ASCO GU 2021: Updated results of postoperative assisted chemotherapy Phase III POUT trial results for upper urinary tract tract skin cancer

Upper urinary tract skin cancer (UTUC) includes renal and ureter cancer, which is the same as bladder cancer.
UTUC incidence age is 50 to 70 years old, accounting for 5% to 10% of all urethra skin cancer, and in China this proportion may be higher, and the tumor invasive, poor prognosis, after surgery, there are still 22% to 47% of patients during follow-up bladder recurrence.
whether postoperative assisted chemotherapy can benefit is not conclusive internationally for UTUC patients who undergo a root-and-treated renal ureter excision.
POUT study is a multi-center randomized controlled Phase III. phase III clinical trial for postoperative complementary chemotherapy and observation in UTUC patients, and is designed to assess the clinical benefits of systemic chemotherapy based on platinum drugs for UTUC patients.
the results of last year's study, published in Lancet, updated the results of the follow-up.
POUT Test (CRUK / 11/027; NCT01993979) has previously reported that complementary chemotherapy can improve disease-free survival (HR 0.45, 95% CI 0.30-0.68) in patients with urethra cancer confirmed by histology as pT2-T4 N0-3 M0.
follow-up time was 30.3 months.
1 at GU ASCO 2021, Dr Alison Birtle and colleagues presented the results of a pre-planned analysis that updated the main endpoints of disease-free survival and reported on major secondary endpoints, including overall survival.
in POUT, from 19 June 2012 to 8 November 2017, the researchers selected UTUC patients in 71 hospitals in the UK to undergo a genomic renal ureter excision, with open-label randomized controlled phase III trials conducted in stages T2-T4 N0-N3 M0 or any T-phase N1-3 M0.
study used a minimized random algorithm to randomly assign 261 patients recruited to a control group of 1:1 (n-129) or Gissythabin-Kapla (Gissythabin-Kapla, if GFR is 30-49ml/min) to an auxiliary chemotherapy group (n-132, receive 4 21-day chemotherapy cycles).
the drug treatment option is: the patient needs to start chemotherapy within 90 days of surgery, the first day of intravenous cisplatin (dose 70 mg /m2) or carabine (dose is curved area (AUC) 4.5/5, and only for renal cystic filtration rate (eGFR) below 50mL/min), and on the first and eighth days intravenous giving Gissythadin (dose 1000mg/m2).
six months of imaging and two years of cystoscopy, followed by five years each year.
end of life is disease-free survival, the secondary endpoint is non-transferable survival, overall survival, toxicity and quality of life reported by patients.
the trial had ended early on the recommendation of the Independent Data Monitoring Board because of evidence of its effectiveness.
POUT's trial programme is as follows: from May 2012 to November 2017, 261 patients (129 monitoring cases; 132 chemotherapy cases) were recruited in 56 centres in the UK.
the patients were 69 years of age (range 37-88), 28% pT2, 66% pT3 and 91% pN0.
the unaljusted risk ratio of disease-free survival was 0.51 (95% CI 0.35-0.76) during the 48.1-month mid-term follow-up period (IQR:36.0-60.1); p - 0.0006), no transfer survival 0.52 (95%CI) 0.36-0.77; P - 0.0007) During follow-up, 93/260 (35.8%) patients died (surveillance rate was 52/129 (40.3%), chemotherapy was 41/131 (31.3%)).
chemical therapy reduced the relative risk of death by 30% (but not statistically significant) (HR 0.70, 95% CI 0.46-1.06; The total three-year survival rate of the monitored patients was 67% (95% CI 58-75%) and 79% (95% CI 71%-86%).
there is no evidence of long-term toxicity associated with chemotherapy, with the most common adverse reactions above level 2 being hypertension (10.4%), drowsiness (10.4%) and hearing loss (5.4%).
There is no evidence of statistically or clinically relevant differences in quality of life in the 12 months after treatment (EORTC Q30 global health status varies by an average of 4.1 and 4.8 in 12 and 24 months, respectively, in favour of chemotherapy).
Birtle summed up the latest analysis of phase III clinical trials in POUT and concluded that the benefits of complementary chemotherapy for disease-free and metastasis-free survival were maintained through additional follow-up.
there was a non-statistically significant improvement in overall survival, and these latest analyses support the use of platinum-assisted chemotherapy as the recommended standard of care