This phase 3 randomized controlled trial evaluated the efficacy of adding atezolizumab to the standard mFOLFOX6 regimen in patients with resected stage III mismatch repair-deficient (dMMR) colon cancer. A total of 712 patients were enrolled and randomized in a 1:1 ratio to receive either atezolizumab plus mFOLFOX6 for 6 months, followed by atezolizumab monotherapy for a total of 12 months, or mFOLFOX6 alone for 6 months. The primary endpoint was disease-free survival (DFS). At a median follow-up of 40.9 months, the 3-year DFS was significantly higher in the atezolizumab-mFOLFOX6 group at 86.3% compared to 76.2% in the mFOLFOX6 group, with a hazard ratio for disease recurrence or death of 0.50 (95% CI, 0.35 to 0.73; P<0.001). Secondary endpoints included overall survival and adverse event profiles. Grade 3 or 4 adverse events were reported in 84.1% of patients receiving atezolizumab plus mFOLFOX6, compared to 71.9% in the mFOLFOX6 alone group. These findings suggest that the addition of atezolizumab to mFOLFOX6 significantly improves DFS in this patient population, although with a higher incidence of severe adverse events. Clinicians should weigh the benefits of improved DFS against the increased risk of adverse events when considering this treatment regimen.
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This study focuses on stage III colon cancer, which is a serious condition where cancer has spread to nearby lymph nodes. Researchers wanted to see if adding a drug called atezolizumab to standard chemotherapy would help patients stay cancer-free after surgery. They compared two groups of patients: one group received the standard treatment plus atezolizumab, while the other group received only the standard treatment. After following the patients for about 41 months, they found that those who received the combination treatment had a significantly better chance of not having their cancer return. This could mean that adding atezolizumab may help some patients with this type of colon cancer live longer without the disease coming back. However, it's important to note that more patients experienced serious side effects with the combination treatment. Future research will help determine the best way to use this new treatment safely.
What this means for you: Adding a new drug to standard treatment may help prevent colon cancer from returning after surgery.
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BACKGROUND: Standard adjuvant chemotherapy for stage III colon cancer consists of a fluoropyrimidine-plus-oxaliplatin regimen. Whether the addition of atezolizumab (an anti-programmed death ligand 1 agent) to a modified FOLFOX6 regimen (fluorouracil, oxaliplatin, and leucovorin; called mFOLFOX6) would improve outcomes in patients with stage III colon cancer with mismatch repair-deficient (dMMR) status is unclear.
METHODS: In a phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with resected stage III dMMR tumors to receive either adjuvant atezolizumab plus mFOLFOX6 for 6 months, with atezolizumab continued as monotherapy (for a total of 12 months of therapy), or mFOLFOX6 alone for 6 months. The primary end point was disease-free survival. Secondary end points were overall survival and the adverse-event profile.
RESULTS: A total of 355 patients were assigned to receive atezolizumab plus mFOLFOX6 and 357 to receive mFOLFOX6 alone. The median age of the patients was 64 years, 55.1% were women, and 53.9% had tumors that were T4, N2, or both (indicating high risk). At a median follow-up of 40.9 months, the 3-year disease-free survival was 86.3% (95% confidence interval [CI], 81.8 to 89.8) in the atezolizumab-mFOLFOX6 group, as compared with 76.2% (95% CI, 70.9 to 80.6) in the mFOLFOX6 group (hazard ratio for disease recurrence or death, 0.50; 95% CI, 0.35 to 0.73; P<0.001). Adverse events of grade 3 or 4 occurred in 84.1% of the patients who received atezolizumab plus mFOLFOX6 and in 71.9% of those who received mFOLFOX6 alone.
CONCLUSIONS: The addition of atezolizumab to mFOLFOX6 significantly improved disease-free survival among patients with stage III dMMR colon cancer. (Funded by the National Cancer Institute of the National Institutes of Health and Genentech; ATOMIC ClinicalTrials.gov number, NCT02912559.).