Investigational therapies for non-muscle invasive bladder cancer

Smaldone, Marc C.; Casella, Daniel P.; Welchons, Daniel R; Gingrich, Jeffrey R.

doi:10.1517/13543780903563372

Cited by 9 publications

(52 citation statements)

References 99 publications

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“…26,27 Concern regarding BCG-related toxicity and disease progression has led to the study of other intravesical chemotherapeutic agents (Table 1) in the treatment of NMIBC, most notably mitomycin C (MMC). 9 However, large meta-analyses examining patients with Ta and T1 TCC have concluded that BCG is superior to intravesical chemotherapy in preventing tumor recurrence in patients at high risk 28,29 and when maintenance therapy is utilized. 17,30 Sylvester et al reviewed nine randomized trials including 700 patients with CIS treated with either BCG or intravesical chemotherapy (MMC, epirubicin, adriamycin, or combination therapy).…”

Section: Bacillus Calmette-guerinmentioning

confidence: 99%

“…31 Further review of these analyses has led to the current American Urological Association (AUA) consensus that an induction course of BCG followed by maintenance therapy is recommended for the treatment of high-grade Ta or T1 TCC and CIS. 6,7,9 Although currently first-line therapy for high-risk NMIBC, five-year recurrence rates are estimated to be 34% in patients receiving BCG maintenance therapy. 7 The efficacy of BCG is also hampered by side effects and treatment intolerance, as well as the risks of understaging or progression to muscle-invasive disease.…”

Section: Bacillus Calmette-guerinmentioning

confidence: 99%

“…6 O'Donnell et al reviewed their experience utilizing BCG plus 50 million units of IFN in 40 patients who had relapsed following induction BCG therapy. 9 With a mean follow-up of 30 months, 63% and 53% recurred at one and two years, respectively. 37 In a multicenter Phase II trial, BCG-IFN was administered to 536 BCG-naïve patients and 467 BCGrefractory patients with NMIBC.…”

mentioning

confidence: 97%

“…6,9 IFNs are glycoproteins that mediate the host immune response in a dose-dependent manner by increasing antibody responsiveness, stimulating NK cells, and inducing expression of Class I major histocompatibility complex antigens. 9,34 The results of early investigations of IFN as monotherapy to prevent disease recurrence have been disappointing, demonstrating no benefit or inferior recurrence rates when compared with placebo controls 35 or other intravesical agents (BCG, MMC, MMC-IFN). 6,36 In contrast, results from initial trials investigating the combination of IFN-BCG have been more promising.…”

mentioning

confidence: 99%

“…40 Based on the available data, BCG-IFN appears to be a well-tolerated alternative to salvage therapy in selected patients with BCG-refractory NMIBC, but radical treatment options should be pursued for early failures and true BCG-refractory disease. 9 …”

mentioning

confidence: 99%

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Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

Tomaszewski¹,

Smaldone²

2010

RRU

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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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Section: Bacillus Calmette-guerinmentioning

confidence: 99%

Section: Bacillus Calmette-guerinmentioning

confidence: 99%

mentioning

confidence: 97%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

Tomaszewski¹,

Smaldone²

2010

RRU

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Hyperthermia

Dewhirst¹,

Stauffer²,

Das³

et al. 2016

Clinical Radiation Oncology

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In Vitro and In Vivo Evaluation of Intravesical Docetaxel Loaded Hydrophobically Derivatized Hyperbranched Polyglycerols in an Orthotopic Model of Bladder Cancer

Mugabe¹,

Matsui²,

So³

et al. 2011

Biomacromolecules

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The objective of this study was to evaluate the tolerability, to establish a dosing regimen, and to evaluate the efficacy of intravesical docetaxel (DTX) formulations in a mouse model of bladder cancer. DTX in commercial formulation (Taxotere, DTX in Tween 80) or loaded in hyperbranched polyglycerols (HPGs) was evaluated. The synthesis and characterization of HPGs with hydrophobic cores and derivatized with methoxy poly(ethylene glycol) in the shell and further functionalized with amine groups (HPG-C(8/10)-MePEG and HPG-C(8/10)-MePEG-NH(2)) is described. Intravesical DTX in either commercial or HPGs formulations (up to 1.0 mg/mL) was instilled in mice with orthotopic bladder cancer xenografts and was well tolerated with no apparent signs of local or systemic toxicities. Furthermore, a single dose of intravesical DTX (0.5 mg/mL) loaded in HPGs was significantly more effective in reducing the tumor growth in an orthotopic model of bladder cancer than the commercial formulation of Taxotere. In addition, DTX-loaded HPG-C(8/10)-MePEG-NH(2) was found to be more effective at lower instillation dose than DTX (0.2 mg/mL)-loaded HPG-C(8/10)-MePEG. Overall, our data show promising antitumor efficacy and safety in a recently validated orthotopic model of bladder cancer. Further research is warranted to evaluate its safety and efficacy in early phase clinical trials in patients refractory to standard intravesical therapy.

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Investigational therapies for non-muscle invasive bladder cancer

Cited by 9 publications

References 99 publications

Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

Emerging intravesical therapies for management of nonmuscle invasive bladder cancer

Hyperthermia

In Vitro and In Vivo Evaluation of Intravesical Docetaxel Loaded Hydrophobically Derivatized Hyperbranched Polyglycerols in an Orthotopic Model of Bladder Cancer

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