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.
Related Videos
The ASCO Post Staff
Sue S. Yom, MD, PhD, of the University of California, San Francisco, discusses a translational analysis from the NRG-HN002 study. This phase II trial established the feasibility of the tumor tissue–modified viral (TTMV) human papillomavirus DNA assay in clinical trial specimens. The goal is to use such an assay to measure tumor volume, levels of TTMV over the course of treatment, and the association of TTMV to treatment outcomes (Abstract 6006).
The ASCO Post Staff
Ruben A. Mesa, MD, of Mays Cancer Center at UT Health San Antonio MD Anderson Cancer Center, discusses new findings from the MOMENTUM study. This trial showed that in symptomatic and anemic patients with myelofibrosis, momelotinib was superior to danazol for symptom and spleen responses, as well as transfusion requirements (Abstract 7002).
The ASCO Post Staff
Mairéad G. McNamara, PhD, MBBCh, of The Christie NHS Foundation Trust, discusses phase II findings of the NET-02 trial, which explored an unmet need in the second-line treatment of patients with progressive, poorly differentiated extrapulmonary neuroendocrine carcinoma. In the trial, the combination of liposomal irinotecan, fluorouracil, and folinic acid, but not docetaxel, met the primary endpoint of 6-month progression-free survival rate (Abstract 4005).
Karim Chamie, MD, of the University of California, Los Angeles, discusses final clinical results on combining the superagonist N-803 with bacillus Calmette-Guérin (BCG) in patients whose carcinoma in situ and high-grade non–muscle-invasive bladder cancers are unresponsive to BCG alone. Of note, cystectomy was avoided in more than 90% of patients with 2 years of follow-up (Abstract 4508).
The ASCO Post Staff
Ursula A. Matulonis, MD, of Dana-Farber Cancer Institute, and Nicoletta Colombo, MD, of the University of Milan and the European Institute of Oncology, discuss phase II results on the overall survival benefit of intermittent relacorilant, a selective glucocorticoid receptor modulator, combined with nab-paclitaxel, compared with nab-paclitaxel alone in patients with recurrent platinum-resistant ovarian cancer. A phase III trial comparing intermittent relacorilant plus nab-paclitaxel with investigator’s choice of chemotherapy in primary platinum-refractory disease is ongoing (Abstract LBA5503).