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
Apar Kishor Ganti, MD, of the University of Nebraska Medical Center, discusses results from the CALGB 30610 study, which showed a similar clinical benefit for once- and twice-daily radiotherapy administered to patients with limited-stage small cell lung cancer. While both regimens were well tolerated, patients who received radiotherapy once daily had better quality-of-life scores at week 3 and slightly worse scores at week 12. Patients believed the once-daily regimen was more convenient (Abstract 8504).
The ASCO Post Staff
Ursula A. Matulonis, MD, of Dana-Farber Cancer Institute, and Ignace Vergote, MD, PhD, of Belgium’s University Hospitals Leuven, discuss interim safety and efficacy results from a third dose-expansion cohort evaluating first-line tisotumab vedotin-tftv plus pembrolizumab in patients with recurrent or metastatic cervical cancer. Data on the combination showed durable antitumor activity with a manageable safety profile (Abstract 5507).
The ASCO Post Staff
Erika Hamilton, MD, of Sarah Cannon Research Institute at Tennessee Oncology, discusses phase III data from the DESTINY-Breast03 study, which reinforced the consistent safety profile of fam-trastuzumab deruxtecan-nxki (T-DXd) vs ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable and/or metastatic breast cancer. The findings also support T-DXd’s risk benefit over that of T-DM1 (Abstract 1000).
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
Richard Finn, MD, of the Geffen School of Medicine at UCLA and the Jonsson Comprehensive Cancer Center, discusses analyses from the PALOMA-2 trial on overall survival with first-line palbociclib plus letrozole vs placebo plus letrozole in women with ER-positive/HER2-negative advanced breast cancer. The study met its primary endpoint of improving progression-free survival but not the secondary endpoint of overall survival. Although patients receiving palbociclib plus letrozole had numerically longer overall survival than those receiving placebo plus letrozole, the results were not statistically significant (Abstract LBA1003).