Results of a European Comparative Randomized Study Comparing Oral Bropirimine versus Intravesical BCG Treatment in BCG-Naive Patients with Carcinoma in situ of the Urinary Bladder

Witjes, Wim P.J.; König, Mark; Boeminghaus, F; Hall, R. R.; Schulman, Claude; Zurlo, Maristella; Fittipaldo, A.; Riggi, Marcello; Debruyne, F.M.J.

doi:10.1159/000020051

Cited by 33 publications

(12 citation statements)

References 11 publications

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“…In a European phase III study comparing oral bropirimine vs intravesical BCG treatment in 55 BCG-naive patients with CIS of the urinary bladder, bropirimine was shown to be almost equally as effective as BCG but with more acceptable local toxicity (150). Unfortunately this study was terminated prematurely by the sponsor and further studies are warranted to evaluate the clinical utility of this drug.…”

Section: Difluoromethylornithinementioning

confidence: 99%

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Wijkström

Cohen

Gardiner

et al. 2000

Scandinavian Journal of Urology and Nephrology

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Bladder cancer is believed to develop through reversible premalignant stages followed by irreversible steps, and ending in invasive cancer giving rise to distant metastases. Because of the variation in the clinical course it has also been suggested that different forms of cancer develop along different molecular pathways leading to tumor presentations of various malignant potential. Today we treat and prognosticate bladder cancer on the basis of clinical and histologic findings that are insufficient to assess all the biologic potential of these tumors. Understanding the pathogenesis of bladder cancer might lead to a more precise identification of particular tumors with regard to clinical aggressiveness, resulting in individualized strategies for treatment and prophylaxis.Bladder cancer is seldom diagnosed in its preclinical stage, it is instead detected at cystoscopy and virtually never recognized as an incidental finding on autopsy. Therefore its "natural history" largely reflects that of "treated" disease. The true incidence of premalignant and malignant epithelial changes is not known. Incidences of hyperplasia and dysplasia of %10% and %5%, respectively and only occasional findings of cancer itself were reported in two autopsy series. Urothelial dysplasia is generally believed to be premalignant and a putative precursor of invasive cancer but unfortunately there has been a lack of standardization in terms of terminology and diagnosis. There is also a need for an agreed definition of the boundary between premalignancy, i.e. urothelial changes that have some but not all the features of carcinoma in situ, and malignancy, especially when considering potentially harmful treatments to prevent this transition. Most new diagnostic tools available and being tested today compare new detection techniques with traditional methods such as cytology or conventional histology of malignant rather than premalignant changes. There is probably also a short preclinical latency, as implied by the incidental findings of bladder cancer at autopsy, which makes it necessary to define how and when to promote early detection and treatment.Future studies therefore have to concentrate on methods for early detection of disease as well as characterization of host susceptibility, evaluation of exposure to carcinogens and potential effects of preventive measures. It is also likely that the improved tools of molecular prognostication will allow us to design trials more precisely in order to tailor therapeutic strategies.

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Section: Difluoromethylornithinementioning

confidence: 99%

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Wijkström

Cohen

Gardiner

et al. 2000

Scandinavian Journal of Urology and Nephrology

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“…Although bropirimine was a very promising drug for oral immuno‐modulation and good results were obtained in the treatment of Tis and upper urinary tract tumour, experiments has been stopped by the company producing the drug. They considered that the side‐effects, mainly flu‐like symptoms, were too serious and frequent for further development [41].…”

Section: Immunotherapy Vs Chemotherapymentioning

confidence: 99%

The management of superficial bladder cancer

Oosterlinck

2001

BJU International

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“…6 Although not currently available in the US, the findings of a recent clinical trial demonstrated equivalent response rates to BCG in 55 BCG-naïve patients with CIS. 41 The results of a Phase II trial examining the utility of bropirimine in 86 BCG-refractory patients reported a complete response in 24% of patients, with a 6% rate of progression to muscleinvasive disease or metastasis. 42 However, a recent Southwest Oncology Group Phase II trial investigating combination bropirimine-BCG therapy in 51 BCG-naïve patients with CIS reported discouraging five-year progression-free (53%) and overall survival (80%) rates, and recommended that no further evaluation of this combination be conducted.…”

Section: Emerging Agents Under Investigationmentioning

confidence: 99%

Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

Smaldone¹,

Tomaszewski²

2010

OAJU

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Transitional cell carcinoma (TCC) is the second most common urologic malignancy, and 70% of patients present with superficial or nonmuscle invasive bladder cancer (NMIBC). Intravesical bacillus Calmette-Guerin (BCG) is the most effective agent for preventing disease recurrence, and the only therapy able to inhibit disease progression. However, recurrence rates as high as 30% and significant local and systemic toxicity have led to increased interest in alternative intravesical therapies. In patients refractory or intolerant to BCG, BCG-interferon α2b, gemcitabine, and anthracyclines (doxorubicin, epirubicin, valrubicin) have demonstrated durable clinical responses. Phase I trials investigating alternative cytotoxic agents, such as apaziquone, taxanes (docetaxel, paclitaxel), and suramin are reporting promising data. Novel immunomodulating agents have demonstrated promise as efficacious alternatives in patients refractory to BCG. Optimization of existing chemotherapeutic regimens using hyperthermia, photodynamic therapy, magnetically-targeted carriers, and liposomes remains an area of active investigation. Despite enthusiasm for new intravesical agents, radical cystectomy remains the treatment of choice for patients with NMIBC who have failed intravesical therapy and selected patients with naïve T1 tumors and aggressive features. This report provides a comprehensive review of contemporary intravesical therapy for NMIBC and refractory NMIBC, with an emphasis on emerging agents and novel treatment modalities.

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Results of a European Comparative Randomized Study Comparing Oral Bropirimine versus Intravesical BCG Treatment in BCG-Naive Patients with Carcinoma in situ of the Urinary Bladder

Cited by 33 publications

References 11 publications

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

Prevention and Treatment of Urothelial Premalignant and Malignant Lesions

The management of superficial bladder cancer

Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

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