Arlene O. Siefker-Radtke, MD, on Metastatic Urothelial Carcinoma: New Data on Erdafitinib vs Chemotherapy From the THOR Study
2023 ASCO Annual Meeting
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III findings showing that for patients with advanced or metastatic urothelial carcinoma and FGFR alteration who already had been treated with a PD-(L)1 inhibitor, erdafitinib significantly improved overall and progression-free survival, as well as overall response rate, compared with investigator’s choice of chemotherapy (LBA4619).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Arlene O. Siefker-Radtke:
We now have results from the THOR clinical trial studying erdafitinib in patients who have metastatic surgically unresectable urothelial carcinoma, who've received prior therapy for their tumor. This is the first clinical trial, showing proof of concept benefit from FGF targeted therapy, compared to what's been observed with chemotherapy.
The design of the trial takes patients who've had prior treatment, typically chemotherapy with platinum or carboplatinum, and patients may have had an immune checkpoint inhibitor. There are two cohorts to this trial. The cohort being presented is the group of patients who've had a prior immune checkpoint inhibitor. Patients were randomized between either erdafitinib alone or single agent taxane, or vinflunine, which is approved in Europe. And the results of the trial looked quite good indeed, with it hitting on all three endpoints.
The primary endpoint of the trial was median overall survival, and erdafitinib came in with a statistically significant improvement in overall survival with a median overall survival of 12 months compared to single agent chemotherapy, which was around 7.8 months. We also saw evidence of benefit in progression-free survival and overall survival. The progression-free survival with erdafitinib was around five and a half months. Single agent chemotherapy was half that amount, and the objective response rate for erdafitinib was around 45%, so that's 45% PRs and CRs, while single agent chemotherapy had a response rate of around 11%.
The toxicity reported is similar to what has been observed with other clinical trials of FGF targeted therapy, and as a result of this work, erdafitinib is here to stay as part of the standard armamentarium for the treatment of our urothelial cancer patients.
The ASCO Post Staff
Marie Plante, MD, of Canada’s Université Laval and the CHUQ Hotel Dieu de Québec, discusses phase III results from a study that compared radical hysterectomy and pelvic node dissection vs simple hysterectomy and pelvic node dissection in patients with low-risk early-stage cervical cancer. The pelvic recurrence rate at 3 years in the women who underwent simple hysterectomy is not inferior to those who had radical hysterectomy. In addition, fewer surgical complications and better quality of life were observed with simple hysterectomy (LBA5511).
The ASCO Post Staff
Alicia K. Morgans, MD, MPH, and Praful Ravi, MRCP, MBBChir, both of Dana-Farber Cancer Institute, discuss an individual patient-data analysis of randomized trials from the ICECAP collaborative. A PSA nadir of ≥ 0.1 ng/mL within 6 months after radiotherapy completion was prognostic for prostate cancer–specific, metastasis-free, and overall survival in patients receiving radiotherapy plus androgen-deprivation therapy for localized prostate cancer. These findings may help identify patients for therapy de-escalation trials (Abstract 5002).
The ASCO Post Staff
Allison Betof Warner, MD, PhD, of Stanford University Medical Center, and Zeynep Eroglu, MD, of H. Lee Moffitt Cancer Center and Research Institute, discusses phase II findings showing that in patients with BRAF-mutant metastatic melanoma, dabrafenib plus trametinib and navitoclax (DTN) was associated with a complete response rate of 20% and an overall response rate of 84%. Additionally, there was a trend toward improved overall survival in patients treated with DTN compared with dabrafenib plus trametinib alone; the difference in overall survival was more pronounced in patients with a smaller tumor burden (Abstract 9511).
The ASCO Post Staff
Penelope Bradbury, MBChB, of Canada’s Princess Margaret Cancer Centre, discusses phase III findings showing that, in patients with treatment-naive unresectable pleural mesothelioma, cisplatin and pemetrexed with pembrolizumab improved median overall survival with acceptable tolerability (Abstract LBA8505).
The ASCO Post Staff
Jennifer L. Crombie, MD, of Dana-Farber Cancer Institute, discusses the historically poor outcomes for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Her study examined real-world data on the use of novel therapies in this population and found that outcomes with second- and third-line regimens of polatuzumab vedotin-piiq plus bendamustine and rituximab and tafasitamab plus lenalidomide remain suboptimal, with worse outcomes particularly after chimeric antigen receptor T-cell therapy (Abstract 7552).
