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Phase II Study to Assess Bladder-Sparing Combination Therapy for Node–Positive Bladder Cancer

By: Kayci Reyer
Posted: Tuesday, July 26, 2022

The phase II study INSPIRE, the details of which were presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting (Abstract TPS4617), aims to identify the potential impact of bladder-sparing chemoradiation plus immunotherapy in patients with stage III lymph node–positive bladder cancer. This patient population is often underrepresented in trials focused on advanced disease.

“INSPIRE is the first prospective study designed for only [lymph node–positive bladder cancer] and will define both short-term and long-term outcomes for bladder sparing in this patient population and has the potential to define a new treatment strategy for stage III [bladder cancer],” noted Monika Joshi, MD, of Penn State Cancer Institute, Hershey, Pennsylvania, and colleagues.

Initiated in August 2020, the randomized study seeks to enroll a total of 114 patients with stage III pure or mixed urothelial cancer, 92 of whom must be evaluable. Eligible patients will have undergone at least three cycles of induction chemotherapy without experiencing disease progression. The primary endpoint is clinical complete response rate. Secondary endpoints are overall, progression-free, and bladder-intact event-free survival as well as toxicity and salvage cystectomy rates. The study is intended to identify a 25% complete response improvement between the treatment arms.

Patients will be randomly assigned to receive either physician’s choice of chemotherapy plus intensity-modulated radiation therapy plus three weekly doses of the monoclonal antibody durvalumab administered every 3 weeks for 6.5 to 8 weeks or chemoradiation alone. Among patients who achieve a complete response or experience clinical benefit, those in the durvalumab group will receive adjuvant durvalumab every 4 weeks for nine cycles, and those in the chemoradiation group will undergo observation. Accrual for this study is ongoing (ClinicalTrials.gov identifier NCT04216290).

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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