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Objective To evaluate the efficacy and safety of tamsulosin 0.4 mg once daily (as a modified-release formulation) compared with placebo in patients with benign prostatic enlargement, lower urinary tract symptoms and prostatic 'obstruction' (symptomatic benign prostatic hyperplasia [BPH]). Patients and methods Of 313 patients with symptomatic BPH enrolled in a 2-week placebo run-in period, 296 were subsequently randomized to receive either placebo (98 patients) or tamsulosin 0.4 mg once daily (198 patients) for 12 weeks. The primary variables assessed to determine efficacy were maximum urinary flow rate (Qmax) from free-flow measurements and the total Boyarsky symptom score. Results Tamsulosin produced greater improvements in Qmax (1.4 mL/s, 13.1%) than did placebo (0.4 mL/s, 3.8%) ( P= 0.028) and a greater decrease in total symptom score (3.4 points, 35.8% reduction) than did placebo (2.2 points, 23.7% reduction) ( P= 0.002). Significantly more tamsulosin-treated patients (67%) than placebo-treated patients (44%) had a ≥ 25% decrease in total symptom score after 12 weeks ( P < 0.001). Treatment with tamsulosin for 12 weeks also produced significant improvements in average urinary flow rate ( P= 0.040), irritative ( P= 0.013) and obstructive ( P= 0.014) symptom scores and symptoms of nocturia ( P= 0.022) and hesitancy ( P= 0.004). Tamsulosin was tolerated well by the patients. The incidence of adverse events emerging during treatment was comparable in the tamsulosin-and placebo-treated groups (34% and 24% respectively, P= 0.109), as was the incidence of cardiovascular-related adverse events (5% and 7% respectively; P= 0.596). There were no significant differences in changes in blood pressure or pulse rates between the tamsulosin-and placebo-treated groups. Conclusion Tamsulosin 0.4 mg once daily is safe, well tolerated and clinically effective in improving symptoms and urinary flow rate in patients with symptomatic BPH. [ABSTRACT FROM AUTHOR]

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bstract [ABSTRACT FROM AUTHOR]

Murine hybridoma antibodies to a human B-cell lymphoma were developed. After screening against normal T cells, monocytes, and granulocytes 11 antibodies that reacted with cells from other B-cell lymphomas remained, of which 10 showed individually distinct staining patterns, as tested by indirect fluorescence. When tested against lymphomas or cell lines, none of these antibodies revealed staining patterns suggesting reactivity with conventional B-cell surface markers, such as immunoglobulin, complement factor 3 receptors, or HLA-DR antigens. Only one of the antibodies (GB1) reacted with human serum, as determined by a blocking assay. The antibodies were found to belong to different immunoglobulin isotypes. Two antibodies (GB13 and GB14) reacted with >5% of normal peripheral blood mononuclcar cells. These reactions were mainly due to reactivity with B cells. The antibodies reacted only in a few cases with acute leukaemias, B-cell lines, and follicular lymphomas. On the other hand, distinct patterns of reactivity in different histological groups of diffuse lymphomas were obtained, suggesting that the antibodies may be useful in delineating phenotypic subsets among human B-cell lymphomas. [ABSTRACT FROM AUTHOR]

Objectives: To assess the efficacy and tolerability of bicalutamide 150 mg (‘Casodex’1‘Casodex’ is a trade mark of the AstraZeneca group of companies.1) as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with early (T1b–T4, any N, M0) prostate cancer.Methods: This randomised, double-blind study was conducted in the Nordic countries as part of the ‘Casodex’ Early Prostate Cancer programme. Patients received bicalutamide 150 mg (n=607) or placebo (n=611) in addition to standard care.Results: More than 80% of patients had not received therapy of primary curative intent. Median follow-up in both groups was 3 years. Median exposure to study treatment in the bicalutamide and standard care alone groups was 2.5 and 2.3 years, respectively. Bicalutamide reduced the risk of objective disease progression by 57% compared with standard care alone (HR 0.43; 95% CI 0.34, 0.55; p≪0.0001). Survival data were immature (11.4% deaths) with no difference between the two treatment groups.Conclusions: Bicalutamide 150 mg as immediate therapy, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with early prostate cancer. The trial is ongoing to assess whether the reduction in risk of objective progression translates into an overall survival benefit. [ABSTRACT FROM AUTHOR]

In 1981 the Scandinavian Association of Urology initiated the Scandinavian Prostate Cancer Group (SPCG) as one of eight collaborative groups representing different fields of urology. The task of the SPCG was to promote research, education and information concerning prostate cancer. In particular it became a forum for conducting clinical multicenter studies within the Nordic countries. This paper summarizes some aspects of the history of the SPCG and reviews the clinical trials initiated by the group on the occasion of its 20th anniversary.

In 1998, 28.5% of diagnosed prostate cancer patients in Norway were aged < 71 years and had organ-localized disease and 74.5% of prostate cancer patients aged < 71 years had organ-localized disease. This study compares the number of prostate cancer patients aged < 71 years with organ-localized disease in the five health regions of Norway with the number of patients who were treated with radical intent. In 1998, only 52% of these patients were treated with radical intent; in 1999 this proportion had increased to 73% but large regional differences existed.

Purpose: We determine the efficacy and tolerability of bicalutamide as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with clinically localized or locally advanced prostate cancer., Materials and Methods: This international program consists of 3 ongoing, randomized, double-blind, placebo controlled clinical trials (trials 23, 24, and 25). Men with localized or locally advanced (T1-T4, Nx/N0, M0) prostate cancer were randomized to receive 150 mg. bicalutamide daily or placebo, in addition to standard care with radical prostatectomy, radiotherapy or watchful waiting. Primary end points are time to objective progression and overall survival. In this first analysis data from the trials were combined in a single overview analysis according to protocol., Results: Data are available for 8,113 patients (4,052 randomized to bicalutamide, 4,061 to standard care alone) at a median followup of 3.0 years. Treatment with bicalutamide provided a highly significant reduction of 42% in the risk of objective progression compared with standard care alone (9.0% versus 13.8%, hazards ratio 0.58; 95% confidence interval 0.51, 0.66; p <<0.0001). The overall result was reflected in 2 of the 3 trials (trials 24 and 25) with trial 3 (trial 23) showing a nonsignificant difference at this time. Reductions in the risk of disease progression were seen across the entire patient population, irrespective of primary treatment or disease stage. Overall survival data are currently immature and longer followup will determine if there is also a survival benefit with bicalutamide. The most frequently reported side effects of bicalutamide were gynecomastia and breast pain., Conclusions: Immediate treatment with 150 mg. bicalutamide daily, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localized or locally advanced prostate cancer. This benefit must be balanced with the morbidity associated with long-term hormonal therapy. Followup is ongoing to determine potential survival benefits of this treatment approach.

Background: Compared with the native drug, liposomal PEG-coated doxorubicin (Caelyx) enhances tumour activity and reduces toxicity. The formulation may therefore be beneficial in anthracycline-sensitive malignancies, where toxicity represents a major problem, as is the case in androgen-insensitive prostate cancer (AIPC)., Methods: In a multi-centre design 28 patients with advanced AIPC received Caelyx 40 mg/m2 as a 1-hour infusion every month. PSA-based biochemical and subjective response was recorded., Results: Three patients had biochemical responses, a subjective response was recorded in a fourth patient. No Grade 4 toxicity was encountered. Three patients developed a spontaneously recovering plantar-palmar erythema. In 3 of the 4 responding patients, the nadir PSA value was noted after 12 and 16 weeks, respectively. A possible flare phenomenon for PSA was evident in 4 patients., Conclusion: Caelyx has limited activity in advanced AIPC. Due to its low toxicity profile the drug may be a worthwhile component of combination treatment of this chemotherapy-resistant condition. In general, clinicians should be aware of possible delay in PSA response as well as possible flare phenomenon during investigational systemic treatment of AIPC. Furthermore, standardization of blood sampling and PSA analyses are necessary in future therapeutic trials of AIPC.

Background: We wanted to provide a survey of the extent and practice of locally performed ritual circumcision of boys born to Muslim parents in Norway., Material and Methods: Newborn boys with Muslim parents in two counties in Norway (Rogaland and Troms) were registered. 56 ritual circumcisions were performed in outpatient departments in the local hospitals during the period under investigation, 11 on newborns, 33 on boys between one and ten, and 12 on boys above ten., Results: The number of circumcised boys in 1999 was 24% of the total number of boys born to Muslim parents that year; in 2000, 48%. Circumcision of boys between one and ten is ten times more time-consuming than circumcision of newborns or boys above ten., Interpretation: An estimated 672 boys are born to Muslim parents in Norway each year. Less than 50% of newborns with Muslim parents are circumcised in local outpatient departments. We recommend that ritual circumcision is restricted to newborns or to boys above ten, and that informed written consent is obtained from boys above ten.

Objective: In the mid-1980s, interest in parenteral estrogen therapy for prostate cancer was renewed when it was found that it influenced liver metabolism only marginally and had very few cardiovascular side-effects. In this study high-dose polyestradiol phosphate (PEP; Estradurin) was compared to combined androgen deprivation (CAD) for the treatment of patients with metastatic prostate cancer. The aim of the study was to compare anticancer efficacy and adverse events, especially cardiovascular side-effects., Material and Methods: A total of 917 patients with T0-4, NX, M1, G1-3 prostate cancer and an Eastern Cooperative Oncology Group performance status of 0-2 were randomized to treatment with either PEP 240 mg i.m. twice a month for 2 months and thereafter once a month or flutamide (Eulexin) 250 mg t.i.d. per os in combination with either triptorelin (Decapeptyl) 3.75 mg per month i.m. or, on an optional basis, bilateral orchidectomy. A total of 556 patients had died at the time of this analysis., Results: There was no difference between the treatment arms in terms of time to biochemical or clinical progression and overall or disease-specific survival. There was no increase in cardiovascular mortality in the PEP arm. The PEP group had a higher prevalence of cardiovascular disease prior to the study and a significantly higher incidence of non-fatal ischemic heart events and heart decompensation during the study., Conclusions: PEP has an equal anticancer efficacy to CAD and does not increase cardiovascular mortality. Final evaluation of cardiovascular morbidity is awaiting further analysis and follow-up. PEP is considerably cheaper than CAD.

Objective: This open-label extension study evaluated the efficacy and safety of tamsulosin (0.4 mg as a modified release formulation) once daily in patients with benign prostatic enlargement, lower urinary tract symptoms and benign prostatic obstruction (symptomatic BPH) for up to 60 weeks., Methods: Patients were enrolled from two European, 12-week, placebo-controlled trials. This 60-week interim analysis includes the patients (n = 244) randomized to tamsulosin in the two placebo-controlled trials., Results: The significant improvements in the primary efficacy parameters, maximum urinary flow rate (Qmax) and total Boyarsky symptom score, that were observed during the placebo-controlled trials, were sustained throughout the long-term extension study. Mean Qmax improved from baseline (before initiation of tamsulosin) to endpoint by 13.7% (p < 0.001) and remained between 11.5 and 12 ml/s during the entire follow-up period. Total Boyarsky symptom score improved by 36.2% from baseline to endpoint (p < 0.001). Similarly, the percentage of treatment responders, defined as an increase in Qmax of > or = 30% or a decrease in total symptom score of > or = 25%, remained constant throughout the 60-week period. At endpoint, 69% of patients demonstrated this clinically significant total Boyarsky symptom score response. During the 60-week study period, 51 patients (21%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of which were dizziness and abnormal ejaculation, both occurring in 5% of patients. There were no clinically significant changes in blood pressure or pulse rate during the study., Conclusion: Long-term tamsulosin therapy is safe, well tolerated and improvements in urinary flow and symptoms are maintained for at least 60 weeks of treatment.

Objective: To evaluate the efficacy and safety of tamsulosin 0.4 mg once daily (as a modified-release formulation) compared with placebo in patients with benign prostatic enlargement, lower urinary tract symptoms and prostatic 'obstruction' (symptomatic benign prostatic hyperplasia [BPH])., Patients and Methods: Of 313 patients with symptomatic BPH enrolled in a 2-week placebo run-in period, 296 were subsequently randomized to receive either placebo (98 patients) or tamsulosin 0.4 mg once daily (198 patients) for 12 weeks. The primary variables assessed to determine efficacy were maximum urinary flow rate (Qmax) from free-flow measurements and the total Boyarsky symptom score., Results: Tamsulosin produced greater improvements in Qmax (1.4 mL/s, 13.1%) than did placebo (0.4 mL/s, 3.8%) (P = 0.028) and a greater decrease in total symptom score (3.4 points, 35.8% reduction) than did placebo (2.2 points, 23.7% reduction) (P = 0.002). Significantly more tamsulosin-treated patients (67%) than placebo-treated patients (44%) had a > or = 25% decrease in total symptom score after 12 weeks (P < 0.001). Treatment with tamsulosin for 12 weeks also produced significant improvements in average urinary flow rate (P = 0.040), irritative (P = 0.013) and obstructive (P = 0.014) symptom scores and symptoms of nocturia (P = 0.022) and hesitancy (P = 0.004). Tamsulosin was tolerated well by the patients. The incidence of adverse events emerging during treatment was comparable in the tamsulosin- and placebo-treated groups (34% and 24% respectively, P = 0.109), as was the incidence of cardiovascular-related adverse events (5% and 7% respectively; P = 0.596). There were no significant differences in changes in blood pressure or pulse rates between the tamsulosin- and placebo-treated groups., Conclusion: Tamsulosin 0.4 mg once daily is safe, well tolerated and clinically effective in improving symptoms and urinary flow rate in patients with symptomatic BPH.

An enquiry into the use of antibiotic prophylaxis in conjunction with diagnostic or therapeutic urological procedures at hospitals in four Scandinavian countries showed manifest national differences to exist for most procedures. In transurethral resection, for instance, antibiotic cover was used at 79 percent of Finnish hospitals, but at only nine percent of Danish hospitals. Not only were dosage regimens characterized by wide national variation, but also the spectrum of antibiotics used, quinolones being most frequently used in Sweden, but ampicillin and pivampicillin in Denmark. For some procedures policy was more uniform in all countries, antibiotic cover rarely being used in connection with ureterocystoscopy (5 percent of hospitals), but often in conjunction with percutaneous stone surgery (72 per cent). In certain procedures where there is strong evidence suggesting the necessity of antibiotic prophylaxis, it was not always used-e.g., in transrectal prostate biopsy where it was used at only 62 per cent of hospitals. The interpretation of published findings and clinical experience would appear to differ markedly, and local traditions would seem to be strong determinants of clinical routines. The wide variation suggests that all patients do not receive optimal treatment. To improve routines, our knowledge of antibiotic preparations needs to be expanded by well executed studies, followed by general implementation of the results at the various centres. A series of consensus conferences should be arranged and the recommendations published as a first step toward a more uniform and probably better use of antibiotic prophylaxis in conjunction with diagnostic and therapeutic urological procedures.

40 patients were treated by aspiration and instillation of a 10% solution of tetracycline. 32 were cured after average 1.45 instillations. The dominating adverse effect was scrotal pain, reported by 55% of the patients. One patient experienced a transient vasovagal reaction due to the pain, and one patient was suspected of having a slight infection. No other adverse effect was registered, and 90% of the patients would prefer to have the same treatment rather than an operation if another treatment were found necessary. The treatment is given as an outpatient procedure at 1/10 of the cost of traditional operative treatment, and with comparable results.

Meckel's diverticulum is a rare, but serious cause of acute abdominal pain. The prevalence of Meckel's diverticulum is 2% and lifetime risk of illness in a diverticulum is 4.2%. The risk declines with age and approaches zero after the age of 70. Morbidity after resection of symptomatic Meckel's diverticulum is 11.1-17.6% with 6.0-7.5% mortality. The morbidity rate for resection of incidentally discovered diverticulum is 1.2-8.9%. Symptoms and complications are related to age. Below the age of one year the most prevalent complication is gastrointestinal obstruction. Later in childhood the most dominating complication is peptic ulcer with serious gastrointestinal bleeding, while various kinds of gastrointestinal obstruction and diverticulitis are most prevalent in adults. The treatment of symptomatic Meckel's diverticulum is resection. However, the treatment of incidentally discovered Meckel's diverticulum is a subject of dispute. After a thorough study of the literature we conclude that resection should be the routine for all incidentally discovered Meckel's diverticulums in persons younger than 40. After this age resection should be reserved for patients with palpable stigmata of heterotopic tissue, diverticulums of some length and the presence of omphaloenteric- or omphalodiverticulare chords.

In 18 biopsy specimens from human breast carcinoma a comparison was made between DNA measurements obtained by microspectrophotometry (MSP) of Feulgen-stained nuclei in imprints and flow cytometry (FCM) of nuclei stained with ethidium bromide. For each specimen FCM was performed both with ethanol-fixed cells and unfixed cells. In addition, single cell suspensions were made from other 11 fresh mammary cancer biopsies. Parts of these suspensions were analysed both by MSP (Feulgen-stained smears) and FCM (ethanol-fixed, mitramycin-stained cells). The MSP histograms show selected tumour cells and tumour-like cells. This explains the higher proportion of cells with DNA content above the 2 c level. A good agreement was found between the results obtained by MSP and FCM with regard to the ploidy of the DNA stemline(s). FCM of fixed cells (multiple-step procedure) yielded a slightly lower proportion of diploid cells than FCM of the unfixed cells (one-step procedure), probably owing to loss of small cells during the different preparation steps. It is concluded that the results from DNA-histograms obtained from MSP and FCM can be compared as to DNA-stemline ploidy of the cell population but not as to the proportion of cells with non-diploid DNA-content.

To study the usefulness of an in vitro colony-forming assay in predicting individual clinical responses to chemotherapy, tumor cells obtained from 150 melanoma metastases (119 patients) were grown in soft agar according to the method of Courtenay and Mills (1978), and tested for sensitivity to DTIC, CCNU, vinblastine, procarbazine, abrin and ricin. In 83% of the cases colony formation was observed (plating efficiency, PE, greater than 0.01%). Twenty-seven per cent of the tumors gave PEs greater than 1%, 45% gave PEs in the range 0.1-0.9%, whereas 11% of the tumors gave 0.01-0.09%. The PEs were not correlated with the degree of pigmentation or with the clinical course. Evaluable chemosensitivity data were obtained on 104 metastases from 83 patients. Large differences in sensitivity were seen. In cases which were evaluable both in vivo and in vitro a clear correlation was found between the in vitro chemosensitivity, expressed as the expected growth delay, and the clinical response to chemotherapy. Tumors from patients with partial response, mixed response or stable disease after prior progression, all had rather high in vitro sensitivity to the drug used (expected growth delay greater than 2.0), whereas patients with progression had lower sensitivity. The results confirm that the soft agar method used here provides good culture conditions for human melanoma cells and show that chemosensitivity data can be obtained in a high percentage of melanoma patients. The approach used seems promising in aiding clinicians to adjust chemotherapy to individual patients.