一线Nivolumab加小剂量Ipilimumab治疗MSI-H/dMMR mCRC效果良好
  • 纳入未接受过治疗的MSI-H/dMMR结直肠癌转移患者45人,每2周接受一次nivolumab,每6周接受一次小剂量ipilimumab,直到疾病进展;
  • 中位年龄为66岁,中位随访期29个月,客观缓解率、疾病控制率和完全缓解率分别是69%、84%、13%;
  • 无论基线人口统计学特征和肿瘤特征,包括BRAF或KRAS突变状态,均观察到临床益处;
  • 14名停止治疗且未接受后续治疗的患者中,10名仍无进展;
  • 22%发生3-4级治疗相关不良事件,13%因与治疗相关的不良事件而停药。
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Journal of Clinical Oncology近期发表的文章,报道了CheckMate 142的II期临床结果。Nivolumab加小剂量ipilimumab作为MSI-H/dMMR mCRC的一线治疗具有良好的耐受性,且显示出强大和持久的临床益处。基于这些研究数据,可推进随机临床试验的进行。
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First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study

一线Nivolumab加小剂量Ipilimumab治疗微卫星不稳定性高/错配修复缺陷型转移性结直肠癌:II期CheckMate 142研究

10.1200/JCO.21.01015

2021-10-12, Article

Abstract & Authors:展开

Abstract:收起
PURPOSE: Nivolumab received US Food and Drug Administration approval as a single agent or in combination with ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) that progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan based on CheckMate 142. Presented are results of nivolumab plus low-dose ipilimumab in the first-line therapy cohort from the phase II CheckMate 142 study.
PATIENTS AND METHODS: Patients with no prior treatment in the metastatic setting for MSI-H/dMMR CRC were treated with nivolumab every 2 weeks plus low-dose ipilimumab every 6 weeks until disease progression. The primary end point was objective response rate (investigator assessment; RECIST v1.1).
RESULTS: Median age of treated patients was 66 years (N = 45). Median follow-up was 29.0 months. Objective response rate and disease control rate were 69% (95% CI, 53 to 82) and 84% (95% CI, 70.5 to 93.5), respectively, with 13% complete response rate. Median duration of response was not reached; 74% of responders had ongoing responses at data cutoff. Median progression-free survival and median overall survival were not reached with minimum follow-up of 24.2 months (24-month rates, 74% and 79%, respectively). Clinical benefit was observed regardless of baseline demographic and tumor characteristics, including or mutation status. In a post hoc analysis, of 14 patients who discontinued treatment and did not receive subsequent therapy, 10 remained progression-free. Patient-reported outcomes were stable over the treatment period. Grade 3-4 treatment-related adverse events occurred in 22% of patients; 13% discontinued because of any-grade treatment-related adverse events.
CONCLUSION: Nivolumab plus low-dose ipilimumab demonstrated robust and durable clinical benefit and was well tolerated as a first-line treatment for MSI-H/dMMR mCRC. Based on these promising data, randomized studies are warranted.

First Authors:
Heinz-Josef Lenz

Correspondence Authors:
Heinz-Josef Lenz

All Authors:
Heinz-Josef Lenz,Eric Van Cutsem,Maria Luisa Limon,Ka Yeung Mark Wong,Alain Hendlisz,Massimo Aglietta,Pilar García-Alfonso,Bart Neyns,Gabriele Luppi,Dana B Cardin,Tomislav Dragovich,Usman Shah,Sandzhar Abdullaev,Joseph Gricar,Jean-Marie Ledeine,Michael James Overman,Sara Lonardi

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