RT Journal Article
T1 Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens
A1 Luis Perez-Gracia, Jose
A1 Loriot, Yohann
A1 Rosenberg, Jonathan E.
A1 Powles, Thomas
A1 Necchi, Andrea
A1 Hussain, Syed A.
A1 Morales-Barrera, Rafael
A1 Retz, Margitta M.
A1 Niegisch, Gunter
A1 Duran, Ignacio
A1 Theodore, Christine
A1 Grande, Enrique
A1 Shen, Xiaodong
A1 Wang, Jingjing
A1 Nelson, Betty
A1 Derleth, Christina L.
A1 van-der-Heijden, Michiel S.
K1 Atezolizumab
K1 Immunotherapy
K1 Number of prior regimens
K1 Previous platinum-based chemotherapy
K1 Urothelial carcinoma
K1 Transitional-cell carcinoma
K1 Long-term-survival
K1 Bladder-cancer
K1 Prognostic-factors
K1 Phase-2 trial
K1 Single-arm
K1 Therapy
K1 Cisplatin
K1 Chemotherapy
K1 Methotrexate
AB Background: Patients with metastatic urothelial carcinoma (mUC) who progress after platinum-based chemotherapy have had few treatment options and uniformly poor outcomes. Atezolizumab (anti-programmed death-ligand 1) was approved in the USA for cisplatin-ineligible and platinum-treated mUC based on IMvigor210, a phase 2, single-arm, two-cohort study.Objective: To evaluate the efficacy and safety of atezolizumab by the number of prior lines of systemic therapy in patients with pretreated mUC.Design, setting, and participants: IMvigor210 enrolled 315 patients with mUC with progression during or following platinum-based therapy at 70 international sites between May 2014 and November 2014. Key inclusion criteria included age >= 18 yr, creatinine clearance >= 30 ml/min, and Eastern Cooperative Oncology Group performance status 0-1, with no limit on prior lines of treatment.Intervention: Patients in this cohort received atezolizumab 1200 mg intravenously every 3 wk until loss of clinical benefit.Outcome measurements and statistical analysis: Centrally assessed Response Evaluation Criteria In Solid Tumors v1.1 objective response rate (ORR), median duration of response, overall survival (OS), and adverse events were evaluated by prior treatment. Potential differences between subgroups were evaluated using log-rank (for OS) and chi-square (for ORR and adverse events frequencies) testing.Results and limitations: Three hundred and ten patients were efficacy and safety evaluable (median follow-up, 21 mo). Objective responses and prolonged OS occurred across all prespecified subgroups; median duration of response was not reached in most subgroups. In patients without prior systemic mUC therapy (first-line subgroup), ORR was 25% (95% confidence interval: 14-38), and median OS was 9.6 mo (95% confidence interval: 5.9-15.8). No significant differences in efficacy or toxicity by therapy line were observed.Conclusions: Atezolizumab demonstrated comparable efficacy and safety in previously treated patients with mUC across all lines of therapy evaluated. 
PB Elsevier BV
SN 0302-2838
YR 2017
FD 2017-12-20
LK http://hdl.handle.net/10668/18776
UL http://hdl.handle.net/10668/18776
LA en
NO Perez-Gracia JL, Loriot Y, Rosenberg JE, Powles T, Necchi A, Hussain SA, et al. Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens. Eur Urol. 2018 Mar;73(3):462-468.
DS RISalud
RD Apr 19, 2025