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R J Babaian

Publications and source records attributed to R J Babaian.

At least 55 records · Page 3Linked to original sources

The results of a five-year early prostate cancer detection intervention. Investigators of the American Cancer Society National Prostate Cancer Detection Project.

BACKGROUND: The American Cancer Society-National Prostate Cancer Detection Project (ACS-NPCDP) is a multidisciplinary evaluation of early prostate cancer detection interventions. This report summarizes the experience of the investigators to date and describes the overall and relative performance of the different detection modalities studied in this project. METHODS: Two thousand nine hundred ninety-nine men aged 55 to 70 years at entry who were not already under evaluation for prostate cancer were recruited to participate in up to 5 annual examinations by prostate specific antigen (PSA), digital rectal examination (DRE), and transrectal ultrasound (TRUS). In the course of 5 years of intervention, ACS-NPCDP investigators have completed 9937 examinations, recommended 1215 biopsies, and detected 203 cancers. RESULTS: Loss to cohort follow-up was greatest in the first year. Overall, TRUS led to twice the number of recommendations for biopsy compared with DRE (8.9% versus 4.4%). Elevated PSA was observed in 13.0% of 9535 measurements performed. The overall cancer detection rate declined significantly during the five years of intervention. Detection was significantly associated with age and symptom status at entry. DRE had lower sensitivity compared with TRUS or PSA, particularly in later years of follow-up. The specificity of TRUS was lower than that for DRE. PSA was elevated in 69.2% of examinations that led to cancer detection, compared with only 10.9% when cancer was not found. PSA level, PSA density, and PSA change were all related to the presence of cancer. Less than 6% of the cancers detected in this study were clinically advanced at the time of diagnosis. CONCLUSIONS: These data quantify the yield of early cancer detection that may be expected when PSA, DRE, and TRUS are used in populations comparable to the men participating in the ACS-NPCDP. Continued follow-up and further research is needed to assess whether men receiving early prostate cancer interventions benefit as a result.

Aged↗

Comparative analysis of prostate specific antigen and its indexes in the detection of prostate cancer.

PURPOSE: Prostate specific antigen (PSA) density and age referenced PSA have been proposed in an attempt to improve the power of PSA in the detection of early prostate cancer. Reported results have been controversial and disappointing. Because the association of gland volume with PSA is stronger than that of age we developed a new index, volume referenced PSA, and compared it to PSA density and other indexes. MATERIALS AND METHODS: Volume referenced PSA was developed from a control group of 408 men without clinical evidence of prostate cancer using a standardized Z score. A retrospective analysis was performed comparing PSA and all its indexes in 580 men who underwent prostate biopsy. In addition to overall analysis, PSA and its indexes were evaluated with receiver operating characteristic curves by age and volume subcategories. RESULTS: Cancer was identified in 35% of the 580 men. The number of missed cancers using established thresholds significantly favored volume referenced PSA clinically and statistically compared to all other indexes but it was equivalent to PSA alone clinically. Age referenced PSA prevented more biopsies from being done than did volume referenced PSA (39% versus 31%) but resulted in the diagnosis of 48% fewer cancers. Receiver operating characteristic curve analysis demonstrated a significantly better performance for volume referenced PSA and PSA density compared to PSA alone and age referenced PSA. CONCLUSIONS: Volume based PSA indexes are superior to PSA and age referenced PSA statistically. However, clinically volume referenced PSA is comparable to PSA, and both are superior to age referenced PSA and PSA density in the detection of prostate cancer.

Adult↗

Bladder preservation and continent urinary diversion in T3b transitional cell carcinoma of the bladder.

The patient with T3b transitional cell carcinoma (TCC) of the bladder has traditionally been treated with radical cystectomy and urinary diversion, but initial success with systemic chemotherapy and renewed interest in quality-of-life issues has increased interest in bladder preservation treatments. Unfortunately, despite multiple trials using limited surgical procedures and neoadjuvant or adjuvant chemotherapy, no combined modality has consistently improved survival over the achieved with radical cystectomy alone in patients with T3b disease. Additionally, continent stomal diversions and orthotopic neobladders allow almost normal continence and voiding in both male and female patients, which calls into question the need for bladder preservation. Although no single treatment modality or urinary diversion is right for all patients, a radical cystectomy with continent diversion provides the best chance for survival and allows the best postoperative quality of life. If bladder preservation treatments are used, inclusion in a clinical trial is recommended.

Carcinoma, Transitional Cell↗

Homozygous deletions at 8p22 and 8p21 in prostate cancer implicate these regions as the sites for candidate tumor suppressor genes.

Frequent loss of an allele at specific chromosomal regions implicates these regions as sites of tumor suppressor genes (TSG) that become inactivated during tumor progression. We have studied chromosome 8p allele losses in 32 primary human prostate carcinomas with 16 polymorphic microsatellite sequences. Overall, 22 of 32 (69%) informative specimens showed loss of allele in at least one locus. The most frequent losses of heterozygosity (LOH) occurred at the LPL locus (46%) on chromosome 8p22 and at the D8S360 (45%) and NEFL (43%) loci on chromosome 8p21. Homozygous deletions were detected at the LPL and NEFL loci at 8p22 and 8p21, respectively. The minimal region with frequent LOH and homozygous deletion, around the LPL locus, was restricted between the MSR locus and the D8S258 marker, separated by less than 9 cM. The second region was restricted between markers D8S1128 and D8S131 separated by 12 cM. The results suggest the existence of two chromosome 8p sites for candidate TSGs in prostate cancer.

Alleles↗

Detection of residual prostate cancer after external radiotherapy. Role of prostate specific antigen and transrectal ultrasonography.

BACKGROUND: Although the incidence of positive post-radiotherapy biopsies has been reported, the range is considerable (19-93%) and depends partly on patient-selection criteria. In addition, the prognostic significance of transrectal ultrasonography (TRUS) and prostate specific antigen (PSA) used alone and in combination in predicting residual cancer after radiotherapy has yet to be determined. METHODS: Transrectal ultrasonography-guided prostate biopsies were performed on 31 unselected patients with prostate cancer 34-77 months (mean, 51 months) after definitive external beam radiotherapy was completed. Biopsy results were compared for pre- and posttreatment parameters (clinical stage, grade, PSA, and TRUS). RESULTS: In 22 patients (71%), residual cancer was detected histologically by biopsy. All but one patient (12/13, 92%) with a pretherapy PSA value greater than 10 ng/mL had a positive biopsy compared with 50% of those (7/14) with a pretherapy PSA value less than or equal to 10 (P < 0.05). After radiotherapy, a positive biopsy was noted for 15 of 16 patients (94%) with a PSA value greater than 2 and in 20 of 23 (87%) of those with abnormal TRUS findings (P < 0.01 and P < 0.005, respectively). CONCLUSIONS: The most clinically useful model for predicting histologically identifiable residual cancer was either a serum PSA value greater than 2 or a PSA value less than or equal to 2 and abnormal TRUS findings. The positive and negative predictive values of the model were 84% and 83%, respectively. The model predicted biopsy results correctly in 26 of 31 patients (84%). Transrectal ultrasonography is recommended as a diagnostic tool for patients whose PSA level ranges from a detectable level to less than or equal to 2 ng/mL.

Aged↗

Tumor volume and prostate specific antigen: implications for early detection and defining a window of curability.

PURPOSE: We attempted to determine the relationship between tumor volume and extent of localized prostate cancer, as well as the interrelationships of tumor volume with prostate specific antigen (PSA) level, grade and stage. MATERIALS AND METHODS: Serial whole mount sections from 128 patients who underwent radical prostatectomy were analyzed using a computer assisted volumetric program. Statistical evaluations were performed using logistic and simple regression analyses. RESULTS: The median tumor volume for patients with organ confined disease was significantly lower than for those with extraprostatic extension (1.25 versus 2.94 cc, p < 0.001). A significant incidence (32%) of small volume cancers (0.51 to 1.5 cc) exhibited extraprostatic extension while that of extraprostatic disease increased to 66% for patients with tumor volumes greater than 1.5 cc (p < 0.001). Of men with clinically significant (greater than 0.5 cc, or Gleason score 7 or more) pathological stage B disease 31% had a serum PSA value of 4 ng./ml. or less. Multivariate regression analysis of tumor volume as a function of PSA, grade and stage demonstrated that log PSA had the strongest association with tumor volume. Goodness-of-fit analysis (coefficient of determination) revealed that only 40 to 50% of the PSA levels are explained by tumor volume. CONCLUSIONS: These data suggest that the window of curability for prostate cancer decreases significantly once the tumor grows to a volume greater than 1.5 cc, and that grade and tumor volume are more significantly related to stage than PSA.

Humans↗

Use of prostate-specific antigen and tumor volume in predicting needle biopsy grading error.

OBJECTIVES: To study the discrepancy between histologic grades of needle biopsy and prostatectomy specimens and to define the potential role of prostate-specific antigen (PSA), PSA density, and tumor volume in predicting the tumor grade. METHODS: Histopathologic grades on needle biopsy and subsequent radical prostatectomy specimens were compared in 135 patients with clinically organ-confined prostate cancer. The frequency of undergrading (difference of one or more grades) by needle biopsy was then compared to PSA, PSA density, and other preoperative parameters. RESULTS: The frequency of undergrading by one level was 45% using the M. D. Anderson Hospital (MDAH) system and 47% using the Gleason system. When the tumor grades were classified into two categories, undergrading rates of 26% (low to high grade by the MDAH system) and 21% (moderately well to poorly differentiated by the Gleason system) were noted. Serum PSA and PSA density correlated with the grading error rate: the higher the PSA and PSA density values, the higher the biopsy undergrading rate. PSA showed a significant correlation with undergrading (P = 0.0019). Undergrading occurred in 32% of patients with a PSA more than 4 and 10 ng/mL or less and in 47% of those with a serum PSA more than 10 ng/mL. In all cases when the PSA was 4 ng/mL or less, the needle biopsy results correctly predicted the final tumor grade category. Tumor volume was not associated with frequency of undergrading. CONCLUSIONS: The ability to predict tumor grade can be enhanced by considering the serum PSA value.

Adult↗

Management of transitional cell carcinoma involving von Brunn's nests.

We reviewed data collected from 371 patients with superficial transitional cell carcinoma of the bladder to determine whether carcinoma within von Brunn's nests is a risk factor for cancer progression and an indication for radical cystectomy. Cystectomy was done in 20 of 73 patients (27%) with transitional cell carcinoma in von Brunn's nests and in 42 of 298 patients (14%) without von Brunn's nest involvement. There was no significant difference in the Kaplan-Meier crude and disease-specific survival between patients with and without transitional cell carcinoma in von Brunn's nests, irrespective of whether radical cystectomy was performed initially. Of those patients with von Brunn's nest involvement none who underwent cystectomy died of bladder carcinoma, while 3 (6%) managed conservatively died of bladder cancer. Of those patients without von Brunn's nest involvement 1 (5%) managed with cystectomy and 9 (4%) managed conservatively died of bladder carcinoma. Furthermore, only 8 patients (15%) with and 29 (11%) without transitional cell carcinoma in von Brunn's nests showed disease progression after initial conservative management. Based on this analysis, our conclusion is that transitional cell carcinoma within von Brunn's nests is not a risk factor for disease progression or an absolute indication for radical cystectomy.

Aged↗

Ultrasonic volume monitoring in patient with prostate cancer treated by external beam radiation therapy.

OBJECTIVE: To determine whether or not tumor volume estimates are useful in predicting and detecting disease progression following radiation therapy in patients being treated for adenocarcinoma of the prostate. METHODS: Compare preradiation therapy ultrasound determined volumetric analysis of the prostate gland, the hypoechoic tumor lesion, and prostate-specific antigen (PSA) values to sequential post-therapy determinations. RESULTS: The average percent volume reduction rates at three months postradiation therapy of the entire prostate gland and the hypoechoic tumor lesion were 18.1 and 60 percent, respectively. The serum PSA value at three months decreased by 69.3 percent. After the first three months, further reductions in all three parameters were minimal. The volume of the histologically confirmed cancer lesions in progressing patients decreased at a slower rate than that of nonprogressing patients during the initial six months of follow-up (p = 0.03). Among the 14 progressing patients, a new hypoechoic lesion (5 of which were biopsy-positive) developed in 7, and 7 had persistent lesions. An elevated PSA was observed in 10 of the progressors. CONCLUSIONS: The volume change of the hypoechoic lesion was sensitive in detecting disease progression and mirrored the change in PSA levels. The monitoring of hypoechoic lesion volume is useful both to predict and to detect disease progression following radiation therapy while volume change of the prostate gland was not sensitive for these purposes.

Adenocarcinoma↗

Therapy and prognosis for male anterior urethral carcinoma: an update.

OBJECTIVE: The scarcity of reports evaluating the effect of current treatment strategies for male urethral carcinoma has prompted a review of our recent experience. Since our last report (1980), we have seen 23 patients with this disease. METHODS: We performed a retrospective chart review of 23 patients seen in our institution between 1979 and 1990 with this type of cancer. RESULTS: Fifty-two percent of our patients are alive without evidence of disease, after a mean follow-up of fifty months (range, 5 to 156 months). Treatment analysis indicates that distal urethrectomy and partial penectomy are adequate in controlling local disease for tumors arising in the fossa navicularis and penile urethra, respectively, and that en bloc excision of the penis, scrotum, prostate, and bladder together with resection of the inferior pubic rami, using myocutaneous flaps to cover the surgical defect, can provide long-term disease-free survival for patients whose tumor originates in the bulbomembranous urethra. Use of cisplatin-based chemotherapy resulted in a prolonged survival for patients who presented with metastatic disease. CONCLUSIONS: We conclude that the prognosis for patients with urethral carcinoma has improved, and some of the patients are having a prolonged disease-free survival due, in part, to more effective local and regional control and improved chemotherapy.

Adult↗

Radioimmunoscintigraphy of pelvic lymph nodes with 111indium-labeled monoclonal antibody CYT-356.

In an attempt to define the possible role of radioimmunoscintigraphy to assess noninvasively the pelvic lymph nodes, we studied 19 patients with prostate cancer. All 19 men underwent conventional radiographic imaging of the pelvis with computerized tomography or magnetic resonance imaging before bilateral pelvic lymph node dissection. In addition, radioimmunological scanning with 111indium-labeled monoclonal antibody CYT-356 was performed. Pathologically 8 of the 19 patients had histological confirmation of metastatic nodal disease ranging from 1 to 15 mm. The monoclonal scan was positive at a site corresponding to the histologically confirmed nodal foci in 4 of the 8 patients. Since each hemipelvis could be independently assessed for pathological disease and imaging status, we report site-specific analysis of the monoclonal antibody scan in 38 hemipelves. The overall accuracy was 76% with a sensitivity and specificity of 44% and 86%, respectively. The negative predictive value was 83% and the positive predictive value was 50%. The administration of a single dose of CYT-356 antibody is safe, feasible and capable of detecting soft tissue nodal disease. A negative scan enables the physician to predict noninvasively a low probability of nodal disease for individuals at high risk. The detection threshold of this antibody scan appears to be disease foci 5 mm. or greater.

Aged↗

Diagnostic testing for prostate cancer detection: less is best.

The incidence of clinically organ-confined prostate cancer has markedly improved in programs designed to detect this disease by utilizing a combination of diagnostic modalities including digital rectal examination (DRE), transrectal ultrasonography (TRUS), and prostate-specific antigen (PSA). Biopsies were performed on 436 men who had abnormal findings on DRE, TRUS, or PSA. Overall, 39 percent of these men had histologic confirmation of prostate cancer. TRUS diagnosed more cancer (94%) than either DRE (80%) or PSA (89%), while the combination of TRUS and PSA diagnosed a similar number of cancers as the combination of DRE and PSA (100% vs 98%). The positive predictive value (PPV) of DRE and PSA combination was significantly better than that of TRUS and PSA (p = 0.01), but was not different from that of a combination of all three tests. DRE and PSA would have missed 4 cancers, but would have cost approximately 140 percent less than any program employing TRUS. Consequently, we recommend that the combination of DRE and PSA be used in primary early detection for prostate cancer and that TRUS be performed only when either or both DRE and PSA results are abnormal.

Costs and Cost Analysis↗

Lymphoepithelioma of the bladder: a clinicopathological study of 3 cases.

Lymphoepithelioma of the bladder is rare and has only recently been described at this site. Based upon the reported sensitivity to chemotherapy of lymphoepitheliomas at more common sites, we treated 3 cases of muscle invasive lymphoepithelioma of the bladder with primary chemotherapy to salvage bladder function.

Aged↗

Analytical performance goals for measuring prostate-specific antigen.

We have assessed the feasibility of using fixed-limit criteria based on medical relevance and biological variation for evaluating the analytical performance of the prostate-specific antigen (PSA) test. The estimated within-subject variation of serum PSA is on the order of 10-20% at clinical decision points. The calculated performance goals of 5-10% CV are attainable with current immunoassay technology and agree with precision goals based on clinical experience and the current clinical use of the test. However, new clinical applications of PSA may require a degree of analytical performance that current methods may not be able to provide. The PSA model demonstrates the need for biologically based fixed-limit criteria for all tumor-marker tests.

Biomarkers, Tumor↗

The relationship of prostate-specific antigen to digital rectal examination and transrectal ultrasonography. Findings of the American Cancer Society National Prostate Cancer Detection Project.

The participating institutions of the American Cancer Society National Prostate Cancer Detection Project did 520 biopsies on 2425 men over a 3.5-year period. A total of 88 cancers were confirmed pathologically, 93% of which clinically were organ confined. In 324 men (62.3%), a recommendation for biopsy was made based solely on the results of transrectal ultrasonography (TRUS); in 69 patients (13.3%), solely on the digital rectal examination (DRE); in 116 patients (22.3%), on abnormal DRE and TRUS examinations; and in 11 patients (2.1%), in whom DRE and TRUS were normal, on elevated prostate-specific antigen (PSA) levels. The TRUS was abnormal in 80.6% of men found to have cancer, and the PSA level and DRE were abnormal for 67% and 50% of cancers, respectively. The influence of PSA level on cancer detection increased as the serum level increased above 4 ng/ml. The positive predictive values of both the DRE and TRUS were influenced significantly by the presence of an elevated PSA level (P = 0.044 and P less than 0.001, respectively). The results of this ongoing multicenter study support the following statements: (1) the prostate cancer detection rate is influenced by this diagnostic triad and (2) the detection rate of organ-confined disease can be improved substantially by early detection programs.

Aged↗

Stage B (P2/3A/N0) transitional cell carcinoma of bladder highly curable by radical cystectomy.

Seventy-one patients with pathologic Stage B (P2/3a/N0) transitional cell carcinoma (TCC) of the bladder underwent radical cystectomy alone without preoperative radiotherapy or perioperative chemotherapy between 1983 and 1987 and have been followed a median of fifty months. The five-year actuarial survival and disease-free survival rates were 82 percent and 77 percent, respectively, and only 13 patients (18%) have relapsed. Histologic parameters were evaluated as to prognostic impact; none correlated with disease-free survival rates although the presence of vessel involvement portended a worse disease-free survival rate (68% versus 80%). During this same period, an additional 15 patients underwent radical cystectomy for pathologic Stage B disease but received adjuvant chemotherapy on the basis of vessel invasion. Their disease-free survival rate at five years was 80 percent, comparable to the disease-free survival rate for patients with vessel invasion treated by surgery alone (68%). Although the role of systemic chemotherapy in the management of invasive bladder cancer remains under investigation, it would appear that patients with Stage B TCC are best treated with radical cystectomy alone. Continued analysis of modern surgical results grouped by current pathologic staging criteria is needed to identify patients who have a relatively low risk of relapse and thus little need for additional therapeutic intervention. These results demonstrate that Stage P2/3a/N0 TCC of the bladder is highly curable by surgery.

Adult↗

BCG-induced granulomatous prostatitis: a comparative ultrasound and pathologic study.

We analyzed the ultrasound findings and the information obtained from serial whole-mount cross-section histologic examination of the prostates from 6 patients with bacillus Calmette-Guérin (BCG)-induced granulomatous prostatitis. Similarities to prostate cancer included a hypoechoic pattern on ultrasound, multifocality, and a propensity for a peripheral zone location. BCG-induced granulomatous prostatitis cannot be distinguished from cancer by ultrasonography. We suggest performing an ultrasound examination prior to starting BCG immunotherapy as a baseline for future reference to aid in the clinical diagnosis of BCG-induced granulomatous prostatitis.

Adenocarcinoma↗