Analysis of clinicopathologic factors predicting outcome after radical prostatectomy.

BACKGROUND: A variable biochemical failure rate has been reported for patients undergoing radical prostatectomy. The authors analyzed their 1987-1993 prostatectomy experience retrospectively to stratify the risk of failure in order to appropriately select patients who potentially may benefit from adjuvant therapy. METHODS: A stepwise logistic regression was used to identify variables associated with biochemical failure in 265 patients who underwent radical prostatectomy only. Prostate tumors were examined by one pathologist using 4-mm step sections. Numerous clinicopathologic variables were evaluated, and the neoplasms were subclassified into five pathologic categories based on tumor extent and margin status. Actuarial projections of biochemical failure were created using the Kaplan-Meier method. RESULTS: Pathologically, 56.2% of the tumors were organ-confined with negative margins, 12.8% had a positive surgical margin without evidence of extraprostatic extension (EPE), 24.2% had EPE (17% with negative margins and 7.2% with positive margins), and 6.8% had seminal vesicle involvement. The Gleason score was > or = 7 in 86.4% of the total population. Values for the preoperative prostate specific antigen assay were < or = 4.0 ng/mL in 23.4% of the men and > 10 ng/mL in 27.7%. The overall observed biochemical failure rate in this patient group with a minimum 48 months of follow-up was 15.5%. Overall, stepwise logistic regression analysis revealed that pathologic category was the variable most strongly associated with biochemical failure and that vascular invasion was the only other examined variable associated with failure. CONCLUSIONS: The combination of pathologic category and the prostatectomy Gleason score can stratify a patient's probability of biochemical failure into three distinct groups and can identify the appropriate patients who may benefit from novel adjuvant therapeutic strategies.

The incidence of prostate cancer in a screening population with a serum prostate specific antigen between 2.5 and 4.0 ng/ml: relation to biopsy strategy.

PURPOSE: It has recently been suggested that the diagnostic threshold for the prostate specific antigen (PSA) assay be lowered to enhance prostate cancer detection. A 22% incidence of prostate cancer has been reported in men with PSA between 2.5 and 4.0 ng/ml. We designed a study to confirm this observation. MATERIALS AND METHODS: Men who participated in our free early detection program and who had serum PSA between 2.5 and 4.0 ng/ml were asked to undergo prostate biopsy. Of 268 eligible men 151 (56%) agreed to participate in this free trial. All men underwent biopsy using an 11-core multisite directed biopsy scheme. All biopsy cores were color coded for location specificity and examined by 1 pathologist. RESULTS: Cancer was identified in 24.5% (37 of 151) of the men biopsied. The median age of men with cancer was 62 years (range 43 to 74). Conventional systematic sextant biopsies, which accounted for 6 of the 11 cores, detected 73.0% (27 of 37) of the cancers and the alternate site biopsies identified the remaining 10. Gleason score was 6 in 25 men, 3 + 4 in 5, 4 + 3 in 4 and 8 or greater in 3 (median Gleason score 6). There were 14 men who had 1 core positive for cancer, 9 had 2 and 14 had more than 2 (median number of positive cores 2). Of the 14 men with 1 positive core 11 had a less than 3 mm focus of cancer and 8 had only a positive alternate site biopsy. There were 11 cases of abnormal results on digital rectal examination, 5 of which were cancer, and 31 cases of abnormal results on ultrasonography, 13 of which were cancer. Median biological variability in PSA was +/-15% (range 0.4% to 440.0%). CONCLUSIONS: We found a significant incidence of cancer (24.5%, 37 of 51) in men with serum PSA between 2.5 and 4.0 ng/ml. In our study 67.6% of the detected cancers were significant based on the biopsy data. If the PSA threshold is lowered the conventional systematic sextant technique may be preferable to an extended strategy.

Impact of radioimmunoscintigraphy on the management of colorectal and ovarian cancer patients: a retrospective study.

Noninvasive differentiation of benign from malignant disease has emerged as an important diagnostic challenge in the current age of health-care cost containment. Most physicians today acknowledge that early and accurate detection of cancer is important in successful treatment. Antibodies have been developed, labeled with radioactive isotopes, and used to detect and treat malignant tumors. During the past few years, several radiolabeled antibodies have received approval from the U.S. Food and Drug Administration for imaging colorectal, lung, ovarian, and prostate carcinomas, thus expanding and improving the physician's ability to detect and follow cancer in patients. At present, there is ample evidence in the literature to suggest that imaging with the 111In-labeled monoclonal antibody B72.3 is clinically useful for detecting primary/recurrent colorectal and recurrent ovarian carcinomas. In this article, we present a retrospective review of 136 patients from 10 moderate-sized hospitals who underwent a study with radioimmunoscintigraphy (RIS), using the 111In B72.3 antibody and standard diagnostic examinations for the detection of recurrent colorectal or ovarian carcinoma. The resulting data were analyzed in an effort to determine if (and how) information obtained from this radioimmunoscintigraphic procedure is being used by referring physicians. Our findings suggest a gradually increasing use of scan findings with the 111In B72.3 antibody in making patient-management decisions.

99Tcm-IMMU4 imaging in recurrent colorectal cancer: efficacy and impact on surgical management.

The aims of this study were to evaluate the efficacy of scintigraphy with the 99Tcm-labelled anti-carcinoembryonic antigen (CEA) monoclonal antibody Fab' fragment (IMMU4) in the diagnosis of recurrent colorectal carcinoma and to investigate its usefulness in the intraoperative surgical management of patients undergoing re-operation because of a rising serum CEA. We evaluated 24 patients prospectively who had rising serum CEA 6-19 months after initial surgery for colorectal carcinoma. Ten patients had lesions confirmed by computed tomography, ultrasound, magnetic resonance imaging, endoscopic examination or barium enema. Fourteen patients had negative findings on one or more of the above studies, but were suspected of having occult disease from their rising serum CEA. All patients were scheduled for surgery for restaging during a "second look' procedure. Planar and single photon emission tomography (SPET) imaging was performed in all patients. All scintigraphic findings were correlated with surgical and histopathological results. The overall sensitivity, specificity and accuracy were 81, 90 and 86% respectively when analysed by lesion, and 95, 60 and 88% respectively when analysed by patient. Ten of 14 (71%) patients with occult disease were correctly diagnosed as having recurrent disease. The SPET images were shown to have superior detectability (80%) compared with the planar images (35%). The surgeon judged the study to have had a neutral impact in 75% of the patients, but to have been helpful in 25%. We conclude that this antibody is potentially useful in detecting recurrent colorectal carcinoma in patients with rising serum CEA, especially when conventional imaging is negative or equivocal. It can also be helpful in altering planned surgery.

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.

Imaging of colorectal carcinoma with technetium-99m radiolabeled Fab' fragments.

In this phase III study, patients who had previously undergone surgery for colorectal cancer were studied using a technetium-99m (99mTc)-labeled anti CEA antibody (IMMU-4 [Immunomedics, Morris Plains, NJ] 1mg of protein) to evaluate recurrence. Total-body, planar, and single photon emission computed tomography (SPECT) images were performed within 6 hours of injection. Objectives were to evaluate the efficacy of the 99mTc-labeled anti-CEA antibody, to assess sensitivity and specificity of the agent in known lesions, and to detect occult disease. The impact of antibody study on subsequent surgery was also evaluated. The Fab' fragment has a molecular weight of 54,000 and is supplied as a lyophilized kit that can be instantaneously labeled with 20 to 30 mCi of [99mTc]pertechnetate. In 9 patients with known disease, planar spot imaging identified lesions in 7 (78% sensitivity), SPECT imaging detected lesions in 8 (88% sensitivity), and 1 patient did not have SPECT. In the group of 10 patients with occult (or equivocal) disease, planar imaging sensitivity was 50%, and SPECT sensitivity was 100%. Analysis by site showed 14 of 24 lesions detected by planar imaging (58% sensitivity), and SPECT detected 24 of 24 lesions (100% sensitivity). Tumors as small as .5 cm were visualized in the 19 patients studied. The surgeon judged the antibody study to be impact neutral in 73% of the cases and helpful in 27% of the cases when antibody study altered the presurgical plan.