Nivolumab after surgery extends disease-free survival in bladder cancer
New York is a city in the United States. In a randomized study that was published in the New England Journal of Medicine (2021; DOI: 10.1056 / NEJMoa2034442), the adjuvant treatment with the checkpoint inhibitor nivolumab, which binds to the PD1 receptor, attacks the T cells the cancer cells stimulated, disease-free survival in patients with muscle-invasive urothelial carcinoma after radical surgery almost doubled.
If the tumor is in the ureter or renal pelvis, the conventional treatment of muscle-invasive urothelial carcinoma is the complete removal of the bladder (cystectomy) or the ureter and kidney (nephroureterectomy). Many patients report a recurrence of the tumor despite the extensive surgery. Although neoadjuvant or properative chemotherapy with cisplatin is recommended in the recommendations, not all patients receive it.
The Checkmate 274 study looked at whether nivolumab could be used as an adjuvant or postoperative treatment to improve patient outcomes. The study included 709 patients who underwent radical surgery (around 80 percent in the urinary bladder) after a diagnosis of muscle-invasive urothelial carcinoma in 156 facilities in 29 countries (with German participation).
Neoadjuvant chemotherapy was administered to about 44 percent of the patients. The expression of PD-L1 was only 1% in 40% of the cases. Patients received either nivolumab (240 mg intravenously every two weeks for a maximum of one year) or placebo. Disease-free survival in the overall group and in patients with high PD-L1 expression were the primary goals.
According to an investigation led by Matthew Galsky of the Memorial Sloan Kettering Tumor Center in New York, it took 20.8 months for the nivolumab group to recur, compared with 10.8 months for the placebo group. The proportion of patients who were still alive 6 months after treatment and were disease-free was 74.9 percent in the nivolumab group and 60.3 percent in the placebo group. With a 98.22 percent confidence interval of 0.55 to 0.90, Galsky calculated a hazard ratio of 0.70, which was very significant.
Patients who had previously received neoadjuvant treatment with cisplatin showed the best results (hazard ratio 0.52; 95 percent confidence interval 0.38 to 0.71).
Disease progression occurred in 74.5 percent and 55.7 percent of patients with PD-L1 expression of 1 percent or higher (hazard ratio, 0.55; 98.72 percent confidence interval, 0.35 to 0.85 ). In that case … This is an abbreviated version of the information. Continue reading another message.