The study found that Opdivo and Abraxane were effective and safe in treating muscle-invasive bladder cancer.
Opdivo (nivolumab) with Abraxane (nab-paclitaxel) could expand the therapeutic opportunities of immune chemotherapy in patients with muscle-invasive bladder cancer (MIBC), according to results from the NURE-Combo trial.
“The NURE-Combo trial provided insights into the potential value of expanding chemotherapy combinations with ICI in the setting of early-stage MIBC,” study authors wrote in findings published in the Journal of Clinical Oncology. “This approach was medically and surgically safe in a population with a high unmet medical need, and the early efficacy signals, coupled with the characteristics of included patients, suggested an opportunity to replace cisplatin chemotherapy as backbone therapy for unselected patients.”
In a study conducted from December 2021 to June 2023, 31 patients were enrolled. Among them, 19 (61.3%) were at cT2 stage, two (6.5%) were at N1 stage and 16 (51.6%) had variant histology.
MIBC cT2 stage indicates the tumor is palpable and confined within the bladder. N1 stage indicates one to three regional lymph nodes that contain cancer were found.
Out of the total number of patients, five (16.1%) received less than four full courses of pre-surgery treatment due to treatment-related side effects. Severe (grade 3) or life-threatening (grade 4) treatment-related side effects were experienced by eight patients (25.8%). Among the patients, 28 underwent the complete removal of the bladder (radical cystectomy), while three declined this procedure after showing a complete response and instead opted for a redo transurethral resection of the bladder tumor (reTURBT; removal of bladder tumor through urethra).
The main goal of the trial was achieved, with 10 patients (32.3%) showing a pathologic complete response (when no cancer cells are found). When including those who underwent reTURBT, 22 patients (70.9%) achieved a major pathologic response (reduction in size of tumor). After 12 months of follow-up, two patients had a recurrence of the disease after surgery. The 12-month event-free survival rate (time a patient lives without the recurrence of cancer) was 89.8%.
The most common side effects of the treatment were gastrointestinal problems (45.2%), fatigue (38.7%), numbness/tingling (29%), and elevated liver enzymes (22.6%). Serious side effects (grade 3) occurred in 25.8% of patients, including low blood cell counts, fatigue, liver problems, skin issues and kidney problems.
Patients received four cycles of Opdivo 360 milligrams (mg) once every three weeks, along with Abraxane 125 mg per square meter (mg/m2) once on days one and eight, every three weeks, followed by radical cystectomy and then adjuvant (post surgery) Opdivo 360 mg once every three weeks for 13 cycles.
Eligible patients had an Eastern Cooperative Oncology Group performance status of 1 or lower (able to perform normal daily activities with slight limitations) and a T2-4aN0-1M0 stage bladder cancer (tumor in muscle layer, no spread to lymph nodes or distant organs). They had less than 50% urothelial carcinoma histology (majority of tumor cells were of a specific type) and were ineligible for or refused cisplatin-based chemotherapy (common treatment for bladder cancer). All patients had undergone a transurethral resection of the bladder tumor (TURBT; removal or biopsy of bladder tumor through urethra) for biopsy, histologic characterization and local staging.
The primary goal of the study was to measure the rate of complete pathological response (CR), meaning no cancer cells were found in the surgical specimen. Other important factors considered were major pathological response (significant reduction in tumor size), safety of the treatment, event-free survival (time without disease recurrence or death) and overall survival.
“The NURE-Combo is the first trial that provided clinical evidence that we can expand the use of chemotherapy agents, in combination with ICI [immune checkpoint inhibitor, which helps immune system fight cancer], beyond platinum while preserving or potentially improving efficacy,” study authors wrote.
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