Bladder Cancer Therapy beyond Bacillus Calmette-Guérin (BCG)

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The agent (CG0070) yielded an overall 12-month complete response (CR) rate of 30% in a phase 2 single-arm trial in patients with BCG-unresponsive, high-grade Ta, T1, or CIS ± Ta/T1 non-muscle-invasive bladder cancer…

Let me try to simplify the study linked below. According to research the key to bladder cancer is the stage at diagnosis. If the cancer is diagnosed within the bladder (non-muscle invasive) the five year average survival rate is 70%. Muscle-invasive bladder cancer, when the cancer is diagnosed outside of the bladder brings an average five year survival rate of less than 5%.

In addition to the issue outlined above, many BC survivors either do not respond to BCG therapy or relapse after BCG therapy. The therapy discussed below is a new therapy for non-muscle invasive bladder cance

Once conventional treatment has been completed, either BCG or the therapy discussed below, consider evidence-based non-toxic therapies shown to reduce the risk of bladder cancer relapse. From curcumin to anti-angiogenic nutrition to frequent, moderate exercise, BC survivors can improve their prognosis.

Have you been diagnosed with bladder cancer? What stage? What therapies are you considering? Scroll down the page, post a question or comment and I will reply to you ASAP.

Thank you,

David Emerson

  • Cancer Survivor
  • Cancer Coach
  • Director PeopleBeatingCancer

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CR Rate of 30% With Agent for High-Risk Bladder Cancer

“With dozens of clinical trials underway, there’s a race to develop, test, and receive approval for the first drug since 1998 for the treatment of high-risk bladder cancer that is unresponsive to bacillus Calmette-Guérin (BCG)…

The agent (CG0070) yielded an overall 12-month complete response (CR) rate of 30% in a phase 2 single-arm trial in patients with BCG-unresponsive, high-grade Ta, T1, or CIS ± Ta/T1 non-muscle-invasive bladder cancer…

CR was defined as the absence of evidence of disease on cystoscopy, cytology, and/or random biopsies…

He explained that the last drug to be approved by the FDA for these patients was valrubicin (Valstar, Endo Pharmaceuticals), in 1998. However, valrubicin is associated with only an 18% CR rate at 6 months. “The response is not very durable, so newer drugs are needed,” said Lee.

Intravesical gemcitabine (Gemzar, Lilly) is also an option, he commented. But both Lee and trial investigator Packiam emphasized that new intravesical agents, which are administered directly into the bladder through a catheter, and systemic immunotherapies (anti-PD-1 or anti-PD-L1 antibodies) could represent important new therapies for this disease.

CG0070 is a selective oncolytic adenovirus that leads to selective expression of granulocyte-macrophage colony-stimulating factor (GM-CSF) in retinoblastoma pathway–defective cells that are found in many tumors. It stimulates the expression of GM-CSF and has a direct oncolytic effect after local treatment (ie, intravesical administration), and it may also induce systemic, tumor-specific immunity (Clin Cancer Res. 2006;12:305-313).

After Failure of BCG

Currently, BCG is the main intravesical immunotherapy for early-stage bladder cancer.

In the current trial, all patients (n = 67) had experienced disease progression while receiving BCG therapy: they were either unable to achieve a disease-free state at 6 months after adequate BCG therapy (BCG-refractory), or they experienced recurrence after CR with BCG therapy (BCG-relapsed).

All of the patients refused the next treatment option, cystectomy or surgical removal of the bladder, and opted instead to take part in the clinical trial.

Ultimately, 10 of the 61 patients who were included in interim analysis underwent cystectomy. Pathology assessment revealed that six patients had muscle-invasive disease, not the less threatening non-muscle-invasive cancer, as first indicated.

These findings clearly illustrate the need for more treatment options, interjected Lee.

“This non-muscle-invasive disease has a high risk of progression to muscle-invasive disease, and we know that bladder cancer is very commonly understaged. So we have a disease in which clinical staging is often inaccurate, progression rates are high, and available therapies for noncystectomy candidates have low durable complete response rates, all of which point to the need for more therapeutic options,” he said…

In his presentation, Packiam highlighted that CG0070 also yielded a CR rate of 27% in patients with carcinoma in situ–containing tumors and in 48% in patients with refractory disease. These are interim results, as the trial is ongoing.

No patients with T1/CIS or Ta/CIS (n = 6) had 12-month CR. Among BCG-relapsed patients, 19% (n = 31) had a 12-month CR.

Treatment-related adverse events at 12 months included influenza-type illness (7%), fatigue (4%), and chills (1%). Five deaths occurred secondary to progressive urothelial carcinoma, esophageal carcinoma, lung carcinoma, and cardiac disease.”

The study was funded by Cold Genesys, the maker of CG0070. Dr Packiam and Dr Lee have disclosed no relevant financial relationships.

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