Understanding treatment patterns and outcomes in bladder cancer patients treated in Ontario in a large administrative data set – Phase I

Summary

Client: Janssen Inc.

Project ID: P2022-111/ 2026 0980 008 000

Research Question/Objectives: Bladder cancer is the 5th most common cancer in Canada with an estimated 12,000 new bladder cancer diagnoses occurring every year. It is one of the top ten causes of cancer deaths and is the fourth and 10th most common cancer diagnosed in males and females, respectively. Patients with bladder cancer generally present with hematuria or voiding symptoms and are diagnosed by cystoscopy with biopsy and/or resection of the Tumour(s) and cross-sectional imaging to evaluate for metastases. Localized bladder cancer is generally divided in two distinct groups on the basis of differences in natural history and treatment approach: non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). NMIBC includes patients with stages Ta, T1, and Tis, while MIBC includes patients with stages T2-T4.

NMIBC accounts for about 75-80% of all bladder cancer cases. Among patients with NMIBC, Ta disease accounts for most NMIBC (60%), whereas T1 and Tis (carcinoma in situ [CIS]) account for 30% and 10%, respectively. Due to the prolonged natural history of the condition, the actual prevalence of NMIBC is 10 times its incidence and creates a major economic burden on healthcare systems. MIBC accounts for approximately 25% of bladder cancer cases at presentation. The five-year mortality of these patients is approximately 40-50% with long-term survival in the metastatic setting being rare.

Objectives:

Primary Objective(s): NMIBC/MIBC

1. To describe the characteristics of bladder cancer patients in Ontario, including:
   • Incidence (i.e., newly diagnosed (de novo) NMIBC patients, de novo MIBC, metachronous progression from NMIBC to MIBC)
   • Prevalence (i.e., existing NMIBC/MIBC patients)
   • Demographic characteristics
   • Pathological tumour staging/grading (Pathological abstraction).
2. To characterize treatment patterns and utilization of therapies in front-line and subsequent lines of therapy in NMIBC and MIBC bladder cancer patients
   • Utilization of intravesical and systemic chemotherapy
   • Utilization of BCG
   • Utilization of Radical Cystectomy
   • Time from diagnosis to first treatment (TURBT, BCG, radical cystectomy, chemotherapy, etc.)
   • Time to next treatment (TTNT) including time to cystectomy
   • Time to progression
   • Time to death
3. Describe guideline-based treatment use
   • Receipt of chemotherapy
   • Receipt of Radiation
   • Receipt of Immunotherapy
   • Tumour Recurrence
4. Physician Management
   • First line treatment management by GP, Urologists, radiation oncologist, medical oncology
5. Treatment Sequencing – NMIBC
   • TURBT with immediate postoperative ChemoTx
   • BCG +/- induction chemo following 1st or 2nd TURBT
   • Cystectomy following 1st or 2nd TURBT and/or Chemotherapy
6. Treatment Sequencing – MIBC
   • Radical Cystectomy with neoadjuvant and/or adjuvant chemotherapy
   • Trimodal therapy
   • Palliative Radiation Care
   • No treatment
7. Cystoscopy use per guidelines by cohort
8. Use of upper tract imaging
9. Disease Progression
   • Diagnosis to MIBC, mUC or cystectomy or death
   • Death by line of therapy
   • Death without progression
10. To evaluate the health outcomes in terms of overall survival (OS) and time to next treatment (TTNT) for NMIBC and MIBC.

Secondary Objective(s):

1. To determine the health care resource utilization (HCRU) and direct medical costs of NMIBC/MIBC patients (e.g., hospitalizations [frequency, length, type], physician visits, specialist visits, monitoring, lab tests, surgical procedures, concomitant medication, etc.)
   • HCRU following initiation of BCG vs. no BCG
   • HCRU and direct medical costs of patients who receive a radical cystectomy vs systemic or IO therapy
   • HCRU and direct medical costs of patients who receive radical cystectomy with post-operative care and complication management
2. To examine whether geographic region of residence is associated with variation in the care and treatment outcomes in patients with NMIBC.
   • Examine the association of geographic region of residence
   • Examine the impact of risk status
   • Uptake of anti-cancer agents
   • Time to next treatment (if feasible)
   • Time to disease progression
   • Time to death

3. To examine impact of incomplete BCG utilization on outcomes

Status: In progress