Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient mismatch repair (ATOMIC, Alliance A021502).

• DOI: 10.1200/jco.2019.37.15_suppl.e15169
• Publication Date: 2019-05-27T16:06:46Z
• Authors: Frank A. Sinicrope; Fang-Shu Ou; Tyler Zemla; Andrew B. Nixon; Kabir Mody; Alexandra Levasseur; Amylou C. Dueck; Asha R. Dhanarajan; Christopher Hanyo...; Deirdre Jill Cohen; Federico Innocenti; Robert J. Behrens; Walter Peters; Nicolas Sommer; Eileen Mary O'Reilly; Jeffrey A. Meyerh...
• Keywords: Atezolizumab; FOLFOX; Carboplatin

e15169 Background: In metastatic colorectal cancer with deficient DNA mismatch repair (dMMR), anti-PD-1 antibody monotherapy produced high tumor response rates and extended progression-free survival compared to lack of benefit for cancers proficient MMR. an ongoing phase III randomized trial, we will determine if the addition anti-PD-L1 antibody, atezolizumab (Genentech), adjuvant FOLFOX can improve patient disease-free (DFS) vs alone in patients stage colon dMMR. By blocking PD-1/PD-L1 interaction, may activate T cells, thereby, restoring their ability detect attack cells. Limited data suggest that increase intratumoral cytotoxic CD8+ cells could serve as ‘immune priming'. Methods: Patients curatively resected carcinomas evidence dMMR are modified FOLFOX6 6 months (12 cycles) (control arm) or combined (840 mg IV q2 wk) continuation additional (total duration 12 months) [experimental arm]. be stratified by T, N sidedness. Local testing MMR proteins is allowed. Atezolizumab must begin by/with cycle 2. One allowed pre-registration. The targeted accrual goal 700 165 events provide 90% power effect size expressed hazard ratio 0.6 primary endpoint DFS at two-sided alpha 0.05. Interim analyses planned 50% 75% events. Secondary endpoints include overall survival, treatment tolerability, quality life. Results: This study being conducted Alliance Clinical Trials Oncology, was approved NCI CTEP activated 09/2017. actively accruing and, 02/11/2019, 152 enrolled. We exploring international collaboration. Conclusions: a current clinical trial progress. information: NCT02912559.