GALVESTON, TX — In Bacillus Calmette Guerin intravesical immunotherapy treatment, medication is inserted directly into the bladder through a catheter. Yet, although BCG is the main immunotherapy used to treat early-stage bladder cancer, it has high failure rates.
That creates a clinical challenge for bladder cancer treatment. To describe real-world patient characteristics, long-term outcomes and the economic burden in a population with high-risk nonmuscle-invasive bladder cancer (NMIBC treated with BCG therapy, according to a new veterans’ study led by University of Texas Medical Branch researchers.
For the retrospective cohort study, the focus was on 412 patients with high-risk NMIBC from 63,139 patients diagnosed with bladder cancer who received at least one dose of BCG within VAMCs from Jan. 1, 2000, to Dec. 31, 2015. Analysis of the study, with results published recently in JAMA Network Open, occurred from Jan. 2, 2020, to Jan. 20, 2021.1
Most of the study group, 81%, were male, with a median age of 67 (IQR, 61-74) years. Follow-up was 2,694 person-years.
Study authors defined intravesical BCG therapy, including adequate induction BCG therapy, as at least five intravesical instillations of BCG within 70 days from BCG therapy start date. They also set parameters for adequate maintenance BCG therapy as at least seven installations of BCG within 274 days of the start (the first instillation) of adequate induction BCG therapy (i.e., adequate induction BCG, plus some form of additional BCG.
Among participants, 392 patients (95%) were considered to have received adequate induction BCG therapy, and 152 (37%) received adequate BCG therapy.
Results indicated that, for all patients with high-risk NMIBC, the 10-year progression-free survival rate and disease-specific death rate were 78% and 92%, respectively. Researchers determined that patients with carcinoma in situ (Cis) had worse disease-free survival than those without Cis (hazard ratio [HR], 1.85; 95% CI, 1.34-2.56).
Total median costs at one year were calculated as $29,459 (IQR, $14,991-$52,060); at two years, $55,267 (IQR, $28,667-$99,846); and at five years, $117,361 (IQR, $59,680-$211,298). The study advised that patients with progressive disease had significantly higher median five-year costs ($232,729 [IQR, $151,321-$341,195] vs. $94,879 [IQR, $52,498-$172,631]; P < .001), with additional expenses from outpatient care, pharmacy and surgery.
“Despite adequate induction BCG therapy, only 37% of patients received adequate BCG therapy,” the authors concluded. “Patients with Cis had increased risk of progression, and progression regardless of Cis was associated with significantly increased costs relative to patients without progression.”
They added that, with extrapolation of costs, regardless of progression, total nationwide expenses at one year were $373 million for patients diagnosed with high-risk NMIBC in 2019.
- Williams SB, Howard LE, Foster ML, Klaassen Z, Sieluk J, De Hoedt AM, Freedland SJ. Estimated Costs and Long-term Outcomes of Patients With High-Risk Non-Muscle-Invasive Bladder Cancer Treated With Bacillus Calmette-Guérin in the Veterans Affairs Health System. JAMA Netw Open. 2021 Mar 1;4(3):e213800. doi: 10.1001/jamanetworkopen.2021.3800. PMID: