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E Solsona

Publications and source records attributed to E Solsona.

At least 19 recordsLinked to original sources
PubMed2005

Immunohistochemical expression of Ki-67 antigen, cox-2 and Bax/Bcl-2 in prostate cancer; prognostic value in biopsies and radical prostatectomy specimens.

PURPOSES: To elucidate the prognostic value of the immunohistochemical (IHC) expression of Bcl-2, Bax, Cox-2 and Ki-67 antigen in biopsy cores (C) and surgical specimens (SP) of prostate cancer (PC) and to determine the C to SP reproducibility. MATERIAL AND METHODS: The IHC study was carried out in 91 patients operated by means of radical prostatectomy (RP) with available formalin-fixed paraffin-embedded material from both C and SP. RESULTS: The IHC expression of Bcl-2 in C and SP was very low (5%). Bax was expressed in almost all the patients and did not show any prognostic value. We observed a good reproducibility between C and SP for all molecules except with Bax. In prostate C, Ki-67 and Cox-2 were considered positive in 42.9% and 67% of the patients respectively, and were related to disease-free survival in the univariate analysis. The expression of these two markers in SP was observed in 51.6% and 79.1% of the patients and the expression of Ki-67 in SP maintained its independence as prognostic factor in the multivariate analysis related to disease-free survival. CONCLUSIONS: The IHC expression of Ki-67 and Cox-2 proteins in our study do offer valuable prognostic information, mostly the first one. Thus, we think these markers might be studied in larger series of patients for its further validation as prognostic factors in prostate biopsies.

Aged↗
PubMed2005

Risk groups in patients with bladder cancer treated with radical cystectomy: statistical and clinical model improving homogeneity.

PURPOSE: In this study we identified homogeneous risk groups, with no survival overlap among the subgroups that make up each risk group, in patients with transitional cell carcinoma of the bladder treated with radical cystectomy alone. MATERIALS AND METHODS: Predictive factors for tumor death were analyzed with univariate and multivariate analysis among a group of 298 patients with transitional cell carcinoma of the bladder treated with radical cystectomy alone. Independent variables were progressively incorporated according to their statistical power in a stepwise process identifying a model with independent subgroups. The risk groups were identified according to different survival cutoff points including subgroups with similar survival. To search a clinical application and to check the strength of this model a new model was also set up using the weight score based on the size of hazard ratio from multivariate analysis. RESULTS: Univariate analysis demonstrated that lymphatic invasion status, pathological stage (P), lymph node status (N) and prostatic stroma status (St) were predictive variables for tumor death, and the latter 3 were independent variables in the multivariate analysis. By taking the most powerful, N, as the reference variable, and progressively incorporating additional variables, a model was found including 7 independent subgroups. In this model only 2 subgroups, N1 and N2-3, included more than 1 category and their survival was also calculated. Three risk groups were identified establishing different survival cutoffs. The 5-year cancer specific survival rate was 86.4% for low risk (P1-2N0St-), 64.4% (range 60.9% to 65.3%) for intermediate risk (P1-2N1St-, P3N0St-, HR = 2.7) and 28.1% (range 0% to 47.7%) for high risk (N2-3, P4, St+, N1P3, HR = 8.7). This model was also reproduced using the weight score based on the size of the hazard ratio from the multivariate analysis CONCLUSIONS: Three homogeneous risk groups were identified with high statistically significant survival differences among them and no survival overlap among subgroups that make up the risk groups.

Adult↗
PubMed2004

EAU Guidelines on Penile Cancer.

OBJECTIVES: The European Association of Urology (EAU) consensus group on penile cancer has prepared these guidelines to help urologists assess the scientific evidence for the management of penile cancer and to incorporate recommendations into their clinical practice. METHOD: References used in the text have been assessed according to the level of scientific evidence involved and guideline recommendations have also been evaluated according to the Agency for Health Care Policy and Research [Clinical Practice Guidelines Development: Methodological Perspectives. Washington DC: US Department of Health and Human Services, Public Health Service; 1992, pp. 115-127]. RESULTS: The diagnosis, treatment and follow-up of patients suspected of, or diagnosed with, penile cancer is listed as an easy reference text. CONCLUSION: A guidelines text is presented which aims at aiding medical specialists in determining the most optimal diagnostic and treatment options for this pathology.

Follow-Up Studies↗
PubMed2004

EAU guidelines on diagnosis and treatment of upper urinary tract transitional cell carcinoma.

OBJECTIVES: On behalf of the European Association of Urology (EAU) guidelines for diagnosis, therapy and follow-up of upper urinary tract transitional cell carcinoma (UUTT) patients were established. Criteria for recommendations are based of level 2 only, as large randomised clinical trials have not been performed in this type of disease. METHOD: A systematic literature research using Medline Services was conducted. References were weighted by a panel of experts. RESULTS: TNM classification 2002 is recommended. Recommendations are developed for diagnosis, radical and conservative treatment and for local chemo-immunotherapy. Prognostic factors are defined. Recommendations for follow-up after different types of treatment are given.

Carcinoma, Transitional Cell↗
PubMed2003

Conservative elective treatment of upper urinary tract tumors: a multivariate analysis of prognostic factors for recurrence and progression.

PURPOSE: We evaluate the safety and efficacy of conservative elective treatment of upper urinary tract tumors, and determine predictive factors for recurrence and progression to optimize indications of this type of treatment. MATERIALS AND METHODS: Since 1984 we have performed a prospective study of conservative treatment of single, low grade and stage, less than 3 cm. upper tract tumors. The study includes 54 patients with a normal contralateral kidney who had been followed for more than 36 months. Open conservative surgery was performed in 31 cases and endourological surgery in 23. Minimum followup was 36 months, maximum 210 and mean 84.8. Univariate and multivariate analyses of recurrence and progression were performed in relation to age, sex, association with a bladder tumor, bladder tumor stage and grade, sequence of bladder tumor in relation to upper urinary tract tumor, number of previous bladder tumor recurrences, association with bladder carcinoma in situ, upper urinary tract tumor grade, stage, location, size and therapy, and upper urinary tract cytology. RESULTS: Of the 54 patients 19 (35%) had recurrence, which was bilateral recurrence in 4, and progression occurred in 9 (16%). At the end of analysis 44 (62.9%) patients were disease-free and alive at a mean time of 92.88 months, 13 (24%) died disease-free at a mean of 72.7 months and 7 (12.9%) died of disease at a mean of 97.85 months. Cause specific mortality occurred in 7 (12.9% cases). Among the 54 initially conservatively treated units 42 (77.7%) kidneys were ultimately preserved. On univariate and multivariate analysis tumor location in the renal pelvis and association with a previous multi-recurrent bladder tumor were variables significantly related to recurrence and progression, as well as bilateral recurrence. CONCLUSIONS: Conservative treatment is an optional approach for select upper urinary tract tumors. The strongest risk factors for recurrence and progression were association with a previous multi-recurrent bladder tumor and tumor location in the renal pelvis but these conditions were also the strongest risk factors for bilateral recurrence. Conservative treatment can also be recommended in these cases but only with compliant patients and close followup.

Adult↗
PubMed2003

Late oncological occurrences following radical cystectomy in patients with bladder cancer.

PURPOSE: To evaluate the prognoses and predictive factors of late oncological occurrences and its impact on follow-up strategy in patients with bladder tumours treated with radical cystectomy. MATERIALS AND METHODS: Late oncological occurrences were considered when they took place after three years from cystectomy or when early recurrence was controlled with therapy and patients developed recurrence again after a three-year disease-free interval. Univariate and multivariate analysis of predictive factors for late oncological occurrences were carried out on 215 patients at risk of late oncological recurrences. RESULTS: Among 357 patients treated with cystectomy, 163 (45.6%) relapsed, 149 (41.7%) of them as early recurrence and 17 (4.7%) were considered as late oncological events. This incidence increased up to 8% when patients at risk were considered. Three patients with early recurrence reached a complete response after treatment and relapsed again as late recurrences. Distant metastases and local recurrence represented 78.5% of early recurrence as opposed to 11.7% in late oncological occurrences, whereas, extravesical urothelium recurrences represented 8.6% and 70% respectively (p<0.01). Among patients with late oncological occurrences, nine (53%) were disease-free, seven with urothelial recurrence and two of three with lymph-node recurrence whereas only eight (5.6%) patients with early recurrence were free of tumour (p<0.0001). Multiple tumours, prostate involvement and organ-confined tumours in cystectomy specimen were the independent variables for predicting late oncological occurrences in multivariate analysis. CONCLUSIONS: Recurrences in the remaining urothelium prevail as the pattern of late oncological occurrences. The prognosis of these events is significantly better than an early recurrence. Patients at risk of late oncological occurrences are those with multiple tumours, prostate involvement and with organ-confined tumours in cystectomy specimen. After three years from cystectomy, the follow-up schedule of these patients be limited to performing an annual CT-scan and urinary cytology to detect essentially upper urinary tract recurrence and extrapelvic lymph-nodal recurrence. Afterwards an annual intravenous urography might replace to CT-scan since lymph-nodal involvement was not detected.

Adult↗
PubMed2002

Long-term follow-up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette-Guérin with a reduced dose of 27 mg in superficial bladder cancer.

OBJECTIVES: To determine the efficacy of a three-fold reduced dose (RD, 27 mg) of intravesical bacille Calmette-Guérin (BCG) against the standard dose (81 mg) in patients with superficial bladder cancer, assessing recurrence, progression and differences in toxicity. PATIENTS AND METHODS: Five hundred patients with superficial bladder cancer (Ta, T1, Tis) were enrolled and randomly assigned to be treated after transurethral resection of all visible lesions with intravesical BCG Connaught strain (weekly x six and thereafter fortnightly x six) either with the standard or RD instillation. RESULTS: All but one of the 500 patients were evaluable for efficacy and toxicity (252 in the standard arm and 247 in the RD arm). The median follow-up was 69 months (maximum 104); 71 (28%) patients in the standard arm and 76 (31%) in the RD arm developed recurrences; the median time to recurrence has not yet been attained, but at 5 years the mean (sd) percentage of recurrence-free patients was 70.5 (3.12) and 70.4 (3.1) for the standard and RD arms, respectively. In patients presenting with multifocal tumours, the standard dose was more effective against recurrences than the RD (P=0.0151). In those with G3 and high-risk tumours overall, the superiority of the standard dose was marginal (P=0.060 and P=0.082). Twenty-nine (11.5%) tumours in the standard arm and 33 (13.3%) in the RD arm progressed to invasive disease; the median time to progression has not yet been attained, but the percentage of progression-free patients at 5 years was 88.8 (2.23) and 86.9 (2.31) for the standard and RD arms, respectively. The standard dose was more effective than the RD against progression only in patients with multifocal disease (P=0.048). Twelve (4.8%) cystectomies were performed in the standard and 15 (6.1%) in the RD arm. Currently, 106 (21.2%) patients have died, but only 38 (7.6%) from bladder cancer, i.e. 20 (7.9%) in the standard and 18 (7.5%) in RD arm. Overall the disease-specific death rate was lower for those patients who completed the scheduled treatment. The cause-specific survival at 5 years did not differ between the arms (P=0.76) but there was a trend toward better cause-specific survival for patients with multifocal tumours in the standard arm. Toxicity differed between the arms, significantly more patients having no toxicity in the RD arm, and fewer having delayed instillations or withdrawing. However, severe systemic toxicity occurred even in patients treated with the RD, in a similar proportion to those receiving the standard dose. CONCLUSION: Overall, the RD gave similar results for recurrence and progression but with significantly less toxicity. However, patients with multifocal tumours fared better with the standard dose and there was a trend towards better recurrence rates in patients with high-risk tumours. We recommend continuing to use the standard dose for high-risk tumours, while we consider the reduced dose safe and effective for intermediate-risk lesions and for maintenance schedules.

Adjuvants, Immunologic↗
PubMed2002

Clinical panurothelial disease in patients with superficial bladder tumors: therapeutic implications.

PURPOSE: We established the prognostic and therapeutic implications of panurothelial involvement in patients with superficial bladder tumors for optimizing therapeutic approaches in those at risk for panurothelial involvement. MATERIALS AND METHODS: We studied the records of 35 patients with clinical panurothelial disease. Since all of these patients presented with high risk superficial bladder cancer during followup, they were included in specific therapeutic and followup regimens. Radical procedures or conservative therapies were indicated mainly according to pathological examination and the recurrence pattern. RESULTS: Panurothelial involvement was a late stage of a recurrent and diffuse process that essentially developed in sequences, in which all patients presented with high risk superficial bladder tumors. This process involved continued relapse after panurothelial involvement developed. Notably 19 patients (79.1%) at risk for recurrence had repeat relapse in the urothelium. In the upper urinary tract 12 patients (34.3%) had bilateral involvement, including 7 (41.2%) of 17 patients after cystectomy. We identified 2 subgroups of patients. The subgroup with a better prognosis included 27 patients in whom late panurothelial disease developed step by step after a complete response to intravesical therapy, including 14 (51.8%) who were free of disease. The other subgroup with a poor prognosis included 8 patients with concurrent bladder carcinoma in situ and prostate involvement as well as early panurothelial disease, of whom only 2 (25%) were disease-free. All patients underwent many therapeutic approaches. A mean of 7.5 surgical procedures per patient were done, including a mean of 5.5 transurethral resections, a mean of 1 conservative approach to the upper urinary tract and a mean of 1.1 radical procedures. At a median followup of 111 months 10 patients (28.5%) were disease-free but only 7 (20%) retained the bladder, while 19 (54.3%) died of tumor. CONCLUSIONS: Patients with high risk superficial bladder multifocal tumors and associated bladder carcinoma in situ are at high risk for panurothelial involvement. Radical cystectomy may be recommended in these patients when initially or during followup, concurrent high risk superficial bladder tumors and prostate involvement develop or prostate involvement recurs. For the upper urinary tract conservative therapies may be advisable when noninfiltrating tumors are diagnosed even after cystectomy due to the high rate of bilateral new onset disease. When cystectomy is performed, extended excision of the upper urinary tract and pyelo-intestinal anastomosis may be considered.

Aged↗
PubMed2001

Prospective validation of the association of local tumor stage and grade as a predictive factor for occult lymph node micrometastasis in patients with penile carcinoma and clinically negative inguinal lymph nodes.

PURPOSE: We prospectively validated the association of local tumor stage and grade as a predictive factor for occult lymph node micrometastasis in patients with penile carcinoma and clinically negative lymph nodes. MATERIALS AND METHODS: In a retrospective study of 66 patients we demonstrated the predictive value of the association of local tumor stage and grade for occult micrometastasis, identifying 3 risk groups. A therapy strategy was designed according to these risk groups. A total of 37 consecutive patients were included in a prospective study in which the same criteria for risk group allocation and the same therapeutic recommendations were used as in the retrospective study. RESULTS: In the prospective study we noted positive lymph nodes in 11% of stage T1, 63% of stages T2-3, 15% of grade 1, 67% of grade 2 and 75% of grade 3 cases. The incidence of positive nodes was 0% in the low, 83.3% in the high and 33.3% in the intermediate risk group. These rates were similar to those in the retrospective study with no significant difference. CONCLUSIONS: The predictive value of the association of local tumor stage and grade for occult lymph node micrometastasis was validated in a prospective study. This factor allows the differentiation of 3 risk groups of patients with high reliability in the low and high risk groups. However, other prognostic factors are needed in the intermediate risk group to improve the prediction of lymph node involvement.

Adult↗
PubMed2000

The 3-month clinical response to intravesical therapy as a predictive factor for progression in patients with high risk superficial bladder cancer.

PURPOSE: We analyzed the 3-month clinical response to intravesical therapy as a factor predictive of progression in patients with high risk superficial bladder cancer. MATERIAL AND METHODS: We evaluated 191 patients with high risk superficial bladder cancer, 111 with secondary or associated bladder carcinoma in situ and 80 with stage T1 grade 3 disease who were treated with intravesical therapy. We considered only clinically complete and no responses at the 3-month endoscopic study. To determine the predictive value of the 3-month clinical response we differentiated progression into superficial and invasive types. RESULTS: At a median followup of 73 months 91 patients (47.6%) had progression, which was superficial in 48 (25. 1%) and invasive in 43 (22.5%). Invasive progression was associated with significantly higher cause specific mortality than superficial progression (p = 0). In the latter cases cause specific mortality was higher than in those without progression (p = 0.001). Although cystectomy significantly decreased the cause specific mortality rate in patients with invasive progression (p = 0.0001), this rate was high at 46.3%. Univariate and multivariate analyses revealed that the 3-month clinical response was a significant predictive factor for progression. Moreover, stratifying this variable showed that this response was the only independent factor predictive of invasive progression in cases of no response with stage T1 grade 3 tumor, bladder carcinoma in situ, or prostate mucosa or duct involvement (p = 0). In our series 41 patients (21.5%) did not respond after intravesical therapy at the 3-month evaluation, including 29 with stage T1 grade 3 disease, bladder carcinoma in situ, or prostate mucosa or duct involvement. Progression in 24 of these 29 patients (82.3%) was classified as invasive in 21 (73.6%). CONCLUSIONS: Invasive progression threatens the cause specific survival of patients with high risk superficial bladder cancer even when cystectomy is performed. The 3-month clinical response was an excellent predictive factor for invasive progression. Early cystectomy should be considered when stage T1 grade 3 tumor, bladder carcinoma in situ, or prostate mucosa or duct involvement is present at the 3-month clinical evaluation.

Administration, Intravesical↗
PubMed1999

Effectiveness of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer: short and long-term followup.

PURPOSE: We analyze the impact of a single mitomycin C instillation in patients with low risk superficial bladder cancer with short and long-term followup. MATERIALS AND METHODS: A total of 131 patients with low risk superficial bladder cancer were included in a prospective randomized controlled trial. All patients had a 3 cm or less single, papillary, primary or recurrent tumor and were disease-free for more than 1 year. Patients with muscular invasion, G3 tumor or bladder carcinoma in situ on pathological examination were excluded from study. The tumor was completely resected before patients were randomized into 2 arms of no further treatment (control group) and a single immediate instillation of 30 mg mitomycin C (mitomycin C group). Recurrences were considered early within the first 2 years of followup. RESULTS: At 24-month followup the recurrence-free interval was significantly increased, and recurrence, and recurrence and tumor per year rates were decreased in the mitomycin C compared to the control group. However, at long-term followup these differences were not statistically significant and the recurrence-free interval curves were parallel. A shorter hospital stay and catheterization period were noted in the mitomycin C group compared to the control group, which were not significant. Early recurrences were concentrated in the first year in the control but not in the mitomycin C group. A significant relationship between early and late recurrences was found in the mitomycin C but not in the control group. CONCLUSIONS: Our analysis confirms the positive effect of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer. This benefit is limited to early recurrence and is not maintained with long-term followup. Thus, this approach is an alternative to observation or endovesical chemotherapy. Our study also suggests that cell implantation as a mechanism of early recurrence can be controlled with a single mitomycin C instillation.

Administration, Intravesical↗
PubMed1999

Parental origin and meiotic stage of non-disjunction in 139 cases of trisomy 21.

The parental origin and the meiotic stage of non-disjunction have been determined in 139 Down syndrome patients with regular trisomy 21 and in their parents through the analysis of DNA polymorphism. The meiotic error is maternal in 91.60% cases and paternal in 8.39% of cases. Of the maternal cases, 72.41% were due to meiosis I errors (MMI) and 27.58% were due to meiosis II errors (MMII). Of the paternal cases, 45.45% were due to meiosis I (PMI) and 54.54% were due to meiosis II (PMII). The mean maternal ages were 31.6 +/- 5.3 (+/- SD) years in errors from MMI, 32.3 +/- 6.4 years in errors from MMII, 31.4 +/- 4.6 years in errors from PMI and 29.5 +/- 2.7 years in errors from PMII. No significant statistical differences were observed between maternal and paternal errors, further supporting the presence of a constant chromosome 21 non-disjunction error type.

Adolescent↗
PubMed1998

Feasibility of transurethral resection for muscle infiltrating carcinoma of the bladder: long-term followup of a prospective study.

PURPOSE: We analyzed the long-term results of radical transurethral resection for the treatment of a large series of patients with muscle infiltrating bladder cancer entered into a prospective study to determine progression predictive factors. MATERIALS AND METHODS: The study included 133 patients with invasive bladder cancer treated by radical transurethral resection who had negative biopsies of the muscle layer of the tumor bed. Followup was more than 5 years for all subjects and more than 10 years in 59 (44.4%). A comparative nonrandomized study was performed of a control group of 76 patients with invasive pathological stage pT2-3a, N0-3 bladder cancer treated by cystectomy. In those patients treated by radical transurethral resection univariate and multivariate analyses were performed to establish clinical progression predictive factors. RESULTS: At 5 and 10 years of followup cause specific survival rates were 80.5 and 74.5%, and bladder preservation rates were 82.7 and 79.6%, respectively. No significant difference was noted in terms of cause specific survival, with respect to the control group. The initial presence of associated bladder carcinoma in situ was the only independent progression predictive factor. CONCLUSIONS: For patients with invasive bladder cancer radical transurethral resection is justified when the tumor is clinically limited to the muscular layer and when all biopsies of the periphery and depth of the tumor bed show muscular tissue negative for tumor cells. Patients with initial associated bladder carcinoma in situ should not be excluded from this treatment but endovesical bacillus Calmette-Guerin immunotherapy should be administered and a closer followup is recommended.

Adult↗
PubMed1997

Upper urinary tract involvement in patients with bladder carcinoma in situ (Tis): its impact on management.

OBJECTIVES: To analyze the biologic behavior and etiologic mechanism of upper-tract involvement in patients with bladder cancer in situ (Tis) and its impact on management of these patients. METHODS: One hundred thirty-eight patients with bladder Tis, 786 with superficial bladder cancer, and 179 patients with invasive bladder cancer treated by cystectomy were studied: 34 (24.6%), 18 (2.3%), and 7 (3.9%) developed upper-tract involvement in each group, respectively. Sixty-three patients with primary urothelial upper-tract tumors were also studied. Taking progression-free survival as an end point, univariate and multivariate analyses were performed. RESULTS: The upper-tract recurrence rate was significantly higher in patients with bladder Tis than in patients with superficial bladder tumors (P <0.001); it was also significantly higher in patients treated with cystectomy because of bladder Tis compared with those treated because of invasive tumors (P <0.01). Patients with bladder Tis and upper-tract involvement showed high rates of upper-tract bilaterality (32.3%) and prostate involvement (67.4%). On pathologic examination, the upper tract showed predominantly superficial (Ta-T1-Tis) tumors (67.4%) and distal ureter location as the only finding (47%). In patients with bladder Tis, upper-tract involvement alone does not have a negative impact on the survival rate according to univariate and multivariate analysis (P = NS). CONCLUSIONS: In patients with bladder Tis, upper-tract involvement represents a diffuse process; therefore, a close evaluation of both the prostate and the upper tract is recommended. Upper-tract involvement has no impact on bladder-preservation strategy. Many of these patients could also be offered a conservative management for the involved upper tract.

Aged↗
PubMed1996

Extravesical involvement in patients with bladder carcinoma in situ: biological and therapy implications.

PURPOSE: The biological and therapeutic implications of extravesical involvement in patients with bladder carcinoma in situ were analyzed. MATERIALS AND METHODS: Of 138 patients with bladder carcinoma in situ 87 (63%) had extravesical involvement, including the prostate in 53, the upper urinary tract in 11 and both structures in 23 (pan-urothelial involvement). With survival free of disease as an end point, univariate and multivariate analyses were done. RESULTS: Patients with extravesical involvement had worse survival than those with bladder carcinoma in situ alone (p < 0.001). In multivariate analysis prostate involvement (p = 0.0007) and pan-urothelial involvement (p = 0.0001) were selected as significant variables. When pathological patterns were considered prostatic stromal invasion (p = 0.0002) was the only variable selected. With these data 3 patient groups with disease mortality risk were defined. CONCLUSIONS: Prostate involvement and pan-urothelial involvement behave as independent prognostic factors, with the latter probably reflecting an extremetly diffuse character of carcinoma in situ. However, the upper urinary tract had no influence on survival. In patients with upper urinary tract and/or prostatic involvement limited to the mucosa treatment can be conservative. Patients with ductal or stromal involvement should undergo radical treatment. For upper tract involvement conservative approaches may be considered if there are no radiological signs of invasion or low grade tumor.

Adult↗
PubMed1995

Improving the safety of BCG immunotherapy by dose reduction. Cooperative Group CUETO.

The preliminary results of a randomized, multicentre, prospective trial conducted by the Spanish Oncology Group (CUETO) are presented. The primary aim of the trial was to determine whether or not lowering the dose of bacillus Calmette-Guérin (BCG) could reduce toxicity without compromising efficacy. From February 1991 to June 1992, 500 patients with superficial bladder cancer (TaG2-3, T1G1-3) entered the trial. Of these patients, 252 were included in group A (BCG, 81 mg) and 248 in group B (BCG, 27 mg). There were no significant differences in clinical and pathological characteristics between the two groups. Following treatment, significant differences arose between groups A and B in local severe toxicity (22.6 vs. 4.2%, respectively; p < 0.01). Systemic toxicity was more common in group A than in group B (p < 0.01): pulmonary effects (2.3 vs. 0.4%), fever (26.9 vs. 12.9%) and malaise (16.2 vs. 8.4%), all p < 0.01. Regarding efficacy, 204 patients in group A and 210 in group B were evaluated after a mean follow-up of 18.6 months. No significant differences in recurrence rate (18.1 vs. 19.5%) or progression rate (2.4 vs. 4.8%) were found. However, in patients with superficial bladder cancer with high risk of recurrence and progression (carcinoma in situ and G3), caution must be exercised in selecting the dose.

Administration, Intravesical↗