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In patients receiving immuno-checkpoint inhibitors, early detection and treatment of treatment-related adverse events (TRAEs) can improve treatment outcomes.
in CheckMate 142, nivolumab (3 mg/kg) plus low dose ipilimumab (1 mg/kg) is previously treated for microsatellitric instability, high and/or mismatch repair defects (MSI) -H/dMMR) metastatic colorectal cancer (mCRC) provides long-lasting clinical benefits (objective response rate (ORR) 55%, medium reaction duration not reached, total 12-month survival (OS) rate 85%) and controlled safety.
this article describes the deep safety and additional efficacy results of CheckMate 142.
safety assessments include the incidence of adverse events in TRAEs, selective TRAEs (sTRAEs) and immunomedulation, the onset time (TTO), the resolution time (TTR), the use of immunomodulative drugs (IMM), dose delays, and the occurrence of straes after the resumption of treatment.
efficacy assessment includes ORR and survival analyses in patients with or without MIM treatment at the same time and patients without straes.
results showed that in 119 patients, 25%, 23%, 19%, 5%, 5% and 29% had endocrine, gastrointestinal, liver, lung, kidney or skin strae, the majority (57%) was 1/2 level, sTRAE occurred earlier (medium TTO, 5.2-12.6 weeks).
non-endocrine straes in the majority of patients (71%) were relieved (medium TTR, 1.5-9.0 weeks).
22%-56% of patients use IMMs to manage straes (most of which are mitigated).
25 out of 29 patients with dose delays caused by straes recovered treatment.
ORR (57% vs. 52%) and 12-month OS rates (93% vs. 75%) were comparable for patients with or without straes.
similar results were observed in patients with or without straes (ORR 52% vs. 57%; OS rate 87% vs. 82%), regardless of whether IM was used or not.
, the results show that the benefit-risk curve of nivolumab plus low dose ilimumab provides a promising treatment option for previously treated MSI-H/dMMR mCRC patients.
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