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Physicians should consider using IV chemo-therapy or immunotherapy as adjuvant therapy following surgery for nonmuscle invasive bladder cancer, according to recently released treatment guidelines from the American Urological Association (AUA) in Baltimore.
Currently, there is wide variation in the use of adjuvant therapy after transurethral resection of the bladder for the more than 50,000 new bladder cancer cases diagnosed each year, note members of the expert panel that developed the guidelines.
"For patients who have not had prior IV therapy, adjuvant IV chemotherapy or immunotherapy is an option for treatment after endoscopic removal of low-grade bladder cancers," the AUA guidelines state. "All the intravesical agents studied, when used after transurethral resection, result in lower probability of recurrence than surgery alone."
However, the data evaluated by the AUA panel indicate that although the IV agents decrease bladder cancer recurrence rates, there is no evidence that they affect long-term progression of the disease and they may not be appropriate in all cases, notes the panel. "Careful follow-up is required because bladder cancer patients are at risk for progression to muscle-invasive cancer, which may require bladder removal," says panel chair Joseph A. Smith Jr., MD, of Vanderbilt University Medical Center in Nashville, TN.
The guidelines include recommendations for three types of patients. They are:
• a patient who presents with an abnormal growth on the urothelium but has not yet been diagnosed with bladder cancer;
• a patient with established bladder cancer of any grade, stages Ta or T1, with or without carcinoma in situ, who has not had prior IV therapy;
• a patient with carcinoma in situ or an aggressive cancer that has begun to penetrate the bladder wall, who has had at least one course of IV therapy.
The panel further categorized its policy recommendations into three grades of flexibility as determined by the strength of the available evidence and the expected amount of variation in patient preferences. The three levels are:
• standards, which are the least flexible;
• guidelines, which are more flexible;
• options, which are most flexible.
Recommendations by the panel include the following:
1. As a standard of practice, physicians should discuss with all three types of index patients treatment alternatives and the benefits and risks of each alternative, including side effects.
2. For the patient who presents to a physician with an abnormal growth on the urothelium but has not yet been diagnosed with bladder cancer, the panel recommends as a standard that a biopsy should be obtained for pathological analysis. If a diagnosis of bladder cancer has been established, the panel recommends as a standard that complete removal of all tumors should be performed if surgically feasible and if the patient’s medical condition permits.
3. As an option that adjuvant IV chemotherapy or immunotherapy be used after surgical removal of tumors because the outcomes data "show a decreased recurrence probability for all the IV therapies studied, compared to transurethral resection alone." However, the panel notes that many patients with low-grade tumors do not require adjuvant IV therapy due to the low risk of disease progression in this group.
4. Panel members recommend as a guideline IV use of either BCG or mitomycin C for treatment of carcinoma in situ and for treatment after removal of tumors that have begun to penetrate the bladder wall and high grade Ta tumors. The guidelines state this recommendation is "based on evidence from the literature and panel opinion that both BCG and mitomycin C are superior to doxorubicin or thiotepa for reducing recurrence of these tumors."
5. The panel states that as an option bladder removal may be considered as an initial treatment option in certain patients based on several factors including large tumor size, high grade of tumor, and tumor location.
[For a complete copy of the Bladder Cancer Clinical Guidelines Report, write the Guideline Division, American Urological Association, 1120 N. Charles St., Baltimore, MD, 21201, or fax a request to (410) 223-4375, or phone (410) 223-4367.]