Primary results of STRONG: An open-label, multicenter, phase 3b study of fixed-dose durvalumab monotherapy in previously treated patients with urinary tract carcinoma.
Eur J Cancer
; 163: 55-65, 2022 03.
Article
em En
| MEDLINE
| ID: mdl-35042068
ABSTRACT
BACKGROUND:
Prior durvalumab (anti-PD-L1 agent) studies in platinum-refractory metastatic urothelial carcinoma evaluated a dose of 10 mg/kg administered every two weeks. The nonrandomised phase 3b STRONG study (NCT03084471) evaluated the safety and efficacy of fixed-dose durvalumab at a more convenient dosing schedule in a previously treated patient population, more similar to a real-world clinical setting. PATIENTS ANDMETHODS:
867 patients with urothelial or nonurothelial urinary tract carcinoma (UTC) who progressed on or after platinum or nonplatinum chemotherapy were treated with durvalumab 1500 mg every four weeks; 87% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and 13% had an ECOG PS of 2. The primary end-point was the incidence of adverse events of special interest (AESIs), including immune-mediated AEs (imAEs). Secondary and exploratory end-points included overall survival (OS), objective response rate (ORR) and disease control rate (at six and 12 months) (DCR).RESULTS:
AESIs of any grade were reported in 51% of patients (8% grade ≥ 3). The incidence of imAEs was 11% (2% grade ≥ 3). The median OS was 7.0 months (95% confidence interval [CI] 6.4-8.2) and ORR was 18% (95% CI 14.8-20.6), with complete responses in 5% of patients and a DCR at six months of 19% (95% CI 16.1-22.1).CONCLUSION:
Fixed-dose durvalumab monotherapy every four weeks has an acceptable safety profile and yields durable clinical activity in previously chemotherapy-treated patients with UTC. Safety and efficacy are consistent with previous durvalumab studies and other anti-PD-1/PD-L1 agents in this setting. CLINICALTRIALS. GOV IDENTIFIER NCT03084471https//clinicaltrials.gov/ct2/show/NCT03084471.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Sistema Urinário
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Neoplasias da Bexiga Urinária
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Carcinoma de Células de Transição
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Neoplasias Urológicas
Tipo de estudo:
Clinical_trials
Limite:
Female
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Humans
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Male
Idioma:
En
Revista:
Eur J Cancer
Ano de publicação:
2022
Tipo de documento:
Article