From the Guidelines
The BCG vaccine is administered to a 53-year-old patient with bladder cancer to stimulate a robust T cell-mediated immune response against the cancer cells, thereby reducing the risk of recurrence and progression of non-muscle invasive bladder cancer (NMIBC) 1.
Background
The use of BCG vaccine in the treatment of NMIBC is supported by several studies, including a guideline published in The Journal of Urology in 2016, which recommends the administration of a six-week induction course of BCG in high-risk patients with newly diagnosed NMIBC 1.
Mechanism of Action
The BCG vaccine works by attaching to the urothelium and being internalized by both cancer cells and normal cells, triggering a local inflammatory response and inducing cytokine production, including interleukin-2, interferon-gamma, and tumor necrosis factor, which further enhance the T cell response 1.
Clinical Evidence
A meta-analysis published in the Journal of the National Comprehensive Cancer Network in 2016 found that BCG therapy after transurethral resection of bladder tumor (TURBT) is superior to TURBT alone or TURBT and chemotherapy in preventing recurrences of high-grade Ta and T1 tumors 1.
Treatment Recommendations
The American Urologic Association (AUA) and the European Association of Urology (EAU) recommend the use of BCG therapy in patients with intermediate- and high-risk NMIBC, with a six-week induction course followed by maintenance therapy for one to three years 1.
Key Points
- BCG vaccine stimulates a robust T cell-mediated immune response against cancer cells
- Reduces the risk of recurrence and progression of NMIBC
- Recommended for patients with intermediate- and high-risk NMIBC
- Six-week induction course followed by maintenance therapy for one to three years
- Supported by clinical evidence from several studies 1
From the FDA Drug Label
CLINICAL PHARMACOLOGY TICE® BCG induces a granulomatous reaction at the local site of administration. Intravesical TICE BCG has been used as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence. The BCG vaccine is administered to a 53-year-old patient with bladder cancer as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence 2.
- The precise mechanism of action is unknown.
- The patient's age is not a contraindication for the use of BCG, as no overall difference in safety or effectiveness was observed between older and younger subjects 2.
From the Research
BCG Vaccine Administration for Bladder Cancer
The BCG vaccine is administered to a 53-year-old patient with bladder cancer due to its effectiveness in treating non-muscle invasive bladder cancer (NMIBC) and carcinoma in-situ (CIS). The key points are:
- BCG immunotherapy has become the standard of care for high-grade NMIBC and CIS in terms of prevention of recurrence and progression 3
- BCG reduces the recurrence rate by an average of 40% and progression by more than 20% in papillary tumors over patients without BCG therapy 4
- The exact mechanism of action of intravesical BCG is yet to be elucidated, but it appears to be mediated by the local immune response, mainly through T-helper cell response 4
Effectiveness of BCG Therapy
The effectiveness of BCG therapy in NMIBC patients is well-documented, with studies showing:
- A statistically significant reduction in tumor recurrence and progression in patients treated with BCG 3, 5
- A marked decrease in or complete prevention of recurrent tumor in high-risk patients treated with BCG 5
- BCG therapy is safe and effective in NMIBC patients with immunomodulating conditions, with similar rates of progression and disseminated BCG complications compared to immunocompetent patients 6
Administration and Side Effects
The administration of BCG therapy typically involves: