Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: post-progression outcomes from the phase II IMvigor210 study
Autor: | Jean H. Hoffman-Censits, Q. Zhu, Jose Luis Perez-Gracia, Constanze Kaiser, Christina Louise Derleth, Richard W. Joseph, Andrea Necchi, Darren Tayama, Daniel P. Petrylak, Beiying Ding, Jonathan E. Rosenberg, Yohann Loriot |
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Přispěvatelé: | Necchi, A, Joseph, Rw, Loriot, Y, Hoffman-Censits, J, Perez-Gracia, Jl, Petrylak, Dp, Derleth, Cl, Tayama, D, Zhu, Q, Ding, B, Kaiser, C, Rosenberg, Je |
Rok vydání: | 2017 |
Předmět: |
Adult
Male 0301 basic medicine Oncology Urologic Neoplasms medicine.medical_specialty Metastatic Urothelial Carcinoma Antineoplastic Agents Antibodies Monoclonal Humanized Systemic therapy Cohort Studies 03 medical and health sciences 0302 clinical medicine Atezolizumab Internal medicine medicine Humans Adverse effect Aged Aged 80 and over business.industry Antibodies Monoclonal Original Articles Hematology Middle Aged 030104 developmental biology Urinary Bladder Neoplasms Tumor progression Response Evaluation Criteria in Solid Tumors 030220 oncology & carcinogenesis Cohort Female Neoplasm Grading business Cohort study |
Zdroj: | Annals of Oncology. 28:3044-3050 |
ISSN: | 0923-7534 |
Popis: | Background Conventional criteria for tumor progression may not fully reflect the clinical benefit of immunotherapy or appropriately guide treatment decisions. The phase II IMvigor210 study demonstrated the efficacy and safety of atezolizumab, a programmed death-ligand 1-directed antibody, in patients with platinum-treated locally advanced or metastatic urothelial carcinoma. Patients could continue atezolizumab beyond Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 progression at the investigator’s discretion: this analysis assessed post-progression outcomes in these patients. Patients and methods Patients were treated with atezolizumab 1200 mg i.v. every 3 weeks until loss of clinical benefit. Efficacy and safety outcomes in patients who experienced RECIST v1.1 progression and did, or did not, continue atezolizumab were analyzed descriptively. Results In total, 220 patients who experienced progression from the overall cohort (n = 310) were analyzed: 137 continued atezolizumab for ≥ 1 dose after progression, 19 received other systemic therapy, and 64 received no further systemic therapy. Compared with those who discontinued, patients continuing atezolizumab beyond progression were more likely to have had a baseline Eastern Cooperative Oncology Group performance status of 0 (43.1% versus 31.3%), less likely to have had baseline liver metastases (27.0% versus 41.0%), and more likely to have had an initial response to atezolizumab (responses in 11.7% versus 1.2%). Five patients (3.6%) continuing atezolizumab after progression had subsequent responses compared with baseline measurements. Median post-progression overall survival was 8.6 months in patients continuing atezolizumab, 6.8 months in those receiving another treatment, and 1.2 months in those receiving no further treatment. Atezolizumab exposure-adjusted adverse event frequencies were generally similar before and following progression. Conclusion In this single-arm study, patients who continued atezolizumab beyond RECIST v1.1 progression derived prolonged clinical benefit without additional safety signals. Identification of patients most likely to benefit from atezolizumab beyond progression remains an important challenge in the management of metastatic urothelial carcinoma. ClinicalTrials.gov ID NCT02108652. |
Databáze: | OpenAIRE |
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