Morano, Federica; Raimondi, Alessandra; Pagani, Filippo; Lonardi, Sara; Salvatore, Lisa; Cremolini, Chiara; Murgioni, Sabina; Randon, Giovanni; Palermo, Federica; Antonuzzo, Lorenzo; Pella, Nicoletta; Racca, Patrizia; Prisciandaro, Michele; Niger, Monica; Corti, Francesca; Bergamo, Francesca; Zaniboni, Alberto; Ratti, Margherita; Palazzo, Michele; Cagnazzo, Celeste; Calegari, Maria Alessandra; Marmorino, Federica; Capone, Iolanda; Conca, Elena; Busico, Adele; Brich, Silvia; Tamborini, Elena; Perrone, Federica; Di Maio, Massimo; Milione, Massimo; Di Bartolomeo, Maria; de Braud, Filippo; Pietrantonio, Filippo published the artcile< Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O6-Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial>, Quality Control of 112-63-0, the main research area is .
This is a multicenter, single-arm phase II trial evaluating the efficacy and safety of an immune-sensitizing strategy with temozolomide priming followed by a combination of low-dose ipilimumab and nivolumab in patients with microsatellite-stable (MSS) and O6-methylguanine-DNA methyltransferase (MGMT)-silenced metastatic colorectal cancer (mCRC). Patients with pretreated mCRC were centrally prescreened for MSS status and MGMT silencing (ie, lack of MGMT expression by immunohistochem. plus MGMT methylation by pyrosequencing). Eligible patients received two priming cycles of oral temozolomide 150 mg/sqm once daily, days 1-5, once every 4 wk (first treatment part) followed, in absence of progression, by its combination with ipilimumab 1 mg/kg once every 8 wk and nivolumab 480 mg once every 4 wk (second treatment part). The primary end point was the 8-mo progression-free survival (PFS) rate calculated from enrollment in patients who started the second treatment part, with ≥ 4 out of 27 subjects progression-free by the 8-mo time point as decision rule. Among 716 prescreened patients, 204 (29%) were molecularly eligible and 135 started the first treatment part. Among these, 102 (76%) were discontinued because of death or disease progression on temozolomide priming, whereas 33 patients (24%) who achieved disease control started the second treatment part and represented the final study population. After a median follow-up of 23.1 mo (interquartile range, 14.9-24.6 mo), 8-mo PFS rate was 36%. Median PFS and overall survival were 7.0 and 18.4 mo, resp., and overall response rate was 45%. Grade 3-4 immune-related adverse events were skin rash (6%), colitis (3%), and hypophysitis (3%). No unexpected adverse events or treatment-related deaths were reported. The MAYA study provided proof-of-concept that a sequence of temozolomide priming followed by a combination of low-dose ipilimumab and nivolumab may induce durable clin. benefit in MSS and MGMT-silenced mCRC.
Journal of Clinical Oncology published new progress about 112-63-0. 112-63-0 belongs to class esters-buliding-blocks, and the molecular formula is C19H34O2, Quality Control of 112-63-0.
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