About The Clinical Trials
A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes is now open at the UNM Comprehensive Cancer Center. Read more about this clinical trial .
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer is now open at the UNM Comprehensive Cancer Center. Read more about this clinical trial .
How Do These Drugs Combat Cancer
Enfortumab vedotin is an antibody-drug conjugate, or compound treatment. The antibody portion of this drug targets Nectin-4, which is a molecule liberally expressed on the surface of bladder cancer cells. This molecule helps cancer cells stick to one another. It also helps them proliferate. After the antibody binds to Nectin-4, the chemotherapy drug MMAE is injected into the cancer cells. MMAE decimates the scaffolding on which the cancer cells are built, in turn stopping the tumor from growing and killing it. Enfortumab vedotin is currently only approved as a second or later line agent, meaning that patients must first fail more traditional therapies before being offered this antibody-drug conjugate.
Pembrolizumab is an immunotherapy drug, which means it primes the patients own immune system in the fight against their cancer. Cancer cells can learn to evade detection by the immune system. They can essentially hijack the PD-1 and PD-L1 pathways to survive. PD-1 is a protein on the surface of immune cells. PD-L1 is a protein on the tumor cells, which can bind to PD-1 and prevent the immune system from killing the cancer cell. Pembrolizumab interrupts this process by binding to PD-1, allowing the immune cells to exterminate cancer. Pembrolizumab is approved by itself for patients with advanced or metastatic bladder cancer who cannot receive cisplatin or if cisplatin fails to stop their cancer from spreading.
Treating Bladder Cancer That Progresses Or Recurs
If cancer continues to grow during treatment or comes back after treatment , treatment options will depend on where and how much the cancer has spread, what treatments have already been used, and the patient’s overall health and desire for more treatment. Its important to understand the goal of any further treatment if its to try to cure the cancer, to slow its growth, or to help relieve symptoms as well as the likely benefits and risks.
For instance, non-invasive bladder cancer often comes back in the bladder. The new cancer may be found either in the same place as the original cancer or in other parts of the bladder. These tumors are often treated the same way as the first tumor. But if the cancer keeps coming back, a cystectomy may be needed. For some non-invasive tumors that keep growing even with BCG treatment, and where a cystectomy is not an option, immunotherapy with pembrolizumab might be recommended.
Cancers that recur in distant parts of the body can be harder to remove with surgery, so other treatments, such as chemotherapy, immunotherapy, targeted therapy, or radiation therapy, might be needed. For more on dealing with a recurrence, see Understanding Recurrence.
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Combination Of Fgfr Inhibitors With Immunotherapy
Erdafitinib, as the first TKI approved in UC therapy, has been demonstrated to be beneficial in clinical trials. Similar to other targeted drugs, toxicity and drug responses become concerns. Research has suggested that the presence of an antitumor T-cell response is fundamental for the activity of immunotherapy . Recently, Sweis et al. showed that UC can be divided into T-cell-inflamed and non-T-cell-inflamed subtypes. The latter phenotype correlated with a resistance to ICIs, but was also linked to FGFR3 mutation, providing a rationale for combining FGFR inhibitors and anti-PD-1/PD-L1 . Preliminary data in the FIERCE-22 study showed that the ORR was 36% in the overall population, and a response was observed in both wild type and mutated FGFR3 patients receiving vofatamab and pembrolizumab . Powles et al. conducted a phase I study enrolled with platinum-resistant and ICI naïve patients with A/M UC harboring FGFR mutations . However, the results showed that AZD4547 plus durvalumab increased response modestly compared to AZD4547 alone , suggesting that the tumor mutations burden might contribute rather small differences to ICI response. A phaseIb/II study of rogaratinib combined with atezolizumab in patients with untreated FGFR-positive UC is currently in progress . Likewise, the safety and efficacy of erdafitinib plus JNJ-63723283 are investigated by a phase Ib/II study in advanced UC patients with FGFR gene alterations.
What Is The Immune System And How Does It Work With Cancer
The immune system is a natural part of our body. Its role is to get rid of foreign or damaged material and cells before they cause trouble.
Most of the time, our immune system can find foreign invaders like bacteria and viruses, and destroy them. The immune system uses signals to attack them while leaving healthy cells alone.
Cancer is different from an illness caused by a bacteria or virus. It involves the uncontrolled growth of normal body cells. In other words, cancer cells may not be found by the immune system. Though they look different under the microscope, cancer cells can hide and grow. One way cancer cells hide is to express proteins on their surface to turn-on a “checkpoint” to stop an immune system attack.
The National Cancer Institute studied common tumors in its Cancer Genome Atlas project. The research showed that bladder cancer, skin cancer and lung cancer have the most cellular changes . These types of cancer may be more likely to respond to treatments that help the immune system find cancer cells, called “immunotherapies”.
What is Immunotherapy?
Immunotherapy is any treatment that makes the immune system stronger. For cancer, it helps the body find and attack cancer cells. The field of immuno-oncology studies how the immune system interacts with cancer. It uses that information to make new treatments.
What Happens Under Normal Conditions?
What Happens When Cancer Cells Grow and Hide?
Three things help cancers hide from the immune system:
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Collaborative Study From The Bladder Cancer Advocacy Network Improves Understanding Of Metastatic Bladder Cancer
Today, the Bladder Cancer Advocacy Network, BCAN, announced publication of a paper in the prestigious journal Nature Communications describing a highly collaborative project that studied the genomic analysis of metastatic urothelial carcinoma. Urothelial carcinoma is the most common type of bladder cancer. The study in more than 200 patients increased our understanding of the role of targeted therapy for patients with metastatic disease and built a foundation for future research that will include developing and validating much needed biomarkers for this disease. Biomarkers help doctors understand which patients are likely to respond to a particular treatment.
This study provided a comprehensive next generation sequencing report at no cost to patients, created a rich repository of clinical data and provided an overarching view of the tumor and the tumor microenvironment, said Diane Zipursky Quale, co-founder of BCAN.
Traditionally, bladder cancer treatments have been developed based on a set of clinical factors, such as the type and stage of a tumor and target an average population rather than specific individuals. Understanding the genomic characteristics of individual patients tumors via NGS can help doctors develop treatments that specifically target their urothelial carcinoma mutations.
This project was sponsored by BCAN through generous donations from the James Family Foundation, The JPB Foundation and The Gerald C. McNamara and Renee K. Petrofes Charitable Fund.
Measuring Surgical Recovery After Radical Cystectomy
open to eligible people ages 18 years and up
The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes and clinician-reported outcomes as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.
San Francisco, California and other locations
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Where Can I Find A Support Group
To find a local group, talk to your healthcare provider. Local and Zoom meeting lists are also available through organizations such as CancerCare.
Joining a support group of people dealing with advanced cancer may help provide camaraderie and knowledge. You can connect with people who understand what you’re going through.
Treating cancer means looking after your whole self. This includes keeping an active lifestyle, eating healthy, practicing mindfulness, and socializing with family and friends to improve your mood and overall health. If you smoke cigarettes or use nicotine products, this is a good time to try to quit or cut down.
It’s also important to look after your mental health. Meeting with a therapist can help you navigate intense emotions and provide you with tools to feel more in control of your daily life.
Palliative care may also be beneficial. Your palliative care provider can help you learn about pain management options. Palliative care providers can also assist with finding mental health services, such as counseling.
Catheterizable Continent Diversion Pouch
This is a reservoir of bowel with a stoma that is catheterizable for emptying the bladder. The urine is siphoned out of the urinary reservoir with a small catheter every four to six hours. The catheterizable pouch may require surgical repair at some point after surgery due to the wear and tear of frequent catheterization. This type of reconstruction is not performed on patients with a history of bowel disease.
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Pembrolizumab Immunotherapeutic Bladder Cancer First Line Treatment
On January 8, 2020, the Food and Drug Administration approved Pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin -unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Pembrolizumab is a FDA approved drug used to treat bladder cancer, head and neck cancer, Hodgkin lymphoma, lung cancer, and melanoma.
According to the FDA, efficacy was investigated in KEYNOTE-057 (NCT, a multicenter, single-arm trial that enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors. Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity, persistent or recurrent high-risk NMIBC or progressive disease, or up to 24 months of therapy without disease progression.
Patients with bladder cancer now have more treatment options available. Read the full FDA Pembrolizumab approval announcement.
Combination Of Ido1 With Immunotherapy
Indoleamine 2,3-dioxygenase 1 enzyme is involved in the catabolism of the essential amino acid tryptophan and plays an important role in immune evasion and tumor growth through production of kynurenine. The IDO1 enzyme is activated in many human cancers including NMIBC . Recent data indicate that IDO1 gene expression characterizes a poorly differentiated, more aggressive NMIBC, with IDO1 gene expression in tumor tissues directly correlating with tumor size =0.24, p=0.04) and stage . Moreover, there was a trend toward longer OS in patients with tumors that did not express IDO1. IDO inhibitors such as BMS-986205, epacadostat, indoximod, navoximod, and HTl-1090 are in various stages of clinical development in several cancers. There is evidence supporting an interrelationship between the PD-1/PD-L1 and IDO1 axes, with IDO functional activity linked with increased PD-L1 positive cytotoxic T-cells and increased CTLA4 expression by regulatory T cells . Therefore, it has been proposed that parallel inhibition of these pathways may lead to a more effective activation of T cell mediated antitumor immune response.
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Treating Stage Ii Bladder Cancer
These cancers have invaded the muscle layer of the bladder wall , but no farther. Transurethral resection is typically the first treatment for these cancers, but it’s done to help determine the extent of the cancer rather than to try to cure it.
When the cancer has invaded the muscle, radical cystectomy is the standard treatment. Lymph nodes near the bladder are often removed as well. If cancer is in only one part of the bladder, a partial cystectomy may be done instead. But this is possible in only a small number of patients.
Radical cystectomy may be the only treatment for people who are not well enough to get chemo. But most doctors prefer to give chemo before surgery because it’s been shown to help patients live longer than surgery alone. When chemo is given first, surgery is delayed. This is not a problem if the chemo shrinks the bladder cancer, but it might be harmful if the tumor continues to grow during chemo.
If cancer is found in nearby lymph nodes, radiation may be needed after surgery. Another option is chemo, but only if it wasn’t given before surgery.
For people who have had surgery, but the features of the tumor show it is at high risk of coming back, the immunotherapy drug, nivolumab, might be offered. When given after surgery, nivolumab is given for up to one year.
For patients who cant have surgery because of other serious health problems, TURBT, radiation, chemotherapy, or some combination of these may be options.
The Phase 2 Trial Helps Fine
The Phase 2 trial begins to gauge the effectiveness and tolerability of the treatment in patients with previously treated metastatic or unresectable urothelial carcinoma.
During our research, we also discovered an important biomarkerphosphate, a mineral found naturally in the body, adds De Porre. Patients who had a higher level of it had a better response to the treatment. This later becomes an important factor in determining effective dosage, which, after much work, the researchers zero in on by the end of 2014.
This class of agents has a very narrow therapeutic indextoo low or too high of a dose wont be effective and safe, says Kiran PatelKiran Patel,Vice President Clinical Development, Solid Tumor Franchise at Janssen, Vice President Clinical Development, Solid Tumor Franchise, Janssen.
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Looking For More About The Latest Research
If you would like additional information about the latest areas of research regarding bladder cancer, explore these related items:
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To find clinical trials specific to your diagnosis, talk with your doctor or search online clinical trial databases.
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Visit the Cancer.Net Blog to read about recent research in bladder cancer and to listen to podcasts with expert perspectives on the topic.
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Visit the website of Conquer Cancer, the ASCO Foundation, to find out how to help support cancer research. Please note that this link takes you to a different ASCO website.
The next section in this guide is Coping with Treatment. It offers some guidance on how to cope with the physical, emotional, social, and financial changes that cancer and its treatment can bring. Use the menu to choose a different section to read in this guide.
A Groundbreaking Bladder Cancer Treatment With Many Firsts
This was groundbreaking for us on many levelsthis was the first Janssen Oncology compound developed from discovery all the way to approval our first drug using pharmacodynamically guided treatment dosing, which means a patients dose is adjusted based on their phosphate levels and our first drug developed with a companion diagnostic, Patel says.
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How Common Is Bladder Cancer
- Bladder cancer is the sixth most common type of cancer overall in the United States, according to the National Cancer Institute, though it is the fourth most common for men.
- Approximately 81,000 new cases of bladder cancer are expected to be diagnosed in 2022 in the U.S., which will result in about 17,000 deaths.
- Around 17% of these cases will be ones in which cancer has spread to the tissues surrounding the bladder, termed locally advanced, or has spread to other parts of the body, termed metastatic.
- Most of these cases occur in people older than 55 years of age. At 5 years, only 5% will survive.
These advanced bladder cancers are usually treated with the chemotherapy drug cisplatin. Cisplatin is very efficacious, but comes at the cost of significant toxicity. It can be particularly harmful for the kidneys. Given that bladder cancers most often afflict the older population with likely impaired kidney function, cisplatin is not a suitable choice. Historically, such cisplatin-ineligible patients have been treated with drugs that are not as effective. Thus, treatments that can prolong the survival for these patients are needed urgently.
The combination of drugs in the trial was enfortumab vedotin and pembrolizumab. Both of these drugs have previously demonstrated success in treating metastatic bladder cancers on their own. Researchers hypothesized that combining these drugs may yield even better results, which was shown by the study results.
Treatment Of Bone Metastases
When bladder cancer has spread to the bone, skeletal complications can occur, such as weakening of the bones or pathological fractures from minor incidents or everyday activity. This causes pain and can have a detrimental effect on your quality of life. Your doctor may suggest radiotherapy, or drug treatment to help strengthen your bones and control the pain.
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Developing A Treatment Plan
In cancer care, different types of doctors often work together to create a patients overall treatment plan that combines different types of treatments. This is called a multidisciplinary team. This team is usually led by a urologist, a doctor who specializes in the genitourinary tract, or a urologic oncologist, a doctor who specializes in treating cancers of the genitourinary tract. Cancer care teams include a variety of other health care professionals, such as physician assistants, nurse practitioners, oncology nurses, social workers, pharmacists, counselors, dietitians, and others.
Treatment options and recommendations depend on several factors, including:
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The type, stage, and grade of bladder cancer
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Possible side effects
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The patients preferences and overall health
Your care plan also includes treatment for symptoms and side effects, an important part of cancer care.
The first treatment a person is given for advanced urothelial cancer is called first-line therapy. If that treatment stops working, then a person receives second-line therapy. In some situations, third-line therapy may also be available.
Adjuvant systemic therapy is treatment that is given after radical surgery has been completed. In bladder cancer, adjuvant therapy is usually cisplatin-based chemotherapy or treatment in a clinical trial. Neoadjuvant therapy is treatment that is given before surgery, such as cisplatin-based chemotherapy.
Treatments by type and stage of bladder cancer: