SOGUG-AUREA Study Overview

EP: 1.Enfortumab Vedotin (EV) Monotherapy and Pembrolizumab (P) Combination Treatments in Urothelial Cancer

EP: 2.Unmet Needs of Patients with Locally Advanced Metastatic Urothelial Cancer (mUC)

EP: 3.EV+P Combination Strategy Changing Bladder Cancer Treatment Landscape

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EP: 4.SOGUG-AUREA Study Overview

EP: 5.SOGUG-AUREA Trial Results Impacting Next-Steps for Bladder Cancer Treatment

EP: 6.Exploring the Role of Disitamab Vedotin in the Treatment of Metastatic Urothelial Cancer

EP: 7.Penpulimab Plus Anlotinib Evaluated for Previously Treated Urothelial Cancers

Arlene Siefker-Radtke, MD: Another exciting abstract from this year’s ESMO [European Society for Medical Oncology Congress] presentation is the SOGUG-AUREA trial, which looked at patients who had borderline kidney function, poor performance status, and were older than 70 years of age. Those patients were treated with split-dose cisplatin with atezolizumab. Why are we interested in split-dose cisplatin? Because it’s commonly done at academic centers as a means of giving patients cisplatin, given the potential survival benefit that has always been observed with cisplatin compared with carboplatin. There have been many strategies utilized for doing split-dose cisplatin. Some have given these combinations on both day 1 and day 8, splitting the cisplatin over 2 weeks. Others have given the cisplatin split on day 1 and day 2. But there are limited data on the impact of cisplatin and whether we see any detrimental effects on either toxicity or clinical outcomes.

In the SOGUG-AUREA trial, we see a response rate that appears promising, especially considering the use of split-dose cisplatin. However, I need to point out that they use criteria that aren’t typical cisplatin eligibility criteria. Keep in mind that what we use for FDA registration trials doesn’t include patients’ age. In this trial, about half of patients had an age greater than 70. It uses some atypical criteria for the definition of cisplatin eligibility.

But in this clinical trial, we aren’t observing a huge decrement in objective response rate. We’re showing a survival that appears fairly similar to what has been observed with either carboplatin- or cisplatin-based strategies. I personally prefer to use cisplatin-based chemotherapy. I’ll give split-dose cisplatin to [patients with] a GFR [glomerular filtration rate] of 40 mL/min or greater, but [using a cutoff of] age 70 doesn’t cut it for me. Age is in the eyes of the beholder. As I gain more years myself, 70 looks younger than ever. It really isn’t age itself, but a person’s biologic age, regarding whether they’re able to tolerate full-dose cisplatin.

Unfortunately, because this is a single-arm trial, it can’t tell us the contribution of components and whether atezolizumab adds anything to the strategy. If we have to consider atezolizumab with chemotherapy, we need to look at that frontline trial where we haven’t yet seen the definitive survival benefit of gemcitabine-cisplatin with or without atezolizumab. Until those data show something significant, I don’t think I could use atezolizumab in this setting. But I will still use split-dose cisplatin for patients who have borderline kidney function or are otherwise unable to tolerate a full-dose cisplatin strategy.

Transcript edited for clarity.