The ultimate goal of prognostic assessment is optimization of individual counseling. Often, however, studies on prognostic factors focus on discriminating between high risk and low risk subgroups without considering the relevance of 1 or more factors for predicting disease outcome in individual patients. We quantified the accuracy of prediction of future recurrences and disease progression in individual patients with primary superficial bladder cancer. The study cohort consisted of 1,674 patients who were followed prospectively between 1983 and 1991 in the Netherlands. By analyzing half of the patients with proportional hazards regression, we computed relative risks of recurrence and progression. A prognostic index score based on these relative risks was then applied to the other half of the patients to determine whether group outcome could be predicted accurately. To assess the accuracy of prediction in individuals we used a method similar to the construction of receiver operating characteristic curves in diagnostic test assessment. The 3-year risk of first recurrence was 55% (95% confidence interval 51 to 59%). The 3-year risk of first progressive disease was 10% (95% confidence interval 8 to 12%). For the risk of first recurrence, tumor stage, tumor extent and multicentricity had statistically significant prognostic ability. Prognostic factors for the risk of disease progression were tumor stage, grade, multicentricity and the result of random biopsies from cystoscopically normal-appearing urothelium. For patients with a prognostic index score that suggested a low risk for recurrent and progressive disease the predicted 3-year risk of first recurrence was still 44% but the predicted 3-year risk of progression was only 3%. For patients with a prognostic index score that suggested a high risk the predicted risks were 74% and 22%, respectively. These predicted risks appeared to be fairly accurate when applied to the other half of our case series. However, in any 2 patients chosen at random the chance that the patient with the worst predicted prognosis would have a shorter recurrence-free and progression-free followup was calculated to be only 58% and 67%, respectively. Although the available prognostic factors in superficial bladder cancer may be useful to identify high risk and low risk subgroups, predictability in individuals is highly inaccurate. More relevant prognostic factors are needed to decrease current overtreatment and undertreatment rates, and to improve the followup policy.

Summary Even though the majority of patients with bladder malignancies initially present with low stage disease, the clinical epidemiology of these so-called superficial bladder tumours is not well known. In this paper, disease characteristics at initial presentation and during follow-up are described in 1,745 primary cases documented prospectively in the Netherlands. The risk of recurrent disease after primary treatment is very high: in 60% of cases, at least one recurrence is diagnosed within 5 years (95% CI: 58-62% Society, 1991). Therefore, the greatest concern in these patients is not to reduce mortality but to lower and postpone the number of recurrences (which are very common in superficial TCC) and thereby to prevent progression to invasive disease (and document) at least four random quadrant biopsies in macroscopically normal-looking urothelium (left and right lateral wall, trigone and dome) at the time of resection of the tumour(s). The therapy to be applied was transurethral resection of the tumour (TUR) in all patients. Urologists were advised to consider adjuvant intravesical instillations with chemotherapy or BCG vaccine in the case of multiple tumours. In pTI grade 3 patients more aggressive therapy, such as radical surgery or external or interstitial radiotherapy, would have to be considered. To detect recurrences, cystoscopy and urine cytology were used every 3 months in the first year after treatment. From the second year onwards, this check-up was performed every 6 months. Follow-up data concerning disease and life status were collected for each patient once every year.Between 1983 and 1990, 2,805 cases were documented. In 1991, all the data in the documentation project were reviewed using the medical files. After this check, the records of 100 cases were excluded. Of these, 30 had an inverted papilloma (which was considered to be benign), 58 had recurrent instead of primary disease at first registration, five did not have TCC in the bladder but in the upper urinary tract. In the records of seven cases, there were major inconsistences, which could not be corrected with information from the medical files. Of the remaining 2,705 cases, 1,745 (64.5%) had superficial TCC. 'Superficial' is defined as tumour extension limited to the mucosa (pTa) or the lamina propria (pTl) of the bladder wall with or without carcinoma in situ in random biopsies. In urology practice, primary carcinoma in situ (pTis) is considered to be very different from pTa and pTI tumours because of its relatively aggressive clinical behaviour. For that reason, patients with primary pTis (n = 52 in our series) were not evaluated in this study. Survival free of recurrence, survival free of progression and survival itself were measured from the data of histological diagnosis to the date of first recurrence, first evidence of disease progression and the date of death, respectively. Survival curves were based on the life table method, statistical significance being determined by the log rank test. The independence of host and tum...

We conclude that, although review pathology caused considerable changes in the pathology results, this did not change the results of treatment, and hardly altered the results of a prognostic factor analysis in this randomized study.

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