Effectiveness of Nivolumab as an Addition to Standard Chemotherapy for Gastric Cancer Treatment
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on July 5th, 2024
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In many Asian countries, the current standard therapy for resectable gastric cancer involves post-surgery chemotherapy, such as docetaxel, oxaliplatin, and tegafur-gimeracil-oteracil, to minimize disease recurrence. A recent article published in The Lancet investigated the effect of adding the PD-1 receptor inhibitor, nivolumab, to this chemotherapy regimen for treating gastric cancer.
The phase 3 clinical trial was conducted in Japan, South Korea, Taiwan, and China, involving 755 patients diagnosed with stage IIIA–C gastric or GEJ adenocarcinoma per the American Joint Committee on Cancer and International Union Against Cancer criteria. Post-surgery, participants received standard chemotherapy with either the S1 combo (docetaxel, oxaliplatin, and tegafur-gimeracil-oteracil) or capecitabine plus oxaliplatin, based on physician choice. Concurrently, patients were randomly assigned to receive either a placebo or 360 mg of nivolumab intravenously every three weeks, continuing treatment up to the 18th week unless safety issues or disease recurrence arose. Researchers found that adding nivolumab to the standard chemotherapy regimen did not significantly reduce the risk of disease recurrence, with 3-year relapse-free survival rates of 65.3% in the placebo group and 68.4% in the nivolumab group. Additionally, nivolumab use was associated with a higher risk of discontinuation due to serious side effects. Therefore, researchers concluded that nivolumab should not be used as a postoperative adjuvant therapy following surgical resection in patients with gastric adenocarcinoma.
The phase 3 clinical trial was conducted in Japan, South Korea, Taiwan, and China, involving 755 patients diagnosed with stage IIIA–C gastric or GEJ adenocarcinoma per the American Joint Committee on Cancer and International Union Against Cancer criteria. Post-surgery, participants received standard chemotherapy with either the S1 combo (docetaxel, oxaliplatin, and tegafur-gimeracil-oteracil) or capecitabine plus oxaliplatin, based on physician choice. Concurrently, patients were randomly assigned to receive either a placebo or 360 mg of nivolumab intravenously every three weeks, continuing treatment up to the 18th week unless safety issues or disease recurrence arose. Researchers found that adding nivolumab to the standard chemotherapy regimen did not significantly reduce the risk of disease recurrence, with 3-year relapse-free survival rates of 65.3% in the placebo group and 68.4% in the nivolumab group. Additionally, nivolumab use was associated with a higher risk of discontinuation due to serious side effects. Therefore, researchers concluded that nivolumab should not be used as a postoperative adjuvant therapy following surgical resection in patients with gastric adenocarcinoma.