Lancet oncol: Phase III Trial: Overall prognostication of patients with PD-L1 inhibitor Durvalumab-Qumei single anti-treatment metastatic urethrial skin cancer.

Patients with metastatic urethra skin cancer with standard first-line chemotherapy based on platinum had poor prognostic prognostics.
study was designed to assess the overall prognostic prognosticity of patients who received PD-L1 inhibitor Durvalumab combined or not combined quercinoma (CTLA-A inhibitor) as a first-line therapy for metastatic urethroid skin cancer.
DANUBE study was an open-label, randomized, controlled phase III trial conducted in 224 academic/hospital centres in 23 countries, recruiting untreated, non-surgically removable, locally advanced or metastatic urethra cancer patients over the age of 18 in a randomized 1:1:1 to three groups: Durvalumab single drug group, 1500 mg, static drops, 1/4 week; Durvalumab combined qumei monoantigroup, 1500 mg plus 75 mg, with 4 sessions in a series, then Durvalumab maintenance (1500 mg/4 weeks); standard chemotherapy group, Gissythabhamidan plus capratin or Gissythab.
end point of the joint is overall survival.
November 24, 2015 - March 21, 2017, a total of 1,032 patients were randomly divided into three groups, 346 in Durvalumab single-drug group, 342 in the joint group, and 344 in the chemotherapy group.
as of January 27, 2020, the mid-level follow-up period was 41.2 months.
in the high PD-L1 expression population, the medium overall survival of Durvalumab single-drug and chemotherapy groups was 14.4 months vs 12.1 months (HR 0.89, 95% CI 0.71).
in the intended therapy population, the medium overall survival of the combined and chemotherapy groups was 15.1 months vs 12.1 months (0.85, 0.72-1.02, p-0.075), respectively.
In the safe population, there were 47 (14%) 3/4 treatment-related adverse reactions in 345 patients in the Durvalumab single-drug group, while 93 cases (27%) and 188 (60%) were reported in the combined and chemotherapy groups, respectively.
The most common level 3/4 treatment-related adverse reactions in the Durvalumab single-drug group and in the joint group were increased lipase (7 cases (2 per cent) and 16 cases (5 per cent) respectively), and the most common type of chemotherapy was a decrease in neutral granulocytes (66 cases (21 per cent).
30 cases (9%), 78 cases (23%) and 50 cases (16%) of severe treatment-related adverse reactions occurred in the Single Drug Group, the Joint Group and the Chemotherapy Group, respectively, and 2 cases, 2 cases and 1 case of death from drug toxicity were reported.
study did not reach any of the main joint endpoints.
further research is needed to identify the efficacy of immuno-checkpoint inhibitors alone or in a joint programme for patients with metastatic urethra cancer who have not been treated in the past.
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