Comparing Nivolumab and Ipilimumab Combination to Standard Chemotherapy in Advanced Metastatic Colorectal Cancer
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on January 8th, 2025
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Colorectal cancer is a common cancer, and patients with mismatch repair deficiency and microsatellite instability mutations generally have a poorer prognosis. Nivolumab, a PD-1 inhibitor, and ipilimumab, a CTLA-4 inhibitor, are immune checkpoint inhibitors that exhibit antitumor activity by counteracting the immune-suppressive effects of tumor cells. A study recently published in the New England Journal of Medicine investigated the impact of nivolumab and ipilimumab in treating colorectal cancer patients with advanced mutations.
The phase 3 clinical study involved 303 participants diagnosed with unresectable or metastatic colorectal cancer. Approximately 50% of participants had stage IV disease, 35% had stage III, and the remaining patients had stage II. Participants were randomly assigned to receive either the current standard chemotherapy regimen (including folinic acid, fluorouracil, oxaliplatin, and irinotecan), nivolumab alone, or a combination of nivolumab and ipilimumab. Nivolumab was administered intravenously at a dose of 240 mg every 2 weeks for the first 12 weeks, with the dose increased to 480 mg every 4 weeks thereafter. In the combination group, 1 mg of ipilimumab per kilogram of body weight was given along with 240 mg of nivolumab every 3 weeks for the first 12 weeks; after that, only nivolumab was given at 480 mg every 4 weeks. After a median follow-up of 31.5 months, the researchers found that the 24-month progression-free survival rate was 72% for those treated with nivolumab and ipilimumab, significantly higher than the 14% observed in those treated with the standard chemotherapy regimen. Furthermore, patients treated with the immune checkpoint inhibitors experienced fewer treatment-related adverse events than those receiving standard chemotherapy, with neutropenia being more common in the chemotherapy group.
The phase 3 clinical study involved 303 participants diagnosed with unresectable or metastatic colorectal cancer. Approximately 50% of participants had stage IV disease, 35% had stage III, and the remaining patients had stage II. Participants were randomly assigned to receive either the current standard chemotherapy regimen (including folinic acid, fluorouracil, oxaliplatin, and irinotecan), nivolumab alone, or a combination of nivolumab and ipilimumab. Nivolumab was administered intravenously at a dose of 240 mg every 2 weeks for the first 12 weeks, with the dose increased to 480 mg every 4 weeks thereafter. In the combination group, 1 mg of ipilimumab per kilogram of body weight was given along with 240 mg of nivolumab every 3 weeks for the first 12 weeks; after that, only nivolumab was given at 480 mg every 4 weeks. After a median follow-up of 31.5 months, the researchers found that the 24-month progression-free survival rate was 72% for those treated with nivolumab and ipilimumab, significantly higher than the 14% observed in those treated with the standard chemotherapy regimen. Furthermore, patients treated with the immune checkpoint inhibitors experienced fewer treatment-related adverse events than those receiving standard chemotherapy, with neutropenia being more common in the chemotherapy group.