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Immunotherapy Plus Chemotherapy Versus Chemotherapy Alone as First-Line Treatment for Advanced Urothelial Cancer: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials - Beyond the Abstract

Bladder cancer ranks as the tenth most common cancer globally, with urothelial carcinoma comprising approximately 90% of cases. For decades, platinum-based chemotherapy (CTX) has been the mainstay of treatment, with cisplatin being preferred over carboplatin whenever possible. However, recent advances, particularly the incorporation of immune checkpoint inhibitors (ICI) into the therapeutic arsenal, have transformed the treatment landscape for patients with advanced disease.

The first breakthrough in first-line therapy occurred with the approval of avelumab as maintenance therapy for patients whose disease did not progress after first-line platinum-based chemotherapy. In 2023, positive results from the Checkmate-901 (CM-901) and EV-302 trials added complexity to the treatment algorithm. Although negative results from similar trials have previously been described, the CM-691 demonstrated the superiority of combining ICI with CTX over standard CTX alone. The EV-302 trial was also positive and showed even more impressive results favoring enfortumab vedotin plus pembrolizumab (EV-P) against the same control arm. Consequently, EV-P has been established as the new preferred first-line treatment. However, this regimen may not yet be accessible to all patients due to cost limitations or availability worldwide.

In this context, we aimed to further assess the effectiveness of ICI-CTX compared to the former standard of care by conducting a meta-analysis titled "Immunotherapy plus Chemotherapy versus Chemotherapy Alone as First-Line Treatment for Advanced Urothelial Cancer: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials." This analysis included three RCTs comparing anti-PD1/anti-PDL1 combined with chemotherapy against chemotherapy alone in advanced urothelial cancer.



The results indicated significantly enhanced survival outcomes with immunotherapy. ICI-CTX groups showed a 16% improvement in overall survival and a 22% improvement in progression-free survival, with this benefit observed in both carboplatin and cisplatin subgroups. Safety analysis revealed a significant increase in grade ⩾ 3 immune-related adverse events in the combination group, as expected. These findings suggest that the ICI-CTX combination should be regarded as a standard of care, especially in cases where EV-P is unavailable.

Written by:

  • Isadora Mamede, Department of Medicine, Federal University of São João del-Rei, Brazil,
  • Carlos Stecca, Department of Clinical Oncology, Oncology Parana Center and Mackenzie Evangelical University Hospital, Brazil
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