Grades of the guideline statements (Standard, Recommendation, Option) are defined at the end of the "Major Recommendations" field.
The American Urological Association Bladder Cancer Clinical Guidelines Panel based the majority of the following guideline statements on a careful analysis of comparative outcomes from randomized controlled trials. Included were data published after the previous guideline was completed as well as results from previous studies involving transurethral resection of bladder tumor (TURBT) and intravesical therapies. These statements apply to the treatment of patients with nonmuscle invasive transitional cell carcinoma of the bladder including Tis as well as stages Ta and T1 tumors (see Table 1 in the original guideline document for staging of primary tumors in bladder cancer). Inherent in these guideline statements is the importance of individualizing patient diagnostic evaluation and therapy. Some of the treatment paradigms addressed below were not based on data but on Panel experience alone.
In an attempt to recognize commonly encountered clinical variations, the Panel has designated certain example settings as "index patients." In establishing these index patients, the Panel closely examined pressing questions involving the use of intravesical chemotherapy versus immunotherapy and the role of maintenance therapy. Each guideline statement addresses a specific index patient.
For All Index Patients
Standard: Physicians should discuss with the patient the treatment options and the benefits and harms, including side effects, of intravesical treatment. [Based on Panel consensus.]
For Index Patient No. 1: A patient who presents with an abnormal growth on the urothelium but who has not yet been diagnosed with bladder cancer:
Standard: If the patient does not have an established histologic diagnosis, a biopsy should be obtained for pathologic analysis. [Based on Panel consensus.]
Standard: Under most circumstances, complete eradication of all visible tumors should be performed. [Based on Panel consensus.]
Standard: If bladder cancer is confirmed, periodic surveillance cystoscopy should be performed. [Based on Panel consensus.]
Option: An initial single dose of intravesical chemotherapy may be administered immediately postoperatively. [Based on Panel consensus.]
For Index Patient No. 2: A patient with small-volume low-grade Ta cancer
Recommendation: An initial single dose of intravesical chemotherapy may be administered immediately postoperatively. [Based on review of the data.]
For Index Patient No. 3: A patient with multifocal and/or large volume, histologically confirmed, low-grade Ta or a patient with recurrent low-grade Ta bladder cancer.
Recommendation: An induction course of intravesical therapy with bacillus Calmette-Guérin or mitomycin C is recommended for the treatment of these patients with the goal of preventing or delaying recurrence. [Based on review of the data.]
Option: Maintenance bacillus Calmette-Guérin or mitomycin C may be considered. [Based on review of the data.]
For Index Patient No. 4: A patient with initial histologically confirmed high-grade Ta, T1, and/or carcinoma in situ bladder cancer.
Standard: For patients with lamina propria invasion (T1) but without muscularis propria in the specimen, repeat resection should be performed prior to additional intravesical therapy. [Based on review of the data and Panel consensus.]
Recommendation: An induction course of bacillus Calmette-Guérin followed by maintenance therapy is recommended for treatment of these patients. [Based on review of the data.]
Option: Cystectomy should be considered for initial therapy in select patients. [Based on review of the data and Panel consensus.]
For Index Patient No. 5: A patient with high- grade Ta, T1, and/or carcinoma in situ bladder cancer which has recurred after prior intravesical therapy.
Standard: For patients with lamina propria invasion (T1) but without muscularis propria in the specimen, repeat resection should be performed prior to additional intravesical therapy. [Based on review of the data and Panel consensus.]
Recommendation: Cystectomy should be considered as a therapeutic alternative for these patients. [Based on review of the data.]
Option: Further intravesical therapy may be considered for these patients. [Based on review of the data and Panel consensus.]
Definitions:
Rating Scheme for Strength of Recommendations
The guideline statements were graded with respect to the degree of flexibility in their application. The three levels of flexibility are defined as follows:
Standard: A guideline statement is a standard if: (1) the health outcomes of the alternative interventions are sufficiently well known to permit meaningful decisions and (2) there is virtual unanimity about which intervention is preferred.
Recommendation: A guideline statement is a recommendation if: (1) the health outcomes of the alternative intervention are sufficiently well known to permit meaningful decisions, and (2) an appreciable but not unanimous majority agrees on which intervention is preferred.
Option: A guideline statement is an option if: (1) the health outcomes of the interventions are not sufficiently well known to permit meaningful decisions, or (2) preferences are unknown or equivocal. Options can exist because of insufficient evidence or because patient preferences are divided and may/should influence choices made.
