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New standard of care recommended for patients with upper tract urothelial cancer

Presented by
Dr Alison Birtle, Rosemere Cancer Centre, UK
ASCO GU 2021
Phase 3, POUT
Results from the POUT trial demonstrated that the implementation of gemcitabine-platinum combination chemotherapy within 90 days following nephroureterectomy resulted in longer periods of disease-free survival (DFS) in patients with locally advanced upper tract urothelial cancer (UTUC).

Dr Alison Birtle (Rosemere Cancer Centre, UK) shared results from an updated analysis of the POUT trial (NCT01993979), a randomised, multi-centre, phase 3 trial assigning 260 post-nephroureterectomy patients with advanced UTUC either to surveillance only or to four 21-day cycles of adjuvant chemotherapy. For participants in the chemotherapy arm, treatment was initiated within 90 days post-surgery and consisted of either a combination of gemcitabine-cisplatin or, in patients with impaired renal function, gemcitabine-carboplatin. Follow-up visits to monitor for signs of recurrence occurred at the same frequency in both treatment arms; namely, at 4, 7, 10, and 13 weeks corresponding to the end of each chemotherapy treatment cycle. Patients underwent imaging and cystoscopy every 6 months for 2 years and then annually up to the 5-year point.

The primary endpoint was DFS within a 3-year time frame. The occurrence of 88 deaths triggered a (pre-planned) updated analysis with data cut-off 11 January 2021; after a median follow-up period of 49.2 months, 109 (41.9%) participants had reached the primary endpoint of DFS; 64/129 (49.6%) in the surveillance group and 45/131 (34.4%) in the chemotherapy group (adjusted HR 0.54; 95% CI 0.36–0.79; P=0.002). There had also occurred 93 deaths: 52 of the 129 patients in the surveillance arm (40.3%) and 41 of the 131 patients in the chemotherapy arm (31.3%) had died.

Secondary outcome measures included overall survival, metastasis-free survival, acute and late toxicity, and quality of life. All secondary outcome measures were tracked for 5 years except quality of life, which was only monitored for up to 2 years. Updated overall survival rates are 57% (95% CI 46–66) for patients under surveillance and 65% (95% CI 71–86) for patients receiving gemcitabine-cisplatin/carboplatin (adjusted HR=0.77; 95% CI 0.50–1.17; P=0.21). Metastasis-free survival was achieved by 66 of the 129 (51.2%) participants assigned to surveillance and by 45 of the 131 (34.4%) participants assigned to chemotherapy (adjusted HR=0.55; 95% CI 0.37–0.82; P=0.003). In the chemotherapy group, 44% of participants experienced grade ≥3 treatment-emergent adverse events (AEs) compared with only 4% of participants in the surveillance group [2]. These AEs were consistent with previous AEs reported for this chemotherapy protocol. The most common AEs experienced were hypertension (25/240, 10.4%), lethargy (25/240, 10.4%), urinary tract infection (14/240, 5.8%), and hearing loss (13/240, 5.4%). Chemotherapy was not associated with any long-term toxicity. Regarding quality-of-life outcomes, no differences were seen between the groups.

Despite a non-significant improvement in overall survival, the improved DFS and metastasis-free survival outcomes achieved by patients treated with platinum-based chemotherapy within 90 days post-nephroureterectomy have prompted the researchers to recommend this protocol be considered a new standard of care for these patients.

  1. Birtle AJ. Updated outcomes of POUT: A phase III randomized trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (UTUC). Abstract 455, ASCO Genitourinary Cancers Symposium, 11–13 February 2021.

  2. Birtle A et al. Lancet. 2020 Apr 18;395(10232):1268–77.


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