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Biomedical subjects

A Wein

Publications and source records attributed to A Wein.

At least 73 records · Page 4Linked to original sources
PubMed1998

Calculated prostate cancer volume greater than 4.0 cm3 identifies patients with localized prostate cancer who have a poor prognosis following radical prostatectomy or external-beam radiation therapy.

PURPOSE: Patients with palpable extraprostatic disease (T3) have a poor prostate-specific antigen (PSA) failure-free (bNED) survival rate after radical prostatectomy (RP) or external-beam radiation therapy (RT). This study was performed to validate or refute the prognostic value of the previously defined calculated prostate cancer volume (cV(Ca)). PATIENTS AND METHODS: For patients with clinically localized disease (T1c,2), a Cox regression multivariable analysis was used to assess the ability of the cV(Ca) value to predict time to posttherapy PSA failure following RP or RT. RESULTS: The cV(Ca) value was a significant predictor (P < or = .0005) of time to posttherapy PSA failure in both an RP and RT data set independent of the one used to derive the cV(Ca)-based clinical staging system. In both RP- and RT-managed patients, estimates of 3-year bNED survival were not statistically different for patients with either T1c,2 disease and a cV(Ca) greater than 4.0 cm3 (RP, 27%; RT, 18%) or T3 disease (RP, 37%; RT, 34%). Despite pathologic T2 disease, the 3-year estimate of bNED survival was at most 51% in RP-managed patients with T1c,2 disease and cV(Ca) greater than 4.0 cm3. CONCLUSION: A cV(Ca) greater than 4.0 cm3 identified patients with T1c.2 disease whose bNED survival was poor after RT or RP despite pathologic T2 disease that suggests the presence of occult micrometastatic disease in many of these patients. Prospective randomized trials to evaluate the impact on survival of adjuvant systemic therapy in these high-risk patients are justified.

Disease-Free Survival↗
PubMed1997

Equivalent 5-year bNED in select prostate cancer patients managed with surgery or radiation therapy despite exclusion of the seminal vesicles from the CTV.

PURPOSE: Prostate Specific Antigen (PSA) failure free survival was determined for select prostate cancer patients managed definitively with external beam radiation therapy to the prostate only or radical retropubic prostatectomy. METHODS AND MATERIALS: A logistic regression multivariable analysis evaluating the variables of PSA, biopsy Gleason score, and clinical stage was used to evaluate the endpoint of pathologic seminal vesicle invasion (SVI) in 749 consecutive prostate cancer patients managed with a radical retropubic prostatectomy. In a subgroup of 332 surgically and 197 radiation managed patients who did not have the clinical predictors of SVI, PSA failure free survival (bNED) was determined. Comparisons were made using the log rank test between surgically and radiation managed patients in this subgroup. In this subgroup, radiation managed patients were treated to a median dose of 66 Gy (66-70 Gy) to the prostate only. RESULTS: The pretreatment PSA (> 10 ng/ml), biopsy Gleason score (> or = 7), and clinical stage (T2b, 2c, or 3) were found to be significant independent predictors (p < 0.001) of SVI. Only 2% of patients without any of these factors had SVI and 17% had extracapsular extension (15% microscopic; 2% macroscopic). In this subgroup the 5-year bNED rates were equivalent [84 vs. 89% (p = 0.67)] for surgically and radiation managed patients, respectively. CONCLUSIONS: Conventional dose external beam radiation therapy directed at the prostate alone resulted in 5-year bNED rates equivalent to surgery on retrospective comparison in patients with clinical stage T1,2a, PSA < or = 10 ng/ml, and biopsy Gleason < or = 6 prostate cancer.

Biopsy↗
PubMed1997

Equivalent biochemical failure-free survival after external beam radiation therapy or radical prostatectomy in patients with a pretreatment prostate specific antigen of > 4-20 ng/ml.

PURPOSE: Biochemical failure-free survival stratified by the pretreatment prostate-specific antigen (PSA) and biopsy Gleason score (bGl) is determined for prostate cancer patients managed definitively with external beam radiation therapy or radical retropubic prostatectomy. METHODS AND MATERIALS: A Cox regression multivariable analysis evaluating the variables of PSA, bGl, and clinical stage was used to evaluate the end point of time to PSA failure in 867 and 757 consecutive prostate cancer patients managed definitively with external beam radiation therapy or radical retropubic prostatectomy, respectively. PSA failure-free survival was determined using Kaplan-Meier analysis. Comparisons were made using the log rank test. RESULTS: The pretreatment PSA, bGl, and clinical stage (T3,4 vs. T1,T2) were found to be independent predictors of time to post-treatment PSA failure for both surgically and radiation managed patients using Cox regression multivariable analysis. Patients with a pretreatment PSA of > 4 ng/ml and < or = 20 ng/ml could be classified into risk groups for time to post-therapy PSA failure: low = PSA > 4-10 ng/ml and bGl < or = 4; intermediate = PSA > 4-10 and bGl 5-7; or PSA > 10-20 ng/ml and bGl < or = 7; high = PSA > 4-20 ng/ml and bGl > or = 8. Two-year PSA failure-free survival for surgically managed and radiation-managed patients, respectively, were 98% vs. 92% (p = 0.45), 77% vs. 81% (p = 0.86), and 51% vs. 53% (p = 0.48) for patients at low, intermediate, and high risk for post-therapy PSA failure. CONCLUSIONS: There was no statistical difference in the 2-year PSA failure-free survival for potentially curable patients managed definitively with surgery or radiation therapy when a retrospective comparison stratifying for the pretreatment PSA and bGl was performed.

Disease-Free Survival↗
PubMed1997

Combined modality staging of prostate carcinoma and its utility in predicting pathologic stage and postoperative prostate specific antigen failure.

OBJECTIVES: This study was performed to predict the factors that can optimize preoperative staging for clinically localized prostate cancer patients. METHODS: Logistic and Cox regression multivariable analyses were performed on 480 surgically-managed prostate cancer patients to evaluate the ability of clinical stage, prostate specific antigen (PSA), biopsy Gleason sum, percent positive biopsies, and endorectal coil magnetic resonance imaging (erMRI) results to predict for pathologic established extracapsular extension (ECE), seminal vesicle invasion (SVI), and time to postoperative PSA failure. RESULTS: The characteristics of clinically organ-confined prostate cancer patients at high risk (> 67%) for postoperative PSA failure within 3 years include: (A) PSA > 20 ng/mL; (B) Biopsy Gleason sum > or = 8; or (C) erMRI positive for extraprostatic disease and intermediate risk disease. For patients at intermediate risk (ie, either a PSA < 4 and biopsy Gleason sum of 7; PSA > 4 to 10 ng/mL and biopsy Gleason sum 5 to 7; or a PSA > 10 to 20 ng/mL and biopsy Gleason sum 2 to 7), despite 100% positive biopsies, 50% of patients had pathologic organ-confined disease. However, in the subset of intermediate-risk patients with a positive erMRI for either ECE or SVI and at least 50% positive biopsies, all had extraprostatic disease and failed biochemically by 47 months postoperatively. Intermediate-risk patients with < 50% positive biopsies had pathologic organ-confined disease in at least 77% of the cases. CONCLUSIONS: Combined modality staging using the PSA, biopsy Gleason sum, percent positive biopsies, and endorectal coil MRI findings in select patients can predict pathologic stage and postoperative PSA failure. Therefore, this combined modality staging may optimize patient selection for phase 3 trials examining the role of neoadjuvant androgen ablative therapy for patients with clinically localized disease.

Genital Neoplasms, Male↗
PubMed1997

Prostate-specific antigen failure despite pathologically organ-confined and margin-negative prostate cancer: the basis for an adjuvant therapy trial.

PURPOSE: A multivariable analysis to evaluate the potential clinical and pathologic factors that predict for early biochemical failure in patients with pathologically organ-confined and margin-negative disease was performed to define patients who may benefit from adjuvant therapy. PATIENTS AND METHODS: Three hundred forty-one prostate cancer patients treated with a radical retropubic prostatectomy between January 1989 and June 1995 and found to have pathologically organ-confined and margin-negative disease comprised the study population. A logistic regression multivariable analysis to evaluate the predictive value of the preoperative prostate-specific antigen (PSA) level, pathologic (prostatectomy) Gleason score, and pathologic stage on PSA failure occurring during the first postoperative year was performed. RESULTS: Predictors of PSA failure during the first postoperative year in patients with pathologically organ-confined disease included pathologic Gleason score > or = 7 (P = .0007) and preoperative PSA level greater than 10 (P < .0001). Corresponding 3-year freedom-from-PSA-failure rates for these pathologic organ-confined patients with both, one, or neither of these factors were 60%, 75% to 84%, and 95%, respectively (P < .0001). CONCLUSION: Prostate cancer patients with pathologically organ-confined and margin-negative disease and a preoperative PSA level greater than 10 ng/mL or a pathologic Gleason score > or = 7 have significant decrements in short-term PSA-failure-free survival. Therefore, these patients should be considered for adjuvant therapy in the setting of a phase III clinical trial.

Humans↗
PubMed1997

Phase I trial of paclitaxel/carboplatin in advanced carcinoma of the urothelium.

We performed a phase I trial of 3-hour paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (dose levels of 150, 175, 200, and 225 mg/m2) plus carboplatin dosed to an area under the concentration-time curve of 6. Sixteen patients were treated. Dose-limiting neuropathy was demonstrated in one patient each at the 175 and 200 mg/m2 dose levels. Grade 3 to 4 granulocytopenia was common; grade 3 to 4 thrombocytopenia was uncommon. The maximum tolerated dose of the regimen was not reached. Two complete and seven partial responses were demonstrated. We conclude that paclitaxel 225 mg/m2 plus carboplatin dosed to an area under the concentration-time curve of 6 can be administered to patients with advanced carcinoma of the urothelium. The regimen has encouraging preliminary activity. Phase II accrual is ongoing.

Aged↗
PubMed1997

Outcome based staging for clinically localized adenocarcinoma of the prostate.

PURPOSE: Some patients with clinically localized prostate cancer are not cured after radical prostatectomy because of the presence of occult systemic disease. The American Joint Commission on Cancer staging classification for prostate cancer does not reliably distinguish between clinically localized patients who are likely or unlikely to be cured after local therapy. This project was undertaken to develop a staging system capable of predicting long-term outcome after radical prostatectomy on the basis of the clinical parameters obtained routinely during the standard workup for patients with adenocarcinoma of the prostate. MATERIALS AND METHODS: A total of 688 clinically localized prostate cancer patients managed with a radical retropubic prostatectomy for adenocarcinoma of the prostate between 1989 and 1996 was evaluated for clinical features predictive of time to prostate specific antigen (PSA) failure using a Cox regression multivariate analysis. A recently defined clinical factor called the calculated prostate cancer volume and its ability to predict time to PSA failure in conjunction with PSA, biopsy Gleason score and clinical stage were evaluated. RESULTS: The calculated prostate cancer volume (p <0.0001) and the pretreatment PSA (p <0.001) provided the optimal staging system for predicting freedom from PSA failure after radical prostatectomy. CONCLUSIONS: The calculated prostate cancer volume and PSA may provide clinically useful information regarding outcome after radical prostatectomy, enabling the selection of a therapeutic approach for an individual patient with clinically localized disease. Validation of this staging system is needed.

Adenocarcinoma↗
PubMed1996

An analysis of the time course of postoperative prostate-specific antigen failure in patients with positive surgical margins: implications on the use of adjuvant therapy.

OBJECTIVES: The role of adjuvant therapy in the postprostatectomy setting for positive margin patients is an unresolved issue. The purpose of this study is to provide the rationale for patient selection in Phase III trials that test the impact of adjuvant therapy on survival in positive margin prostate cancer patients. METHODS: Early (12 months or less) and delayed (more than 12 months) postoperative prostate-specific antigen (PSA) failure have been correlated with distant and local failure, respectively, as the site of first failure. In this study, a Cox regression multivariate analysis was used to determine the significant independent clinical and pathologic predictors of early and delayed postoperative PSA failure in 143 margin-positive prostate cancer patients. RESULTS: Margin-positive patients with positive pelvic lymph nodes, seminal vesicle invasion, or prostatectomy Gleason sum 8 or higher were excluded. For the remaining patients, a prostatectomy Gleason sum of 7, preoperative PSA more than 20 ng/mL, and an endorectal coil magnetic resonance imaging (erMRI) scan showing extensive disease were significant independent predictors of early postoperative PSA failure. Conversely, a prostatectomy Gleason sum of 6 or less, preoperative PSA 20 ng/mL or less, and an erMRI showing limited disease predicted delayed PSA failure. CONCLUSIONS: Preliminary data suggest that the pattern of first failure can be predicted by the time course of rise in the postoperative PSA. The preliminary results of this study suggest that patient selection for clinical trials examining the efficacy of postoperative adjuvant therapy in the positive margin patient may be determined on the basis of the clinical and pathologic characteristics that predict early versus delayed postoperative PSA failure.

Clinical Trials, Phase III as Topic↗
PubMed1996

Critical analysis of the ability of the endorectal coil magnetic resonance imaging scan to predict pathologic stage, margin status, and postoperative prostate-specific antigen failure in patients with clinically organ-confined prostate cancer.

PURPOSE: To determine whether there is a role for endorectal coil magnetic resonance imaging (erMRI) in the prediction of pathologic stage, margin status, and/or postoperative prostate-specific antigen (PSA) failure in patients with clinically organ-confined prostate cancer. PATIENTS AND METHODS: Using erMRI, the radiologic-pathologic correlation of extracapsular extension (ECE) and seminal vesicle invasion (SVI) was evaluated in 445 surgically managed patients. Logistic regression multivariable analysis was applied to the clinical stage, PSA, biopsy Gleason grade, and erMRI findings to assess the outcomes of ECE, SVI, positive surgical margins (PSM), and postoperative PSA failure. RESULTS: The accuracy of erMRI to predict for ECE and SVI numerically decreased with both increasing PSA and biopsy Gleason score because of the increasing false-negative scans in cases of microscopic transcapsular or seminal vesicle disease. Of patients who could not be categorized into low or high risk for postoperative PSA failure on the basis of clinical stage, preoperative PSA, and biopsy Gleason score, a negative or positive erMRI for ECE or SVI stratified these patients into groups with a 78% versus 21% (P < .0001) 3-year rate of actuarial freedom from PSA failure. In this subgroup, the overall accuracy of the erMRI was 70% +/- 6% and 94% +/- 2% for ECE and SVI, respectively. The most significant predictor on multivariable analysis of PSM was the erMRI finding of ECE (P = .0001). CONCLUSION: This initial report suggests that a preoperative erMRI can identify clinically organ-confined prostate cancer patients at high risk for having ECE, SVI, and PSM that otherwise would be missed on the basis of the clinical stage, preoperative PSA, and biopsy Gleason score. Confirmatory studies are needed.

Adenocarcinoma↗
PubMed1995

The impact of the inclusion of endorectal coil magnetic resonance imaging in a multivariate analysis to predict clinically unsuspected extraprostatic cancer.

BACKGROUND: The introduction of the endorectal coil magnetic resonance imaging (MRI) technique has improved the accuracy of preoperative staging for prostate cancer. This study quantifies the improvement in the ability to identify clinically unsuspected extraprostatic disease with the use of the endorectal coil MRI. METHODS: A retrospective review of the pathologic findings of 347 patients with prostate cancer treated with a radical retropubic prostatectomy was performed. The preoperative clinical indicators including prostate specific antigen (PSA), clinical stage, Gleason score, and endorectal coil MRI data were employed in a multivariate analysis to identify patients who were at high risk for seminal vesicle invasion (SVI) or extracapsular extension (ECE). The sensitivity, specificity, and positive and negative predictive values for predicting SVI and ECE were calculated using the significant clinical indicators found on the multivariate analysis. RESULTS: The clinical factors identified on multivariate analysis as significant predictors of SVI include the endorectal coil MRI data (P < 0.0001), PSA (P = 0.0096), and the Gleason score (P = 0.012). Endorectal coil MRI data (P < 0.0001), PSA (P = .0001), and Gleason score (P < .0001) were significant predictors of ECE. In the patient subgroup with PSA (> 10-20 ng/ml) and Gleason score of 5 to 7, the addition of the endorectal coil MRI data enabled an additional 71 and 27% of patients with SVI and ECE, respectively, to be correctly identified. These patients would have been missed based on the prediction obtained from the PSA and Gleason score alone. CONCLUSIONS: The use of the endorectal coil magnetic resonance imaging data, in addition to prostate specific antigen and Gleason score, provides a more accurate prediction of the pathologic outcome of seminal vesicle invasion and extracapsular extension than the PSA and Gleason score alone for the patient subgroup with a PSA of greater than 10 to 20 ng/ml and Gleason score of 5 to 7.

Adenocarcinoma↗
PubMed1995

A multivariate analysis of clinical and pathological factors that predict for prostate specific antigen failure after radical prostatectomy for prostate cancer.

A Cox regression multivariate analysis was done to determine the clinical and pathological indicators that predict for prostate specific antigen (PSA) failure in 347 patients who underwent radical prostatectomy for clinically localized prostate cancer between 1989 and 1993. In the patient subgroups (PSA less than 20 ng./ml. and biopsy Gleason sum 5 to 7 or PSA more than 10 to 20 ng./ml. and biopsy Gleason sum 2 to 4) not classifiable into those at high and low risk for postoperative PSA failure using PSA and biopsy Gleason sum, the status of the seminal vesicles and prostatic capsule on endo-rectal coil magnetic resonance imaging (MRI) allowed for this categorization. Specifically, 2-year actuarial PSA failure rates were 84% versus 23% in patients with and without seminal vesicle invasion, respectively, on MRI (p < 0.0001) and 58% versus 21% in those with and without extracapsular extension, respectively (p = 0.0001). In patients with extracapsular extension but without pathological involvement of the seminal vesicle(s) or poorly differentiated tumors (pathological Gleason sum 8 to 10), the 2-year actuarial PSA failure rates were 50% (margin positive), 28% (margin negative with established extracapsular disease) and 9% (margin negative with focal microscopic extracapsular disease). Therefore, endo-rectal coil MRI showing seminal vesicle invasion or extracapsular extension when the PSA level is less than 20 ng./ml. and the biopsy Gleason sum is 5 to 7 or the PSA level is more than 10 but less than 20 ng./ml. and the biopsy Gleason sum is 2 to 4 predicted for PSA failure. In patients with extracapsular extension who had pathological Gleason sum less than 8 disease with uninvolved seminal vesicles, the margin status and extent of extracapsular disease predicted for PSA failure.

Actuarial Analysis↗
PubMed1994

A multivariable analysis of clinical factors predicting for pathological features associated with local failure after radical prostatectomy for prostate cancer.

PURPOSE: A multivariate analysis is used to determine the predictive value of pretreatment clinical indicators on pathologic features associated with local failure after radical prostatectomy in patients with prostate cancer. METHODS AND MATERIALS: A retrospective review of the pathologic findings of 235 patients with adenocarcinoma of the prostate treated between 1990 and 1993 with a radical retropubic prostatectomy was performed. The preoperative clinical data including the serum prostate specific antigen, clinical stage, Gleason sum, and endorectal magnetic resonance scan findings are used to identify patients prior to definitive treatment who would be at high risk for having pathologic features associated with local failure at radical prostatectomy. Outcome prediction curves are constructed from a logistic regression multivariate analysis displaying the probability of pathologic involvement of the seminal vesicle, extracapsular disease, or positive surgical margins as a function of the preoperative prostate specific antigen and Gleason sum for the cases when the endorectal magnetic resonance scan is positive, negative, or not included in the multivariate analysis. RESULTS: Factors identified on multivariate analysis as significant predictors of seminal vesicle invasion include endorectal magnetic resonance scan findings (p < 0.0001), and preoperative prostate specific antigen (p = 0.017). Endorectal magnetic resonance scan findings (p = 0.0016), preoperative prostate specific antigen (p = 0.0002), and Gleason sum (p < 0.0001) were significant predictors of extracapsular extension and preoperative prostate specific antigen (p < 0.0001) and Gleason sum (p = 0.03) were significant predictors of disease extending to the margins of resection. Clinical stage was not a significant predictor (p > 0.05) of pathologic features associated with local failure on multivariate analysis. As a single modality, endorectal surface coil magnetic resonance imaging was accurate 93%, 69%, and 72% of the time for predicting seminal vesicle invasion, transcapsular disease, and final pathologic stage, respectively. Failure to recognize microscopic penetration of the capsule found at the time of pathologic evaluation in a prostate gland with a grossly intact capsule accounts for the majority (70%) of the staging inaccuracies. CONCLUSIONS: The use of the endorectal surface coil magnetic resonance scan findings in conjunction with both the serum prostate specific antigen and Gleason sum improves the clinical accuracy of predicting those patients at high risk for clinically unsuspected extraprostatic disease. In particular, for the subgroup of patients with moderately elevated prostate specific antigen (> 10-20 ng/mL) and intermediate grade clinically organ confined prostate cancer [Gleason sum: 5-7] where the specificity of these tests to predict for occult extraprostatic disease is suboptimal, the additional information obtained from the endorectal coil magnetic resonance scan allows the physician to definitively subgroup these patients into low and high risk for seminal vesicle invasion or transcapsular disease.

Adenocarcinoma↗
PubMed1991

Carcinosarcoma of bladder following long-term cyclophosphamide therapy.

Since the advent of long-term cyclophosphamide therapy, an association between this agent and the subsequent development of bladder neoplasms has been documented. Only six sarcomas have been reported, to our knowledge. This report describes the first case in which a leiomyosarcoma and an invasive transitional cell carcinoma (ie, carcinosarcoma) developed in a patient with non-Hodgkin's lymphoma treated with 240 g of cyclophosphamide over a 6.5-year period.

Carcinosarcoma↗