Following failure of Bacillus Calmette-Guerin (BCG) for high-grade non–muscle-invasive bladder cancer (NMIBC), there are no intravesical second-line options. OncoTherad is a nanostructured inorganic phosphate complex associated to glycosidic protein developed by University of Campinas/Brazil that exhibits antitumor properties. Research presented at the 2019 ASCO Annual Meeting assessed the OncoTherad immunomodulator for BCG-refractory or -relapsed NMIBC and found that it is a safe and effective treatment.
This prospective, single-center, single-arm, phase I/II study took place at the Municipal Hospital of Paulinia in São Paulo, Brazil, and enrolled 15 consecutive patients (10 male) with high-grade relapsed/refractory NMIBC who received one or more previous courses of BCG intravesical therapy. Patients with muscle-invasive disease were excluded.
OncoTherad regimen consisted of an induction course of six weekly intravesical instillations followed by a maintenance course of one monthly instillation through one year of treatment. Follow-up was performed with systematic mapping biopsies of the bladder, cystoscopy, ultrasound, and urinary cytology. The primary endpoint was recurrence-free survival (RFS), and recurrence was defined as any-grade histology-proven tumor recurrence, which was monitored at three-month intervals.
The median patient age was 71 years, and median follow-up was 14.0 months. At 14 months, the RFS rate was 86.7% among all patients. This treatment option allows for “potentially avoiding or postponing the need for radical surgery in these patients,” the authors noted. Two patients (13.3%) had recurrence during follow-up; however, these patients showed incipient malignant lesions, according to the authors. Researchers observed moderate hypersensitivity to OncoTherad in two patients (13.3%), as well as dysuria and cystitis in six patients (40.0%).
“OncoTherad … may provide benefit for preventing tumor recurrence,” they concluded.
Fávaro WJ, Iantas SR, Gonçalves JM, et al. Single-arm phase I/II study of the safety and efficacy of OncoTherad immunomodulator in patients BCG-refractory or relapsed non-muscle invasive bladder cancer. Abstract #e16000. Presented at the 2019 ASCO Annual Meeting, Chicago, IL, May 31-June 4, 2019.