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Actos Lawsuit: The urinary bladder is a hollow, balloon-like organ located in the pelvis that collects and stores urine until it is ready to be excreted from the body. Urine is produced in the kidneys and is transported to the bladder through two tube-like structures called ureters. Pressure from the accumulation of urine in the urinary bladder forces the wall of the bladder to contract producing the urge to urinate. The urine is then excreted from the bladder via the urethra (a thin tube that carries urine from the bladder to the outside of the body).
A basic understanding of the terminology used by doctors to describe the various subtypes of bladder tumors is important in order to more fully appreciate the various approaches to treatment, the treatment options, and the prognosis (chances for recovery). Superficial bladder tumors are those that are localized (confined) to the transitional epithelium (urothelium) – the layer of epithelial cells that lines the inside of the bladder wall and is in direct contact with the urine – but have not spread to the deeper layers of the bladder. Additionally, bladder tumors that have invaded the lamina propria but have not invaded the muscularis propria can be considered as superficial. Invasive bladder cancer refers to a bladder tumor that is either invading the muscularis propria – the deeper layer of muscle cells that forms the wall of the bladder – or the perivesical fat located beyond the bladder muscle. This type of tumor is referred to as muscle-invasive bladder cancer. Muscle-invasive bladder cancer carries a higher risk of spreading beyond the bladder (metastases) and must be treated more aggressively than superficial bladder cancer. The term metastatic bladder cancer is used when the cancer cells have spread beyond the bladder to distant sites.
Hematuria – Blood in the urine (hematuria) is often the first warning signal and the most common symptom of bladder cancer. It has been estimated that approximately 80% to 90% of patients with bladder cancer develop hematuria which is often painless. In some cases, sufficient numbers of red blood cells are present to turn the color of the urine to dark brown or red. This is known as gross hematuria and is easily recognized by the patient upon urinating. In other cases, insufficient numbers of red blood cells may be present in the urine to cause any evident changes in the color of the urine but red blood cells can be detected by examining the urine under a microscope. This type of hematuria is called microscopic hematuria and may also indicate the presence of bladder cancer. It is important to note that although hematuria is the most common symptom of bladder cancer.
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Actos Lawsuit: Cystoscopy is an important diagnostic tool that enables the physician to directly examine the urinary tract with an instrument called a cystoscope. During this procedure, which is usually performed by an urologist on an outpatient basis, the cystoscope – a long, flexible lighted tube – is inserted through the urethra (the tube that carries urine from the bladder to the outside of the body) and is advanced into the bladder. The cystoscope enables the doctor to view the bladder and urethra and look for any abnormalities including a tumor, infection, or obstruction. During this procedure, the physician may also remove a small piece of tissue from the bladder (biopsy) and submit the biopsy specimen to the pathology laboratory where it is examined under a microscope for the presence of cancer cells. If you have signs and symptoms suggestive of bladder cancer (hematuria and/or changes in bladder habits), your doctor will recommend a cystoscopy to rule out bladder cancer.
A small piece of bladder tissue (biopsy specim en) is obtained by the urologist during cystoscopy for microscopic evaluation. During the biopsy procedure, muscle tissue must be obtained as it is important to determine the extension of the tumor (how far the tumor has spread) since the treatment of superficial bladder cancer differs from muscle-invasive bladder cancer. The biopsy specimen will then be examined under a microscope by another doctor known as a pathologist.
In general, early diagnosis and treatment significantly improves the prognosis for patients with bladder cancer. A high level of suspicion of bladder cancer should be considered for any patient who presents with gross hematuria and known risk factors for the disease. Once the diagnosis is confirmed, patients are evaluated thoroughly to determine the stage (extent of spread) of the disease. The choice of treatment depends upon a variety of factors including the type of bladder cancer, stage of the disease, the presence of other underlying medical conditions, and the patient’s preferences.
Transurethral resection of the bladder tumor (TURBT) represents the primary treatment modality for superficial bladder cancer. During this procedure, which may be performed either under general or regional anesthesia, the tumor is removed using a cystoscope that is inserted into the bladder via the urethra. After surgical removal of the bladder tumor, any remaining cancer cells can be destroyed with either electrical current (fulguration) or with a high-energy laser.
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Actos Lawsuit: The term “intravesical therapy” refers to the instillation of a biological agent or a chemotherapy drug directly into the bladder in order to destroy any residual cancer cells. Intravesical therapy is a form of local drug therapy whereby the treatment is targeted directly at the site of the cancer (bladder) as opposed to systemic drug therapy where a drug is injected into a vein or is given orally and travels throughout the circulatory system in order to reach the target organ (e.g., bladder).
The most common type of intravesical therapy for superficial bladder cancer is immunotherapy with Bacillus Calmette-Guerin (BCG). BCG is a vaccine that is sometimes used to vaccinate people against tuberculosis. The rationale for using BCG for the treatment of superficial bladder cancer is to boost the body’s natural immune system to destroy the bladder cancer cells. It is thought that BCG induces regression of the bladder tumor through a non-specific inflammatory reaction at the tumor site. Intravesical therapy with BCG is a form of immunotherapy. Intravesical BCG immunotherapy is the treatment of choice for patients with carcinoma in situ (Stage Tis) where the bladder cancer is limited to the lamina propria of the bladder but has not invaded the surrounding tissue.
Patients who undergo a radical cystectomy for muscle-invasive bladder cancer also require urinary diversion reconstructive surgery to collect and eliminate urine. Urinary diversion, also known as urostomy, is the general term used to describe reconstructive surgical procedures that bypass the normal structures of the urinary system by creating a “diversion” or conduit for the passage of urine through an opening in the abdominal wall called a stoma.
Orthotopic continent diversion – In this type of continent diversion, a new bladder, called a neobladder, is created by the surgeon using a long segment of the small or large bowel that serves as a reservoir to collect and store the urine. One technique involves surgically connecting the neobladder to the urethra which enables the patient to void urine normally. This procedure may be more advantageous for younger patients who may not wish to wear a bag attached to the abdomen for collecting the urine.
Another potential side effect of radical cystectomy in men is nerve damage that results when the neurovascular bundles are not spared during surgery. Nerve damage often results in the loss of the ability to have an erection (erectile dysfunction). Younger men under age 60 have a greater likelihood of regaining erectile function following a radical cystectomy than men over age 60. Patients should discuss with their surgeon the advantages and disadvantages of using nerve-sparing procedures during radical cystectomy.
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Actos Lawsuit: In women, part of the vagina is also usually surgically removed during a radical cystectomy making sexual intercourse more difficult and painful. Intercourse may be made less painful by using lubricating gels, vaginal moisturizers, or vaginal dilators. Women who undergo radical cystectomy are, however, still capable of achieving sexual climax (orgasm). It is evident that radical cystectomy can have a significant impact on the sexual health of both men and women. Patients should talk openly with their doctor about the potential negative side-effects of radical cystectomy on their sexual well-being and discuss the options that may be available for resuming an active and pleasurable sexual relationship after surgery for bladder cancer.
Over the years, doctors have come to learn that radical cystectomy alone is not sufficient as the sole treatment modality for muscle-invasive bladder cancer because about 50% of patients develop recurrent distant metastasis after undergoing radical cystectomy. More recently, the role of systemic chemotherapy has become better defined in the management of patients with muscle-invasive bladder cancer. Systemic chem otherapy may be administered either before radical cystectomy in order to shrink the bladder tumor ( neoadjuvant chemotherapy) or it may be given following surgery to destroy any residual cancer cells remaining in the body (adjuvant chemotherapy).
An important study published in 2003 in the New England Journal of Medicine (Volume 349; pages 859-866) clearly demonstrated the benefits in terms of significantly prolonged survival among bladder cancer patients receiving neoadjuvant combination systemic chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) as compared to the survival rate for patients treated with radical cystectomy alone. The median survival rate over an 11-year period of patients in this study who were treated with neoadjuvant M-VAC systemic chemotherapy followed by radical cystectomy was 77 months compared to only 46 months for patients treated with radical cystectomy alone. Based on the results of this study, the use of neoadjuvant combination chemotherapy has becom e much more prevalent for the treatment of muscle-invasive bladder cancer.
The data supporting the use of adjuvant chemotherapy for high-risk bladder cancer patients remains controversial. Nevertheless, it is generally accepted that patients with Stage T3 or T4 tumors and/or the presence of cancer in one or more lymph nodes at the time of surgery should receive 4-6 cycles of chemotherapy with either GC (gemcitabine) or M-VAC. Patients should discuss with their physicians the benefits and potential side effects of either neoadjuvant or adjuvant chemotherapy approaches.
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Actos Lawsuit: Although radical cystectomy is currently considered as the first-line treatment modality for muscle-invasive bladder cancer, some patients may be either unwilling or, due to other underlying medical conditions, may not be eligible to undergo this surgical procedure. What are the treatment options available to these patients?
In recent years, doctors have developed a combination of three treatment modalities (trimodality therapy or multimodality therapy) consisting of transurethral resection (TUR), radiation therapy, and systemic chemotherapy as a means of eradicating the bladder tumor while, at the same time, preserving the patient’s own bladder. The primary advantages of the trimodality therapy approach is that it enables the patient to keep their own bladder by avoiding the need for a radical cystectomy and, thereby, experience an improved quality of life after treatment for bladder cancer.
Although some studies have reported similar survival rates between trimodality therapy and radical cystectomy for patients with muscle-invasive bladder cancer, some experts have expressed the opinion that the risk of local recurrence of the cancer along with the risk of metastatic disease is higher for patients treated with the trimodality approach as compared to patients undergoing radical cystectomy. For these reasons, radical cystectomy is currently still considered as the standard of care for most patients with muscle-invasive bladder cancer, while trimodality therapy is usually reserved for a small subset of patients who are either unwilling or unable to undergo radical cystectomy or those who may wish to enroll in a clinical trial involving trimodality therapy.
Currently, combination systemic chemotherapy is considered as the first-line treatment for patients with metastatic (Stage IV) bladder cancer. The chemotherapeutic regimen that has been used most commonly since 1990 for metastatic bladder cancer is M-VAC (methotrexate, vinblastine, doxorubicin, cisplatin). The median survival rate for patients with metastatic bladder cancer who are treated with M-VAC is only about one-year, however, a small percentage of patients achieve longer survival.
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