Perioperative Chemotherapy Versus Surveillance in Urothelial Cancer: POUT Trial Update
Posted: Tuesday, March 23, 2021
According to an update from the phase III POUT trial, presented during the virtual edition of the 2021 Genitourinary (GU) Cancers Symposium (Abstract 455), treatment with adjuvant chemotherapy for patients with histologically confirmed upper tract urothelial cancer improved disease-free survival, confirming previous results. The benefit was reported with no detriment to long-term toxicity, concluded Alison Jane Birtle, MD, of the Rosemere Cancer Centre, Preston, United Kingdom, and colleagues. However, according to the authors, “No statistically significant improvement in overall survival was observed.”
In this trial, the authors enrolled 261 patients from 56 centers in the United Kingdom who had upper tract urothelial cancer and underwent nephroureterectomy. The patients were treated with four cycles of gemcitabine/cisplatin (132 patients) or surveillance, with subsequent chemotherapy if required (129 patients). The patients underwent monthly imaging and cystoscopy for 2 years and then annually for 5 years.
After a median follow-up of 48.1 months, the unadjusted and adjusted hazard ratios for disease-free survival were 0.48 and 0.50, respectively, whereas the unadjusted and adjusted hazard ratios for metastasis-free survival were 0.52 and 0.54, respectively. There were 52 deaths among patients under surveillance (40.3%), compared with 41 deaths (31.3%) among those who received chemotherapy. The authors noted there was a nonstatistically significant 28% reduction in the relative risk of death for those who received chemotherapy.
The authors found no evidence of long-term toxicity associated with chemotherapy. The most common grade 2 or higher adverse events were hypertension (10.4% among all patients), lethargy (10.4%), and hearing loss (5.4%). There was also no evidence of statistically or clinically relevant difference in the quality of life between the patient groups.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.