Patients with pT3/4 and/or node-positive disease those who did not receive neoadjuvant therapy and those who received neoadjuvant therapy but demonstrated persistent muscle-invasive disease may be considered for adjuvant treatment. Milowsky explained that the eligibility criteria for the CheckMate 274 trial were reasonable and should be part of real-world clinical decision-making. The CheckMate 274 trial was designed to evaluate adjuvant immunotherapy with nivolumab. In view of these issues in the adjuvant setting, there is an unmet need for non-cisplatin–based regimens that can decrease the risk for recurrence and improve survival outcomes for these patients after surgery. Systematic reviews of such trials suggest that overall survival is improved with adjuvant cisplatin-based therapy, but the level of evidence is not the same as for neoadjuvant treatment.” 6 Moreover, about one-third of patients will not be eligible for cisplatin-based treatment in the adjuvant setting within the first 90 days after surgery because of issues that arise in the postoperative setting. The EORTC 30994 study was a large trial, 5 but it, too, was underpowered. Milowsky, who is also Co-Director of the Urologic Oncology Program at the Lineberger Comprehensive Cancer Center, told JNCCN 360 there has been a series of studies in the adjuvant setting, “but they have all been underpowered, in large part, due to accrual issues. “In contrast, there is no level 1 evidence to support the use of cisplatin-based chemotherapy in the adjuvant setting.” 4ĭr. 3 That represents best practice for patients who are eligible to receive cisplatin-based therapy. There is level 1 evidence to support the use of cisplatin-based, combination chemotherapy in the neoadjuvant setting. “The critical question,” he observed, “is what are the best perioperative strategies for patients with muscle-invasive bladder cancer in this setting?” Milowsky, MD, FASCO, The George Gabriel and Frances Gable Villere Distinguished Professor of Bladder and Genitourinary Cancer Research at the University of North Carolina School of Medicine/Lineberger Comprehensive Cancer Center in Chapel Hill. “This gives us a very strong rationale for employing an adjuvant strategy,” stated Matthew I. 2 For most of those patients, disease recurrence will not be curable. Those with muscle-invasive disease at the time of radical cystectomy are at very high risk (50%) for recurrence. 1 Bladder preservation with concurrent chemoradiotherapy is another option for these patients. Patients with stage II and III muscle-invasive bladder cancer are often treated with surgery, usually radical cystectomy. Early-Stage Muscle-Invasive Bladder Cancer: Role of Perioperative Systemic Treatment
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