4.2. Pharmacological Treatment Delivered to NMIBC Patients: OncoTherad
muscle-invasive carcinoma, bladder tumor, Paulínia, NMIBC, urothelial carcinoma
RECURRENCE, BLADDER TUMOR, DISEASE, RECURRENT DISEASE, UROTHELIAL CARCINOMA, URETER, ADVERSE EVENT, URETHRA, METASTATIC UROTHELIAL CARCINOMA
In total, 58 patients originating at Paulínia Municipal Hospital (HMP), Paulínia City, São Paulo State, Brazil, who had been diagnosed with NMIBC classified as refractory, recurrent, or intolerant to Bacillus Calmette–Guérin (BCG) and/or to intravesical chemotherapy, were included in the current study. Forty-four (44) of them met the predefined inclusion criteria and started being treated with OncoTheradEligible participants were patients aged 18 years or older, presenting with histologically confirmed high-risk NMIBC, who were either not suitable candidates for or declined radical cystectomy. Hematological and biochemical laboratory assessments were mandatory 14 days prior to the commencement of the study. To meet eligibility criteria, patients underwent transurethral resection of the bladder tumor (TURBT) four weeks prior to the initiation of the study. This procedure was conducted at HMP and was performed under either general or epidural anesthesia, with the choice being determined through consultation between anesthetists and patients. Confirmation of diagnosis through bladder biopsies was carried out by the Pathology Department of HMP (BCG-unresponsive disease was defined as: (i) BCG refractory: failure to achieve a disease-free state by six months after initial BCG therapy because of persistent or rapidly recurrent disease. This category also includes patients with stage or grade progression at three months despite BCG therapy; (ii) persistent high-risk NMIBC within six months after adequate BCG therapy; (iii) recurrent high-risk NMIBC within nine months after the last BCG instillation, despite adequate BCG therapy; (iv) BCG intolerant: disease recurrence after the administration of a less than adequate course of BCG therapy because of a serious adverse event or symptomatic intolerance. Adequate BCG therapy was defined as a minimum of five induction instillations (adequate induction) and at least seven instillations of BCG within nine months after the first instillation, consistent with the FDA-recommended definition (≥5 out of six doses of an initial induction course plus ≥2 out of three doses of maintenance therapy or ≥2 out of six doses of a second induction course). Eligible patients had not received intervening intravesical chemotherapy or immunotherapy from the time of the most recent cystoscopy or TURBT until study entry.Patients with histologically confirmed muscle-invasive carcinoma, locally advanced unresectable or metastatic urothelial carcinoma, or concurrent extravesical urothelial carcinoma (in the prostatic urethra, distal urethra, ureter, or renal pelvis) were excluded (Upon diagnosis, patients provided informed consent and subsequently started treatment with OncoTheradInduction Phase: Intravesical (at concentration of 120 mg/mL, intravesically retained for 1 h, while patients were asked to rotate positions to maximise bladder surface exposure) and intramuscular (at concentration of 25 mg/mL) OncoTheradMaintenance Phase: Biweekly OncoTheradThe current study was approved by the Research Ethics Committee/UNICAMP (CAAE: 93619718.7.0000.5404) and registered in the Brazilian Clinical Trials Registry (RBR-6swqd2).