Atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (IMblaze370): a multicentre, open-label, phase 3, randomised, controlled trial
| Autor: | S Mullamitha, P Potemski, JB Ahn, Gavin Marx, David Cunningham, CG Ponce, James A. Jr Reeves, Cathy Eng, J Cultrera, Rachel Kerr, Neil H. Segal, Josep Tabernero, Marwan Fakih, J-L Canon, Salvatore Siena, JO Streb, YJ Cha, A Smolin, Javier Sastre Valera, S Begbie, Anne Uyei, Alberto Sobrero, Andrew Strickland, S Dowden, Ruth Vera Garcia, N Segal, AS Lee, Evaristo Maiello, E Chmielowska, S Badarinath, Niall C. Tebbutt, Tae Won Kim, K King, J Lee, B Lesperance, Ko Lam, M Van den Eynde, Vinod Ganju, B Tan, R. Young, K Chang, Brigette B.Y. Ma, Mark Kozloff, TY Kim, M Dvorkin, Maria Di Bartolomeo, Jo Park, Nick Pavlakis, M Kozloff, Philippe Vergauwe, Yibing Yan, E. Van Cutsem, M Wroblewska, M Womack, Michael M Vickers, Fortunato Ciardiello, Alfredo Falcone, A Chaudhry, Gabriele Luppi, J Kortmansky, Johanna C. Bendell, Ilsung Chang, John Marshall, RG Carbone, PJ Cuyle, R Mandanas, M Nechaeva, Félix Couture, Andrés Cervantes, Guillem Argiles, Scott M. Berry, Sherif Raouf, E Szutowicz-Zielinska, D Chu, SH Cho, John Davies, J. Asselah, S Baijal, Louise Roberts |
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| Přispěvatelé: | Eng, Cathy, Kim, Tae Won, Bendell, Johanna, Argilés, Guillem, Tebbutt, Niall C, Di Bartolomeo, Maria, Falcone, Alfredo, Fakih, Marwan, Kozloff, Mark, Segal, Neil H, Sobrero, Alberto, Yan, Yibing, Chang, Ilsung, Uyei, Anne, Roberts, Louise, Ciardiello, Fortunato, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'hépato-gastro-entérologie, UCL - (SLuc) Service d'oncologie médicale |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Pyridines Perforation (oil well) Phases of clinical research Salvage therapy Antibodies Monoclonal Humanized Gastroenterology 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Piperidines Atezolizumab Internal medicine Regorafenib Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Survival rate Aged Salvage Therapy Cobimetinib business.industry Phenylurea Compounds Liver Neoplasms Middle Aged Prognosis Survival Rate Editorial Commentary 030104 developmental biology chemistry Oncology 030220 oncology & carcinogenesis Azetidines Female Colorectal Neoplasms business Follow-Up Studies |
| Zdroj: | The Lancet Oncology, Vol. 20, no.6, p. 849-861 (2019) |
| Popis: | Background Microsatellite-stable metastatic colorectal cancer is typically unresponsive to immunotherapy. This phase 3 study was designed to assess atezolizumab plus cobimetinib in metastatic colorectal cancer. Here, we report the comparison of atezolizumab plus cobimetinib or atezolizumab monotherapy versus regorafenib in the third-line setting. Methods IMblaze 370 is a multicentre, open-label, phase 3, randomised, controlled trial, done at 73 academic medical centres and community oncology practices in 11 countries. Patients aged at least 18 years with unresectable locally advanced or metastatic colorectal cancer, baseline Eastern Cooperative Oncology Group performance status of 0–1, and disease progression on or intolerance to at least two previous systemic chemotherapy regimens were enrolled. We used permuted-block randomisation (block size four) to assign patients (2:1:1) via an interactive voice and web response system to atezolizumab (840 mg intravenously every 2 weeks) plus cobimetinib (60 mg orally once daily for days 1–21 of a 28-day cycle), atezolizumab monotherapy (1200 mg intravenously every 3 weeks), or regorafenib (160 mg orally once daily for days 1–21 of a 28-day cycle). Stratification factors were extended RAS status (wild-type vs mutant) and time since diagnosis of first metastasis ( |
| Databáze: | OpenAIRE |
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