Neoadjuvant Nivolumab-Ipilimumab versus Platinum-Based Chemotherapy in Muscle-Invasive Bladder Cancer: A Single-Institution, Propensity-Weighted Cohort Study.
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Abstract
Introduction: Neoadjuvant chemotherapy (NAC) is standard for muscle-invasive bladder cancer (MIBC), yet many patients are platinum-ineligible. We compared outcomes of neoadjuvant nivolumab plus ipilimumab versus platinum-based NAC.
Methods: This single-institution comparative cohort study compared a prospective immune checkpoint inhibitor (ICI) cohort (n=11) receiving nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) against a retrospective platinum-based NAC cohort (n=30). Propensity score-based overlap weighting was used to reduce measured confounding. Main outcomes included pathologic complete response (pCR), downstaging (
Results: Among surgically evaluable patients (ICI n=9; NAC n=30), pCR rates were 22.2% and 26.7%, respectively (p=1.00), and downstaging rates were 44.4% and 50.0% (p=1.00). Propensity-weighted analyses likewise showed no statistically significant differences in pathologic response. In the total ICI cohort (n=11), four patients (36.4%) did not complete all four planned cycles, including three because of grade 3 immune-related toxicity and one who died following an on-treatment acute myocardial infarction. At a median follow-up of 58.3 months in the ICI cohort, no recurrences were observed among the nine surgically treated patients during the available follow-up, compared with nine recurrences (30.0%) in the NAC cohort. Two-year OS was 100% in the ICI group and approximately 80% in the NAC group (log-rank p=0.18).
Conclusion: Neoadjuvant dual ICI demonstrated pathologic activity, with response rates numerically within the range observed with standard NAC. Clinically meaningful immune-related adverse events were observed in the ICI cohort; however, no recurrences were observed among surgically treated ICI patients during the available follow-up. These findings support further investigation of dual ICI as a potential option when platinum-based NAC is not feasible or is declined.
期刊介绍:
Cancer Management and Research is an international, peer reviewed, open access journal focusing on cancer research and the optimal use of preventative and integrated treatment interventions to achieve improved outcomes, enhanced survival, and quality of life for cancer patients. Specific topics covered in the journal include:
◦Epidemiology, detection and screening
◦Cellular research and biomarkers
◦Identification of biotargets and agents with novel mechanisms of action
◦Optimal clinical use of existing anticancer agents, including combination therapies
◦Radiation and surgery
◦Palliative care
◦Patient adherence, quality of life, satisfaction
The journal welcomes submitted papers covering original research, basic science, clinical & epidemiological studies, reviews & evaluations, guidelines, expert opinion and commentary, and case series that shed novel insights on a disease or disease subtype.