LOW DOSE vs STANDARD DOSE BCG THERAPY OF SUPERFICIAL BLADDER CANCER

Bassi, Pierfrancesco; Pappagallo, Giovanni; Piazza, N.; Carando, Roberto; Mazzariol, Clara; Balta, G.; Pagano, Francesco

doi:10.1097/00005392-199904020-00145

Cited by 6 publications

(7 citation statements)

References 0 publications

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“…However, the only study to date to confirm the value of maintenance BCG is that of the South-west Oncology Group [8], which used an entirely different schedule, with three weekly standard dose instillations at 3, 6, 12, 18, 24, 30 and 36 months. The discrepancy between the present results and the Italian trial [7] might be a consequence of the 2-year monthly maintenance therapy used in the latter. In the present study the efficacy was better when all 12 instillations (six weekly plus six fortnightly) were completed.…”

Section: Discussioncontrasting

confidence: 98%

“…The Chilean experience with 1 mg intravesical BCG highlights the ignorance about the optimal dose per instillation; their results do not agree with those in the present study and from other low-dose trials [7,9]. However, the series was not randomized, and comprised relatively few patients and poorly defined groups, but the data are intriguing.…”

Section: Discussioncontrasting

confidence: 85%

“…The present results do not agree with those of other studies assessing low BCG doses. Bassi et al [7] reported the definitive results of the only phase III study conducted so far. The trial showed similar or improved responses for disease-free survival and progression for each T stage in the low-dose arm (75 mg) and significantly less toxicity than the standard dose (150 mg).…”

Section: Discussionmentioning

confidence: 97%

“…It is also likely that the 2-year maintenance programme of Bassi et al may have influenced their results, in view of the recent data from another trial [8]. The report by Bassi et al [7] lacks important details, e.g. the number of tumours by T category and the grade of malignancy.…”

Section: Discussionmentioning

confidence: 99%

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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

̃eiro¹,

Flores²,

Isorna³

et al. 2002

BJU International

191

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Objectives To determine the efficacy of a three-fold reduced dose (RD, 27 mg) of intravesical bacille CalmetteGuérin (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 (weeklyrsix and thereafter fortnightlyrsix) 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 highrisk tumours. We recommend continuing to use the standard dose for high-risk tumours, while we consider the reduced dose safe and effective for intermediaterisk lesions and for maintenance schedules.

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Section: Discussioncontrasting

confidence: 98%

Section: Discussioncontrasting

confidence: 85%

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

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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

̃eiro¹,

Flores²,

Isorna³

et al. 2002

BJU International

191

View full text Add to dashboard Cite

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“…Böhle et al [10] have also deomonstrated the need of periodic instillations to maintain the immunologic response at the bladder wall.The problem with maintenance regimens is severe toxicity, which has been approached in two manners: first, trying to adapt therapy according to the production of urinary cytokines or overexpression of p53 protein after an induction course of BCG [11], and second reducing the dose per instillation. The results of two randomized studies, one Italian with a 50% dose reduction (75 mg Pasteur BCG vs. 150 mg) [12], and another Spanish with a threefold dose reduction (27 mg Connaught BCG vs. 81 mg) [13] suggest that in the particular case of Cis the low-dose regimen is equally effective, with much less toxicity. What can be done in case of failure?…”

Section: J a Martínez-piñeiromentioning

confidence: 99%