrupt disease onset, presence of anti-Ro antibodies, absence of HLA-DRB1*0301, higher levels of helplessness, and abnormal illness-related behaviors. CONCLUSION: Socioeconomic, immunologic, immunogenetic, behavioral, and psychological variables were all predictive of disease activity early in the course of SLE, irrespective of ethnic group. However, there remain ethnic group differences in disease activity that were not explained by these factors.

Adolescent↗
PubMed1998

The effect of a self-monitoring tool on self-efficacy, health beliefs, and adherence in patients receiving hemodialysis.

OBJECTIVE: Assess the effectiveness of a self-monitoring tool on perceptions of self-efficacy, health beliefs, and adherence in patients receiving hemodialysis. DESIGN: A monthly intervention using a pretest, posttest design over a 6-month period. Both the treatment and control groups were randomly selected and received surveys to assess health beliefs, perceptions of self-efficacy for performing specific healthful behaviors, and renal diet knowledge at baseline, before intervention, and 6 months later. The treatment group also received monthly feedback of monthly phosphorus levels and interdialytic weight gains. SETTING: A university hospital-based 43-chair ambulatory dialysis center. SUBJECTS: Forty patients with end-stage renal disease (25 men and 15 women, age 26 to 78 years), on chronic hemodialysis for at least 2 months and with a history of noncompliance with phosphorus and/or fluid restrictions for 1 or more months. MAIN OUTCOME MEASURES: Self-efficacy, health beliefs, knowledge, biochemical, and demographic variables were analyzed. Analysis of variance tests of repeated measures were used to examine relationships between adherence with phosphorus and fluid restrictions to health beliefs and perceptions of self-efficacy after training in self-monitoring. RESULTS: Overall, there were no significant improvements in adherence with phosphorus and fluid restrictions between the two groups, although a comparison within the groups revealed the treatment group had a statistically significant decrease in mean phosphorus levels of 7.14 to 6.22 mg/dL (P = .005) from baseline to month 3. However, because this value was not maintained, it was not statistically significant. No significant differences existed between the two groups for health beliefs and perceptions of self-efficacy. Knowledge scores in the treatment group, however, improved significantly as compared to the control group (P = .008) and was a significant increase from baseline (P = . 002). In the control group, all scores fell slightly but this difference was not significant. CONCLUSIONS: The benefits of patient self-monitoring and behavioral contracting upon adherence in patients on hemodialysis are inconclusive, as serum phosphorus and interdialytic weight gains did not differ between the two groups. The interventional tools also appeared to have little effect on perceptions of self-efficacy and health beliefs. Trends of improvement, however, did exist for phosphorus within the treatment group and subjects in this group had a statistically significant increase in knowledge scores over time. Additional research using repeated measures design is needed to explore the effects of increased frequency and duration of an intervention on the attainment of patient clinical outcome measures.

Adult↗
PubMed1998

Surgical adjuvant active specific immunotherapy for patients with stage III melanoma: the final analysis of data from a phase III, randomized, double-blind, multicenter vaccinia melanoma oncolysate trial.

BACKGROUND: A phase III, randomized, double-blind, multicenter trial of active specific immunotherapy (ASI) using vaccinia melanoma oncolysate (VMO) was performed in patients with stage III (American Joint Commission on Cancer) melanoma to determine the efficacy of VMO to increase the disease-free interval (DFI) or overall survival (OS) in these patients. Two interim analyses of data from this trial were performed in May 1994 and June 1995. Although the results from these analyses showed no statistically significant improvement in DFI or OS in all patients using VMO, two subsets-men aged 44-57 years with one to five positive nodes and all patients with clinical stage I and pathologic stage II disease-showed an overall survival advantage with VMO therapy. A final analysis of data from this trial was performed in May 1996 and is reported here. The design of future melanoma vaccine trials is discussed based on information learned from this first randomized, multicenter trial of ASI therapy. STUDY DESIGN: A polyvalent VMO was prepared using melanoma cells derived from four melanoma cell lines and vaccinia vaccine virus (V). Patients were accrued from 11 United States institutions and were randomized by the Statistical Center at the University of Alabama, Birmingham. Two hundred fifty patients were randomized to treatment with either VMO (1 U containing 2 mg of total protein derived from 5 x 10(6) melanoma cells and 10(5.6) 50% tissue culture infectious dose of vaccinia virus) or control V (1 U containing 10(5.4) 50% tissue culture infectious dose of vaccinia virus) once a week for 13 weeks and then once every 2 weeks for a total of 12 months, or until recurrence. Patient data were collected by the Statistical Center and analyzed as of May 1996 for DFI and OS using Wilcoxon test and log-rank analysis. RESULTS: Two hundred seventeen patients were found to be eligible according to the inclusion criteria. Data from these patients were analyzed for DFI and OS after a median followup of 46.3 months (50.2 months for VMO and 41.3 months for V). This final analysis showed no statistically significant increase in either DFI (p = 0.61) or OS (p = 0.79) of patients treated with VMO (n = 104) compared with V (n = 113). At 2-, 3-, and 5-year intervals, 47.8%, 43.8%, and 41.7% of patients treated with VMO were disease-free, respectively, compared with 51.2%, 44.8%, and 40.4% of patients treated with V. At the same intervals, 70.0%, 60.0%, and 48.6% of patients treated with VMO survived, compared with 65.4%, 55.6%, and 48.2% of patients treated with V. In a retrospective subset analysis, male patients aged 44-57 years (n = 20) with one to five positive nodes showed 18.9%, 26.82%, and 21.3% improvement in survival at 2-, 3-, and 5-year intervals, respectively, after treatment with VMO when compared with V (n = 18) (p = 0.046). CONCLUSIONS: This study was a randomized, multicenter, placebo-controlled evaluation of an active specific immunotherapeutic agent to increase the DFI or OS of patients with stage III melanoma in a surgical adjuvant setting. In this trial, ASI with VMO when compared with V showed no difference in either DFI or OS. In a retrospective subset analysis, however, a subset of men with one to five positive nodes, between the ages of 44 and 57 years, showed a survival advantage with VMO. This result suggests that one must include a detailed subset analysis in the design of future trials of ASI for patients with American Joint Commission on Cancer stage III melanoma. An appropriate control arm also must be included in ASI trials.

Adolescent↗