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

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Sinicrope, FA; Ou, F-S; Shi, Q; Nixon, AB; Mody, K; Levasseur, A; Dueck, AC; Dhanarajan, AR; Lieu, CH; Cohen, DJ; Innocenti, F; Behrens, RJ ...
Published in: Journal of Clinical Oncology
May 20, 2017

TPS3630 Background: In metastatic colorectal cancer with deficient DNA mismatch repair (MMR), anti-PD-1 antibody monotherapy produced high tumor response rates and extended progression-free survival compared to lack of benefit for proficient MMR tumors (Le, M, et al, NEJM 2016). We propose a phase III randomized trial to determine if the addition of the anti-PD-L1 antibody, atezolizumab (Genentech™), to adjuvant FOLFOX can improve patient disease-free survival (DFS) vs FOLFOX alone in patients with stage III colon cancers with dMMR or microsatellite instability (MSI). By blocking the PD-1/PD-L1 interaction, atezolizumab may activate T cells, thereby, restoring their ability to detect and attack tumor cells. Limited data suggest that FOLFOX may increase intratumoral cytotoxic CD8+ T cells that may serve as ‘immune priming.’ Methods: Patients with curatively resected stage III colon carcinomas with evidence of dMMR or MSI will be randomized to modified FOLFOX6 for 6 months (12 cycles) alone or combined with atezolizumab (840 mg IV q2 wk) continued as monotherapy for an additional 6 months (total duration of 12 months). Patients will be stratified by T, N stage and tumor sidedness. Local testing for MSI or MMR proteins is allowed. Atezolizumab must begin by/with cycle 2. The targeted accrual goal of 700 patients provides 90% power to detect an effect size expressed as hazard ratio of 0.6 for the primary endpoint DFS at two-sided alpha of 0.05. Interim analyses are planned at 50% and 75% of events. Secondary endpoints include overall survival, treatment tolerability, and quality of life. This study will be conducted by the Alliance for Clinical Trials in Oncology. The protocol has been approved by NCI CTEP and is expected to be activated in mid 2017. Clinical trial information: NCT02912559.

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Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

May 20, 2017

Volume

35

Issue

15_suppl

Start / End Page

TPS3630 / TPS3630

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Sinicrope, F. A., Ou, F.-S., Shi, Q., Nixon, A. B., Mody, K., Levasseur, A., … Meyerhardt, J. (2017). Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC, Alliance A021502). In Journal of Clinical Oncology (Vol. 35, pp. TPS3630–TPS3630). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2017.35.15_suppl.tps3630
Sinicrope, Frank A., Fang-Shu Ou, Qian Shi, Andrew B. Nixon, Kabir Mody, Alexandra Levasseur, Amylou C. Dueck, et al. “Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC, Alliance A021502).” In Journal of Clinical Oncology, 35:TPS3630–TPS3630. American Society of Clinical Oncology (ASCO), 2017. https://doi.org/10.1200/jco.2017.35.15_suppl.tps3630.
Sinicrope FA, Ou F-S, Shi Q, Nixon AB, Mody K, Levasseur A, et al. Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC, Alliance A021502). In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2017. p. TPS3630–TPS3630.
Sinicrope, Frank A., et al. “Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC, Alliance A021502).Journal of Clinical Oncology, vol. 35, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2017, pp. TPS3630–TPS3630. Crossref, doi:10.1200/jco.2017.35.15_suppl.tps3630.
Sinicrope FA, Ou F-S, Shi Q, Nixon AB, Mody K, Levasseur A, Dueck AC, Dhanarajan AR, Lieu CH, Cohen DJ, Innocenti F, Behrens RJ, Peters W, Sargent DJ, Sommer N, O’Reilly EM, Meyerhardt J. Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC, Alliance A021502). Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2017. p. TPS3630–TPS3630.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

May 20, 2017

Volume

35

Issue

15_suppl

Start / End Page

TPS3630 / TPS3630

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences