Key Findings
The FDA approved atezolizumab (Tecentriq) and atezolizumab with hyaluronidase-tqjs (Tecentriq Hybreza) in combination with chemotherapy for the adjuvant treatment of stage III dMMR colon cancer. The approval is supported by the phase 3 ATOMIC/Alliance A021502 trial, which demonstrated that atezolizumab plus modified FOLFOX6 (mFOLFOX6) reduced the risk of recurrence or death compared to mFOLFOX6 alone (HR, 0.50; 95% CI, 0.35-0.73; P <.001). The 3-year disease-free survival (DFS) rate was 86.3% for the combination group versus 76.2% for the chemotherapy-only group.
Technical Details
The ATOMIC trial was a randomized, open-label, multicenter study involving 712 patients aged 12 years and older with completely resected stage III dMMR colon cancer. Patients were assigned 1:1 to receive 12 cycles of mFOLFOX6 every 14 days, with or without atezolizumab. Those in the experimental arm received an additional 13 cycles of atezolizumab monotherapy following chemotherapy.
- Dosage (IV): Adults receive 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Pediatric patients receive 10 mg/kg (max 840 mg) every 2 weeks or 15 mg/kg (max 1200 mg) every 3 weeks.
- Dosage (SC): For patients 12 years and older weighing 40 kg or more, a 15 mL injection (1875 mg atezolizumab and 30,000 units hyaluronidase) is administered every 3 weeks.
- Safety: Grade 3 or 4 adverse events occurred in 84.1% of the atezolizumab arm vs 71.9% in the control arm. Common toxicities included decreased neutrophil count (43.6%) and peripheral sensory neuropathy (18.5%).
Background and Significance
Standard treatment for stage III colon cancer has traditionally been surgery followed by chemotherapy, yet approximately 30% of patients relapse within 5 years. dMMR/MSI-H tumors represent roughly 15% of colon cancers. While immunotherapy agents like pembrolizumab and nivolumab have been approved for advanced or metastatic settings, atezolizumab is now an option earlier in the disease course for patients treated with curative intent.
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