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Recently, the Journal of Clinical Oncology published the results of a single-arm phase II study (MAYA) of temozolomide sensitization in previously treated metastatic colorectal cancer (mCRC) patients with MSS and MGMT loss.
Efficacy and safety of a follow-up combination of low-dose ipilimumab (ipilimumab) and nivolumab (nivolumab)
.
Efficacy and safety of a follow-up combination of low-dose ipilimumab (ipilimumab) and nivolumab (nivolumab)
.
Primarily in previously treated patients with metastatic colorectal cancer (mCRC) with MSS and MGMT deletion, sensitization with temozolomide and subsequent combination with low-dose ipilimumab and nivolumab Efficacy and safety
The study included previously treated metastatic colorectal cancer (mCRC) with MSS status and MGMT loss on examination
.
The patients were treated with the first part of the treatment first: temozolomide 150mg/sqm, qd, d1-d5, once every 4 weeks, for a total of 2 cycles; patients who were controlled after 2 cycles entered the second part of the treatment: temozolomide combined with low-dose ipilimumab (1 mg/kg/time, 1 course every 8 weeks) and nivolumab (480 mg/time, 1 course every 4 weeks)
The study included previously treated metastatic colorectal cancer (mCRC) with MSS status and MGMT loss on examination
Of the 716 prescreened patients, 204 patients (29%) were molecularly profiled, of whom 135 patients started the first part of treatment
.
Of these, 102 (76%) discontinued treatment due to death or disease progression after temozolomide initiation, while 33 (24%) patients who achieved disease control initiated a second portion of treatment and represented the final study population
Of the 716 prescreened patients, 204 patients (29%) were molecularly profiled, of whom 135 patients started the first part of treatment
After a median follow-up of 23.
According to RECIST1.
1, the ORR for the entire treatment strategy was 45% (95% CI, 29 to 62), with 15 PRs and 0 CRs
.
Of the 33 patients, tumor shrinkage of any extent was observed in 26 (79%)
According to RECIST1.
Grade 3-4 immune-related adverse events were rash (6%), colitis (3%), and hypophysitis (3%)
.
No unexpected adverse events or treatment-related deaths were reported
Grade 3-4 immune-related adverse events were rash (6%), colitis (3%), and hypophysitis (3%)
Taken together, the MAYA study suggests that priming with temozolomide followed by a combination of low-dose ipilimumab and nivolumab may result in durable clinical benefit in MSS and MGMT-deficient mCRC
.
.
The MAYA study suggests that priming with temozolomide followed by low-dose ipilimumab and nivolumab may result in durable clinical benefit in MSS and MGMT-deficient mCRC
.
The MAYA study suggests that priming with temozolomide followed by low-dose ipilimumab and nivolumab may result in durable clinical benefit in MSS and MGMT-deficient mCRC
.
Original source:
Original source:Morano F, Raimondi A, Pagani F, et al .
Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O 6 -Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial.
J Clin Oncol .
2022 Mar 8: JCO2102583.
doi: 10.
1200/JCO.
21.
02583.
Epub ahead of print.
PMID: 35258987.
Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O 6 -Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial.
J Clin Oncol .
2022 Mar 8: JCO2102583.
doi: 10.
1200/JCO.
21.
02583.
Epub ahead of print.
PMID: 35258987.
Morano F, Raimondi A, Pagani F, et al .
Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O 6 -Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial.
J Clin Oncol.
2022 Mar 8:JCO2102583.
doi: 10.
1200/JCO.
21.
02583.
Epub ahead of print.
PMID: 35258987.
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