Shilpa Gupta, MD, on Urothelial Cancer: Defining Who Is 'Platinum-Ineligible'
2022 ASCO Annual Meeting
Shilpa Gupta, MD, of the Cleveland Clinic Foundation, discusses an updated consensus definition for standard therapy and clinical trial eligibility for patients with metastatic urothelial cancer who are platinum-ineligible, criteria that are proposed to guide treatment recommendations for this population. This may be especially important now that the U.S. Food and Drug Administration has restricted the use of first-line pembrolizumab to those who are considered platinum-ineligible (Abstract 4577).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Frontline therapy for patients with metastatic urothelial cancer who are Cisplatin ineligible has continued to evolve. And the current standard of care is Gemcitabine and Carboplatin chemotherapy followed by durvalumab maintenance. In 2017, Atezolizumab and Pembrolizumab were approved as single agents for this patient population. But then the label was restricted to patients who are Cisplatin ineligible with high PD-L1 expressing tumors, or those who are not eligible for any platinum. And now Pembrolizumab use is only restricted to patients who are platinum-ineligible. Back in 2019, we presented results from our survey for defining platinum-ineligibility by sending a survey out to around 60 US-based medical oncologists. And we presented a consensus definition at GU ASCO that year. And now with the changing landscape, we updated the survey and used the similar cohort of responders to provide a consensus definition update. So we ask questions like: what equal performance status would physicians use to deem someone platinum-ineligible? What creatinine clearance cutoff would they use? What peripheral neuropathy cutoff, heart failure, cutoff? And in any person with ECOG performance status two, what would be the creatinine clearance cutoff? And based on the majority of responses, we found that most physicians found that creatinine clearance less than 30 milliliters per minute, peripheral neuropathy greater than are equal to grade two, significant heart failure that is NYHA class three or higher, equal performance status greater than our equal to three, and in a patient with equal performance status two, creatinine clearance of less than 30 milliliters per minute. Those were the factors that would make them hesitant to use Carboplatin. So we proposed that if any one of these criteria are met, that patient can be deemed as platinum-ineligible and be a candidate for single agent immunotherapy. Otherwise, we offered Gemcitabine and Carboplatin followed by durvalumab maintenance. Notably age was not a cutoff for these patients based on our survey.
The ASCO Post Staff
Etienne Brain, MD, PhD, of the Institut Curie, discusses phase III findings from the Unicancer ASTER 70s trial, in which patients aged 70 or older with estrogen receptor–positive, HER2-negative breast cancer and a high genomic grade index received adjuvant endocrine therapy with or without chemotherapy. The data did not find a statistically significant overall survival benefit with this treatment after surgery (Abstract 500).
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses phase III findings from the DETERMINATION trial, which showed that, for patients with newly diagnosed multiple myeloma, lenalidomide, bortezomib, and dexamethasone (RVd) with or without autologous stem cell transplant (ASCT) and lenalidomide maintenance to disease progression resulted in the longest median progression-free survival reported for each approach, and a highly significant difference in progression-free survival in favor of early transplant. While overall response rates were similar, rates of MRD favored early transplant also, but toxicity was greater and quality of life was transiently but significantly diminished. No overall survival advantage has been observed to date (Abstract LBA4).
The ASCO Post Staff
Neal D. Shore, MD, of the Carolina Urologic Research Center, discusses his study findings, showing that germline genetic testing influenced care for patients with prostate cancer. Men whose genetic test was positive for a pathogenic germline variant received more recommendations for changes to follow-up and treatment, and for testing and counseling of relatives, than did patients with negative or uncertain test results (Abstract 10500).
The ASCO Post Staff
Sumanta K. Pal, MD, of City of Hope National Medical Center, discusses findings from the COSMIC-021 study, which showed that cabozantinib plus atezolizumab demonstrated encouraging clinical activity with manageable toxicity in patients with inoperable locally advanced or metastatic urothelial carcinoma. The combination was administered as first-line therapy in cisplatin-based chemotherapy–eligible and –ineligible patients and as second- or later-line treatment in those who received prior immune checkpoint inhibitors (Abstract 4504).
The ASCO Post Staff
Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and Jorge E. Cortes, MD, of Georgia Cancer Center at Augusta University, discuss phase III results from the ASCEMBL trial, which showed that after more than 2 years of follow-up, asciminib continued to yield superior efficacy and better safety and tolerability vs bosutinib in patients with chronic myeloid leukemia (CML) in chronic phase. These results continue to support the use of this kinase inhibitor as a new CML therapy, says Dr. Cortes, with the potential to transform the standard of care (Abstract 7004).