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Concurrent Nivolumab and Radiotherapy in Elderly Patients With Bladder Cancer

By: Sarah Campen, PharmD
Posted: Friday, October 30, 2020

Treatment with concurrent nivolumab and radiation therapy for localized or locally advanced urothelial cancer showed “promising” early efficacy in elderly patients who were ineligible for standard chemoradiation therapy, according to the initial results of the phase II NUTRA trial presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 776P). Ulka N. Vaishampayan, MBBS, of the University of Michigan, Ann Arbor, and colleagues reported that 43% of patients demonstrated a complete response, and the treatment regimen was “tolerable.”

The study enrolled 17 patients with muscle-invasive bladder cancer who were not candidates for standard chemoradiation therapy; the median patient age was 78 years. Nivolumab was started within 3 days of radiation therapy at 240 mg intravenously every 2 weeks for a maximum of 6 months. The total radiation dose of 64 Gy in 32 fractions was administered per the standard of care for bladder cancer.

A total of 6 of 14 patients (43%) achieved a complete response, 4 patients (29%) had residual T1 disease or carcinoma in situ, and 4 patients (29%) had disease progression. As for safety, no new nivolumab or radiation therapy toxicities were reported. Immune-mediated adverse events that required steroids were noted in five patients: two with diarrhea, two with thyroid dysfunction, and one with immune cystitis.

Of note, the PD-L1 Combined Positive Score (CPS) was less than 1% in all nonresponding patients, except for one patient with a CPS of 5%. “PD-L1 expression is a potential biomarker to guide patient selection,” concluded the study authors.

Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.



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