Benchmarking Maintenance Therapy Survival in First-Line Platinum-Based Chemotherapy–Treated Patients with Advanced Urothelial CarcinomaUsing Simulated Disease Modeling

Traditional randomized controlled trials are designed to measure outcomes from start of the line of therapy in an intent-to-treat population. Switch maintenance trials typically enroll patients with stable disease after chemotherapy with subsequent randomization to maintenance or no maintenance. Substantial differences prevent typical methods of indirect treatment comparison to traditional randomized controlled trials.

• Only patients without progression on chemotherapy are included

• Outcomes (eg, survival) are measured from time at randomization to maintenance rather than the start of chemotherapy

Switch maintenance treatment has become the standard of care in some cancers. However, other emerging treatments are designed as traditional randomized controlled trials from start of the line of therapy.

Outcomes from emerging non-maintenance treatments with a more traditional trial design are expected to compare against standard of care switch maintenance.

So, what do we do?

In this worked example of a methodologic framework using Curta’s Oncology Simulation Model (OSM), Curta researchers examined the true overall population-level survival of avelumab as first line maintenance treatment option in metastatic urothelial carcinoma. Results can help to inform the clinical community on how a typical patient might fare at the outset of first line therapy, considering the chances that they might not respond to chemotherapy and might not make it to maintenance at all. Findings also can serve as a benchmark to compare a chemotherapy ± maintenance pathway to an alternative first line treatment strategy.

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