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Adjuvant Chemotherapy Benefits In Locally Advanced UTUC Confirmed – Renal And Urology News – Renal.PlatoHealth.ai

Final results from the phase 3 POUT trial further support the use of adjuvant chemotherapy for patients with locally advanced upper tract urothelial cancer (UTUC), according to a recent report.

Adjuvant chemotherapy given after radical nephroureterectomy was significantly associated with improved disease-free survival (DFS) compared with surveillance, Alison Jane Birtle, MD, MBBS, of Royal Preston Hospital in Preston, United Kingdom, and colleagues concluded in a paper published in the Journal of Clinical Oncology.

POUT was a randomized, open-label trial that included 261 patients with muscle-invasive or lymph node-positive nonmetastatic UTUC (ClinicialTrials.gov Identifier: NCT01993979). Following radical nephroureterectomy, investigators randomly assigned 132 patients to receive platinum-based chemotherapy and 129 to undergo surveillance. The chemotherapy regimen consisted of four 21-day cycles of gemcitabine and either cisplatin or carboplatin. The primary end point was DFS, defined as either freedom from a first recurrence in the tumor bed, first metastasis, or death from any cause. Overall survival (OS) was a key secondary end point.

Investigators reported initial findings from the POUT trial in the Lancet in 2020. At that time, OS data were immature. On the advice of an independent data monitoring committee, the trial was ended early because of superior efficacy in the chemotherapy arm. The new report provides updated data on DFS and a pre-specified final analysis of OS and other secondary end points.

At a median follow-up of 65 months, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups, respectively. The 5-year DFS rate was significantly higher in the chemotherapy group compared with the surveillance arm (62% vs 45%). Patients in the chemotherapy group had a restricted mean survival time (RMST) that was 18 months longer than in the surveillance arm.

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The chemotherapy and surveillance groups had 46 and 60 deaths, respectively. The 5-year OS rate was 66% vs 57%, respectively. On multivariable analysis, OS did not differ significantly between the chemotherapy and surveillance arms. The RMST, however, was a significant 11 months longer in the chemotherapy group.

The authors explained that they used RMST to estimate differences between study arms in average survival time with a 9-year period without assuming a constant hazard ratio. They defined OS as the time from random assignment to death from any cause.

Treatment effects were consistent across disease stage and chemotherapy regimens, according to the investigators. Toxicities were similar to those previously reported, with no clinically relevant differences in quality of life (QoL) between study arms, they noted.

“In the current analysis, data on both clinician-report toxicity and patient-reported QoL provide reassurance that there are no important long-term adverse impacts, which might offset the benefits,” the investigators wrote.

The authors concluded that “updated outcomes from the POUT trial added further support to the value of adjuvant systemic gemcitabine:platinum combination chemotherapy after nephroureterectomy for UTUC.”

Disclosures: The study was supported by the National Institute for Health Research Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and The Institute for Cancer Research in London, UK. A number of authors reported relationships with the pharmaceutical industry. Please see the original reference for a full list of disclosures.