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
Gilberto de Lima Lopes, Jr, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, and Karen L. Reckamp, MD, of Cedars-Sinai Medical Center, discuss phase II findings from substudy S1800A of the Lung-MAP protocol. The data showed that ramucirumab and pembrolizumab improved overall survival compared with the standard of care for patients with advanced non–small cell lung cancer who were previously treated with immunotherapy and platinum-based chemotherapy (Abstract 9004).
The ASCO Post Staff
Pamela L. Kunz, MD, of the Yale University School of Medicine, discusses new findings from the ECOG-ACRIN E2211 trial, which showed the longest progression-free survival and highest response rates with temozolomide plus capecitabine reported to date for patients with pancreatic neuroendocrine tumors. The presence of a deficiency of MGMT, the drug-resistance gene, was associated with greater odds of an objective response (Abstract 4004).
The ASCO Post Staff
Ann H. Partridge, MD, MPH, of Dana-Farber Cancer Institute, and Véronique Diéras, MD, of the Centre Eugène Marquis, discuss the many challenges posed by next-generation antibody-drug conjugates (ADCs). They include side effects such as hematotoxicity, gastrointestinal toxicities, and interstitial lung disease; tumor targeting and payload release; drug resistance; and the urgent need to understand ADCs’ mechanisms of action to better sequence and combine drugs.
The ASCO Post Staff
Nabil F. Saba, MD, of Winship Cancer Institute of Emory University, discusses new data from a trial of pembrolizumab and cabozantinib in patients with recurrent metastatic head and neck squamous cell carcinoma. The study met its primary endpoint of overall response rate. The regimen was well tolerated and exhibited encouraging clinical activity in this patient population (Abstract 6008).
The ASCO Post Staff
Stephanie Walker, a former nurse and current activist with the Metastatic Breast Cancer Alliance, discusses findings from the BECOME project (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement). They show that, even though Black patients comprise between 4% and 6% of all clinical trial participants, Black women with metastatic breast cancer are willing to consider taking part if steps were taken to increase their awareness, build trust through clear communication with health-care providers, involve people of shared racial/ethnic identity and health experience, and help patients find and access trials (Abstract 1014).