SITC Guidelines Bundle

Immunotherapy for Bladder Cancer

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Key Points General ➤ ➤ Non-muscle invasive bladder cancer (NMIBC – sometimes referred to as "superficial" bladder cancer) is the most common presentation of urothelial cancer. Bacillus Calme e-Guérin (BCG) ➤ ➤ Treatment of NMIBC depends on clinical and pathological risk stratification. The mainstay of treatment is transurethral resection followed by intravesical chemotherapy or immunotherapy with BCG, a live attenuated strain of Mycobacterium bovis. • BCG activates the immune system to recognize and destroy malignant cells. ➤ ➤ Intravesical BCG reduces the risk of progression and recurrence of NMIBC after transurethral resection (TUR) compared to chemotherapy and is hence preferred primary choice for all high risk and intermediate risk tumors. Immuno-Oncology ➤ ➤ The approval of immune checkpoint blockade for patients with platinum- resistant or -ineligible metastatic bladder cancer supports expanded use for both advanced and, potentially, localized disease. • Novel treatment strategies — such as those involving immune checkpoint blockade, cytokines, monoclonocal antibodies, T-cell therapies, oncolytic viruses and vaccines — rely on agents with immunomodulatory mechanisms. These treatments have allowed a subset of patients to benefit from durable response rates, often with a more tolerable adverse event profile than traditional therapies. • Atezolizumab, durvalumab, avelumab, pembrolizumab and nivolumab are FDA-approved and recommended in locally advanced or metastatic urothelial carcinoma that has previously been treated with platinum-based chemotherapy, or has relapsed within 12 months of perioperative platinum-based chemotherapy. • Pembrolizumab demonstrated significant improvement in overall survival over chemotherapy. It is the first and only therapy to show level A evidence at this time. • There is no reason to select one agent over the others, aside from practical considerations of dosing and convenience.

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